FYLNETRA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].

Limitations of Use

FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)].

The recommended dosage of FYLNETRA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer FYLNETRA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

The recommended dose of FYLNETRA is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.

Obtain a baseline complete blood count (CBC). Do not delay administration of FYLNETRA if a CBC is not readily available. Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

FYLNETRA is administered subcutaneously via a single-dose prefilled syringe for manual use.

Prior to use‚ remove the carton from the refrigerator and allow the FYLNETRA prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 72 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer FYLNETRA if discoloration or particulates are observed.

The needle cap on the prefilled syringe is not made with natural rubber latex.

Pediatric Patients weighing less than 45 kg

The FYLNETRA prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks, which are necessary to accurately measure doses of FYLNETRA less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

Table 1. Dosing of FYLNETRA for pediatric patients weighing less than 45 kg

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="865px"> <col width="1pt"/> <col width="215.578px"/> <col width="244.484px"/> <tbody class="Headless"> <tr class="First"> <td> <p class="First"> <span class="Bold">Body Weight</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">FYLNETRA Dose</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Volume to Administer</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First">Less than 10 kg<span class="Bold">*</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">See below<span class="Bold">*</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">See below<span class="Bold">*</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First">10 to 20 kg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">1.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">0.15 mL</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First">21 to 30 kg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">2.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">0.25 mL</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"> <p class="First">31 to 44 kg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">4 mg</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">0.4 mL</p> </td> </tr> </tbody> </table></div>

*For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of FYLNETRA.

FYLNETRA is a clear, colorless to slightly yellow, preservative-free solution available as:

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{ "type": "ul", "children": [ "Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. " ], "text": "" }

FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].\n" }

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving FYLNETRA.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving FYLNETRA, for ARDS. Discontinue FYLNETRA in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue FYLNETRA in patients with serious allergic reactions. Do not administer FYLNETRA to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue FYLNETRA if sickle cell crisis occurs.

Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of FYLNETRA.

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during FYLNETRA therapy is recommended.

Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.

Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FYLNETRA if aortitis is suspected.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received pegfilgrastim after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg pegfilgrastim (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American, or other.

The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity.

Table 2. Adverse Reactions with ≥ 5% Higher Incidence in pegfilgrastim Patients Compared to Placebo in Study 3

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0"> <col width="1pt"/> <col width="14.64%"/> <col width="36.98%"/> <tbody class="Headless"> <tr class="First"> <td> <p class="First"> <span class="Bold">Body System</span> </p> <p> <span class="Bold">Adverse Reaction </span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N= 461)</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Pegfilgrastim 6 mg SC on Day 2</span> </p> <p> <span class="Bold">(N= 467)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">Musculoskeletal and connective tissue disorders</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First">Bone pain </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">26%</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">31%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"> <p class="First">Pain in extremity </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">4%</p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">9%</p> </td> </tr> </tbody> </table></div>

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of pegfilgrastim or of other pegfilgrastim products.

Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

The following adverse reactions have been identified during post approval use of pegfilgrastim products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Risk Summary

Although available data with FYLNETRA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

 Animal Data

Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.

Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

Risk Summary

There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FYLNETRA and any potential adverse effects on the breastfed child from FYLNETRA or from the underlying maternal condition.

The safety and effectiveness of FYLNETRA have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.

Use of FYLNETRA in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients with sarcoma [see Clinical Pharmacology (12.3) andClinical Studies (14.1)].

The use of FYLNETRA to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies of pegfilgrastim conducted in animals and clinical data supporting the use of pegfilgrastim in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of pegfilgrastim (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.3), Clinical Pharmacology (12.3) and Clinical Studies (14.2)].

Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)].

{ "type": "p", "children": [], "text": "Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)]." }

Pegfilgrastim-pbbk is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-pbbk, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-pbbk is approximately 39 kD. Kanamycin is used during the manufacturing process but is undetectable in the final product.

{ "type": "p", "children": [], "text": "Pegfilgrastim-pbbk is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-pbbk, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-pbbk is approximately 39 kD. Kanamycin is used during the manufacturing process but is undetectable in the final product." }

FYLNETRA (pegfilgrastim-pbbk) injection is supplied in 0.6 mL prefilled syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).

{ "type": "p", "children": [], "text": "FYLNETRA (pegfilgrastim-pbbk) injection is supplied in 0.6 mL prefilled syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL)." }

The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-pbbk (based on protein weight) in a sterile, clear, colorless to slightly yellow, preservative-free solution (pH 4.0) containing acetic acid (0.36 mg), polysorbate 20 (0.02 mg), sodium hydroxide (0.03 mg), and sorbitol (30 mg) in Water for Injection, USP.

{ "type": "p", "children": [], "text": "The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-pbbk (based on protein weight) in a sterile, clear, colorless to slightly yellow, preservative-free solution (pH 4.0) containing acetic acid (0.36 mg), polysorbate 20 (0.02 mg), sodium hydroxide (0.03 mg), and sorbitol (30 mg) in Water for Injection, USP." }

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Animal data and clinical data in humans suggest a correlation between pegfilgrastim products’ exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of FYLNETRA is based on reducing the duration of severe neutropenia.

The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection.

Specific Populations

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)].

Renal Impairment

In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.

Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy

The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14.1)]. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg.hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13). The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively.

Patients Acutely Exposed to Myelosuppressive Doses of Radiation

 The pharmacokinetics of pegfilgrastim products is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of pegfilgrastim, appears to be greater than in humans receiving a 6 mg dose. Results from population modeling and simulation indicate that two 6 mg doses of pegfilgrastim administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration, Section 2.3, Table 1] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products.

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of pegfilgrastim. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of pegfilgrastim was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.

Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of pegfilgrastim-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI - 0.2, 0.6)] and in Study 2 were 1.7 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI - 0.2, 0.4)].

A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x 109/L) was lower for pegfilgrastim-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.

Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see Clinical Pharmacology (12.3)] of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous pegfilgrastim as a single-dose of 100 mcg/kg (n = 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n = 6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.

Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval of this indication was based on efficacy studies conducted in animals and data supporting pegfilgrastim’s effect on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy [see Dosage and Administration (2.1)].

The recommended dose of FYLNETRA is two doses, 6 mg each, administered one week apart for humans exposed to myelosuppressive doses of radiation. For pediatric patients weighing less than 45 kg, dosing of FYLNETRA is weight based and is provided in Table 1 [see Dosage and Administration (2.3)]. This dosing regimen is based on population modeling and simulation analyses. The exposure associated with this dosing regimen is expected to provide sufficient pharmacodynamic activity to treat humans exposed to myelosuppressive doses of radiation [see Clinical Pharmacology (12.3)]. The safety of pegfilgrastim at a dose of 6 mg has been assessed on the basis of clinical experience in patients with cancer receiving myelosuppressive chemotherapy.

The efficacy of pegfilgrastim for the acute radiation syndrome setting was studied in a randomized, placebo-controlled non-human primate model of radiation injury. Rhesus macaques were randomized to either a control (n = 23) or treated (n = 23) cohort. On study day 0, animals (n = 6 to 8 per irradiation day) were exposed to total body irradiation (TBI) of 7.50 ± 0.15 Gy delivered at 0.8 ± 0.03 Gy/min, representing a dose that would be lethal in 50% of animals by 60 days of follow-up (LD50/60). Animals were administered subcutaneous injections of a blinded treatment (control article [5% dextrose in water] or pegfilgrastim [300-319 mcg/kg/day]) on study day 1 and on study day 8. The primary endpoint was survival. Animals received medical management consisting of intravenous fluids, antibiotics, blood transfusions, and other support as required.

Pegfilgrastim significantly (at 0.0014 level of significance) increased 60-day survival in irradiated non-human primates: 91% survival (21/23) in the pegfilgrastim group compared to 48% survival (11/23) in the control group.

FYLNETRA single-dose prefilled syringe for manual use

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FYLNETRA (pegfilgrastim-pbbk) injection is a clear, colorless to slightly yellow, preservative-free solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-pbbk, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe PlusTM Passive Needle Guard.

{ "type": "p", "children": [], "text": "FYLNETRA (pegfilgrastim-pbbk) injection is a clear, colorless to slightly yellow, preservative-free solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-pbbk, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe PlusTM Passive Needle Guard." }

The needle cap on the prefilled syringe is not made with natural rubber latex.

{ "type": "p", "children": [], "text": "The needle cap on the prefilled syringe is not made with natural rubber latex." }

FYLNETRA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70121-1627-1).

{ "type": "p", "children": [], "text": "FYLNETRA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70121-1627-1)." }

FYLNETRA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

{ "type": "p", "children": [], "text": "FYLNETRA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe." }

Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature [68°F to 77°F (20°C to 25°C)] for more than 72 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

{ "type": "p", "children": [], "text": "Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature [68°F to 77°F (20°C to 25°C)] for more than 72 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once." }

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). " }

Advise patients of the following risks and potential risks with FYLNETRA:

{ "type": "p", "children": [], "text": "Advise patients of the following risks and potential risks with FYLNETRA:" }

{ "type": "ul", "children": [ "Splenic rupture and splenomegaly", "Acute Respiratory Distress Syndrome", "Serious allergic reactions", "Sickle cell crisis", "Glomerulonephritis", "Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive FYLNETRA in conjunction with chemotherapy and/or radiation therapy", "Capillary Leak Syndrome", "Aortitis" ], "text": "" }

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)].

{ "type": "p", "children": [], "text": "Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)]." }

Instruct patients who self-administer FYLNETRA using the single-dose prefilled syringe of the:

{ "type": "p", "children": [], "text": "Instruct patients who self-administer FYLNETRA using the single-dose prefilled syringe of the:" }

{ "type": "ul", "children": [ "Importance of following the Instructions for Use.", "Dangers of reusing syringes.", "Importance of following local requirements for proper disposal of used syringes." ], "text": "" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by: " }

Kashiv BioSciences, LLC

{ "type": "p", "children": [], "text": "\nKashiv BioSciences, LLC\n" }

Piscataway, NJ 08854

{ "type": "p", "children": [], "text": "Piscataway, NJ 08854" }

US License No. 2131

{ "type": "p", "children": [], "text": "US License No. 2131" }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Amneal Pharmaceuticals LLC

{ "type": "p", "children": [], "text": "\nAmneal Pharmaceuticals LLC\n" }

Bridgewater, NJ 08807

{ "type": "p", "children": [], "text": "Bridgewater, NJ 08807" }

Rev. 04-2025-02

{ "type": "p", "children": [], "text": "Rev. 04-2025-02" }

LBL-0003

{ "type": "p", "children": [], "text": "LBL-0003" }

<div class="scrollingtable"><table> <col/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule"> <br/> <p class="First"> <span class="Bold">FYLNETRA<span class="Sup">®</span> (fil-ne-trah)</span> </p> <p> <span class="Bold">(pegfilgrastim-pbbk)</span> </p> <p> <span class="Bold">injection</span> </p> <span class="Bold"><span class="Bold">Single-Dose Prefilled Syringe</span></span></td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What is</span><span class="Bold"> FYLNETRA?</span> </p> <p>FYLNETRA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.</p> <p>Acute Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied in animals, because it could not be studied in people.</p> </td> </tr> <tr> <td class="Lrule Rrule Toprule"><span class="Bold"><span class="Bold">Do not take </span><span class="Bold">FYLNETRA </span></span>if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.</td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Before you receive</span><span class="Bold"> FYLNETRA, tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <ul class="Disc"> <li>have a sickle cell disorder.</li> <li>have kidney problems.</li> <li>are pregnant or plan to become pregnant. It is not known if FYLNETRA will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if FYLNETRA passes into your breast milk.</li> </ul> <span class="Bold"><span class="Bold">Tell your healthcare provider about all of the medicines you take</span>,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">How will I receive</span><span class="Bold"> FYLNETRA?</span> </p> <ul class="Disc"> <li> <span class="Bold">FYLNETRA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your FYLNETRA for information on how to prepare and inject a dose of FYLNETRA.</span> </li> <li>You and your caregiver will be shown how to prepare and inject FYLNETRA before you use it.</li> <li>You should not inject a dose of FYLNETRA to children weighing less than 45 kg from a FYLNETRA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the FYLNETRA prefilled syringe.</li> <li>If you are receiving FYLNETRA because you are also receiving chemotherapy, the last dose of FYLNETRA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li> <li>If you miss a dose of FYLNETRA, talk to your healthcare provider about when you should give your next dose.</li> </ul> </td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What are the possible side effects of</span><span class="Bold"> FYLNETRA?</span> </p> <p> <span class="Bold">FYLNETRA may cause serious side effects, including:</span> </p> <ul class="Disc"> <li> <span class="Bold">Spleen rupture. </span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.</li> <li> <span class="Bold">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). </span>Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li> <li> <span class="Bold">Serious allergic reactions.</span> FYLNETRA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using FYLNETRA and call your healthcare provider or get emergency medical help right away.</li> <li> <span class="Bold">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive FYLNETRA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li> <li> <span class="Bold">Kidney injury (glomerulonephritis).</span> FYLNETRA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms.</li> </ul> <ul class="Circle"> <li>swelling of your face or ankles</li> <li>blood in your urine or dark colored urine</li> <li>you urinate less than usual</li> </ul> <ul class="Disc"> <li> <span class="Bold">Increased white blood cell count (leukocytosis)</span>. Your healthcare provider will check your blood during treatment with FYLNETRA.</li> <li> <span class="Bold">Decreased platelet count (thrombocytopenia)</span>. Your healthcare provider will check your blood during treatment with FYLNETRA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with FYLNETRA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li> <li> <span class="Bold">Capillary Leak Syndrome</span>. FYLNETRA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:</li> </ul> <ul class="Circle"> <li>swelling or puffiness and are urinating less than usual</li> <li>trouble breathing</li> <li>swelling of your stomach area (abdomen) and feeling of fullness</li> <li>dizziness or feeling faint</li> <li>a general feeling of tiredness</li> </ul> <ul class="Disc"> <li> <span class="Bold">Myelodysplastic syndrome and acute myeloid leukemia.  </span>If you have breast cancer or lung cancer, when FYLNETRA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with FYLNETRA.</li> <li> <span class="Bold">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products.  Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li> </ul> <p>The most common side effects of FYLNETRA are pain in the bones, arms, and legs.</p> <p>These are not all the possible side effects of FYLNETRA.</p> Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">How should I store </span><span class="Bold">FYLNETRA?</span> </p> <ul class="Disc"> <li>Store FYLNETRA in the refrigerator between 36°F to 46°F (2°C to 8°C).</li> <li> <span class="Bold">Do not</span> freeze. If FYLNETRA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.</li> <li> <span class="Bold">Do not </span>use a FYLNETRA prefilled syringe that has been frozen more than 1 time. Use a new FYLNETRA prefilled syringe. </li> <li>Keep the prefilled syringe in the original carton to protect from light or physical damage.</li> <li>Do not shake the prefilled syringe.</li> <li>Take FYLNETRA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.</li> <li>Throw away (dispose of) any FYLNETRA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.</li> </ul> <span class="Bold"><span class="Bold">Keep the </span><span class="Bold">FYLNETRA </span><span class="Bold">prefilled syringe out of the reach of children.</span></span></td> </tr> <tr> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">General information about the safe and effective use of </span><span class="Bold">FYLNETRA.</span> </p> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.  Do not use FYLNETRA for a condition for which it was not prescribed.  Do not give FYLNETRA to other people, even if they have the same symptoms that you have. It may harm them.  You can ask your pharmacist or healthcare provider for information about FYLNETRA that is written for health professionals.</td> </tr> <tr class="Last"> <td class="Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What are the ingredients in</span><span class="Bold">FYLNETRA?</span> </p> <p>Active ingredient: pegfilgrastim-pbbk</p> <p>Inactive ingredients: acetic acid, polysorbate 20, sodium hydroxide and sorbitol in water for injection.</p> <p>Manufactured by:<span class="Bold"> Kashiv BioSciences, LLC,</span> Piscataway, NJ 08854</p> <p>US License No. 2131</p> <p>Distributed by:<span class="Bold"> Amneal Pharmaceuticals LLC,</span> Bridgewater, NJ 08807</p> For more information, go to www.fylnetra.us or call 1-877-835-5472.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<col/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule Rrule Toprule\">\n<br/>\n<p class=\"First\">\n<span class=\"Bold\">FYLNETRA<span class=\"Sup\">®</span> (fil-ne-trah)</span>\n</p>\n<p>\n<span class=\"Bold\">(pegfilgrastim-pbbk)</span>\n</p>\n<p>\n<span class=\"Bold\">injection</span>\n</p>\n<span class=\"Bold\"><span class=\"Bold\">Single-Dose Prefilled Syringe</span></span></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What is</span><span class=\"Bold\"> FYLNETRA?</span>\n</p>\n<p>FYLNETRA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.</p>\n<p>Acute Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied in animals, because it could not be studied in people.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\"><span class=\"Bold\"><span class=\"Bold\">Do not take </span><span class=\"Bold\">FYLNETRA </span></span>if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Before you receive</span><span class=\"Bold\"> FYLNETRA, tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<ul class=\"Disc\">\n<li>have a sickle cell disorder.</li>\n<li>have kidney problems.</li>\n<li>are pregnant or plan to become pregnant. It is not known if FYLNETRA will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if FYLNETRA passes into your breast milk.</li>\n</ul>\n<span class=\"Bold\"><span class=\"Bold\">Tell your healthcare provider about all of the medicines you take</span>,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">How will I receive</span><span class=\"Bold\"> FYLNETRA?</span>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">FYLNETRA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your FYLNETRA for information on how to prepare and inject a dose of FYLNETRA.</span>\n</li>\n<li>You and your caregiver will be shown how to prepare and inject FYLNETRA before you use it.</li>\n<li>You should not inject a dose of FYLNETRA to children weighing less than 45 kg from a FYLNETRA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the FYLNETRA prefilled syringe.</li>\n<li>If you are receiving FYLNETRA because you are also receiving chemotherapy, the last dose of FYLNETRA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li>\n<li>If you miss a dose of FYLNETRA, talk to your healthcare provider about when you should give your next dose.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of</span><span class=\"Bold\"> FYLNETRA?</span>\n</p>\n<p>\n<span class=\"Bold\">FYLNETRA may cause serious side effects, including:</span>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Spleen rupture. </span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.</li>\n<li>\n<span class=\"Bold\">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). </span>Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> FYLNETRA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using FYLNETRA and call your healthcare provider or get emergency medical help right away.</li>\n<li>\n<span class=\"Bold\">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive FYLNETRA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li>\n<li>\n<span class=\"Bold\">Kidney injury (glomerulonephritis).</span> FYLNETRA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms.</li>\n</ul>\n<ul class=\"Circle\">\n<li>swelling of your face or ankles</li>\n<li>blood in your urine or dark colored urine</li>\n<li>you urinate less than usual</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Increased white blood cell count (leukocytosis)</span>. Your healthcare provider will check your blood during treatment with FYLNETRA.</li>\n<li>\n<span class=\"Bold\">Decreased platelet count (thrombocytopenia)</span>. Your healthcare provider will check your blood during treatment with FYLNETRA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with FYLNETRA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li>\n<li>\n<span class=\"Bold\">Capillary Leak Syndrome</span>. FYLNETRA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:</li>\n</ul>\n<ul class=\"Circle\">\n<li>swelling or puffiness and are urinating less than usual</li>\n<li>trouble breathing</li>\n<li>swelling of your stomach area (abdomen) and feeling of fullness</li>\n<li>dizziness or feeling faint</li>\n<li>a general feeling of tiredness</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Myelodysplastic syndrome and acute myeloid leukemia.  </span>If you have breast cancer or lung cancer, when FYLNETRA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with FYLNETRA.</li>\n<li>\n<span class=\"Bold\">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products.  Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li>\n</ul>\n<p>The most common side effects of FYLNETRA are pain in the bones, arms, and legs.</p>\n<p>These are not all the possible side effects of FYLNETRA.</p>\n Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store </span><span class=\"Bold\">FYLNETRA?</span>\n</p>\n<ul class=\"Disc\">\n<li>Store FYLNETRA in the refrigerator between 36°F to 46°F (2°C to 8°C).</li>\n<li>\n<span class=\"Bold\">Do not</span> freeze. If FYLNETRA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.</li>\n<li>\n<span class=\"Bold\">Do not </span>use a FYLNETRA prefilled syringe that has been frozen more than 1 time. Use a new FYLNETRA prefilled syringe. </li>\n<li>Keep the prefilled syringe in the original carton to protect from light or physical damage.</li>\n<li>Do not shake the prefilled syringe.</li>\n<li>Take FYLNETRA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.</li>\n<li>Throw away (dispose of) any FYLNETRA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.</li>\n</ul>\n<span class=\"Bold\"><span class=\"Bold\">Keep the </span><span class=\"Bold\">FYLNETRA </span><span class=\"Bold\">prefilled syringe out of the reach of children.</span></span></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of </span><span class=\"Bold\">FYLNETRA.</span>\n</p>\n Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.  Do not use FYLNETRA for a condition for which it was not prescribed.  Do not give FYLNETRA to other people, even if they have the same symptoms that you have. It may harm them.  You can ask your pharmacist or healthcare provider for information about FYLNETRA that is written for health professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in</span><span class=\"Bold\">FYLNETRA?</span>\n</p>\n<p>Active ingredient: pegfilgrastim-pbbk</p>\n<p>Inactive ingredients: acetic acid, polysorbate 20, sodium hydroxide and sorbitol in water for injection.</p>\n<p>Manufactured by:<span class=\"Bold\"> Kashiv BioSciences, LLC,</span> Piscataway, NJ 08854</p>\n<p>US License No. 2131</p>\n<p>Distributed by:<span class=\"Bold\"> Amneal Pharmaceuticals LLC,</span> Bridgewater, NJ 08807</p>\n For more information, go to www.fylnetra.us or call 1-877-835-5472.</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration.                                                                                                          Rev. 04-2025-02

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration.                                                                                                          Rev. 04-2025-02" }

Instructions for Use FYLNETRA® (fil-ne-trah) (pegfilgrastim-pbbk) Injection, for subcutaneous use Single-Dose Prefilled Syringe

{ "type": "p", "children": [], "text": "\nInstructions for Use\nFYLNETRA® (fil-ne-trah)\n(pegfilgrastim-pbbk)\nInjection, for subcutaneous use\nSingle-Dose Prefilled Syringe" }

 Guide to parts

{ "type": "p", "children": [], "text": "\n Guide to parts\n" }

 Important: The needle is covered by the gray needle cap before use.

{ "type": "p", "children": [], "text": "\n Important: The needle is covered by the gray needle cap before use." }

Important

{ "type": "p", "children": [], "text": "\nImportant\n" }

 Read the Patient Information for important information you need to know about FYLNETRA before using these Instructions for Use.

{ "type": "p", "children": [], "text": "\n Read the Patient Information for important information you need to know about FYLNETRA before using these Instructions for Use." }

Before you use a FYLNETRA prefilled syringe, read this important information.

{ "type": "p", "children": [], "text": "\nBefore you use a FYLNETRA prefilled syringe, read this important information.\n" }

 Storing the prefilled syringe

{ "type": "p", "children": [], "text": "\n Storing the prefilled syringe\n" }

{ "type": "ul", "children": [ "Store FYLNETRA in the refrigerator between 36°F to 46°F (2°C to 8°C).", "\nDo not freeze.", "Keep the prefilled syringe in the original pack to protect from light or physical damage.", "Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.", "Throw away (dispose of) any FYLNETRA that has been at left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.", "Keep the FYLNETRA prefilled syringe out of the reach of children." ], "text": "" }

Using the prefilled syringe

{ "type": "p", "children": [], "text": "\nUsing the prefilled syringe\n" }

{ "type": "ul", "children": [ "\nIt is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.\n", "Make sure the name FYLNETRA appears on the pack and prefilled syringe label.", "Check the pack and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL.", "You should not inject a dose of FYLNETRA to children weighing less than 45 kg from a FYLNETRA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the FYLNETRA prefilled syringe.", "\nDo not use a prefilled syringe after the expiration date on the label.", "\nDo not shake the prefilled syringe.", "\nDo not remove the gray needle cap from the prefilled syringe until you are ready to inject.", "\nDo not use the prefilled syringe if the pack is open or damaged.", "\nDo not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.", "\nDo not attempt to activate the needle safety guard prior to injection." ], "text": "" }

Call your healthcare provider if you or your caregiver have any questions.

{ "type": "p", "children": [], "text": "Call your healthcare provider if you or your caregiver have any questions." }

Step 1: Prepare

{ "type": "p", "children": [], "text": "\nStep 1: Prepare\n" }

 A. Remove the prefilled syringe pack from the refrigerator.

{ "type": "p", "children": [], "text": "\n A. Remove the prefilled syringe pack from the refrigerator." }

Put the original pack with any unused prefilled syringes back in the refrigerator.

{ "type": "p", "children": [], "text": "Put the original pack with any unused prefilled syringes back in the refrigerator." }

Remove the syringe tray from the pack. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.

{ "type": "p", "children": [], "text": "Remove the syringe tray from the pack. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection." }

{ "type": "ul", "children": [ "\nDo not use the prefilled syringe if the pack is damaged.", "\nDo not try to warm the prefilled syringe by using a heat source such as hot water or microwave.", "\nDo not leave the prefilled syringe in direct sunlight.", "\nDo not shake the prefilled syringe." ], "text": "" }

Open the tray by peeling away the cover. Grab the clear safety guard to remove the prefilled syringe from the tray.

{ "type": "p", "children": [], "text": "Open the tray by peeling away the cover. Grab the clear safety guard to remove the prefilled syringe from the tray." }

For safety reasons:

{ "type": "p", "children": [], "text": "For safety reasons:" }

{ "type": "ul", "children": [ "\nDo not grab the plunger rod.", "\nDo not grab the gray needle cap." ], "text": "" }

 B. Inspect the medicine and prefilled syringe.

{ "type": "p", "children": [], "text": "\n B. Inspect the medicine and prefilled syringe." }

Make sure the medicine in the prefilled syringe is clear and colorless.

{ "type": "p", "children": [], "text": "\nMake sure the medicine in the prefilled syringe is clear and colorless.\n" }

{ "type": "ul", "children": [ "\nDo not use the prefilled syringe if:" ], "text": "" }

{ "type": "ul", "children": [ "The medicine is cloudy or discolored, or contains flakes or particles", "Any part appears cracked or broken", "The prefilled syringe has been dropped", "The gray needle cap is missing or not securely attached.", "The expiration date printed on the label has passed." ], "text": "" }

In all cases, use a new prefilled syringe and call your healthcare provider.

{ "type": "p", "children": [], "text": "In all cases, use a new prefilled syringe and call your healthcare provider." }

C Gather all materials needed for the injection.

{ "type": "p", "children": [], "text": "\nC Gather all materials needed for the injection." }

Wash your hands thoroughly with soap and water.

{ "type": "p", "children": [], "text": "Wash your hands thoroughly with soap and water." }

On a clean, well-lit work surface place the:

{ "type": "p", "children": [], "text": "On a clean, well-lit work surface place the:" }

{ "type": "ul", "children": [ "Prefilled syringe", "Alcohol wipe", "Cotton ball or gauze pad", "Adhesive bandage", "Sharps disposal container" ], "text": "" }

 Step 2: Get ready

{ "type": "p", "children": [], "text": "\n Step 2: Get ready\n" }

 D Prepare and clean the injection site(s).

{ "type": "p", "children": [], "text": "\n D Prepare and clean the injection site(s)." }

 You can use:

{ "type": "p", "children": [], "text": "\n You can use:" }

{ "type": "ul", "children": [ "Thigh", "Stomach area (abdomen), except for a 2-inch area around the navel (belly button)", "Upper outer area of the buttocks (only if someone else is giving you the injection)", "Outer area of upper arm (only if someone else is giving you the injection)" ], "text": "" }

Clean the injection site with an alcohol wipe. Let the skin dry.

{ "type": "p", "children": [], "text": "Clean the injection site with an alcohol wipe. Let the skin dry." }

{ "type": "ul", "children": [ "\nDo not touch this area again before injecting.", "If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.", "\nDo not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks." ], "text": "" }

 E Hold the prefilled syringe by the barrel. Carefully pull the gray needle cap straight off and away from the body.

{ "type": "p", "children": [], "text": "\n E Hold the prefilled syringe by the barrel. Carefully pull the gray needle cap straight off and away from the body." }

{ "type": "ul", "children": [ "\nDo not remove the gray needle cap from the prefilled syringe until you are ready to inject.", "\nDo not twist or bend the gray needle cap.", "\nDo not hold the prefilled syringe by the plunger rod.", "\nDo not put the gray needle cap back onto the prefilled syringe." ], "text": "" }

 Important: Throw the gray needle cap into the sharps disposal container.

{ "type": "p", "children": [], "text": "\n Important: Throw the gray needle cap into the sharps disposal container." }

Step 3: Subcutaneous (under the skin) injection

{ "type": "p", "children": [], "text": "\nStep 3: Subcutaneous (under the skin) injection\n" }

 F Pinch the injection site to create a firm surface.

{ "type": "p", "children": [], "text": "\n F Pinch the injection site to create a firm surface." }

 Important: Keep skin pinched while injecting.

{ "type": "p", "children": [], "text": "\n Important: Keep skin pinched while injecting." }

G Hold the pinch. Insert the needle into the skin at 45 to 90 degrees.

{ "type": "p", "children": [], "text": "\nG Hold the pinch. Insert the needle into the skin at 45 to 90 degrees." }

H Using slow and constant pressure, push the plunger rod until it reaches the bottom and the plunger head is completely between the needle guard wings.

{ "type": "p", "children": [], "text": "\nH Using slow and constant pressure, push the plunger rod until it reaches the bottom and the plunger head is completely between the needle guard wings." }

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away.

{ "type": "p", "children": [], "text": "\nImportant: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away." }

Step 4: Finish

{ "type": "p", "children": [], "text": "\nStep 4: Finish\n" }

I   Before you finish!

{ "type": "p", "children": [], "text": "\nI   Before you finish!\n" }

{ "type": "ul", "children": [ "While you continue to hold the syringe, slowly let go of the plunger head.", "As you let go of the plunger head, the needle will automatically slide into the clear safety guard until the needle is completely covered." ], "text": "" }

Important: If the clear safety guard does not activate after Step I, remove the needle from the skin and throw away (discard of) the used prefilled syringe as instructed in Step J right away.

{ "type": "p", "children": [], "text": "\nImportant: If the clear safety guard does not activate after Step I, remove the needle from the skin and throw away (discard of) the used prefilled syringe as instructed in Step J right away." }

Keep your hands away from the needle at all times.

{ "type": "p", "children": [], "text": "Keep your hands away from the needle at all times." }

J Discard (throw away) the used prefilled syringe

{ "type": "p", "children": [], "text": "\nJ Discard (throw away) the used prefilled syringe" }

{ "type": "ul", "children": [ "Put the used prefilled syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in the household trash.", "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:" ], "text": "" }

{ "type": "ul", "children": [ "made of a heavy-duty plastic,", "can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,", "upright and stable during use,", "leak-resistant, and", "properly labeled to warn of hazardous waste inside the container." ], "text": "" }

{ "type": "ul", "children": [ "When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at http://www.fda.gov/safesharpsdisposal", "\nDo not reuse the prefilled syringe.", "\nDo not recycle the prefilled syringe or sharps disposal container or throw them into the household trash.\n" ], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

K Examine the injection site.

{ "type": "p", "children": [], "text": "\nK Examine the injection site.\n" }

 If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

{ "type": "p", "children": [], "text": "\n If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Kashiv BioSciences, LLC

{ "type": "p", "children": [], "text": "\nKashiv BioSciences, LLC\n" }

 Piscataway, NJ 08854

{ "type": "p", "children": [], "text": "\n Piscataway, NJ 08854" }

US License No. 2131

{ "type": "p", "children": [], "text": "US License No. 2131" }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Amneal Pharmaceuticals LLC

{ "type": "p", "children": [], "text": "\nAmneal Pharmaceuticals LLC\n" }

 Bridgewater, NJ 08807

{ "type": "p", "children": [], "text": "\n Bridgewater, NJ 08807" }

Rev. 05-2022-00

{ "type": "p", "children": [], "text": "Rev. 05-2022-00" }

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].

Limitations of Use

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)].

The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

The recommended dose of Neulasta is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.

Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available. Estimate a patient's absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

Neulasta is administered subcutaneously via a single-dose prefilled syringe for manual use or for use with the on-body injector (OBI) for Neulasta, which is co-packaged with a single-dose prefilled syringe. Use of the OBI for Neulasta is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome. Use of the OBI for Neulasta has not been studied in pediatric patients.

Prior to use‚ remove the carton from the refrigerator and allow the Neulasta prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 48 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.

The needle cap on the prefilled syringes contains dry natural rubber (derived from latex); persons with latex allergies should not administer these products.

Pediatric Patients weighing less than 45 kg

The Neulasta prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks, which are necessary to accurately measure doses of Neulasta less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1. Dosing of Neulasta for pediatric patients weighing less than 45 kg</span> </caption> <col align="center" valign="middle" width="20%"/> <col align="center" valign="middle" width="50%"/> <col align="center" valign="middle" width="30%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Body Weight</th><th align="center" class="Rrule">Neulasta Dose</th><th align="center" class="Rrule">Volume to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Neulasta.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">Less than 10 kg<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Rrule">See below<a class="Sup" href="#footnote-1">*</a></td><td align="center" class="Rrule">See below<a class="Sup" href="#footnote-1">*</a></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">10 - 20 kg</td><td align="center" class="Rrule">1.5 mg</td><td align="center" class="Rrule">0.15 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">21 - 30 kg</td><td align="center" class="Rrule">2.5 mg</td><td align="center" class="Rrule">0.25 mL</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">31 - 44 kg</td><td align="center" class="Rrule">4 mg</td><td align="center" class="Rrule">0.4 mL</td> </tr> </tbody> </table></div>

A healthcare provider must fill the on-body injector (OBI) with Neulasta using the prefilled syringe and then apply the OBI for Neulasta to the patient's skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI for Neulasta. Approximately 27 hours after the OBI for Neulasta is applied to the patient's skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI for Neulasta on the same day as the administration of cytotoxic chemotherapy, as long as the OBI for Neulasta delivers Neulasta no less than 24 hours after administration of cytotoxic chemotherapy.

The prefilled syringe co-packaged in Neulasta Onpro® kit must only be used with the OBI for Neulasta. The prefilled syringe contains additional solution to compensate for liquid loss during delivery through the OBI for Neulasta. If the prefilled syringe co-packaged in Neulasta Onpro kit is used for manual subcutaneous injection, the patient will receive an overdose. If the single-dose prefilled syringe for manual use is used with the OBI for Neulasta, the patient may receive less than the recommended dose.

Do not use the OBI for Neulasta to deliver any other drug product except the Neulasta prefilled syringe co-packaged with the OBI for Neulasta.

The OBI for Neulasta should be applied to intact, non-irritated skin on the arm or abdomen.

A missed dose could occur due to an OBI for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single-dose prefilled syringe for manual use, as soon as possible after detection.

Refer to the Healthcare Provider Instructions for Use for the OBI for Neulasta for full administration information.

Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (OBI) for Neulasta (this includes the 45-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.

Refer the patient to the dose delivery information written on the Patient Instructions for Use. Provide training to patients to ensure they understand when the dose delivery of Neulasta will begin and how to monitor the OBI for Neulasta for completed delivery. Ensure patients understand how to identify signs of malfunction of OBI for Neulasta [see Warnings and Precautions (5.12) and Patient Counseling Information (17)]. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of Neulasta if they suspect that the device may not have performed as intended [see Warnings and Precautions (5.12)].

Neulasta is a clear, colorless, preservative-free solution available as:

{ "type": "p", "children": [], "text": "Neulasta is a clear, colorless, preservative-free solution available as:" }

{ "type": "ul", "children": [ "Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.", "Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta (Neulasta Onpro kit)." ], "text": "" }

Neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)]." }

Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

The on-body injector (OBI) for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue Neulasta if sickle cell crisis occurs.

Glomerulonephritis has occurred in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta.

White blood cell (WBC) counts of 100 × 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of complete blood count (CBC) during pegfilgrastim therapy is recommended.

Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary leak syndrome has been reported after G-CSF administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

MDS and AML have been associated with the use of Neulasta in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Missed or partial doses have been reported in patients receiving Neulasta via the on-body injector (OBI) due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of Neulasta if they suspect that the device may not have performed as intended.

Aortitis has been reported in patients receiving Neulasta. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta if aortitis is suspected.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American, or other.

The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2. Adverse Reactions with ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3</span> </caption> <col align="left" valign="bottom" width="50%"/> <col align="center" valign="bottom" width="20%"/> <col align="center" valign="bottom" width="30%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Body System<br/>  Adverse Reaction</th><th align="center" class="Rrule">Placebo<br/>(N = 461)</th><th align="center" class="Rrule">Neulasta 6 mg SC on Day 2<br/>(N = 467)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="3">Musculoskeletal and connective tissue disorders</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Bone pain</td><td align="center" class="Rrule">26%</td><td align="center" class="Rrule">31%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  Pain in extremity</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">9%</td> </tr> </tbody> </table></div>

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 × 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to pegfilgrastim in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Risk Summary

Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.

Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

Risk Summary

There are no data on the presence of pegfilgrastim in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neulasta and any potential adverse effects on the breastfed child from Neulasta or from the underlying maternal condition.

The safety and effectiveness of Neulasta have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.

Use of Neulasta in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1)].

The use of Neulasta to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals and clinical data supporting the use of Neulasta in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of Neulasta (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.3), Clinical Pharmacology (12.3) and Clinical Studies (14.2)].

Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Overdosage of Neulasta may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered Neulasta on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)].

{ "type": "p", "children": [], "text": "Overdosage of Neulasta may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered Neulasta on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)]." }

Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

{ "type": "p", "children": [], "text": "Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD." }

Neulasta is provided in two presentations:

{ "type": "p", "children": [], "text": "Neulasta is provided in two presentations:" }

{ "type": "ul", "children": [ "Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).", "On-body injector (OBI) for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the OBI for Neulasta. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta." ], "text": "" }

The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.

{ "type": "p", "children": [], "text": "The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP." }

Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Animal data and clinical data in humans suggest a correlation between pegfilgrastim exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of Neulasta is based on reducing the duration of severe neutropenia.

The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the on-body injector (OBI) for Neulasta.

Specific Populations

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)].

Renal Impairment

In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.

Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy

The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14.1)]. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of Neulasta after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg∙hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg∙hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg∙hr/mL in the 12 to 21 years age group (n = 13). The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively.

Patients Acutely Exposed to Myelosuppressive Doses of Radiation

The pharmacokinetics of pegfilgrastim is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of Neulasta, appears to be greater than in humans receiving a 6 mg dose. Results from population modeling and simulation indicate that two 6 mg doses of Neulasta administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration, Section 2.3, Table 1] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim.

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

Neulasta was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of Neulasta. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 × 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of Neulasta (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.

Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of Neulasta-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI - 0.2, 0.6)] and in Study 2 were 1.7 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI - 0.2, 0.4)].

A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 × 109/L) was lower for Neulasta-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the Neulasta-treated patients compared to the placebo-treated patients.

Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see Clinical Pharmacology (12.3)] of Neulasta in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous Neulasta as a single-dose of 100 mcg/kg (n = 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n = 6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the Neulasta and filgrastim groups. The most common adverse reaction reported was bone pain.

Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval of this indication was based on efficacy studies conducted in animals and data supporting Neulasta's effect on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy [see Dosage and Administration (2.1)].

The recommended dose of Neulasta is two doses, 6 mg each, administered one week apart for humans exposed to myelosuppressive doses of radiation. For pediatric patients weighing less than 45 kg, dosing of Neulasta is weight based and is provided in Table 1 [see Dosage and Administration (2.3)]. This dosing regimen is based on population modeling and simulation analyses. The exposure associated with this dosing regimen is expected to provide sufficient pharmacodynamic activity to treat humans exposed to myelosuppressive doses of radiation [see Clinical Pharmacology (12.3)]. The safety of Neulasta at a dose of 6 mg has been assessed on the basis of clinical experience in patients with cancer receiving myelosuppressive chemotherapy.

The efficacy of Neulasta for the acute radiation syndrome setting was studied in a randomized, placebo-controlled non-human primate model of radiation injury. Rhesus macaques were randomized to either a control (n = 23) or treated (n = 23) cohort. On study day 0, animals (n = 6 to 8 per irradiation day) were exposed to total body irradiation (TBI) of 7.50 ± 0.15 Gy delivered at 0.8 ± 0.03 Gy/min, representing a dose that would be lethal in 50% of animals by 60 days of follow-up (LD50/60). Animals were administered subcutaneous injections of a blinded treatment (control article [5% dextrose in water] or pegfilgrastim [300-319 mcg/kg/day]) on study day 1 and on study day 8. The primary endpoint was survival. Animals received medical management consisting of intravenous fluids, antibiotics, blood transfusions, and other support as required.

Pegfilgrastim significantly (at 0.0014 level of significance) increased 60-day survival in irradiated non-human primates: 91% survival (21/23) in the pegfilgrastim group compared to 48% survival (11/23) in the control group.

Neulasta single-dose prefilled syringe for manual use

Neulasta injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.

The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).

Neulasta is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 55513-190-01).

Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

Neulasta Onpro® kit

Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for Neulasta (NDC 55513-192-01).

The Neulasta injection single-dose prefilled syringe contains 0.64 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the OBI for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta.

The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).

Store Neulasta Onpro kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until 30 minutes prior to use. Because the OBI for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature longer than 12 hours prior to use. Discard Neulasta Onpro kit if stored at room temperature for more than 12 hours.

Do not use the OBI for Neulasta if its packaging has been previously opened.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)." }

Advise patients of the following risks and potential risks with Neulasta:

{ "type": "p", "children": [], "text": "Advise patients of the following risks and potential risks with Neulasta:" }

{ "type": "ul", "children": [ "Splenic rupture and splenomegaly", "Acute Respiratory Distress Syndrome", "Serious allergic reactions", "Sickle cell crisis", "Glomerulonephritis", "Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive Neulasta in conjunction with chemotherapy and/or radiation therapy", "Capillary Leak Syndrome", "Aortitis" ], "text": "" }

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of Neulasta for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)].

{ "type": "p", "children": [], "text": "Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of Neulasta for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)]." }

Instruct patients who self-administer Neulasta using the single-dose prefilled syringe of the:

{ "type": "p", "children": [], "text": "Instruct patients who self-administer Neulasta using the single-dose prefilled syringe of the:" }

{ "type": "ul", "children": [ "Importance of following the Instructions for Use.", "Dangers of reusing syringes.", "Importance of following local requirements for proper disposal of used syringes." ], "text": "" }

Advise patients on the use of the on-body injector (OBI) for Neulasta:

{ "type": "p", "children": [], "text": "Advise patients on the use of the on-body injector (OBI) for Neulasta:" }

{ "type": "ul", "children": [ "Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.", "Refer the patient to the dose delivery information written on the Patient Instructions for Use. ", "Tell the patient when their dose delivery of Neulasta will begin and when their dose delivery should be completed. ", "Advise the patient that serious allergic reactions can happen with Neulasta. Patients should have a caregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the OBI for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery. Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the OBI for Neulasta. ", "If the OBI for Neulasta is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the OBI for Neulasta. ", "If a patient calls the healthcare provider regarding any OBI for Neulasta problems, the healthcare provider is advised to call Amgen at 1-800-772-6436.", "Advise the patient:\nto call their healthcare provider immediately if the status light on the OBI for Neulasta is flashing red (see the Patient Instructions for Use).\nto inform their healthcare provider if the adhesive on the OBI for Neulasta becomes saturated with fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in inadequate or missed dose (see the Patient Instructions for Use).\nto keep the OBI for Neulasta dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection.\nthat the OBI for Neulasta should only be exposed to temperatures between 41°F and 104°F (5°C-40°C).\nto keep the OBI for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves, and other common appliances. Failure to keep the OBI for Neulasta at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.\nthat if the needle is exposed after OBI for Neulasta removal, place the used OBI for Neulasta in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately.\nto remove the OBI for Neulasta after the green light shines continuously and to place the used OBI for Neulasta in a sharps disposal container (see the Patient Instructions for Use).\n\n", "Advise the patient:\n do not reapply the OBI for Neulasta if the OBI for Neulasta comes off before full dose is delivered and instead call their healthcare provider immediately, as they may need a replacement dose.\n avoid bumping the OBI for Neulasta or knocking the OBI for Neulasta off the body.\n do not use other materials to hold the on-body injector in place that could cover audio/visual indicators or compress the on-body injector against the patient's skin, as this could dislodge the cannula and lead to a missed dose or incomplete dose of Neulasta.\ndo not expose the OBI for Neulasta to medical imaging studies (e.g., X-ray scan, MRI, CT scan and ultrasound), radiation treatment, and oxygen rich environments such as hyperbaric chambers to avoid OBI for Neulasta damage and patient injury.\n\n", "Advise the patient to avoid:\nairport X-ray scans and request a manual pat down instead; remind patients who elect to request a manual pat down to exercise care to avoid having the OBI for Neulasta dislodged during the pat down process.\nsleeping on the OBI for Neulasta or applying pressure on the OBI for Neulasta as this may affect OBI for Neulasta performance.\ngetting body lotions, creams, oils, and cleaning agents near the OBI for Neulasta as these products may loosen the adhesive.\nuse of lotions, creams, or oils on their arms and abdomen prior to their next scheduled OBI for Neulasta dose (to help with device adherence to the skin).\nusing bath tubs, hot tubs, whirlpools, or saunas and avoid exposing the OBI for Neulasta to direct sunlight as these may affect the drug.\npeeling off or disturbing the OBI for Neulasta adhesive before delivery of full dose is complete.\n\n" ], "text": "" }

Neulasta® (pegfilgrastim) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799U.S. License No. 1080

{ "type": "p", "children": [], "text": "Neulasta® (pegfilgrastim) \nManufactured by:\nAmgen Inc. One Amgen Center Drive\tThousand Oaks, California 91320-1799U.S. License No. 1080" }

Patent: http://pat.amgen.com/onpro/

{ "type": "p", "children": [], "text": "Patent: http://pat.amgen.com/onpro/" }

© 2002-2025 Amgen Inc. All rights reserved. www.neulasta.com 1-800-77-AMGEN (1-800-772-6436) v28

{ "type": "p", "children": [], "text": "© 2002-2025 Amgen Inc. All rights reserved. www.neulasta.com 1-800-77-AMGEN (1-800-772-6436) v28" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="85%"/> <col align="right" valign="top" width="15%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" colspan="2">Patient Information <br/>Neulasta<span class="Sup">®</span> (nu-las-tah) <br/>(pegfilgrastim) <br/>injection <br/>Single-Dose Prefilled Syringe</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration. </td><td align="right" valign="top">Revised: 01/2021</td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is Neulasta?</span> <br/>Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.<br/>Acute Radiation Syndrome: The effectiveness of Neulasta for this use was only studied in animals, because it could not be studied in people. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Do not take Neulasta</span> if you have had a serious allergic reaction to pegfilgrastim or filgrastim.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>have a sickle cell disorder.</li> <li>have kidney problems.</li> <li>are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neulasta using the prefilled syringe if you have latex allergies.</li> <li>are pregnant or plan to become pregnant. It is not known if Neulasta will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk.</li> </ul> <span class="Bold">Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How will I receive Neulasta?</span> <ul> <li> <span class="Bold">Neulasta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" that comes with your Neulasta for information on how to prepare and inject a dose of Neulasta.</span> </li> <li>You and your caregiver will be shown how to prepare and inject Neulasta before you use it.</li> <li>You should not inject a dose of Neulasta to children weighing less than 45 kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringe.</li> <li>If you are receiving Neulasta because you are also receiving chemotherapy, the last dose of Neulasta should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li> <li>If you miss a dose of Neulasta, talk to your healthcare provider about when you should give your next dose.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are possible side effects of Neulasta? <br/>Neulasta may cause serious side effects, including:</span> <ul> <li> <span class="Bold">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. </li> <li> <span class="Bold">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li> <li> <span class="Bold">Serious allergic reactions.</span> Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Neulasta and call your healthcare provider or get emergency medical help right away.</li> <li> <span class="Bold">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li> <li> <span class="Bold">Kidney injury (glomerulonephritis).</span> Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: <ul class="Circle"> <li>swelling of your face or ankles </li> <li>blood in your urine or dark colored urine </li> <li>you urinate less than usual</li> </ul> </li> <li> <span class="Bold">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with Neulasta.</li> <li> <span class="Bold">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with Neulasta. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. </li> <li> <span class="Bold">Capillary Leak Syndrome.</span> Neulasta can cause fluid to leak from blood vessels into your body's tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul class="Circle"> <li>swelling or puffiness and are urinating less than usual</li> <li>trouble breathing </li> <li>swelling of your stomach area (abdomen) and feeling of fullness </li> <li>dizziness or feeling faint</li> <li>a general feeling of tiredness</li> </ul> </li> <li> <span class="Bold">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when Neulasta is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta. </li> <li> <span class="Bold">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li> </ul>The most common side effects of Neulasta are pain in the bones, arms, and legs. <br/>These are not all the possible side effects of Neulasta. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How should I store Neulasta?</span> <ul> <li>Store Neulasta in the refrigerator between 36°F to 46°F (2°C to 8°C). </li> <li> <span class="Bold">Do not</span> freeze.</li> <li>Keep the prefilled syringe in the original carton to protect from light or physical damage. </li> <li>Do not shake the prefilled syringe.</li> <li>Take Neulasta out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. </li> <li>Throw away (dispose of) any Neulasta that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours. </li> </ul> <span class="Bold">Keep the Neulasta prefilled syringe out of the reach of children.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of Neulasta.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Neulasta for a condition for which it was not prescribed. Do not give Neulasta to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Neulasta that is written for health professionals.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in Neulasta?</span> <br/>Active ingredient: pegfilgrastim <br/>Inactive ingredients: acetate, polysorbate 20, sodium and sorbitol in water for injection. <br/>Manufactured by: <br/>Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799 <br/>U.S. License No. 1080<br/>Patent: http://pat.amgen.com/onpro/ <br/>©2002- 2025 Amgen Inc. All rights reserved. <br/>For more information go to www.neulasta.com, or call 1-800-77-AMGEN (1-800-772-6436). <br/>1xxxxx v17</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"right\" valign=\"top\" width=\"15%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">Patient Information <br/>Neulasta<span class=\"Sup\">®</span> (nu-las-tah) <br/>(pegfilgrastim) <br/>injection <br/>Single-Dose Prefilled Syringe</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration. </td><td align=\"right\" valign=\"top\">Revised: 01/2021</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is Neulasta?</span>\n<br/>Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.<br/>Acute Radiation Syndrome: The effectiveness of Neulasta for this use was only studied in animals, because it could not be studied in people. </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Do not take Neulasta</span> if you have had a serious allergic reaction to pegfilgrastim or filgrastim.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>have a sickle cell disorder.</li>\n<li>have kidney problems.</li>\n<li>are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neulasta using the prefilled syringe if you have latex allergies.</li>\n<li>are pregnant or plan to become pregnant. It is not known if Neulasta will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How will I receive Neulasta?</span>\n<ul>\n<li>\n<span class=\"Bold\">Neulasta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed \"Instructions for Use\" that comes with your Neulasta for information on how to prepare and inject a dose of Neulasta.</span>\n</li>\n<li>You and your caregiver will be shown how to prepare and inject Neulasta before you use it.</li>\n<li>You should not inject a dose of Neulasta to children weighing less than 45 kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringe.</li>\n<li>If you are receiving Neulasta because you are also receiving chemotherapy, the last dose of Neulasta should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li>\n<li>If you miss a dose of Neulasta, talk to your healthcare provider about when you should give your next dose.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are possible side effects of Neulasta? <br/>Neulasta may cause serious side effects, including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. </li>\n<li>\n<span class=\"Bold\">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Neulasta and call your healthcare provider or get emergency medical help right away.</li>\n<li>\n<span class=\"Bold\">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li>\n<li>\n<span class=\"Bold\">Kidney injury (glomerulonephritis).</span> Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: <ul class=\"Circle\">\n<li>swelling of your face or ankles </li>\n<li>blood in your urine or dark colored urine </li>\n<li>you urinate less than usual</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with Neulasta.</li>\n<li>\n<span class=\"Bold\">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with Neulasta. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. </li>\n<li>\n<span class=\"Bold\">Capillary Leak Syndrome.</span> Neulasta can cause fluid to leak from blood vessels into your body's tissues. This condition is called \"Capillary Leak Syndrome\" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul class=\"Circle\">\n<li>swelling or puffiness and are urinating less than usual</li>\n<li>trouble breathing </li>\n<li>swelling of your stomach area (abdomen) and feeling of fullness </li>\n<li>dizziness or feeling faint</li>\n<li>a general feeling of tiredness</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when Neulasta is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta. </li>\n<li>\n<span class=\"Bold\">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li>\n</ul>The most common side effects of Neulasta are pain in the bones, arms, and legs. <br/>These are not all the possible side effects of Neulasta. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I store Neulasta?</span>\n<ul>\n<li>Store Neulasta in the refrigerator between 36°F to 46°F (2°C to 8°C). </li>\n<li>\n<span class=\"Bold\">Do not</span> freeze.</li>\n<li>Keep the prefilled syringe in the original carton to protect from light or physical damage. </li>\n<li>Do not shake the prefilled syringe.</li>\n<li>Take Neulasta out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. </li>\n<li>Throw away (dispose of) any Neulasta that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours. </li>\n</ul>\n<span class=\"Bold\">Keep the Neulasta prefilled syringe out of the reach of children.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of Neulasta.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Neulasta for a condition for which it was not prescribed. Do not give Neulasta to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Neulasta that is written for health professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in Neulasta?</span>\n<br/>Active ingredient: pegfilgrastim <br/>Inactive ingredients: acetate, polysorbate 20, sodium and sorbitol in water for injection. <br/>Manufactured by: <br/>Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799 <br/>U.S. License No. 1080<br/>Patent: http://pat.amgen.com/onpro/ <br/>©2002- 2025 Amgen Inc. All rights reserved. <br/>For more information go to www.neulasta.com, or call 1-800-77-AMGEN (1-800-772-6436). <br/>1xxxxx v17</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="85%"/> <col align="right" valign="top" width="15%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" colspan="2">Patient Information <br/>Neulasta<span class="Sup">®</span> (nu-las-tah) <br/>(pegfilgrastim) <br/>injection <br/>On-body injector for Neulasta</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align="right" valign="top">Revised: 01/2021</td> </tr> </tfoot> <tbody> <tr class="First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold"><a name="whatis"></a>What is the most important information I need to know about receiving Neulasta with the on-body injector for Neulasta?</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"> <ul> <li> <span class="Bold">See the <a href="#IFU2">Instructions for Use</a> for the on-body injector for Neulasta for detailed information about the on-body injector for Neulasta and important information about your dose delivery that has been written by your healthcare provider.</span> <ul class="Circle"> <li>Know the time that delivery of your dose of Neulasta is expected to start. </li> <li>Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied. Avoid activities and places that may interfere with monitoring during the <span class="Bold">45-minute</span> period that Neulasta is expected to be delivered by the on-body injector for Neulasta, and for 1 hour after delivery. </li> </ul> </li> <li>A caregiver should be with you the first time that you receive Neulasta with the on-body injector for Neulasta.</li> <li>Before your next scheduled Neulasta dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin. </li> <li>If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector. </li> <li> <span class="Bold">If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. Get emergency medical help right away.</span> </li> <li> <span class="Bold">You should only receive a dose of Neulasta on the day your healthcare provider tells you. </span> </li> <li> <span class="Bold">You should not receive your dose of Neulasta any sooner than 24 hours after you finish receiving your chemotherapy.</span> The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta on your skin.</li> <li> <span class="Bold">Do not</span> expose the on-body injector for Neulasta to the following because the on-body injector for Neulasta may be damaged and you could be injured:<ul class="Circle"> <li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li> <li>Radiation treatment</li> <li>Oxygen rich environments, such as hyperbaric chambers</li> </ul> </li> <li>Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector for Neulasta from being accidentally removed. </li> <li> <span class="Bold">Keep the on-body injector for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances.</span> If the on-body injector for Neulasta is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of Neulasta. </li> <li>The on-body injector is for adult patients only. </li> <li> <span class="Bold">If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose of Neulasta. If you miss your dose or do not receive your full dose of Neulasta, you may have an increased risk of developing fever or infection. </span> </li> <li> <span class="Bold">Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:</span> <ul class="Circle"> <li>on-body injector for Neulasta comes off before or during a dose delivery. <span class="Bold">Do not re-apply it.</span> </li> <li>on-body injector for Neulasta is leaking.</li> <li>adhesive on your on-body injector for Neulasta becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that Neulasta is leaking out of your on-body injector for Neulasta. If this happens you may only receive some of your dose of Neulasta, or you may not receive a dose at all. </li> <li>on-body injector for Neulasta status light is flashing red.</li> </ul> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is Neulasta?</span> <br/>Neulasta is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Do not take Neulasta</span> if you have had a serious allergic reaction to pegfilgrastim or filgrastim.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>have a sickle cell disorder</li> <li>have had severe skin reactions to acrylic adhesives</li> <li>are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). </li> <li>have kidney problems</li> <li>are pregnant or plan to become pregnant. It is not known if Neulasta may harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk. </li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How will I receive Neulasta?<br/>See the <a href="#IFU2">Instructions for Use</a> for detailed information about how you will receive a dose of Neulasta with the on-body injector for Neulasta, and how to remove and dispose of the on-body injector for Neulasta.</span> <ul> <li> <span class="Bold">See the section "<a href="#whatis">What is the most important information I need to know about receiving Neulasta with the on-body injector for Neulasta?</a>"</span> </li> <li>Neulasta is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with Neulasta to fill the on-body injector prior to applying it. The prefilled syringe with Neulasta and the on-body injector are provided to your healthcare provider as part of Neulasta Onpro<span class="Sup">®</span> kit. The on-body injector for Neulasta will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider. If the on-body injector for Neulasta was placed on the back of your arm, a caregiver must be available to monitor the on-body injector for Neulasta.</li> <li>Your healthcare provider should place the on-body injector for Neulasta on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the on-body injector for Neulasta application area after it has been applied.</li> <li>The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta on your skin. </li> <li>The dose of Neulasta will be delivered over about 45 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the on-body injector for Neulasta to make sure you receive your full dose of Neulasta and watch for symptoms of an allergic reaction.</li> <li>Your healthcare provider will show you how to monitor the on-body injector for Neulasta to make sure delivery has been completed. </li> <li>Keep the on-body injector for Neulasta dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from the on-body injector for Neulasta.</li> <li>Only expose the on-body injector for Neulasta to temperatures between 41°F to 104°F (5°C to 40°C).</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">While the on-body injector for Neulasta is in place you should avoid:</span> <ul> <li>traveling, driving or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied.</li> <li>sleeping on the on-body injector for Neulasta or applying pressure on the on-body injector for Neulasta. The on-body injector for Neulasta may not work properly.</li> <li>bumping the on-body injector for Neulasta or knocking it off your body.</li> <li>using other materials to hold the on-body injector in place. Using other materials could cover audio or visual indicators or press the on-body injector against your skin, and lead to a missed dose or incomplete dose of Neulasta. </li> <li>getting body lotion, creams, oils, and skin cleansing products near the on-body injector for Neulasta. These products may loosen the adhesive that holds the on-body injector for Neulasta onto your body. </li> <li>using bath tubs, hot tubs, whirlpools, or saunas, and direct sunlight. These may affect Neulasta. </li> <li>peeling off or disturbing the on-body injector for Neulasta adhesive before you receive your full dose of Neulasta.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the possible side effects of Neulasta? <br/>Neulasta may cause serious side effects, including: </span> <ul> <li> <span class="Bold">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder. </li> <li> <span class="Bold">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. </li> <li> <span class="Bold">Serious allergic reactions.</span> Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate and sweating. <br/> <span class="Bold">If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. Get emergency medical help right away. </span> </li> <li> <span class="Bold">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.</li> <li> <span class="Bold">Kidney injury (glomerulonephritis).</span> Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: <ul class="Circle"> <li>swelling of your face or ankles</li> <li>blood in your urine or dark colored urine</li> <li>you urinate less than usual</li> </ul> </li> <li> <span class="Bold">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with Neulasta.</li> <li> <span class="Bold">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with Neulasta. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. </li> <li> <span class="Bold">Capillary Leak Syndrome.</span> Neulasta can cause fluid to leak from blood vessels into your body's tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul class="Circle"> <li>swelling or puffiness and are urinating less than usual</li> <li>trouble breathing </li> <li>swelling of your stomach-area (abdomen) and feeling of fullness </li> <li>dizziness or feeling faint</li> <li>a general feeling of tiredness</li> </ul> </li> <li> <span class="Bold">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when Neulasta is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta. </li> <li> <span class="Bold">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li> </ul>The most common side effect of Neulasta is pain in your bones, and in your arms, and legs. <br/>These are not all the possible side effects of Neulasta. For more information, ask your healthcare provider or pharmacist. <br/>Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of Neulasta</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about Neulasta, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about Neulasta that is written for health professionals.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in Neulasta?</span> <br/> <span class="Bold">Active ingredient:</span> pegfilgrastim <br/> <span class="Bold">Inactive ingredients:</span> acetate, polysorbate 20, sodium and sorbitol in Water for Injection <br/>Manufactured by<span class="Bold">:</span> <br/>Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799 <br/>US License No. 1080 <br/>Patent: http://pat.amgen.com/onpro/ <br/>© 2002 to 2025 Amgen Inc. All rights reserved. <br/>For more information, go to www.neulasta.com or call 1-844-696-3852 (1-844-MYNEULASTA). <br/>v8</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"right\" valign=\"top\" width=\"15%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">Patient Information <br/>Neulasta<span class=\"Sup\">®</span> (nu-las-tah) <br/>(pegfilgrastim) <br/>injection <br/>On-body injector for Neulasta</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\" valign=\"top\">Revised: 01/2021</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\"><a name=\"whatis\"></a>What is the most important information I need to know about receiving Neulasta with the on-body injector for Neulasta?</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">\n<ul>\n<li>\n<span class=\"Bold\">See the <a href=\"#IFU2\">Instructions for Use</a> for the on-body injector for Neulasta for detailed information about the on-body injector for Neulasta and important information about your dose delivery that has been written by your healthcare provider.</span>\n<ul class=\"Circle\">\n<li>Know the time that delivery of your dose of Neulasta is expected to start. </li>\n<li>Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied. Avoid activities and places that may interfere with monitoring during the <span class=\"Bold\">45-minute</span> period that Neulasta is expected to be delivered by the on-body injector for Neulasta, and for 1 hour after delivery. </li>\n</ul>\n</li>\n<li>A caregiver should be with you the first time that you receive Neulasta with the on-body injector for Neulasta.</li>\n<li>Before your next scheduled Neulasta dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin. </li>\n<li>If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector. </li>\n<li>\n<span class=\"Bold\">If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. Get emergency medical help right away.</span>\n</li>\n<li>\n<span class=\"Bold\">You should only receive a dose of Neulasta on the day your healthcare provider tells you. </span>\n</li>\n<li>\n<span class=\"Bold\">You should not receive your dose of Neulasta any sooner than 24 hours after you finish receiving your chemotherapy.</span> The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta on your skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector for Neulasta to the following because the on-body injector for Neulasta may be damaged and you could be injured:<ul class=\"Circle\">\n<li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li>\n<li>Radiation treatment</li>\n<li>Oxygen rich environments, such as hyperbaric chambers</li>\n</ul>\n</li>\n<li>Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector for Neulasta from being accidentally removed. </li>\n<li>\n<span class=\"Bold\">Keep the on-body injector for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances.</span> If the on-body injector for Neulasta is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of Neulasta. </li>\n<li>The on-body injector is for adult patients only. </li>\n<li>\n<span class=\"Bold\">If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose of Neulasta. If you miss your dose or do not receive your full dose of Neulasta, you may have an increased risk of developing fever or infection. </span>\n</li>\n<li>\n<span class=\"Bold\">Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:</span>\n<ul class=\"Circle\">\n<li>on-body injector for Neulasta comes off before or during a dose delivery. <span class=\"Bold\">Do not re-apply it.</span>\n</li>\n<li>on-body injector for Neulasta is leaking.</li>\n<li>adhesive on your on-body injector for Neulasta becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that Neulasta is leaking out of your on-body injector for Neulasta. If this happens you may only receive some of your dose of Neulasta, or you may not receive a dose at all. </li>\n<li>on-body injector for Neulasta status light is flashing red.</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is Neulasta?</span>\n<br/>Neulasta is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Do not take Neulasta</span> if you have had a serious allergic reaction to pegfilgrastim or filgrastim.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>have a sickle cell disorder</li>\n<li>have had severe skin reactions to acrylic adhesives</li>\n<li>are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). </li>\n<li>have kidney problems</li>\n<li>are pregnant or plan to become pregnant. It is not known if Neulasta may harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk. </li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How will I receive Neulasta?<br/>See the <a href=\"#IFU2\">Instructions for Use</a> for detailed information about how you will receive a dose of Neulasta with the on-body injector for Neulasta, and how to remove and dispose of the on-body injector for Neulasta.</span>\n<ul>\n<li>\n<span class=\"Bold\">See the section \"<a href=\"#whatis\">What is the most important information I need to know about receiving Neulasta with the on-body injector for Neulasta?</a>\"</span>\n</li>\n<li>Neulasta is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with Neulasta to fill the on-body injector prior to applying it. The prefilled syringe with Neulasta and the on-body injector are provided to your healthcare provider as part of Neulasta Onpro<span class=\"Sup\">®</span> kit. The on-body injector for Neulasta will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider. If the on-body injector for Neulasta was placed on the back of your arm, a caregiver must be available to monitor the on-body injector for Neulasta.</li>\n<li>Your healthcare provider should place the on-body injector for Neulasta on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the on-body injector for Neulasta application area after it has been applied.</li>\n<li>The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta on your skin. </li>\n<li>The dose of Neulasta will be delivered over about 45 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the on-body injector for Neulasta to make sure you receive your full dose of Neulasta and watch for symptoms of an allergic reaction.</li>\n<li>Your healthcare provider will show you how to monitor the on-body injector for Neulasta to make sure delivery has been completed. </li>\n<li>Keep the on-body injector for Neulasta dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from the on-body injector for Neulasta.</li>\n<li>Only expose the on-body injector for Neulasta to temperatures between 41°F to 104°F (5°C to 40°C).</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">While the on-body injector for Neulasta is in place you should avoid:</span>\n<ul>\n<li>traveling, driving or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied.</li>\n<li>sleeping on the on-body injector for Neulasta or applying pressure on the on-body injector for Neulasta. The on-body injector for Neulasta may not work properly.</li>\n<li>bumping the on-body injector for Neulasta or knocking it off your body.</li>\n<li>using other materials to hold the on-body injector in place. Using other materials could cover audio or visual indicators or press the on-body injector against your skin, and lead to a missed dose or incomplete dose of Neulasta. </li>\n<li>getting body lotion, creams, oils, and skin cleansing products near the on-body injector for Neulasta. These products may loosen the adhesive that holds the on-body injector for Neulasta onto your body. </li>\n<li>using bath tubs, hot tubs, whirlpools, or saunas, and direct sunlight. These may affect Neulasta. </li>\n<li>peeling off or disturbing the on-body injector for Neulasta adhesive before you receive your full dose of Neulasta.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the possible side effects of Neulasta? <br/>Neulasta may cause serious side effects, including: </span>\n<ul>\n<li>\n<span class=\"Bold\">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder. </li>\n<li>\n<span class=\"Bold\">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. </li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate and sweating. <br/>\n<span class=\"Bold\">If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. Get emergency medical help right away. </span>\n</li>\n<li>\n<span class=\"Bold\">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.</li>\n<li>\n<span class=\"Bold\">Kidney injury (glomerulonephritis).</span> Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: <ul class=\"Circle\">\n<li>swelling of your face or ankles</li>\n<li>blood in your urine or dark colored urine</li>\n<li>you urinate less than usual</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with Neulasta.</li>\n<li>\n<span class=\"Bold\">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with Neulasta. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. </li>\n<li>\n<span class=\"Bold\">Capillary Leak Syndrome.</span> Neulasta can cause fluid to leak from blood vessels into your body's tissues. This condition is called \"Capillary Leak Syndrome\" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul class=\"Circle\">\n<li>swelling or puffiness and are urinating less than usual</li>\n<li>trouble breathing </li>\n<li>swelling of your stomach-area (abdomen) and feeling of fullness </li>\n<li>dizziness or feeling faint</li>\n<li>a general feeling of tiredness</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when Neulasta is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta. </li>\n<li>\n<span class=\"Bold\">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. </li>\n</ul>The most common side effect of Neulasta is pain in your bones, and in your arms, and legs. <br/>These are not all the possible side effects of Neulasta. For more information, ask your healthcare provider or pharmacist. <br/>Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of Neulasta</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about Neulasta, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about Neulasta that is written for health professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in Neulasta?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> pegfilgrastim <br/>\n<span class=\"Bold\">Inactive ingredients:</span> acetate, polysorbate 20, sodium and sorbitol in Water for Injection <br/>Manufactured by<span class=\"Bold\">:</span>\n<br/>Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799 <br/>US License No. 1080 <br/>Patent: http://pat.amgen.com/onpro/ <br/>© 2002 to 2025 Amgen Inc. All rights reserved.\t <br/>For more information, go to www.neulasta.com or call 1-844-696-3852 (1-844-MYNEULASTA). <br/>v8</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">Guide to Parts<br/> Neulasta Prefilled Syringe</span></td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-01.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"><span class="Bold">On-body Injector for Neulasta</span></td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-02.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">Guide to Parts<br/> Neulasta Prefilled Syringe</span></td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-01.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">On-body Injector for Neulasta</span></td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-02.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n</tbody>\n</table></div>" }

Important

{ "type": "p", "children": [], "text": "\nImportant\n" }

READ THE FOLLOWING INSTRUCTIONS BEFORE USING NEULASTA ONPRO KIT

{ "type": "p", "children": [], "text": "\nREAD THE FOLLOWING INSTRUCTIONS BEFORE USING NEULASTA ONPRO KIT\n" }

Prescribing Information

{ "type": "p", "children": [], "text": "\nPrescribing Information\n" }

{ "type": "ul", "children": [ "See Prescribing Information for information on Neulasta.", "The on-body injector is for adult patients only. ", "The on-body injector is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.", "Neulasta prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex.", "For patients who have had severe skin reactions to acrylic adhesives, consider the benefit:risk profile before administering pegfilgrastim via the on-body injector for Neulasta." ], "text": "" }

Application Information

{ "type": "p", "children": [], "text": "\nApplication Information\n" }

{ "type": "ul", "children": [ "The on-body injector should be applied to intact, non-irritated skin on the abdomen or back of the arm. The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector.", "The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could dislodge the cannula and lead to a missed or incomplete dose of Neulasta." ], "text": "" }

Environmental Information

{ "type": "p", "children": [], "text": "\nEnvironmental Information\n" }

{ "type": "ul", "children": [ "\nDo not expose the on-body injector for Neulasta to the following environments as the on-body injector may be damaged and the patient could be injured:\nDiagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)\nRadiation treatment\nOxygen rich environments such as hyperbaric chambers\n\n" ], "text": "" }

Cautions

{ "type": "p", "children": [], "text": "\nCautions\n" }

{ "type": "ul", "children": [ "\nDo not use Neulasta Onpro kit to deliver any other drug product", "\nDo not use the on-body injector if its packaging has been previously opened, or the expiration date on the carton or any components has passed.", "\nDo not use if the name Neulasta does not appear on Neulasta Onpro kit carton.", "\nDo not modify the on-body injector.", "\nDo not attempt to reapply the on-body injector.", "\nDo not use if either the on-body injector or prefilled syringe is dropped. Start again with a new kit" ], "text": "" }

Storage Information

{ "type": "p", "children": [], "text": "\nStorage Information\n" }

{ "type": "ul", "children": [ "Store the kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. If the kit is stored at room temperature for more than 12 hours, do not use. Start again with a new kit.", "Keep the prefilled syringe in the kit carton until use to protect from light.", "\nDo not freeze the kit.", "\nDo not separate the components of Neulasta Onpro kit until ready for use." ], "text": "" }

For all questions, or if a patient calls you regarding any injector problems, call Amgen at 1-800-772-6436.

{ "type": "p", "children": [], "text": "For all questions, or if a patient calls you regarding any injector problems, call Amgen at 1-800-772-6436." }

Step 1: Prepare

{ "type": "p", "children": [], "text": "\nStep 1: Prepare\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="75%"/> <col align="center" valign="top" width="20%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">A</span></td><td align="left" colspan="2"><span class="Bold">Place the syringe tray and the on-body injector tray on a clean, well-lit work surface.</span> <br/>Allow the syringe and on-body injector to come naturally to room temperature for 30 minutes prior to activating. <span class="Bold">Do not</span> warm the kit components using a heat source.</td> </tr> <tr class="Botrule"> <td align="left"><span class="Bold">B</span></td><td align="left" colspan="2"><span class="Bold">Choose the patient's injection site.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-03.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/> <span class="Bold">Ask the patient about their ability to monitor and remove the on-body injector.</span> <ul class="Disc"> <li>Use the left or right side of the abdomen, except for a two-inch area right around navel.</li> <li>Use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector.</li> <li>Apply the on-body injector to intact, non-irritated skin.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on surgical sites or areas with scar tissue, moles, or excessive hair. In case of excessive hair, carefully trim hair to get the on-body injector close to the skin.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on areas where the on-body injector will be affected by folds in the skin.</li> </ul> </td> </tr> <tr> <td align="left"><span class="Bold">C</span></td><td align="left"><span class="Bold">Clean an area on the injection site larger than the on-body injector adhesive backing.</span></td><td align="center"></td> </tr> <tr> <td align="left"></td><td align="left">Thoroughly clean the site with alcohol to enhance on-body adherence to the skin. <ul class="Disc"> <li>Only use alcohol to clean the skin. Make sure the skin is oil-free prior to applying the on-body injector. </li> <li>Allow the skin to <span class="Bold">completely dry</span> before attaching the on-body injector<span class="Bold Italics">.</span> </li> <li> <span class="Bold">Do not</span> touch this area again before attaching the on-body injector.</li> </ul> </td><td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-04.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="left"></td><td align="left"><span class="Bold">Remove Neulasta prefilled syringe from tray.</span> <br/> </td><td align="center"></td> </tr> <tr> <td align="left"><span class="Bold">D</span></td><td align="left"></td><td align="center"></td> </tr> <tr> <td align="left"></td><td align="left"><span class="Bold">For safety reasons:</span> <ul class="Disc"> <li> <span class="Bold">Do not</span> grasp the gray needle cap.</li> <li> <span class="Bold">Do not</span> grasp the plunger rod.</li> </ul> </td><td align="center"></td> </tr> <tr> <td align="left"><span class="Bold">E</span></td><td align="left" colspan="2"><span class="Bold">Inspect Neulasta prefilled syringe. Neulasta liquid should always be clear and colorless.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-05.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><ul class="Disc"> <li> <span class="Bold">Do not</span> use if the liquid contains particulate matter or discoloration is observed prior to administration.</li> <li> <span class="Bold">Do not</span> use the prefilled syringe if the expiration date has passed. </li> <li> <span class="Bold">Do not</span> use if any part appears cracked or broken.</li> <li> <span class="Bold">Do not</span> use if the gray needle cap is missing or not securely attached.</li> <li> <span class="Bold">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li> <li> <span class="Bold">Do not</span> shake the prefilled syringe.</li> </ul>In all the above cases, start again with a new kit.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"75%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Place the syringe tray and the on-body injector tray on a clean, well-lit work surface.</span>\n<br/>Allow the syringe and on-body injector to come naturally to room temperature for 30 minutes prior to activating. <span class=\"Bold\">Do not</span> warm the kit components using a heat source.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">B</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Choose the patient's injection site.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-03.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>\n<span class=\"Bold\">Ask the patient about their ability to monitor and remove the on-body injector.</span>\n<ul class=\"Disc\">\n<li>Use the left or right side of the abdomen, except for a two-inch area right around navel.</li>\n<li>Use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector.</li>\n<li>Apply the on-body injector to intact, non-irritated skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on surgical sites or areas with scar tissue, moles, or excessive hair. In case of excessive hair, carefully trim hair to get the on-body injector close to the skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on areas where the on-body injector will be affected by folds in the skin.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">C</span></td><td align=\"left\"><span class=\"Bold\">Clean an area on the injection site larger than the on-body injector adhesive backing.</span></td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\">Thoroughly clean the site with alcohol to enhance on-body adherence to the skin. <ul class=\"Disc\">\n<li>Only use alcohol to clean the skin. Make sure the skin is oil-free prior to applying the on-body injector. </li>\n<li>Allow the skin to <span class=\"Bold\">completely dry</span> before attaching the on-body injector<span class=\"Bold Italics\">.</span>\n</li>\n<li>\n<span class=\"Bold\">Do not</span> touch this area again before attaching the on-body injector.</li>\n</ul>\n</td><td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-04.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">Remove Neulasta prefilled syringe from tray.</span>\n<br/>\n</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">D</span></td><td align=\"left\"></td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">For safety reasons:</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> grasp the gray needle cap.</li>\n<li>\n<span class=\"Bold\">Do not</span> grasp the plunger rod.</li>\n</ul>\n</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">E</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Inspect Neulasta prefilled syringe. Neulasta liquid should always be clear and colorless.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-05.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> use if the liquid contains particulate matter or discoloration is observed prior to administration.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the prefilled syringe if the expiration date has passed. </li>\n<li>\n<span class=\"Bold\">Do not</span> use if any part appears cracked or broken.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if the gray needle cap is missing or not securely attached.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the prefilled syringe.</li>\n</ul>In all the above cases, start again with a new kit.</td>\n</tr>\n</tbody>\n</table></div>" }

Step 2: Fill

{ "type": "p", "children": [], "text": "\n\tStep 2: Fill\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">A</span></td><td align="left" colspan="2"><span class="Bold">Remove air bubbles in prefilled syringe.</span> <br/>Injecting air bubbles could interfere with proper operation of the on-body injector.<br/> <ul class="Disc"> <li>Remove the gray needle cap.</li> <li>Gently tap the syringe with your finger until air bubbles rise to the top.</li> <li>Slowly push air out of the syringe, taking care to not expel medicine.</li> <li>A small droplet at the tip of the needle during air purging is normal.</li> <li> <span class="Bold">Do not</span> recap the syringe. </li> </ul> </td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-06.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="left"><span class="Bold">B</span></td><td align="left" colspan="4"><span class="Bold">Center the needle directly over the medicine port and insert all the way into the port, avoiding sides.</span></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left"></td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-07.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Remove air bubbles in prefilled syringe.</span>\n<br/>Injecting air bubbles could interfere with proper operation of the on-body injector.<br/>\n<ul class=\"Disc\">\n<li>Remove the gray needle cap.</li>\n<li>Gently tap the syringe with your finger until air bubbles rise to the top.</li>\n<li>Slowly push air out of the syringe, taking care to not expel medicine.</li>\n<li>A small droplet at the tip of the needle during air purging is normal.</li>\n<li>\n<span class=\"Bold\">Do not</span> recap the syringe. </li>\n</ul>\n</td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-06.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">B</span></td><td align=\"left\" colspan=\"4\"><span class=\"Bold\">Center the needle directly over the medicine port and insert all the way into the port, avoiding sides.</span></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-07.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"></td>\n</tr>\n</tbody>\n</table></div>" }

Insert needle into medicine port at a 90 degree angle only.

{ "type": "p", "children": [], "text": "\nInsert needle into medicine port at a 90 degree angle only.\n" }

{ "type": "ul", "children": [ "\nDo not remove the blue needle cover before filling the on-body injector.", "\nDo not insert the needle more than once.", "\nDo not bend the needle. Avoid spilling the medicine." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">C</span></td><td align="left" colspan="2"><span class="Bold">Push the plunger rod to empty entire syringe contents into the on-body injector. </span></td> </tr> <tr> <td align="center"></td><td align="left"> <ul class="Disc"> <li>During filling, you will hear beeping.</li> <li>The status light will flash amber.</li> <li>You now have 3 full minutes to apply the on-body injector to your patient.</li> </ul>Discard used syringe in sharps container.</td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-08.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"><span class="Bold">D</span></td><td align="left" colspan="2"><span class="Bold">Check to see if the on-body injector is full and the amber light is flashing. You should see a black line next to FULL on the fill indicator.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-09.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/>If this is not the case, do not use. Start again with a new Neulasta Onpro kit.</td> </tr> <tr> <td align="center"><span class="Bold">E</span></td><td align="left" colspan="2"><span class="Bold">Firmly lift and remove the blue needle cover away from the on-body injector.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-10.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">C</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Push the plunger rod to empty entire syringe contents into the on-body injector. </span></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\">\n<ul class=\"Disc\">\n<li>During filling, you will hear beeping.</li>\n<li>The status light will flash amber.</li>\n<li>You now have 3 full minutes to apply the on-body injector to your patient.</li>\n</ul>Discard used syringe in sharps container.</td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-08.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">D</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Check to see if the on-body injector is full and the amber light is flashing. You should see a black line next to FULL on the fill indicator.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-09.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>If this is not the case, do not use. Start again with a new Neulasta Onpro kit.</td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">E</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Firmly lift and remove the blue needle cover away from the on-body injector.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-10.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n</tbody>\n</table></div>" }

Step 3: Apply

{ "type": "p", "children": [], "text": "\nStep 3: Apply\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="30%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">A</span></td><td align="left" colspan="3"><span class="Bold">Peel away both pull tabs to show the adhesive. Never touch hands or gloves to the adhesive.</span> <br/>Make sure skin is dry prior to applying the on-body injector.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-11.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><ul class="Disc"> <li> <span class="Bold">Do not</span> pull off the adhesive pad or fold it.</li> <li> <span class="Bold">Do not</span> touch or contaminate the automatic needle area.</li> <li> <span class="Bold">Do not</span> use if the needle or cannula is extended past the adhesive or is extended before the on-body injector is placed on the patient.</li> <li> <span class="Bold">Do not place adhesive on skin that is damp.</span> </li> </ul> </td> </tr> <tr> <td align="center"><span class="Bold">B</span></td><td align="left" colspan="3"><span class="Bold">Before the cannula inserts, securely apply the on-body injector so it is visible and can be monitored by the patient or caregiver.<br/>You now have time to carefully apply the on-body injector without folding or wrinkling the adhesive.</span></td> </tr> <tr> <td align="center"></td><td align="left" colspan="2"> <ul class="Disc"> <li> <span class="Bold">Do not</span> touch the adhesive.</li> <li>Grasp the on-body injector's plastic case with your fingertips and only by sides, keeping fingers off of the adhesive.</li> <li> <span class="Bold">Do not</span> let the adhesive bend or curl while applying the on-body injector to skin.</li> <li> <span class="Bold">Important:</span> Once on the skin, <span class="Bold">press firmly on the on-body injector</span> to ensure proper adhesion to the patient's skin. </li> <li>Press around the entire adhesive so it lies down without folds or wrinkles.</li> <li>Hold the top of the on-body injector and run finger around the adhesive to create a secure attachment.</li> <li>If additional adhesion is deemed appropriate, an adhesive extender that fits around the on-body injector can be obtained by calling 1-844-MYNEULASTA (1-844-696-3852).</li> <li> <span class="Bold">Do not</span> use other materials to secure the on-body injector to the patient that could cover audio/visual indicators or compress the on-body injector against the patient's skin.</li> </ul> </td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-12.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"></td><td align="left"><span class="Bold">Back of upper arm (triceps)</span> <br/>Vertical with the light facing down toward the elbow</td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-13.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"></td><td align="left"><span class="Bold">Abdomen</span> <br/>Horizontal with the light facing up and visible to the patient</td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-14.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"3\"><span class=\"Bold\">Peel away both pull tabs to show the adhesive. Never touch hands or gloves to the adhesive.</span>\n<br/>Make sure skin is dry prior to applying the on-body injector.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-11.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> pull off the adhesive pad or fold it.</li>\n<li>\n<span class=\"Bold\">Do not</span> touch or contaminate the automatic needle area.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if the needle or cannula is extended past the adhesive or is extended before the on-body injector is placed on the patient.</li>\n<li>\n<span class=\"Bold\">Do not place adhesive on skin that is damp.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">B</span></td><td align=\"left\" colspan=\"3\"><span class=\"Bold\">Before the cannula inserts, securely apply the on-body injector so it is visible and can be monitored by the patient or caregiver.<br/>You now have time to carefully apply the on-body injector without folding or wrinkling the adhesive.</span></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> touch the adhesive.</li>\n<li>Grasp the on-body injector's plastic case with your fingertips and only by sides, keeping fingers off of the adhesive.</li>\n<li>\n<span class=\"Bold\">Do not</span> let the adhesive bend or curl while applying the on-body injector to skin.</li>\n<li>\n<span class=\"Bold\">Important:</span> Once on the skin, <span class=\"Bold\">press firmly on the on-body injector</span> to ensure proper adhesion to the patient's skin. </li>\n<li>Press around the entire adhesive so it lies down without folds or wrinkles.</li>\n<li>Hold the top of the on-body injector and run finger around the adhesive to create a secure attachment.</li>\n<li>If additional adhesion is deemed appropriate, an adhesive extender that fits around the on-body injector can be obtained by calling 1-844-MYNEULASTA (1-844-696-3852).</li>\n<li>\n<span class=\"Bold\">Do not</span> use other materials to secure the on-body injector to the patient that could cover audio/visual indicators or compress the on-body injector against the patient's skin.</li>\n</ul>\n</td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-12.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\"><span class=\"Bold\">Back of upper arm (triceps)</span>\n<br/>Vertical with the light facing down toward the elbow</td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-13.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\"><span class=\"Bold\">Abdomen</span>\n<br/>Horizontal with the light facing up and visible to the patient</td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-14.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="10%"/> <col align="left" valign="top" width="90%"/> <tbody class="Headless"> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-15.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"><span class="Bold">Do not worry if the on-body injector is quiet. <br/>When 3 minutes are up, the on-body injector will beep telling you the cannula is about to insert.</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"90%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-15.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"><span class=\"Bold\">Do not worry if the on-body injector is quiet. <br/>When 3 minutes are up, the on-body injector will beep telling you the cannula is about to insert.</span></td>\n</tr>\n</tbody>\n</table></div>" }

Step 4: Finish

{ "type": "p", "children": [], "text": "\nStep 4: Finish\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="95%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">A</span></td><td align="left"><span class="Bold">Wait for the status light to turn green. This means the cannula has been inserted.<br/>Do not</span> remove the on-body injector during cannula insertion to avoid needle stick injury to you or to the patient.<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"95%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">A</span></td><td align=\"left\"><span class=\"Bold\">Wait for the status light to turn green. This means the cannula has been inserted.<br/>Do not</span> remove the on-body injector during cannula insertion to avoid needle stick injury to you or to the patient.<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="10%"/> <col align="left" valign="middle" width="90%"/> <tbody class="Headless"> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-17.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></p> </td><td align="left"><span class="Bold">Check the quality of adhesion before sending the patient home.</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"10%\"/>\n<col align=\"left\" valign=\"middle\" width=\"90%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-17.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></p>\n</td><td align=\"left\"><span class=\"Bold\">Check the quality of adhesion before sending the patient home.</span></td>\n</tr>\n</tbody>\n</table></div>" }

If the adhesive is wrinkled in front of the cannula window or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new kit and call Amgen at 1-800-772-6436.

{ "type": "p", "children": [], "text": "\nIf the adhesive is wrinkled in front of the cannula window or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new kit and call Amgen at 1-800-772-6436.\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="95%"/> <tbody class="Headless"> <tr> <td align="center"></td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-18.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"><span class="Bold">B</span></td><td align="left"><span class="Bold">Provide the Patient IFU Booklet for the patient to take home. <br/>Fill in the Dose Delivery information on the booklet, and review the following instructions with your patient:</span> <ul class="Disc"> <li>The on-body injector will always flash a slow green light to let them know it is working properly.</li> <li>The patient should keep the on-body injector dry for at least 3 hours after it was placed on their skin.</li> <li>After approximately 27 hours, the dose delivery will begin. Dose delivery will take about 45 minutes, during this time, the on-body injector will flash a fast green light.</li> <li> <span class="Bold">When dose delivery is complete, the on-body injector will sound a long beep, and the status light will turn SOLID GREEN.</span> </li> <li> <span class="Bold">Do not remove the on-body injector until the status light is SOLID GREEN.</span> </li> <li>If the red error light is flashing, or the adhesive is noticeably wet (saturated), or the on-body injector is dislodged, the patient should contact their healthcare provider immediately as they may need a replacement dose.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" colspan="2"><span class="Bold">Attention!<br/>What to do if you hear beeping or when you look at status light and it is flashing red.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-19.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/> If at any time the on-body injector beeps continuously for 5 minutes, and the status light is flashing red, take the on-body injector off of the patient. <ul class="Disc"> <li> <span class="Bold">Do not</span> apply or leave the on-body injector on the patient if red error light is on.</li> </ul> In all cases, do not use. Start over with a new Neulasta Onpro kit, and call Amgen at 1-800-772-6436.</td> </tr> <tr class="Botrule"> <td align="left" colspan="2"><span class="Bold">What to do if your patient reports the status light is flashing red.</span> <br/>If the patient reports the status light is flashing red, they may not have received the full dose. Schedule a follow-up appointment with your patient.</td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">What to do if your patient reports the adhesive is saturated with fluid or the on-body injector is dripping.</span> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-20.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/>If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment with your patient.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"95%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"></td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-18.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">B</span></td><td align=\"left\"><span class=\"Bold\">Provide the Patient IFU Booklet for the patient to take home. <br/>Fill in the Dose Delivery information on the booklet, and review the following instructions with your patient:</span>\n<ul class=\"Disc\">\n<li>The on-body injector will always flash a slow green light to let them know it is working properly.</li>\n<li>The patient should keep the on-body injector dry for at least 3 hours after it was placed on their skin.</li>\n<li>After approximately 27 hours, the dose delivery will begin. Dose delivery will take about 45 minutes, during this time, the on-body injector will flash a fast green light.</li>\n<li>\n<span class=\"Bold\">When dose delivery is complete, the on-body injector will sound a long beep, and the status light will turn SOLID GREEN.</span>\n</li>\n<li>\n<span class=\"Bold\">Do not remove the on-body injector until the status light is SOLID GREEN.</span>\n</li>\n<li>If the red error light is flashing, or the adhesive is noticeably wet (saturated), or the on-body injector is dislodged, the patient should contact their healthcare provider immediately as they may need a replacement dose.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">Attention!<br/>What to do if you hear beeping or when you look at status light and it is flashing red.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-19.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>\t\t\t\t\t\t\t\t\tIf at any time the on-body injector beeps continuously for 5 minutes, and the status light is flashing red, take the on-body injector off of the patient. \t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> apply or leave the on-body injector on the patient if red error light is on.</li>\n</ul>\t\t\t\t\t\t\t\t\tIn all cases, do not use. Start over with a new Neulasta Onpro kit, and call Amgen at 1-800-772-6436.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">What to do if your patient reports the status light is flashing red.</span>\n<br/>If the patient reports the status light is flashing red, they may not have received the full dose. Schedule a follow-up appointment with your patient.</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">What to do if your patient reports the adhesive is saturated with fluid or the on-body injector is dripping.</span>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-20.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment with your patient.</td>\n</tr>\n</tbody>\n</table></div>" }

In all cases report the incident to Amgen at 1-800-772-6436.

{ "type": "p", "children": [], "text": "In all cases report the incident to Amgen at 1-800-772-6436." }

Neulasta® (pegfilgrastim)

{ "type": "p", "children": [], "text": "Neulasta® (pegfilgrastim)" }

Manufactured by: Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License No. 1080

{ "type": "p", "children": [], "text": "\nManufactured by:\nAmgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License No. 1080" }

Patent: http://pat.amgen.com/onpro/© 2002 to 2025 Amgen Inc. All rights reserved.

{ "type": "p", "children": [], "text": "Patent: http://pat.amgen.com/onpro/© 2002 to 2025 Amgen Inc. All rights reserved." }

http://www.neulasta.com/1-844-MYNEULASTA (1-844-696-3852) Issued: 03/2021V13

{ "type": "p", "children": [], "text": "http://www.neulasta.com/1-844-MYNEULASTA (1-844-696-3852) Issued: 03/2021V13" }

Before You Begin

{ "type": "p", "children": [], "text": "\nBefore You Begin\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="10%"/> <col align="left" valign="top" width="70%"/> <col align="center" valign="top" width="20%"/> <tbody class="Headless"> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-21.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"><span class="Bold">The following is an overview of on-body injector preparation steps. Read this section first</span> <br/> To prepare and apply the on-body injector, you will use a pre-filled syringe to fill and activate it. <br/>As part of this process, the on-body injector uses lights and sounds as signals to help guide you through the preparation and application process. <br/>As you fill the on-body injector, the status light flashes amber and the on-body injector beeps 3 times.<br/>When the status light flashes amber and the on-body injector beeps, this means it has been properly filled and activated.</td><td align="center"></td> </tr> <tr> <td align="center"></td><td align="left">After the on-body injector activates, you will have 3 full minutes to remove the blue needle guard and adhesive backing, and then apply the on-body injector to your patient. <ul class="Disc"> <li>The on-body injector will beep several times prior to inserting the cannula. </li> <li>Make sure you have the on-body injector properly secured to your patient before the cannula inserts. </li> </ul> </td><td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-22.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"></td><td align="left" class="Botrule">When the status light flashes green, this means the on-body injector has successfully inserted the cannula.</td><td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-23.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="center"></td><td align="left">For all questions, or if a patient calls you regarding any on-body injector problems, call Amgen at 1-800-772-6436.<br/>←<span class="Bold"> Turn over to continue with the Instructions for Use</span></td><td align="center"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"70%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-21.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"><span class=\"Bold\">The following is an overview of on-body injector preparation steps. Read this section first</span>\n<br/>\t\t\t\t\t\t\t\t\tTo prepare and apply the on-body injector, you will use a pre-filled syringe to fill and activate it. <br/>As part of this process, the on-body injector uses lights and sounds as signals to help guide you through the preparation and application process. <br/>As you fill the on-body injector, the status light flashes amber and the on-body injector beeps 3 times.<br/>When the status light flashes amber and the on-body injector beeps, this means it has been properly filled and activated.</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\">After the on-body injector activates, you will have 3 full minutes to remove the blue needle guard and adhesive backing, and then apply the on-body injector to your patient. \t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>The on-body injector will beep several times prior to inserting the cannula. </li>\n<li>Make sure you have the on-body injector properly secured to your patient before the cannula inserts. </li>\n</ul>\n</td><td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-22.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\" class=\"Botrule\">When the status light flashes green, this means the on-body injector has successfully inserted the cannula.</td><td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-23.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\">For all questions, or if a patient calls you regarding any on-body injector problems, call Amgen at 1-800-772-6436.<br/>←<span class=\"Bold\"> Turn over to continue with the Instructions for Use</span></td><td align=\"center\"></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="middle" width="25%"/> <col align="left" valign="middle" width="75%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Symbol</th><th align="left" class="Rrule">Meaning</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-24.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Do not reuse this on-body injector. Single-use only</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-25.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Refer to Instructions for Use</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-26.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Do not use if packaging is damaged</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-27.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Temperature limitation</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-28.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Humidity limitation</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-29.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Expiration date (use by date)</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-30.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Reference/model number</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-31.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Lot number</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-32.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Type BF medical device (protection from electrical shock)</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-33.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Sterilized by ethylene oxide</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-34.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Waterproof up to 8 feet for 1 hour</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-35.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Prescription use only</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-36.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">MR Unsafe</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-37.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">On-body injector for Neulasta<span class="Sup">®</span> (pegfilgrastim)</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-38.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Neulasta<span class="Sup">®</span> (pegfilgrastim) prefilled syringe</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-39.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" class="Rrule">Pressure Limitation</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"25%\"/>\n<col align=\"left\" valign=\"middle\" width=\"75%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Symbol</th><th align=\"left\" class=\"Rrule\">Meaning</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-24.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Do not reuse this on-body injector. Single-use only</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-25.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Refer to Instructions for Use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-26.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Do not use if packaging is damaged</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-27.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Temperature limitation</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-28.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Humidity limitation</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-29.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Expiration date (use by date)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-30.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Reference/model number</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-31.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Lot number</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-32.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Type BF medical device (protection from electrical shock)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-33.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Sterilized by ethylene oxide</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-34.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Waterproof up to 8 feet for 1 hour</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-35.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Prescription use only</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-36.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">MR Unsafe</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-37.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">On-body injector for Neulasta<span class=\"Sup\">®</span> (pegfilgrastim)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-38.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Neulasta<span class=\"Sup\">®</span> (pegfilgrastim) prefilled syringe</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-39.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" class=\"Rrule\">Pressure Limitation</td>\n</tr>\n</tbody>\n</table></div>" }

Do not expose the on-body injector for Neulasta to the following environments as the on-body injector may be damaged and the patient could be injured:

{ "type": "p", "children": [], "text": "\nDo not expose the on-body injector for Neulasta to the following environments as the on-body injector may be damaged and the patient could be injured:" }

{ "type": "ul", "children": [ "Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)", "Radiation treatment", "Oxygen rich environments such as hyperbaric chambers" ], "text": "" }

Electromagnetic Compatibility

{ "type": "p", "children": [], "text": "\nElectromagnetic Compatibility\n" }

The information contained in this section (such as separation distances) is, in general, specifically written in regard to the on-body injector for Neulasta. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.

{ "type": "p", "children": [], "text": "The information contained in this section (such as separation distances) is, in general, specifically written in regard to the on-body injector for Neulasta. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference." }

General Notes:

{ "type": "p", "children": [], "text": "General Notes:" }

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in this document.

{ "type": "p", "children": [], "text": "Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in this document." }

Portable and mobile RF communications equipment can affect medical electrical equipment.

{ "type": "p", "children": [], "text": "Portable and mobile RF communications equipment can affect medical electrical equipment." }

Cables and accessories not specified within the instructions for use are not authorized. Using cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity).

{ "type": "p", "children": [], "text": "Cables and accessories not specified within the instructions for use are not authorized. Using cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity)." }

Care should be taken if the on-body injector for Neulasta is used adjacent to other electrical equipment; if adjacent use is inevitable, the on-body injector for Neulasta should be observed to verify normal operation in this setting.

{ "type": "p", "children": [], "text": "Care should be taken if the on-body injector for Neulasta is used adjacent to other electrical equipment; if adjacent use is inevitable, the on-body injector for Neulasta should be observed to verify normal operation in this setting." }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="34%"/> <col align="left" valign="top" width="33%"/> <col align="left" valign="top" width="33%"/> <thead> <tr class="Botrule First"> <th align="center" class="Lrule Rrule" colspan="3">Electromagnetic Emissions</th> </tr> <tr class="Botrule"> <th align="left" class="Lrule Rrule" colspan="3">The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of the on-body injector for Neulasta should ensure that it is used in such an environment.</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule">Emissions</th><th align="left" class="Rrule">Compliance according to</th><th align="left" class="Rrule">Electromagnetic environment</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">RF Emissions (CISPR 11)</td><td align="left" class="Rrule">Group 1 </td><td align="left" class="Rrule">The on-body injector for Neulasta uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby equipment.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">CISPR B<br/>Emissions Classification</td><td align="left" class="Rrule">Class B</td><td align="left" class="Rrule"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"34%\"/>\n<col align=\"left\" valign=\"top\" width=\"33%\"/>\n<col align=\"left\" valign=\"top\" width=\"33%\"/>\n<thead>\n<tr class=\"Botrule First\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"3\">Electromagnetic Emissions</th>\n</tr>\n<tr class=\"Botrule\">\n<th align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of the on-body injector for Neulasta should ensure that it is used in such an environment.</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Emissions</th><th align=\"left\" class=\"Rrule\">Compliance according to</th><th align=\"left\" class=\"Rrule\">Electromagnetic environment</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">RF Emissions (CISPR 11)</td><td align=\"left\" class=\"Rrule\">Group 1\t</td><td align=\"left\" class=\"Rrule\">The on-body injector for Neulasta uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby equipment.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">CISPR B<br/>Emissions Classification</td><td align=\"left\" class=\"Rrule\">Class B</td><td align=\"left\" class=\"Rrule\"></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <thead> <tr class="Botrule First"> <th align="center" class="Lrule Rrule" colspan="4">Electromagnetic Immunity</th> </tr> <tr class="Botrule"> <th align="left" class="Lrule Rrule" colspan="4">The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of this equipment should ensure that it is used in such an environment.</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule">Immunity Test</th><th align="left" class="Rrule">IEC 60601 Test Level</th><th align="left" class="Rrule">Compliance Level</th><th align="left" class="Rrule">Electromagnetic Environment-Guidance</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">ESD<br/>IEC 61000-4-2</td><td align="left" class="Rrule">±8 kV Contact<br/>±15 kV Air</td><td align="left" class="Rrule">±8 kV Contact<br/>±15 kV Air</td><td align="left" class="Rrule">Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Power Frequency<br/>50/60 Hz<br/>Magnetic Field IEC<br/>61000-4-8</td><td align="left" class="Rrule">30 A/m</td><td align="left" class="Rrule">30 A/m</td><td align="left" class="Rrule">Power frequency magnetic fields should be that of typical commercial or hospital environment.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Radiated RF Fields<br/>61000-4-3</td><td align="left" class="Rrule">3 V/m<br/>80 MHz to 2.7 GHz</td><td align="left" class="Rrule">(E1)=3 V/m</td><td align="left" class="Rrule">Portable and mobile communications equipment should be separated from the on-body injector for Neulasta by no less than the distances calculated/listed below:<br/>D=(3.5/V1)(√P)150 kHz to 80 MHz<br/>D=(3.5/E1)(√P)80 to 800 MHz<br/>D=(7/E1)(√P)800 MHz to 2.5 GHz<br/>Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<thead>\n<tr class=\"Botrule First\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"4\">Electromagnetic Immunity</th>\n</tr>\n<tr class=\"Botrule\">\n<th align=\"left\" class=\"Lrule Rrule\" colspan=\"4\">The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of this equipment should ensure that it is used in such an environment.</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Immunity Test</th><th align=\"left\" class=\"Rrule\">IEC 60601 Test Level</th><th align=\"left\" class=\"Rrule\">Compliance Level</th><th align=\"left\" class=\"Rrule\">Electromagnetic Environment-Guidance</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">ESD<br/>IEC 61000-4-2</td><td align=\"left\" class=\"Rrule\">±8 kV Contact<br/>±15 kV Air</td><td align=\"left\" class=\"Rrule\">±8 kV Contact<br/>±15 kV Air</td><td align=\"left\" class=\"Rrule\">Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Power Frequency<br/>50/60 Hz<br/>Magnetic Field IEC<br/>61000-4-8</td><td align=\"left\" class=\"Rrule\">30 A/m</td><td align=\"left\" class=\"Rrule\">30 A/m</td><td align=\"left\" class=\"Rrule\">Power frequency magnetic fields should be that of typical commercial or hospital environment.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Radiated RF Fields<br/>61000-4-3</td><td align=\"left\" class=\"Rrule\">3 V/m<br/>80 MHz to 2.7 GHz</td><td align=\"left\" class=\"Rrule\">(E1)=3 V/m</td><td align=\"left\" class=\"Rrule\">Portable and mobile communications equipment should be separated from the on-body injector for Neulasta by no less than the distances calculated/listed below:<br/>D=(3.5/V1)(√P)150 kHz to 80 MHz<br/>D=(3.5/E1)(√P)80 to 800 MHz<br/>D=(7/E1)(√P)800 MHz to 2.5 GHz<br/>Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="14%"/> <thead> <tr class="Botrule First"> <th align="center" class="Lrule Rrule" colspan="7">Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment</th> </tr> <tr class="Botrule"> <th align="center" class="Lrule Rrule" colspan="7">The on-body injector for Neulasta is intended for use in the radio frequency environment specified below. The user of this equipment should ensure that it is used in such an environment.</th> </tr> <tr> <th align="center" class="Lrule Rrule">Test Frequency</th><th align="center" class="Rrule">Band<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></th><th align="center" class="Rrule">Service <a class="Sup" href="#footnote-2">*</a></th><th align="center" class="Rrule">Modulation<a class="Sup" href="#footnote-3" name="footnote-reference-3">†</a></th><th align="center" class="Rrule">Maximum Power</th><th align="center" class="Rrule">Distance</th><th align="center" class="Rrule">Immunity Test Level</th> </tr> <tr class="Last"> <th align="center" class="Lrule Rrule">(MHz)</th><th align="center" class="Rrule">(MHz)</th><th align="center" class="Rrule"></th><th align="center" class="Rrule"></th><th align="center" class="Rrule">(W)</th><th align="center" class="Rrule">(m)</th><th align="center" class="Rrule">(V/m)</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="7">NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT OF ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.</td> </tr> <tr> <td align="left" colspan="7"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>For some services, only the uplink frequencies are included.</dd> <dt> <a href="#footnote-reference-3" name="footnote-3">†</a> </dt> <dd>The carrier shall be modulated using a 50% duty cycle square wave signal.</dd> <dt> <a href="#footnote-reference-4" name="footnote-4">‡</a> </dt> <dd>As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">385</td><td align="center" class="Rrule">380-390</td><td align="center" class="Rrule"> TETRA 400</td><td align="center" class="Rrule">Pulse modulation<a class="Sup" href="#footnote-3">†</a> <br/>18 Hz</td><td align="center" class="Rrule">1.8</td><td align="center" class="Rrule">0.3</td><td align="center" class="Rrule">27</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">450</td><td align="center" class="Rrule">430-470</td><td align="center" class="Rrule">GMRS 460, <br/>FRS 460</td><td align="center" class="Rrule">FM <a class="Sup" href="#footnote-4" name="footnote-reference-4">‡</a> <br/>± 5 kHz deviation<br/>1 kHz sine</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">0.3</td><td align="center" class="Rrule">28</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">710</td><td align="center" class="Rrule" rowspan="3">704-787</td><td align="center" class="Rrule" rowspan="3">LTE Band 13, 17</td><td align="center" class="Rrule" rowspan="3">Pulse modulation <a class="Sup" href="#footnote-3">†</a> <br/>217 Hz</td><td align="center" class="Rrule" rowspan="3">0.2</td><td align="center" class="Rrule" rowspan="3">0.3</td><td align="center" class="Rrule" rowspan="3">9</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">745</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">780</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">810</td><td align="center" class="Rrule" rowspan="3">800-960</td><td align="center" class="Rrule" rowspan="3">GSM 800/900,<br/>TETRA 800,<br/>iDEN 820,<br/>CDMA 850,<br/>LTE Band 5</td><td align="center" class="Rrule" rowspan="3">Pulse modulation <a class="Sup" href="#footnote-3">†</a> <br/>18 Hz</td><td align="center" class="Rrule" rowspan="3">2</td><td align="center" class="Rrule" rowspan="3">0.3</td><td align="center" class="Rrule" rowspan="3">28</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">870</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">930</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1720</td><td align="center" class="Rrule" rowspan="3">1700-1990</td><td align="center" class="Rrule" rowspan="3">GSM 1800;<br/>CDMA 1900;<br/>GSM 1900;<br/>DECT;<br/>LTE Band 1, 3, 4, 25; UMTS</td><td align="center" class="Rrule" rowspan="3">Pulse modulation<a class="Sup" href="#footnote-3">†</a> <br/>217 Hz</td><td align="center" class="Rrule" rowspan="3">2</td><td align="center" class="Rrule" rowspan="3">0.3</td><td align="center" class="Rrule" rowspan="3">28</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1845</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1970</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">2450</td><td align="center" class="Rrule">2400-2570</td><td align="center" class="Rrule">Bluetooth,<br/>WLAN,<br/>802.11 b/g/n,<br/>RFID 2450,<br/>LTE Band 7</td><td align="center" class="Rrule">Pulse modulation<a class="Sup" href="#footnote-3">†</a> <br/>217 Hz</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">0.3</td><td align="center" class="Rrule">28</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">5240</td><td align="center" class="Rrule" rowspan="3">5100-5800</td><td align="center" class="Rrule" rowspan="3">WLAN 802.11 a/n</td><td align="center" class="Rrule" rowspan="3">Pulse modulation<a class="Sup" href="#footnote-3">†</a> <br/>217 Hz</td><td align="center" class="Rrule" rowspan="3">0.2</td><td align="center" class="Rrule" rowspan="3">0.3</td><td align="center" class="Rrule" rowspan="3">9</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">5500</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule">5785</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<thead>\n<tr class=\"Botrule First\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"7\">Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment</th>\n</tr>\n<tr class=\"Botrule\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"7\">The on-body injector for Neulasta is intended for use in the radio frequency environment specified below. The user of this equipment should ensure that it is used in such an environment.</th>\n</tr>\n<tr>\n<th align=\"center\" class=\"Lrule Rrule\">Test Frequency</th><th align=\"center\" class=\"Rrule\">Band<a class=\"Sup\" href=\"#footnote-2\" name=\"footnote-reference-2\">*</a></th><th align=\"center\" class=\"Rrule\">Service <a class=\"Sup\" href=\"#footnote-2\">*</a></th><th align=\"center\" class=\"Rrule\">Modulation<a class=\"Sup\" href=\"#footnote-3\" name=\"footnote-reference-3\">†</a></th><th align=\"center\" class=\"Rrule\">Maximum Power</th><th align=\"center\" class=\"Rrule\">Distance</th><th align=\"center\" class=\"Rrule\">Immunity Test Level</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"center\" class=\"Lrule Rrule\">(MHz)</th><th align=\"center\" class=\"Rrule\">(MHz)</th><th align=\"center\" class=\"Rrule\"></th><th align=\"center\" class=\"Rrule\"></th><th align=\"center\" class=\"Rrule\">(W)</th><th align=\"center\" class=\"Rrule\">(m)</th><th align=\"center\" class=\"Rrule\">(V/m)</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"7\">NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT OF ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"7\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-2\" name=\"footnote-2\">*</a>\n</dt>\n<dd>For some services, only the uplink frequencies are included.</dd>\n<dt>\n<a href=\"#footnote-reference-3\" name=\"footnote-3\">†</a>\n</dt>\n<dd>The carrier shall be modulated using a 50% duty cycle square wave signal.</dd>\n<dt>\n<a href=\"#footnote-reference-4\" name=\"footnote-4\">‡</a>\n</dt>\n<dd>As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">385</td><td align=\"center\" class=\"Rrule\">380-390</td><td align=\"center\" class=\"Rrule\">\tTETRA 400</td><td align=\"center\" class=\"Rrule\">Pulse modulation<a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>18 Hz</td><td align=\"center\" class=\"Rrule\">1.8</td><td align=\"center\" class=\"Rrule\">0.3</td><td align=\"center\" class=\"Rrule\">27</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">450</td><td align=\"center\" class=\"Rrule\">430-470</td><td align=\"center\" class=\"Rrule\">GMRS 460, <br/>FRS 460</td><td align=\"center\" class=\"Rrule\">FM <a class=\"Sup\" href=\"#footnote-4\" name=\"footnote-reference-4\">‡</a>\n<br/>± 5 kHz deviation<br/>1 kHz sine</td><td align=\"center\" class=\"Rrule\">2</td><td align=\"center\" class=\"Rrule\">0.3</td><td align=\"center\" class=\"Rrule\">28</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">710</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">704-787</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">LTE Band 13, 17</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">Pulse modulation <a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>217 Hz</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.2</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.3</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">9</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">745</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">780</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">810</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">800-960</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">GSM 800/900,<br/>TETRA 800,<br/>iDEN 820,<br/>CDMA 850,<br/>LTE Band 5</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">Pulse modulation <a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>18 Hz</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">2</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.3</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">28</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">870</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">930</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">1720</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">1700-1990</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">GSM 1800;<br/>CDMA 1900;<br/>GSM 1900;<br/>DECT;<br/>LTE Band 1, 3, 4, 25; UMTS</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">Pulse modulation<a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>217 Hz</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">2</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.3</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">28</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">1845</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">1970</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">2450</td><td align=\"center\" class=\"Rrule\">2400-2570</td><td align=\"center\" class=\"Rrule\">Bluetooth,<br/>WLAN,<br/>802.11 b/g/n,<br/>RFID 2450,<br/>LTE Band 7</td><td align=\"center\" class=\"Rrule\">Pulse modulation<a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>217 Hz</td><td align=\"center\" class=\"Rrule\">2</td><td align=\"center\" class=\"Rrule\">0.3</td><td align=\"center\" class=\"Rrule\">28</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">5240</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">5100-5800</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">WLAN 802.11 a/n</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">Pulse modulation<a class=\"Sup\" href=\"#footnote-3\">†</a>\n<br/>217 Hz</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.2</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">0.3</td><td align=\"center\" class=\"Rrule\" rowspan=\"3\">9</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">5500</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule Rrule\">5785</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="25%"/> <thead> <tr class="Botrule First"> <th align="center" class="Lrule Rrule" colspan="4">Recommended separation distances between portable and mobile RF communications equipment and the on-body injector for Neulasta </th> </tr> <tr class="Botrule"> <th align="left" class="Lrule Rrule" colspan="4">You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the on-body injector for Neulasta, as recommended below, according to the maximum power of the communication equipment.</th> </tr> <tr class="Botrule"> <th align="left" class="Lrule Rrule" rowspan="3">Rated maximum output power of transmitter, in watts</th><th align="left" class="Rrule" colspan="3">Separation distance according to frequency of transmitter, in meters</th> </tr> <tr> <th align="left" class="Lrule Rrule">150 kHz to 80 MHz</th><th align="left" class="Rrule">80 MHz to 800 MHz</th><th align="left" class="Rrule">800 MHz to 2.5 GHz</th> </tr> <tr class="Last"> <th align="center" class="Lrule Rrule">D=(3.5/V1)(√P)</th><th align="left" class="Rrule">D=(3.5/E1)(√P)</th><th align="left" class="Rrule">D=(7/E1)(√P)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">0.01</td><td align="left" class="Rrule">0.11667</td><td align="left" class="Rrule">0.11667</td><td align="left" class="Rrule">0.23333</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">0.1</td><td align="left" class="Rrule">0.36894</td><td align="left" class="Rrule">0.36894</td><td align="left" class="Rrule">0.73785</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">1</td><td align="left" class="Rrule">1.1667</td><td align="left" class="Rrule">1.1667</td><td align="left" class="Rrule">2.3333</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">10</td><td align="left" class="Rrule">3.6894</td><td align="left" class="Rrule">3.6894</td><td align="left" class="Rrule">7.3785</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">100</td><td align="left" class="Rrule">11.667</td><td align="left" class="Rrule">11.667</td><td align="left" class="Rrule">23.333</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<thead>\n<tr class=\"Botrule First\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"4\">Recommended separation distances between portable and mobile RF communications equipment and the on-body injector for Neulasta </th>\n</tr>\n<tr class=\"Botrule\">\n<th align=\"left\" class=\"Lrule Rrule\" colspan=\"4\">You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the on-body injector for Neulasta, as recommended below, according to the maximum power of the communication equipment.</th>\n</tr>\n<tr class=\"Botrule\">\n<th align=\"left\" class=\"Lrule Rrule\" rowspan=\"3\">Rated maximum output power of transmitter, in watts</th><th align=\"left\" class=\"Rrule\" colspan=\"3\">Separation distance according to frequency of transmitter, in meters</th>\n</tr>\n<tr>\n<th align=\"left\" class=\"Lrule Rrule\">150 kHz to 80 MHz</th><th align=\"left\" class=\"Rrule\">80 MHz to 800 MHz</th><th align=\"left\" class=\"Rrule\">800 MHz to 2.5 GHz</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"center\" class=\"Lrule Rrule\">D=(3.5/V1)(√P)</th><th align=\"left\" class=\"Rrule\">D=(3.5/E1)(√P)</th><th align=\"left\" class=\"Rrule\">D=(7/E1)(√P)</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">0.01</td><td align=\"left\" class=\"Rrule\">0.11667</td><td align=\"left\" class=\"Rrule\">0.11667</td><td align=\"left\" class=\"Rrule\">0.23333</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">0.1</td><td align=\"left\" class=\"Rrule\">0.36894</td><td align=\"left\" class=\"Rrule\">0.36894</td><td align=\"left\" class=\"Rrule\">0.73785</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">1</td><td align=\"left\" class=\"Rrule\">1.1667</td><td align=\"left\" class=\"Rrule\">1.1667</td><td align=\"left\" class=\"Rrule\">2.3333</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">10</td><td align=\"left\" class=\"Rrule\">3.6894</td><td align=\"left\" class=\"Rrule\">3.6894</td><td align=\"left\" class=\"Rrule\">7.3785</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">100</td><td align=\"left\" class=\"Rrule\">11.667</td><td align=\"left\" class=\"Rrule\">11.667</td><td align=\"left\" class=\"Rrule\">23.333</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use Neulasta (nu-las-tah) (pegfilgrastim)Injection, for subcutaneous use Single-Dose Prefilled Syringe

{ "type": "p", "children": [], "text": "\nInstructions for Use Neulasta (nu-las-tah) (pegfilgrastim)Injection, for subcutaneous use\nSingle-Dose Prefilled Syringe" }

Guide to parts

{ "type": "p", "children": [], "text": "\nGuide to parts\n" }

Important: The needle is covered by the gray needle cap before use.

{ "type": "p", "children": [], "text": "\nImportant: The needle is covered by the gray needle cap before use." }

Important

{ "type": "p", "children": [], "text": "\nImportant\n" }

Read the Patient Information for important information you need to know about Neulasta before using these Instructions for Use.

{ "type": "p", "children": [], "text": "Read the Patient Information for important information you need to know about Neulasta before using these Instructions for Use." }

Before you use a Neulasta prefilled syringe, read this important information.

{ "type": "p", "children": [], "text": "\nBefore you use a Neulasta prefilled syringe, read this important information.\n" }

Storing the prefilled syringe

{ "type": "p", "children": [], "text": "\nStoring the prefilled syringe\n" }

{ "type": "ul", "children": [ "Store Neulasta in the refrigerator between 36°F to 46°F (2°C to 8°C).", "\nDo not freeze. ", "Keep the prefilled syringe in the original carton to protect from light or physical damage.", "Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.", "Throw away (dispose of) any Neulasta that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours. ", "Keep the Neulasta prefilled syringe out of the reach of children. " ], "text": "" }

Using the prefilled syringe

{ "type": "p", "children": [], "text": "\nUsing the prefilled syringe\n" }

{ "type": "ul", "children": [ "\nIt is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.\n", "Make sure the name Neulasta appears on the carton and prefilled syringe label.", "Check the carton and prefilled syringe label to make sure the dose strength is 6 mg.", "You should not inject a dose of Neulasta to children weighing less than 45 kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringe. ", "\nDo not use a prefilled syringe after the expiration date on the label.", "\nDo not shake the prefilled syringe. ", "\nDo not remove the gray needle cap from the prefilled syringe until you are ready to inject.", "\nDo not use the prefilled syringe if the carton is open or damaged.", "\nDo not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.", "\nDo not slide the blue safety guard over the needle before you give the injection. This will \"activate\" or lock the blue safety guard. Use another prefilled syringe that has not been activated and is ready to use.", "The gray needle cap on the prefilled syringe contains dry natural rubber (made from latex). Tell your healthcare provider if you are allergic to latex. You should not give Neulasta using the prefilled syringe if you have latex allergies.\n" ], "text": "" }

Call your healthcare provider if you have any questions.

{ "type": "p", "children": [], "text": "Call your healthcare provider if you have any questions." }

Step 1: Prepare

{ "type": "p", "children": [], "text": "\nStep 1: Prepare\n" }

A Remove the prefilled syringe carton from the refrigerator.

{ "type": "p", "children": [], "text": "\nA Remove the prefilled syringe carton from the refrigerator. " }

Put the original carton with any unused prefilled syringes back in the refrigerator.

{ "type": "p", "children": [], "text": "Put the original carton with any unused prefilled syringes back in the refrigerator." }

Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.

{ "type": "p", "children": [], "text": "Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection." }

{ "type": "ul", "children": [ "\nDo not use the prefilled syringe if the carton is damaged.", "\nDo not try to warm the prefilled syringe by using a heat source such as hot water or microwave.", "\nDo not leave the prefilled syringe in direct sunlight.", "\nDo not shake the prefilled syringe." ], "text": "" }

Open the tray by peeling away the cover. Grab the blue safety guard to remove the prefilled syringe from the tray.

{ "type": "p", "children": [], "text": "Open the tray by peeling away the cover. Grab the blue safety guard to remove the prefilled syringe from the tray." }

For safety reasons:

{ "type": "p", "children": [], "text": "For safety reasons:" }

{ "type": "ul", "children": [ "\nDo not grab the plunger rod.", "\nDo not grab the gray needle cap." ], "text": "" }

B Inspect the medicine and prefilled syringe.

{ "type": "p", "children": [], "text": "\nB Inspect the medicine and prefilled syringe." }

Make sure the medicine in the prefilled syringe is clear and colorless.

{ "type": "p", "children": [], "text": "\nMake sure the medicine in the prefilled syringe is clear and colorless.\n" }

{ "type": "ul", "children": [ "\nDo not use the prefilled syringe if:\nThe medicine is cloudy or discolored or contains flakes or particles.\nAny part appears cracked or broken.\nThe prefilled syringe has been dropped.\nThe gray needle cap is missing or not securely attached.\nThe expiration date printed on the label has passed.\n\n" ], "text": "" }

In all cases, use a new prefilled syringe and call your healthcare provider.

{ "type": "p", "children": [], "text": "In all cases, use a new prefilled syringe and call your healthcare provider." }

C Gather all materials needed for the injection.

{ "type": "p", "children": [], "text": "\nC Gather all materials needed for the injection." }

Wash your hands thoroughly with soap and water.

{ "type": "p", "children": [], "text": "Wash your hands thoroughly with soap and water. " }

On a clean, well-lit work surface, place the:

{ "type": "p", "children": [], "text": "On a clean, well-lit work surface, place the:" }

{ "type": "ul", "children": [ "Prefilled syringe ", "Alcohol wipe", "Cotton ball or gauze pad", "Adhesive bandage", "Sharps disposal container" ], "text": "" }

Step 2: Get ready

{ "type": "p", "children": [], "text": "\nStep 2: Get ready\n" }

D Prepare and clean the injection site(s).

{ "type": "p", "children": [], "text": "\nD Prepare and clean the injection site(s)." }

You can use:

{ "type": "p", "children": [], "text": "\nYou can use:\n" }

{ "type": "ul", "children": [ "Thigh", "Stomach area (abdomen), except for a 2-inch area right around the navel (belly button)", "Upper outer area of the buttocks (only if someone else is giving you the injection)", "Outer area of upper arm (only if someone else is giving you the injection)" ], "text": "" }

Clean the injection site with an alcohol wipe. Let the skin dry.

{ "type": "p", "children": [], "text": "Clean the injection site with an alcohol wipe. Let the skin dry." }

{ "type": "ul", "children": [ "\nDo not touch this area again before injecting.", "If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.", "\nDo not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks." ], "text": "" }

E Hold the prefilled syringe by the syringe barrel. Carefully pull the gray needle cap straight off and away from the body.

{ "type": "p", "children": [], "text": "\nE Hold the prefilled syringe by the syringe barrel. Carefully pull the gray needle cap straight off and away from the body. " }

{ "type": "ul", "children": [ "\nDo not remove the gray needle cap from the prefilled syringe until you are ready to inject.", "\nDo not twist or bend the gray needle cap.", "\nDo not hold the prefilled syringe by the plunger rod.", "\nDo not put the gray needle cap back onto the prefilled syringe. " ], "text": "" }

Important: Throw the gray needle cap into the sharps disposal container.

{ "type": "p", "children": [], "text": "\nImportant: Throw the gray needle cap into the sharps disposal container." }

Step 3: Subcutaneous (under the skin) injection

{ "type": "p", "children": [], "text": "\nStep 3: Subcutaneous (under the skin) injection\n" }

F Pinch the injection site to create a firm surface.

{ "type": "p", "children": [], "text": "\nF Pinch the injection site to create a firm surface." }

Important: Keep skin pinched while injecting.

{ "type": "p", "children": [], "text": "\nImportant: Keep skin pinched while injecting." }

G Hold the pinch. Insert the needle into the skin at 45 to 90 degrees.

{ "type": "p", "children": [], "text": "\nG Hold the pinch. Insert the needle into the skin at 45 to 90 degrees." }

H Using slow and constant pressure, push the plunger rod until it reaches the bottom.

{ "type": "p", "children": [], "text": "\nH Using slow and constant pressure, push the plunger rod until it reaches the bottom. " }

When done, gently pull the syringe off of the skin.

{ "type": "p", "children": [], "text": "When done, gently pull the syringe off of the skin." }

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away.

{ "type": "p", "children": [], "text": "\nImportant: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away." }

Step 4: Finish

{ "type": "p", "children": [], "text": "\nStep 4: Finish\n" }

For your safety, pull the blue safety guard until it clicks and covers the needle.

{ "type": "p", "children": [], "text": "\nFor your safety, pull the blue safety guard until it clicks and covers the needle.\n" }

Once extended, the blue safety guard will lock into position and will not slide back over the needle.

{ "type": "p", "children": [], "text": "Once extended, the blue safety guard will lock into position and will not slide back over the needle." }

Keep your hands away from the needle at all times.

{ "type": "p", "children": [], "text": "Keep your hands away from the needle at all times." }

J Discard (throw away) the used prefilled syringe.

{ "type": "p", "children": [], "text": "\nJ Discard (throw away) the used prefilled syringe." }

{ "type": "ul", "children": [ "Put the used prefilled syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in the household trash. ", "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:\nmade of a heavy-duty plastic,\ncan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,\nupright and stable during use,\nleak-resistant, and\nproperly labeled to warn of hazardous waste inside the container. \n\n", "When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal", "\nDo not reuse the prefilled syringe.", "\nDo not recycle the prefilled syringe or sharps disposal container or throw them into household trash." ], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

K Examine the injection site.

{ "type": "p", "children": [], "text": "\nK Examine the injection site. " }

If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

{ "type": "p", "children": [], "text": "If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by: \t\t\t\t\t\t" }

Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799U.S. License No. 1080

{ "type": "p", "children": [], "text": "Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799U.S. License No. 1080" }

Patent: http://pat.amgen.com/onpro/

{ "type": "p", "children": [], "text": "Patent: http://pat.amgen.com/onpro/" }

© 2002-2025 Amgen Inc. All rights reserved. 1xxxxxxRevised: 01/2025 v3

{ "type": "p", "children": [], "text": "© 2002-2025 Amgen Inc. All rights reserved. 1xxxxxxRevised: 01/2025 v3" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="center" valign="top" width="40%"/> <col align="left" valign="top" width="10%"/> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="10%"/> <tbody class="Headless"> <tr> <td align="center"></td><td align="left" colspan="3">Your On-body injector was applied:</td> </tr> <tr> <td align="center" rowspan="12"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-52.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"></td><td align="left"></td><td align="right">AM</td> </tr> <tr> <td align="left">Day</td><td align="center">Time</td><td align="right">PM</td> </tr> <tr> <td align="center"> </td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="left" colspan="3">Injection of your dose (delivery) will start around:</td> </tr> <tr> <td align="center"></td><td align="left"></td><td align="right">AM</td> </tr> <tr> <td align="left">Day</td><td align="center">Time</td><td align="right">PM</td> </tr> <tr> <td align="center"> </td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="left" colspan="3">Healthcare Provider name:</td> </tr> <tr> <td align="center"> </td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="left" colspan="3">Healthcare Provider contact number:</td> </tr> <tr> <td align="center"> </td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="left" colspan="3">On-body Injector lot number:</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"center\" valign=\"top\" width=\"40%\"/>\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"40%\"/>\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"></td><td align=\"left\" colspan=\"3\">Your On-body injector was applied:</td>\n</tr>\n<tr>\n<td align=\"center\" rowspan=\"12\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-52.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"></td><td align=\"left\"></td><td align=\"right\">AM</td>\n</tr>\n<tr>\n<td align=\"left\">Day</td><td align=\"center\">Time</td><td align=\"right\">PM</td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"3\">Injection of your dose (delivery) will start around:</td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\"></td><td align=\"right\">AM</td>\n</tr>\n<tr>\n<td align=\"left\">Day</td><td align=\"center\">Time</td><td align=\"right\">PM</td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"3\">Healthcare Provider name:</td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"3\">Healthcare Provider contact number:</td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"3\">On-body Injector lot number:</td>\n</tr>\n</tbody>\n</table></div>" }

AMGEN

{ "type": "p", "children": [], "text": "\nAMGEN\n" }

Neulasta® (pegfilgrastim) Onpro® kit

{ "type": "p", "children": [], "text": "\nNeulasta®\n(pegfilgrastim)\nOnpro®\nkit" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Get to Know Your On-body Injector</span> </caption> <col align="center" valign="top" width="50%"/> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">Parts and Signals</span></td><td align="center"></td><td align="left"></td> </tr> <tr> <td align="center"></td><td align="center"></td><td align="left"><span class="Bold">Status Light</span></td> </tr> <tr> <td align="center" rowspan="3"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-53.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-54.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"><span class="Bold">Flashing Green:</span> <br/>The on-body injector is working properly.<br/> <span class="Bold">Do not</span> remove the on-body injector if the status light is flashing green.</td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-55.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"><span class="Bold">Solid Green (or off):</span> <br/>Signals dose delivery is complete.<br/>Check to see if fill indicator reads empty.</td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-56.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"><span class="Bold">Flashing Red:</span> <br/>On-body injector error.<br/>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away as you may need a replacement dose.</td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-57.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="center"></td><td align="left"><span class="Bold">Fill Indicator:</span> <br/>Black line shows how much Neulasta is in the on-body injector.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<caption>\n<span>Get to Know Your On-body Injector</span>\n</caption>\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">Parts and Signals</span></td><td align=\"center\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"center\"></td><td align=\"left\"><span class=\"Bold\">Status Light</span></td>\n</tr>\n<tr>\n<td align=\"center\" rowspan=\"3\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-53.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-54.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"><span class=\"Bold\">Flashing Green:</span>\n<br/>The on-body injector is working properly.<br/>\n<span class=\"Bold\">Do not</span> remove the on-body injector if the status light is flashing green.</td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-55.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"><span class=\"Bold\">Solid Green (or off):</span>\n<br/>Signals dose delivery is complete.<br/>Check to see if fill indicator reads empty.</td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-56.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"><span class=\"Bold\">Flashing Red:</span>\n<br/>On-body injector error.<br/>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away as you may need a replacement dose.</td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-57.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"center\"></td><td align=\"left\"><span class=\"Bold\">Fill Indicator:</span>\n<br/>Black line shows how much Neulasta is in the on-body injector.</td>\n</tr>\n</tbody>\n</table></div>" }

Contents

{ "type": "p", "children": [], "text": "\nContents\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="90%"/> <col align="left" valign="top" width="10%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">IMPORTANT INFORMATION</span> <br/>Learn about your Neulasta On-body Injector.</td><td align="left">INFO</td> </tr> <tr> <td align="left"><span class="Bold">STEP 1: MONITOR</span> <br/>What to expect from your device for most of the day.</td><td align="left"></td> </tr> <tr> <td align="left"><span class="Bold">STEP 2: OBSERVE</span> <br/>What to watch for during dose delivery and what to do if there is an issue.</td><td align="left"></td> </tr> <tr> <td align="left"><span class="Bold">STEP 3: VERIFY</span> <br/>Understand when delivery is complete and when you may remove the device.</td><td align="left"></td> </tr> <tr> <td align="left"><span class="Bold">STEP 4: FINISH</span> <br/>Confirm the dose was delivered and dispose of the device.</td><td align="left"></td> </tr> <tr> <td align="left"><span class="Bold">FAQ</span> <br/>When it is safe to remove your on-body injector and answers to frequently asked questions.</td><td align="left"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"90%\"/>\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">IMPORTANT INFORMATION</span>\n<br/>Learn about your Neulasta On-body Injector.</td><td align=\"left\">INFO</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">STEP 1: MONITOR</span>\n<br/>What to expect from your device for most of the day.</td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">STEP 2: OBSERVE</span>\n<br/>What to watch for during dose delivery and what to do if there is an issue.</td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">STEP 3: VERIFY</span>\n<br/>Understand when delivery is complete and when you may remove the device.</td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">STEP 4: FINISH</span>\n<br/>Confirm the dose was delivered and dispose of the device.</td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">FAQ</span>\n<br/>When it is safe to remove your on-body injector and answers to frequently asked questions.</td><td align=\"left\"></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="10%"/> <col align="left" valign="top" width="90%"/> <tbody class="Headless"> <tr> <td align="left"></td><td align="left"><span class="Bold">Important Information</span></td> </tr> <tr> <td align="left"></td><td align="left"><span class="Bold">On-body Injector for Neulasta Description</span></td> </tr> <tr> <td align="left">INFO</td><td align="left"> <ul> <li>The on-body injector for Neulasta is intended for delivery of Neulasta. This on-body injector delivers Neulasta with an injection under-the-skin (subcutaneous). See the <a href="#PatientInformation">Patient Information</a> that comes with your on-body injector for important information.</li> <li>Your healthcare provider will use a prefilled syringe with Neulasta to fill the on-body injector prior to applying it. The prefilled syringe with Neulasta and the on-body injector are provided to your healthcare provider as part of Neulasta Onpro kit. The on-body injector is applied directly to your skin using a self-adhesive backing. The on-body injector lets you know its status with sounds and lights.</li> </ul> </td> </tr> <tr> <td align="left"></td><td align="left"><span class="Bold">Warnings</span> <ul> <li>You should only receive a dose of Neulasta on the day your healthcare provider tells you.</li> <li>You should not receive your dose of Neulasta any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin.</li> <li>If you have concerns about your medicine, call your healthcare provider right away. Serious allergic reactions can happen with Neulasta. Ask your caregiver to be nearby for the first use. Plan to be in a place where you or your caregiver can closely monitor the on-body injector for Neulasta for about 45-minutes during Neulasta delivery and for an hour after the delivery.</li> <li> <span class="Bold">Do not</span> take Neulasta if you have had a serious allergic reaction to pegfilgrastim (Neulasta) or to filgrastim (Neupogen).</li> </ul> </td> </tr> <tr> <td align="left"></td><td align="left"> <ul> <li>Tell your healthcare provider if you are allergic to latex. A prefilled syringe is used to fill the on-body injector by your healthcare provider prior to applying the on-body injector. The prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex. Latex may be transferred to your skin.</li> <li>Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.</li> <li>If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector by grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency medical help right away.</li> <li>Call your healthcare provider right away if you have severe pain or skin discomfort around your on-body injector. </li> <li>Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. This pain could mean your spleen is enlarged or ruptured.</li> <li>Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ARDS): fever, shortness of breath, trouble breathing, or a fast rate of breathing. </li> <li>Call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.</li> <li>Call your healthcare provider if you have persistent or worsening redness or tenderness at the application site (may be a sign of infection).</li> <li>The on-body injector is for adult patients only.</li> </ul> </td> </tr> <tr> <td align="left"></td><td align="left"><span class="Bold">Important Information <br/> Wearing the On-body Injector</span> <ul> <li>This on-body injector delivers Neulasta with an under-the-skin (subcutaneous) injection.</li> <li>The on-body injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 8 feet for 1 hour.</li> <li>The on-body injector can be worn in a shower. After showering, check the on-body injector to ensure it has not become loose (dislodged).</li> <li>Avoid getting body lotions, creams, oils or cleaning agents near the on-body injector as these products may loosen the adhesive. Before your next scheduled Neulasta dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen). </li> <li>Only expose the on-body injector to temperatures between 41°F and 104°F (5°C and 40°C).</li> <li> <span class="Bold">Do not</span> use bath tubs, hot tubs, whirlpools, or saunas while wearing the on-body injector. This may affect your medicine.</li> <li> <span class="Bold">Do not</span> expose the on-body injector to direct sunlight. If the on-body injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the on-body injector under clothing.</li> <li> <span class="Bold">Do not</span> sleep on the on-body injector or apply pressure during wear, especially during dose delivery. This may affect on-body injector performance.</li> <li> <span class="Bold">Do not</span> peel off or disturb the on-body injector adhesive before your full dose is complete. This may result in a missed or incomplete dose of Neulasta.</li> </ul> </td> </tr> <tr> <td align="left"></td><td align="left"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"90%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">Important Information</span></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">On-body Injector for Neulasta Description</span></td>\n</tr>\n<tr>\n<td align=\"left\">INFO</td><td align=\"left\">\n<ul>\n<li>The on-body injector for Neulasta is intended for delivery of Neulasta. This on-body injector delivers Neulasta with an injection under-the-skin (subcutaneous). See the <a href=\"#PatientInformation\">Patient Information</a> that comes with your on-body injector for important information.</li>\n<li>Your healthcare provider will use a prefilled syringe with Neulasta to fill the on-body injector prior to applying it. The prefilled syringe with Neulasta and the on-body injector are provided to your healthcare provider as part of Neulasta Onpro kit. The on-body injector is applied directly to your skin using a self-adhesive backing. The on-body injector lets you know its status with sounds and lights.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">Warnings</span>\n<ul>\n<li>You should only receive a dose of Neulasta on the day your healthcare provider tells you.</li>\n<li>You should not receive your dose of Neulasta any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin.</li>\n<li>If you have concerns about your medicine, call your healthcare provider right away. Serious allergic reactions can happen with Neulasta. Ask your caregiver to be nearby for the first use. Plan to be in a place where you or your caregiver can closely monitor the on-body injector for Neulasta for about 45-minutes during Neulasta delivery and for an hour after the delivery.</li>\n<li>\n<span class=\"Bold\">Do not</span> take Neulasta if you have had a serious allergic reaction to pegfilgrastim (Neulasta) or to filgrastim (Neupogen).</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\">\n<ul>\n<li>Tell your healthcare provider if you are allergic to latex. A prefilled syringe is used to fill the on-body injector by your healthcare provider prior to applying the on-body injector. The prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex. Latex may be transferred to your skin.</li>\n<li>Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.</li>\n<li>If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector by grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency medical help right away.</li>\n<li>Call your healthcare provider right away if you have severe pain or skin discomfort around your on-body injector. </li>\n<li>Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. This pain could mean your spleen is enlarged or ruptured.</li>\n<li>Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ARDS): fever, shortness of breath, trouble breathing, or a fast rate of breathing. </li>\n<li>Call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.</li>\n<li>Call your healthcare provider if you have persistent or worsening redness or tenderness at the application site (may be a sign of infection).</li>\n<li>The on-body injector is for adult patients only.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">Important Information <br/> Wearing the On-body Injector</span>\n<ul>\n<li>This on-body injector delivers Neulasta with an under-the-skin (subcutaneous) injection.</li>\n<li>The on-body injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 8 feet for 1 hour.</li>\n<li>The on-body injector can be worn in a shower. After showering, check the on-body injector to ensure it has not become loose (dislodged).</li>\n<li>Avoid getting body lotions, creams, oils or cleaning agents near the on-body injector as these products may loosen the adhesive. Before your next scheduled Neulasta dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen). </li>\n<li>Only expose the on-body injector to temperatures between 41°F and 104°F (5°C and 40°C).</li>\n<li>\n<span class=\"Bold\">Do not</span> use bath tubs, hot tubs, whirlpools, or saunas while wearing the on-body injector. This may affect your medicine.</li>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector to direct sunlight. If the on-body injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the on-body injector under clothing.</li>\n<li>\n<span class=\"Bold\">Do not</span> sleep on the on-body injector or apply pressure during wear, especially during dose delivery. This may affect on-body injector performance.</li>\n<li>\n<span class=\"Bold\">Do not</span> peel off or disturb the on-body injector adhesive before your full dose is complete. This may result in a missed or incomplete dose of Neulasta.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="10%"/> <col align="left" valign="top" width="85%"/> <col align="right" valign="top" width="5%"/> <tbody class="Headless"> <tr> <td align="left"></td><td align="left"><span class="Bold"> Environmental Precautions </span></td><td align="right"></td> </tr> <tr> <td align="left"></td><td align="left"> <ul> <li> <span class="Bold">Do not</span> expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: <ul> <li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li> <li>Radiation treatment</li> <li>Oxygen rich environments, such as hyperbaric chambers</li> </ul> </li> </ul> </td><td align="right" valign="bottom">1</td> </tr> <tr> <td align="left"></td><td align="left"> <ul> <li>Keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.</li> <li>Avoid activities and places that may interfere with monitoring during the dosing of Neulasta administered by the on-body injector. For example, <span class="Bold">avoid</span> traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector for Neulasta (this includes the 45-minute dose delivery period plus an hour post-delivery).</li> <li>If you must travel by airplane <span class="Bold">before</span> the approximately 45-minute dose delivery period with the on-body injector, avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector from being accidentally removed. For more information go to: <span class="Bold">http://www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions</span> </li> </ul> </td><td align="right"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"right\" valign=\"top\" width=\"5%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"></td><td align=\"left\"><span class=\"Bold\">\tEnvironmental Precautions\t</span></td><td align=\"right\"></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\">\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector to the following because the on-body injector may be damaged and you could be injured:\t<ul>\n<li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li>\n<li>Radiation treatment</li>\n<li>Oxygen rich environments, such as hyperbaric chambers</li>\n</ul>\n</li>\n</ul>\n</td><td align=\"right\" valign=\"bottom\">1</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\">\n<ul>\n<li>Keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.</li>\n<li>Avoid activities and places that may interfere with monitoring during the dosing of Neulasta administered by the on-body injector. For example, <span class=\"Bold\">avoid</span> traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector for Neulasta (this includes the 45-minute dose delivery period plus an hour post-delivery).</li>\n<li>If you must travel by airplane <span class=\"Bold\">before</span> the approximately 45-minute dose delivery period with the on-body injector, avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector from being accidentally removed. For more information go to: <span class=\"Bold\">http://www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions</span>\n</li>\n</ul>\n</td><td align=\"right\"></td>\n</tr>\n</tbody>\n</table></div>" }

A healthcare provider who is familiar with Neulasta should answer your questions. For general questions or support call 1-844-MYNEULASTA (1-844-696-3852) or visit www.neulasta.com.

{ "type": "p", "children": [], "text": "A healthcare provider who is familiar with Neulasta should answer your questions. For general questions or support call 1-844-MYNEULASTA (1-844-696-3852) or visit www.neulasta.com." }

Step 1: Monitor On-body Injector

{ "type": "p", "children": [], "text": "\n\tStep 1: Monitor On-body Injector\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="middle" width="5%"/> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="85%"/> <col align="left" valign="top" width="5%"/> <tbody class="Headless"> <tr> <td align="left"></td><td align="left" class="Rrule"><span class="Bold">A</span></td><td align="left" colspan="2"><span class="Bold">For the next 27 hours, occasionally check the status light for at least 10 seconds. If the status light is flashing green, it is okay.</span></td> </tr> <tr> <td align="left">1</td><td align="left"></td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-58.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left" colspan="2"> <ul class="Disc"> <li>Keep the on-body injector and adhesive backing dry for at least 3 hours after it was placed on your skin, and for 3 hours prior to dose delivery.</li> <li>Be careful not to bump the on-body injector, or knock the on-body injector off your body.</li> <li>The on-body injector has a self-adhesive backing to attach it to the skin. Do not add other materials to hold it in place as this could dislodge the cannula and lead to a missed or incomplete dose of Neulasta.</li> </ul> </td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-59.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><ul class="Disc"> <li>If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor the status of the on-body injector.</li> <li>If the on-body injector comes away from your skin at any time, do not reapply it. Call your healthcare provider right away as you may need a replacement dose.</li> <li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> </td><td align="left" valign="middle">2</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"></td><td align=\"left\" class=\"Rrule\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">For the next 27 hours, occasionally check the status light for at least 10 seconds. If the status light is flashing green, it is okay.</span></td>\n</tr>\n<tr>\n<td align=\"left\">1</td><td align=\"left\"></td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-58.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>Keep the on-body injector and adhesive backing dry for at least 3 hours after it was placed on your skin, and for 3 hours prior to dose delivery.</li>\n<li>Be careful not to bump the on-body injector, or knock the on-body injector off your body.</li>\n<li>The on-body injector has a self-adhesive backing to attach it to the skin. Do not add other materials to hold it in place as this could dislodge the cannula and lead to a missed or incomplete dose of Neulasta.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-59.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><ul class=\"Disc\">\n<li>If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor the status of the on-body injector.</li>\n<li>If the on-body injector comes away from your skin at any time, do not reapply it. Call your healthcare provider right away as you may need a replacement dose.</li>\n<li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n</td><td align=\"left\" valign=\"middle\">2</td>\n</tr>\n</tbody>\n</table></div>" }

Step 2: Observe Dose Delivery

{ "type": "p", "children": [], "text": "\nStep 2: Observe Dose Delivery\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="middle" width="5%"/> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="85%"/> <col align="left" valign="top" width="5%"/> <tbody class="Headless"> <tr> <td align="left"></td><td align="left" class="Rrule"><span class="Bold">A</span></td><td align="left" colspan="2"><span class="Bold">After about 27 hours, your on-body injector will begin to deliver your dose of Neulasta.</span></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left" colspan="2"> <ul class="Disc"> <li>Dose delivery will take around 45-minutes to complete. The on-body injector will flash a fast, green light.</li> <li>You may hear a series of clicks. This is okay.</li> </ul> </td> </tr> <tr> <td align="left">2</td><td align="left"></td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-60.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left" colspan="2"> <ul class="Disc"> <li>When dose delivery is complete, a long beep will sound and the status light will turn solid green.</li> <li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li> <li> <span class="Bold">Do not remove the on-body injector if the status light is flashing green.</span> </li> </ul> </td> </tr> <tr> <td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-61.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" colspan="2"><span class="Bold">Check your on-body injector often for leaks during the 45-minute dose delivery. If the on-body injector was placed on the back of your arm, a caregiver must be available to check your on-body injector.</span></td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-62.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><ul class="Disc"> <li>If the adhesive is noticeably wet or dripping with medicine, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> </td><td align="left" valign="middle">3</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"></td><td align=\"left\" class=\"Rrule\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">After about 27 hours, your on-body injector will begin to deliver your dose of Neulasta.</span></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>Dose delivery will take around 45-minutes to complete. The on-body injector will flash a fast, green light.</li>\n<li>You may hear a series of clicks. This is okay.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\">2</td><td align=\"left\"></td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-60.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>When dose delivery is complete, a long beep will sound and the status light will turn solid green.</li>\n<li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li>\n<li>\n<span class=\"Bold\">Do not remove the on-body injector if the status light is flashing green.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-61.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Check your on-body injector often for leaks during the 45-minute dose delivery. If the on-body injector was placed on the back of your arm, a caregiver must be available to check your on-body injector.</span></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-62.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><ul class=\"Disc\">\n<li>If the adhesive is noticeably wet or dripping with medicine, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n</td><td align=\"left\" valign=\"middle\">3</td>\n</tr>\n</tbody>\n</table></div>" }

Step 3: Verify Dose Complete

{ "type": "p", "children": [], "text": "\n\tStep 3: Verify Dose Complete\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="middle" width="5%"/> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="5%"/> <tbody class="Headless"> <tr> <td align="left"></td><td align="left" class="Lrule"><span class="Bold">A</span></td><td align="left" colspan="3"><span class="Bold">After the beep, check the color of the status light.</span></td> </tr> <tr> <td align="left">3</td><td align="left"></td><td align="left"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-63.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/> Check to see if the status light is <span class="Bold">SOLID GREEN</span> or has switched off. This means the dose is complete.<br/> If the dose is complete, go to the next step.<br/> <span class="Bold">Do not</span> remove the on-body injector if the status light is flashing green.</td><td align="left" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-64.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/><br/> If you see the status light is <span class="Bold">FLASHING RED</span>, and your on-body injector is beeping, your on-body injector is not functioning properly. <br/> Call your healthcare provider right away, as you may need a replacement dose.</td> </tr> <tr> <td align="left" valign="top">B</td><td align="left" class="Lrule" colspan="3"><span class="Bold">Grab the edge of the adhesive pad. Slowly peel off the on-body injector.</span></td><td align="left"></td> </tr> <tr> <td align="left"></td><td align="left" colspan="3"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-65.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" valign="bottom">4</td> </tr> <tr> <td align="left"></td><td align="left" colspan="3"> <ul> <li> <span class="Bold">Do not</span> grasp the on-body injector itself to try to pull it off of your body.</li> <li>If medicine has leaked or the adhesive is noticeably wet or dripping, call your healthcare provider right away, as you may not have received your full dose and you may need a replacement dose. </li> <li>Remove any extra adhesive using soap and water.</li> </ul> </td><td align="left"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<col align=\"left\" valign=\"top\" width=\"40%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"></td><td align=\"left\" class=\"Lrule\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"3\"><span class=\"Bold\">After the beep, check the color of the status light.</span></td>\n</tr>\n<tr>\n<td align=\"left\">3</td><td align=\"left\"></td><td align=\"left\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-63.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>\t\t\t\t\t\t\t\t\tCheck to see if the status light is <span class=\"Bold\">SOLID GREEN</span> or has switched off. This means the dose is complete.<br/>\t\t\t\t\t\t\t\t\tIf the dose is complete, go to the next step.<br/>\n<span class=\"Bold\">Do not</span> remove the on-body injector if the status light is flashing green.</td><td align=\"left\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-64.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/><br/>\t\t\t\t\t\t\t\t\tIf you see the status light is <span class=\"Bold\">FLASHING RED</span>, and your on-body injector is beeping, your on-body injector is not functioning properly. <br/>\t\t\t\t\t\t\t\t\tCall your healthcare provider right away, as you may need a replacement dose.</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\">B</td><td align=\"left\" class=\"Lrule\" colspan=\"3\"><span class=\"Bold\">Grab the edge of the adhesive pad. Slowly peel off the on-body injector.</span></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\" colspan=\"3\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-65.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" valign=\"bottom\">4</td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\" colspan=\"3\">\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> grasp the on-body injector itself to try to pull it off of your body.</li>\n<li>If medicine has leaked or the adhesive is noticeably wet or dripping, call your healthcare provider right away, as you may not have received your full dose and you may need a replacement dose. </li>\n<li>Remove any extra adhesive using soap and water.</li>\n</ul>\n</td><td align=\"left\"></td>\n</tr>\n</tbody>\n</table></div>" }

Step 4: Finish

{ "type": "p", "children": [], "text": "\n\tStep 4: Finish\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="5%"/> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="60%"/> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="5%"/> <tbody class="Headless"> <tr> <td align="center" colspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-66.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left" colspan="3" valign="bottom"><span class="Bold">Check to see if your on-body injector is empty.</span></td> </tr> <tr> <td align="center" valign="middle">4</td><td align="left"></td><td align="left" colspan="3"> <ul class="Disc"> <li>Check your status light. Watch for at least 10 seconds. If the status light is solid green or it has switched off, it is okay.</li> <li>You should see a black line next to the EMPTY indicator. If the on-body injector is not empty, call your healthcare provider right away, as you may need a replacement dose. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=neulasta-67.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></li> <li>If you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider right away.</li> <li>If the needle is exposed, call your healthcare provider right away.</li> </ul> </td> </tr> <tr> <td align="center" class="Rrule"><span class="Bold">A</span></td><td align="left" colspan="4"><span class="Bold">Check off the box below to record how your on-body injector looks after use.</span></td> </tr> <tr> <td align="center"></td><td align="right">⃞</td><td align="left" colspan="3">Status light is solid green or the status light has switched off.<br/>This means that the delivery is complete.</td> </tr> <tr> <td align="center"></td><td align="right">⃞</td><td align="left" colspan="3">On-body injector leaked, call your healthcare provider right away, as you may need a replacement dose.</td> </tr> <tr> <td align="center"></td><td align="right">⃞</td><td align="left" colspan="3">Status light is red, call your healthcare provider right away, as you may need a replacement dose.</td> </tr> <tr> <td align="center" class="Rrule"><span class="Bold">B</span></td><td align="left" colspan="2"><span class="Bold">Properly dispose of the on-body injector.</span></td><td align="left"></td><td align="left"></td> </tr> <tr> <td align="center"></td><td align="left" colspan="2"> <ul class="Disc"> <li>After on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not.</li> <li>The on-body injector contains batteries, electronics, and a needle. Put the on-body injector in a FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) the on-body injector in your household trash.</span> </li> <li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<ul class="Circle"> <li>made of a heavy-duty plastic,</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li> <li>upright and stable during use, </li> <li>leak-resistant, and</li> <li>properly labeled to warn of hazardous waste inside the container</li> </ul> </li> <li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. </li> <li>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</li> <li>For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA's website at: http://www.fda.gov/safesharpsdisposal.</li> </ul> </td><td align="left" valign="middle"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-68.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"></td> </tr> <tr> <td align="center"></td><td align="left" colspan="2"> <ul class="Disc"> <li>To participate in Amgen's voluntary disposal program, please call <span class="Bold">1-844-MYNEULASTA (1-844-696-3852)</span> or visit <span class="Bold">www.neulasta.com</span> to enroll. </li> </ul> </td><td align="left"></td><td align="left" valign="bottom">FAQ</td> </tr> <tr> <td align="center"></td><td align="left" colspan="4"> <ul class="Disc"> <li> <span class="Bold">Keep the used on-body injector and sharps disposal container away from children. </span> </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<col align=\"left\" valign=\"top\" width=\"60%\"/>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"5%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" colspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-66.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\" colspan=\"3\" valign=\"bottom\"><span class=\"Bold\">Check to see if your on-body injector is empty.</span></td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"middle\">4</td><td align=\"left\"></td><td align=\"left\" colspan=\"3\">\n<ul class=\"Disc\">\n<li>Check your status light. Watch for at least 10 seconds. If the status light is solid green or it has switched off, it is okay.</li>\n<li>You should see a black line next to the EMPTY indicator. If the on-body injector is not empty, call your healthcare provider right away, as you may need a replacement dose. \t\t\t\t\t\t\t\t\t\t<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-67.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></li>\n<li>If you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider right away.</li>\n<li>If the needle is exposed, call your healthcare provider right away.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Rrule\"><span class=\"Bold\">A</span></td><td align=\"left\" colspan=\"4\"><span class=\"Bold\">Check off the box below to record how your on-body injector looks after use.</span></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"right\">⃞</td><td align=\"left\" colspan=\"3\">Status light is solid green or the status light has switched off.<br/>This means that the delivery is complete.</td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"right\">⃞</td><td align=\"left\" colspan=\"3\">On-body injector leaked, call your healthcare provider right away, as you may need a replacement dose.</td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"right\">⃞</td><td align=\"left\" colspan=\"3\">Status light is red, call your healthcare provider right away, as you may need a replacement dose.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Rrule\"><span class=\"Bold\">B</span></td><td align=\"left\" colspan=\"2\"><span class=\"Bold\">Properly dispose of the on-body injector.</span></td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>After on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not.</li>\n<li>The on-body injector contains batteries, electronics, and a needle. Put the on-body injector in a FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) the on-body injector in your household trash.</span>\n</li>\n<li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<ul class=\"Circle\">\n<li>made of a heavy-duty plastic,</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li>\n<li>upright and stable during use, </li>\n<li>leak-resistant, and</li>\n<li>properly labeled to warn of hazardous waste inside the container</li>\n</ul>\n</li>\n<li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. </li>\n<li>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</li>\n<li>For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA's website at: http://www.fda.gov/safesharpsdisposal.</li>\n</ul>\n</td><td align=\"left\" valign=\"middle\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-68.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\"></td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\" colspan=\"2\">\n<ul class=\"Disc\">\n<li>To participate in Amgen's voluntary disposal program, please call <span class=\"Bold\">1-844-MYNEULASTA (1-844-696-3852)</span> or visit <span class=\"Bold\">www.neulasta.com</span> to enroll. </li>\n</ul>\n</td><td align=\"left\"></td><td align=\"left\" valign=\"bottom\">FAQ</td>\n</tr>\n<tr>\n<td align=\"center\"></td><td align=\"left\" colspan=\"4\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Keep the used on-body injector and sharps disposal container away from children. </span>\n</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Frequently Asked Questions

{ "type": "p", "children": [], "text": "\nFrequently Asked Questions\n" }

How do I know it is safe to remove the on-body injector?

{ "type": "p", "children": [], "text": "\nHow do I know it is safe to remove the on-body injector?\n" }

It is safe to remove the on-body injector after checking the following:

{ "type": "p", "children": [], "text": "\nIt is safe to remove the on-body injector after checking the following:\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-69.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"> <ul class="Disc"> <li>The status light should be solid green.</li> <li>If the status light is flashing green, the dose delivery is not complete. Wait until you hear a long beep and the status light turns solid green before removing your on-body injector.</li> <li>The status light turns off 1 hour after delivery completion </li> </ul> </td> </tr> <tr> <td align="center"><img alt="Figure" src="/dailymed/image.cfm?name=neulasta-70.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce"/></td><td align="left"> <ul class="Disc"> <li>The fill indicator should have a black line next to EMPTY </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-69.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\">\n<ul class=\"Disc\">\n<li>The status light should be solid green.</li>\n<li>If the status light is flashing green, the dose delivery is not complete. Wait until you hear a long beep and the status light turns solid green before removing your on-body injector.</li>\n<li>The status light turns off 1 hour after delivery completion </li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=neulasta-70.jpg&amp;setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce\"/></td><td align=\"left\">\n<ul class=\"Disc\">\n<li>The fill indicator should have a black line next to EMPTY </li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

FAQ

{ "type": "p", "children": [], "text": "FAQ" }

What to do if you hear beeping or when you look at the status light and it is flashing red?

{ "type": "p", "children": [], "text": "\nWhat to do if you hear beeping or when you look at the status light and it is flashing red?\n" }

{ "type": "ul", "children": [ "If the status light is flashing red, you may not have received your full dose and may need a replacement dose. Call your healthcare provider right away. " ], "text": "" }

What do I do if the on-body injector comes off before the full dose is delivered?

{ "type": "p", "children": [], "text": "\nWhat do I do if the on-body injector comes off before the full dose is delivered?\n" }

{ "type": "ul", "children": [ "Call your healthcare provider right away if the on-body injector at any time comes away from your skin before your full dose delivery, as you may need a replacement dose. Do not reapply it." ], "text": "" }

What if there is blood at my application site after the on-body injector has been removed?

{ "type": "p", "children": [], "text": "\nWhat if there is blood at my application site after the on-body injector has been removed?\n" }

{ "type": "ul", "children": [ "If there is blood, press a clean cotton ball or gauze pad on the application site. Apply an adhesive bandage if needed." ], "text": "" }

What if my application site is red or tender after on-body injector removal?

{ "type": "p", "children": [], "text": "\nWhat if my application site is red or tender after on-body injector removal?\n" }

{ "type": "ul", "children": [ "Call your healthcare provider right away if you experience persistent or worsening redness or tenderness at the application site, as this can be a sign of infection." ], "text": "" }

Notes

{ "type": "p", "children": [], "text": "Notes" }

Neulasta® Onpro®

{ "type": "p", "children": [], "text": "\nNeulasta® Onpro®\n" }

Patient INSTRUCTIONS FOR USE

{ "type": "p", "children": [], "text": "\nPatient INSTRUCTIONS FOR USE\n" }

Neulasta® (pegfilgrastim)

{ "type": "p", "children": [], "text": "Neulasta® (pegfilgrastim)" }

Manufactured by: Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License No. 1080

{ "type": "p", "children": [], "text": "\nManufactured by:\nAmgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License No. 1080" }

Patent: http://pat.amgen.com/onpro/

{ "type": "p", "children": [], "text": "Patent: http://pat.amgen.com/onpro/" }

© 2002 to 2025 Amgen Inc. All rights reserved.

{ "type": "p", "children": [], "text": "© 2002 to 2025 Amgen Inc. All rights reserved." }

http://www.neulasta.com

{ "type": "p", "children": [], "text": "http://www.neulasta.com" }

1-844-MYNEULASTA (1-844-696-3852) Revised: 11/2020 V10

{ "type": "p", "children": [], "text": "1-844-MYNEULASTA (1-844-696-3852) Revised: 11/2020 V10" }

1 - Single Dose Neulasta Prefilled Syringe

{ "type": "p", "children": [], "text": "1 - Single Dose Neulasta Prefilled Syringe" }

1 - Sterile On-body Injector for Neulasta

{ "type": "p", "children": [], "text": "1 - Sterile On-body Injector for Neulasta" }

NDC 55513-192-01

{ "type": "p", "children": [], "text": "NDC 55513-192-01" }

AMGEN

{ "type": "p", "children": [], "text": "AMGEN" }

Neulasta® (pegfilgrastim) injection Onpro® kit

{ "type": "p", "children": [], "text": "Neulasta®\n(pegfilgrastim) injection Onpro®\n kit" }

Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli

{ "type": "p", "children": [], "text": "Pegylated Recombinant Methionyl Human Granulocyte \t\t\t\t\t\tColony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli" }

6 mg/0.6 mL*

{ "type": "p", "children": [], "text": "6 mg/0.6 mL*" }

6 mg/0.6 mL*

{ "type": "p", "children": [], "text": "6 mg/0.6 mL*" }

* Prefilled syringe contains 0.64 mL to deliver6 mg/0.6 mL when used with on-body injector

{ "type": "p", "children": [], "text": "* Prefilled syringe contains 0.64 mL to deliver6 mg/0.6 mL when used with on-body injector" }

For Subcutaneous Use Only

{ "type": "p", "children": [], "text": "For Subcutaneous Use Only" }

Carton Contents (intended to be dispensed as a unit):

{ "type": "p", "children": [], "text": "Carton Contents (intended to be dispensed as a unit):" }

{ "type": "ul", "children": [ "1 sterile On-body Injector for Neulasta", "1 Neulasta prefilled syringe labeled for use with on-body injector only", "1 patient instructions for use", "1 healthcare provider instructions for use, 1 package insert" ], "text": "" }

This Product Contains Dry Natural Rubber Store at 2° to 8°C (36° to 46°F).Do Not Freeze or Shake. Keep in Carton to Protect from Light.

{ "type": "p", "children": [], "text": "This Product Contains Dry Natural Rubber\t\t\t\t\t\tStore at 2° to 8°C (36° to 46°F).Do Not Freeze or Shake. \t\t\t\t\t\tKeep in Carton to Protect from Light." }

See package insert for full prescribing information and Instructions for Use

{ "type": "p", "children": [], "text": "See package insert for full prescribing \t\t\t\t\t\tinformation and Instructions for Use" }

Rx Only

{ "type": "p", "children": [], "text": "Rx Only" }

Principal Display Panel

{ "type": "p", "children": [], "text": "Principal Display Panel" }

NDC 55513-190-01

{ "type": "p", "children": [], "text": "NDC 55513-190-01" }

1 - 0.6 mL Single Dose Prefilled Syringe

{ "type": "p", "children": [], "text": "1 - 0.6 mL Single Dose Prefilled Syringe" }

AMGEN®

{ "type": "p", "children": [], "text": "AMGEN®\n" }

Neulasta ®

{ "type": "p", "children": [], "text": "Neulasta ®\n" }

(pegfilgrastim) injection

{ "type": "p", "children": [], "text": "(pegfilgrastim) injection" }

Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor

{ "type": "p", "children": [], "text": "Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor" }

(PEG-r-metHuG-CSF) derived from E Coli

{ "type": "p", "children": [], "text": "(PEG-r-metHuG-CSF) derived from E Coli\n" }

6 mg

{ "type": "p", "children": [], "text": "6 mg" }

6 mg in 0.6 mL Single Dose Prefilled Syringe

{ "type": "p", "children": [], "text": "6 mg in 0.6 mL Single Dose Prefilled Syringe" }

For Subcutaneous Use Only

{ "type": "p", "children": [], "text": "For Subcutaneous Use Only" }

This Product Contains Dry Natural Rubber

{ "type": "p", "children": [], "text": "This Product Contains Dry Natural Rubber" }

Sterile Solution – No Preservative

{ "type": "p", "children": [], "text": "Sterile Solution – No Preservative" }

Rx Only

{ "type": "p", "children": [], "text": "Rx Only" }

Manufactured by Amgen Inc.

{ "type": "p", "children": [], "text": "Manufactured by Amgen Inc." }

Thousand Oaks, CA 91320-1799 U.S.A.

{ "type": "p", "children": [], "text": "Thousand Oaks, CA 91320-1799 U.S.A." }

U.S. License No. 1080

{ "type": "p", "children": [], "text": "U.S. License No. 1080" }

UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)].

The recommended dosage of UDENYCA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer UDENYCA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

The recommended dose of UDENYCA is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.

Obtain a baseline complete blood count (CBC). Do not delay administration of UDENYCA if a CBC is not readily available. Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

UDENYCA is administered subcutaneously via a single-dose prefilled autoinjector, a single-dose prefilled syringe for manual use or for use with the on-body injector (OBI) for UDENYCA, which is co-packaged with a single dose prefilled syringe for OBI. Use of the OBI for UDENYCA is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome. Use of the OBI has not been studied in pediatric patients.

Prior to use‚ remove the carton from the refrigerator and allow UDENYCA to reach room temperature for a minimum of 30 minutes. Discard any UDENYCA left at room temperature for greater than 48 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer UDENYCA if discoloration or particulates are observed.

The needle cap on the prefilled syringe and prefilled autoinjector is not made with natural rubber latex.

Pediatric Patients Weighing Less than 45 kg

The UDENYCA prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks which are necessary to accurately measure doses of UDENYCA less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

<div class="scrollingtable"><table width="95%"> <caption> <span>Table 1. Dosing of UDENYCA for pediatric patients weighing less than 45 kg</span> </caption> <col align="left" valign="middle" width="25%"/> <col align="left" valign="middle" width="50%"/> <col align="left" valign="middle" width="25%"/> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of UDENYCA</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <th align="left" class="Botrule Lrule Rrule">Body Weight</th><th align="left" class="Botrule Rrule">UDENYCA Dose</th><th align="left" class="Botrule Rrule">Volume to Administer</th> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Less than 10 kg<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></td><td align="left" class="Botrule Rrule">See below<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Botrule Rrule">See below<a class="Sup" href="#footnote-2">*</a></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">10 - 20 kg</td><td align="left" class="Botrule Rrule">1.5 mg</td><td align="left" class="Botrule Rrule">0.15 mL</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">21 - 30 kg</td><td align="left" class="Botrule Rrule">2.5 mg</td><td align="left" class="Botrule Rrule">0.25 mL</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule">31 - 44 kg</td><td align="left" class="Botrule Rrule">4 mg</td><td align="left" class="Botrule Rrule">0.4 mL</td> </tr> </tbody> </table></div>

The UDENYCA prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45 kg. The UDENYCA prefilled autoinjector delivers the entire contents (6 mg in 0.6 mL) in a single injection and is not adjustable.

Only adults can self-administer UDENYCA with the prefilled autoinjector. If subcutaneous injections can be given at home, refer the patient or caregiver to the dose delivery information provided in the Instructions for Use. Provide training to patients or caregivers to ensure they understand how to administer UDENYCA via the prefilled autoinjector. Ensure patients or caregivers understand how to identify that a full dose has been administered by listening for the second 'click' and checking that the 'Orange Indicator' completely blocks the viewing window. Instruct patients or caregivers using the prefilled autoinjector to notify their healthcare provider immediately in order to determine the need for a replacement dose of UDENYCA if they suspect that the full dose may not have been administered.

A healthcare provider must fill the on-body injector (OBI) with UDENYCA using the prefilled syringe and then apply the OBI for UDENYCA to the patient's skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI for UDENYCA. Approximately 27 hours after the OBI for UDENYCA is applied to the patient's skin, UDENYCA will be delivered over approximately 5 minutes. A healthcare provider may initiate administration with the OBI for UDENYCA on the same day as the administration of cytotoxic chemotherapy, as long as the OBI for UDENYCA delivers UDENYCA no less than 24 hours after administration of cytotoxic chemotherapy.

The prefilled syringe co-packaged in UDENYCA ONBODY must only be used with the OBI for UDENYCA. The prefilled syringe contains additional solution to compensate for liquid loss during filling of the OBI and delivery through the OBI for UDENYCA. If the prefilled syringe co-packaged in UDENYCA ONBODY is used for manual subcutaneous injection, the patient will receive an overdose. If the single-dose prefilled syringe for manual use is used with the OBI for UDENYCA, the patient may receive less than the recommended dose.

Do not use the OBI for UDENYCA to deliver any other drug product except the UDENYCA prefilled syringe co-packaged with the OBI for UDENYCA.

The OBI for UDENYCA should be applied to intact, non-irritated skin on the arm or abdomen.

A missed dose could occur due to an OBI for UDENYCA failure or leakage. If the patient misses a dose, a new dose should be administered by single-dose prefilled syringe for manual use, as soon as possible after detection.

Refer to the Healthcare Provider Instructions for Use for the OBI for UDENYCA for full administration information.

Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (OBI) for UDENYCA (this includes the 5-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.

Refer the patient to the dose delivery information written on the Patient Instructions for Use. Provide training to patients to ensure they understand when the dose delivery of UDENYCA will begin and how to monitor the OBI for UDENYCA for completed delivery. Ensure patients understand how to identify signs of malfunction of OBI for UDENYCA [see Warnings and Precautions (5.12) and Patient Counseling Information (17)]. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended [see Warnings and Precautions (5.12)].

UDENYCA is a clear, colorless, preservative free solution available as:

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UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)]." }

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving UDENYCA.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving UDENYCA for ARDS. Discontinue UDENYCA in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions. Do not administer UDENYCA to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products.

The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue UDENYCA if sickle cell crisis occurs.

Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of UDENYCA.

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.

Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.

Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Missed or partial doses have been reported in patients receiving UDENYCA via the on-body injector (OBI) due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered.

Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue UDENYCA if aortitis is suspected.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received pegfilgrastim after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg pegfilgrastim (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American or other.

The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity.

<div class="scrollingtable"><table width="95%"> <caption> <span>Table 2. Adverse Reactions with ≥ 5% Higher Incidence in pegfilgrastim Patients Compared to Placebo in Study 3</span> </caption> <col align="left" valign="middle" width="50%"/> <col align="left" valign="middle" width="15%"/> <col align="left" valign="middle" width="35%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule">Body System<br/>     Adverse Reaction</th><th align="left" class="Botrule Rrule">Placebo<br/>(N = 461)</th><th align="left" class="Botrule Rrule">pegfilgrastim 6 mg SC on Day 2<br/>(N = 467)</th> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Botrule Lrule Rrule" colspan="3">Musculoskeletal and connective tissue disorders</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">Bone pain</td><td align="left" class="Botrule Rrule">26%</td><td align="left" class="Botrule Rrule">31%</td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule">Pain in extremity</td><td align="left" class="Botrule Rrule">4%</td><td align="left" class="Botrule Rrule">9%</td> </tr> </tbody> </table></div>

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 x 109/L was observed in less than 1% of 932 patients with non-myeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of pegfilgrastim or of other pegfilgrastim products.

Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

The following adverse reactions have been identified during post approval use of pegfilgrastim products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Risk Summary

Although available data with UDENYCA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryo lethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.

Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

Risk Summary

There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UDENYCA and any potential adverse effects on the breastfed child from UDENYCA or from the underlying maternal condition.

The safety and effectiveness of UDENYCA have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.

Use of UDENYCA in pediatric patients for chemotherapy-induced neutropenia is based on UDENYCA's approval as a biosimilar to pegfilgrastim and evidence from adequate and well controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1)].

The use of UDENYCA to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on UDENYCA's approval as a biosimilar to pegfilgrastim and evidence from efficacy studies of pegfilgrastim conducted in animals and clinical data supporting the use of pegfilgrastim in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of pegfilgrastim (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.3), Clinical Pharmacology (12.3) and Clinical Studies (14.2)].

Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)].

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Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa.

{ "type": "p", "children": [], "text": "Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and\nmonomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa." }

UDENYCA (pegfilgrastim-cbqv) injection is provided in three presentations:

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The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection, the prefilled autoinjector or the OBI for UDENYCA contains 6 mg pegfilgrastim-cbqv (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.

{ "type": "p", "children": [], "text": "The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection, the prefilled autoinjector or the OBI for UDENYCA contains 6 mg pegfilgrastim-cbqv (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP." }

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Animal data and clinical data in humans suggest a correlation between pegfilgrastim products exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of UDENYCA is based on reducing the duration of severe neutropenia.

The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the on-body-injector (OBI) for UDENYCA.

Specific Populations

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)].

Renal Impairment

In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.

Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy

The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies 14.1]. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13). The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively.

Patients Acutely Exposed to Myelosuppressive Doses of Radiation

The pharmacokinetics of pegfilgrastim is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of pegfilgrastim, appears to be greater than in humans receiving a 6 mg dose. Results from population modeling and simulation indicate that two 6 mg doses of pegfilgrastim administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight-based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration, Section 2.3, Table 1] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products.

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active- controlled studies that employed doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of pegfilgrastim. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of pegfilgrastim was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.

Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of pegfilgrastim-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)].

A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x109/L) was lower for pegfilgrastim-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.

Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see Clinical Pharmacology (12.3)] of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous pegfilgrastim as a single dose of 100 mcg/kg (n= 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n=6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.

Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval of this indication was based on efficacy studies conducted in animals and data supporting pegfilgrastim's effect on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy [see Dosage and Administration (2.1)].

The recommended dose of UDENYCA is two doses, 6 mg each, administered one week apart for humans exposed to myelosuppressive doses of radiation. For pediatric patients weighing less than 45 kg, dosing of UDENYCA is weight based and is provided in Table 1 [see Dosage and Administration (2.3)]. This dosing regimen is based on population modeling and simulation analyses. The exposure associated with this dosing regimen is expected to provide sufficient pharmacodynamic activity to treat humans exposed to myelosuppressive doses of radiation [see Clinical Pharmacology (12.3)]. The safety of pegfilgrastim at a dose of 6 mg has been assessed on the basis of clinical experience in patients with cancer receiving myelosuppressive chemotherapy.

The efficacy of pegfilgrastim for the acute radiation syndrome setting was studied in a randomized, placebo- controlled non-human primate model of radiation injury. Rhesus macaques were randomized to either a control (n = 23) or treated (n = 23) cohort. On study day 0, animals (n = 6 to 8 per irradiation day) were exposed to total body irradiation (TBI) of 7.50 ± 0.15 Gy delivered at 0.8 ± 0.03 Gy/min, representing a dose that would be lethal in 50% of animals by 60 days of follow-up (LD50/60). Animals were administered subcutaneous injections of a blinded treatment (control article [5% dextrose in water] or pegfilgrastim [300-319 mcg/kg/day]) on study day 1 and on study day 8. The primary endpoint was survival. Animals received medical management consisting of intravenous fluids, antibiotics, blood transfusions, and other support as required.

Pegfilgrastim significantly (at 0.0014 level of significance) increased 60-day survival in irradiated non-human primates: 91% survival (21/23) in the pegfilgrastim group compared to 48% survival (11/23) in the control group.

UDENYCA single-dose prefilled syringe for manual use

{ "type": "p", "children": [], "text": "\nUDENYCA single-dose prefilled syringe for manual use\n" }

UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe containing 6 mg pegfilgrastim-cbqv, supplied with a 29-gauge, 1⁄2-inch needle with an UltraSafe Passive™ Needle Guard.

{ "type": "p", "children": [], "text": "UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe containing 6 mg pegfilgrastim-cbqv, supplied with a 29-gauge, 1⁄2-inch needle with an UltraSafe Passive™ Needle Guard." }

The needle cap of the prefilled syringe is not made with natural rubber latex.

{ "type": "p", "children": [], "text": "The needle cap of the prefilled syringe is not made with natural rubber latex." }

UDENYCA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70114-101-01).

{ "type": "p", "children": [], "text": "UDENYCA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70114-101-01)." }

UDENYCA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

{ "type": "p", "children": [], "text": "UDENYCA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe." }

Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once.

{ "type": "p", "children": [], "text": "Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once." }

UDENYCA single-dose prefilled autoinjector

{ "type": "p", "children": [], "text": "\nUDENYCA single-dose prefilled autoinjector\n" }

UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose autoinjector containing 6 mg pegfilgrastim-cbqv.

{ "type": "p", "children": [], "text": "UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose autoinjector containing 6 mg pegfilgrastim-cbqv." }

The needle cap of the prefilled autoinjector is not made with natural rubber latex.

{ "type": "p", "children": [], "text": "The needle cap of the prefilled autoinjector is not made with natural rubber latex." }

UDENYCA is provided in a dispensing pack containing one 6 mg/0.6 mL prefilled autoinjector (NDC 70114-120-01).

{ "type": "p", "children": [], "text": "UDENYCA is provided in a dispensing pack containing one 6 mg/0.6 mL prefilled autoinjector (NDC 70114-120-01).\n" }

The UDENYCA prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45 kg. The UDENYCA prefilled autoinjector delivers the entire contents (6 mg in 0.6 mL) in a single injection and is not adjustable.

{ "type": "p", "children": [], "text": "The UDENYCA prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45 kg. The UDENYCA prefilled autoinjector delivers the entire contents (6 mg in 0.6 mL) in a single injection and is not adjustable." }

Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once.

{ "type": "p", "children": [], "text": "Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once." }

UDENYCA ONBODY

{ "type": "p", "children": [], "text": "\nUDENYCA ONBODY\n" }

UDENYCA ONBODY is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for UDENYCA (NDC 70114-130-01).

{ "type": "p", "children": [], "text": "UDENYCA ONBODY is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for UDENYCA (NDC 70114-130-01)." }

The UDENYCA injection single-dose prefilled syringe contains 0.67 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim-cbqv when used with the OBI for UDENYCA. The prefilled syringe is supplied with a 29-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA.

{ "type": "p", "children": [], "text": "The UDENYCA injection single-dose prefilled syringe contains 0.67 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim-cbqv when used with the OBI for UDENYCA. The prefilled syringe is supplied with a 29-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA." }

The needle cap of the prefilled syringe is not made with natural rubber latex.

{ "type": "p", "children": [], "text": "The needle cap of the prefilled syringe is not made with natural rubber latex." }

Store UDENYCA ONBODY in the refrigerator at 2°C to 8°C (36°F to 46°F) until 30 minutes prior to use. Because the OBI for UDENYCA is at room temperature during the period of use, UDENYCA ONBODY should not be held at room temperature longer than 12 hours prior to use. Discard UDENYCA ONBODY if stored at room temperature for more than 12 hours.

{ "type": "p", "children": [], "text": "Store UDENYCA ONBODY in the refrigerator at 2°C to 8°C (36°F to 46°F) until 30 minutes prior to use. Because the OBI for UDENYCA is at room temperature during the period of use, UDENYCA ONBODY should not be held at room temperature longer than 12 hours prior to use. Discard UDENYCA ONBODY if stored at room temperature for more than 12 hours." }

Do not use the OBI for UDENYCA if its packaging has been previously opened.

{ "type": "p", "children": [], "text": "Do not use the OBI for UDENYCA if its packaging has been previously opened." }

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)" }

Advise patients of the following risks and potential risks with UDENYCA:

{ "type": "p", "children": [], "text": "Advise patients of the following risks and potential risks with UDENYCA:" }

{ "type": "ul", "children": [ "Splenic rupture and splenomegaly", "Acute Respiratory Distress Syndrome", "Serious allergic reactions", "Sickle cell crisis", "Glomerulonephritis", "Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive UDENYCA in conjunction with chemotherapy and/or radiation therapy", "Capillary Leak Syndrome", "Aortitis" ], "text": "" }

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)].

{ "type": "p", "children": [], "text": "Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)]." }

Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the:

{ "type": "p", "children": [], "text": "Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the:" }

{ "type": "ul", "children": [ "Importance of following the Instructions for Use (see Instructions for Use).", "Dangers of reusing syringes.", "Importance of following local requirements for proper disposal of used syringes." ], "text": "" }

For patients who will use the UDENYCA prefilled autoinjector, tell them that they:

{ "type": "p", "children": [], "text": "For patients who will use the UDENYCA prefilled autoinjector, tell them that they:" }

{ "type": "ul", "children": [ "Will hear two \"clicks\" during the UDENYCA injection. The first 'click' means the start of injection and second 'click' means the end of injection.", "To start injection, push the prefilled autoinjector body down. Continue holding down after hearing the first 'click'.", "In the viewing window, the orange indicator will advance to show the progress of the injection." ], "text": "" }

When injection has finished, there will be a second 'click' and the 'Orange Indicator' will completely block the viewing window.

{ "type": "p", "children": [], "text": "When injection has finished, there will be a second 'click' and the 'Orange Indicator' will completely block the viewing window." }

Advise patients on the use of the on-body injector (OBI) for UDENYCA:

{ "type": "p", "children": [], "text": "Advise patients on the use of the on-body injector (OBI) for UDENYCA:" }

{ "type": "ul", "children": [ "Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.", "Refer the patient to the dose delivery information written on the Patient Instructions for Use.", "Tell the patient when their dose delivery of UDENYCA will begin and when their dose delivery should be\ncompleted.", "Advise the patient that serious allergic reactions can happen with UDENYCA. Patients should have a\ncaregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the OBI for UDENYCA during the approximately 5 minutes UDENYCA delivery and for an hour after the delivery. Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the OBI for UDENYCA.", "If the OBI for UDENYCA is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the OBI for UDENYCA.", "If a patient calls the healthcare provider regarding any OBI for UDENYCA problems, the healthcare provider is advised to call Coherus at 1-800-483-3692.", "Advise the patient:\n \nto call their healthcare provider immediately if the status light on the OBI for UDENYCA is\nflashing red (see the Patient Instructions for Use).\nto inform their healthcare provider if the adhesive on the OBI for UDENYCA becomes saturated\nwith fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in\ninadequate or missed dose (see the Patient Instructions for Use).\nto keep the OBI for UDENYCA dry for approximately the last 3 hours prior to the dose delivery\nstart to better enable potential leak detection.\nthat the OBI for UDENYCA should only be exposed to temperatures between 41°F and 104°F\n(5°C to 40°C).\nto keep the OBI for UDENYCA at least 4 inches away from electrical equipment such as cell\nphones, cordless telephones, microwaves, and other common appliances. Failure to keep the OBI for UDENYCA at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA.\nthat if the needle is exposed after OBI for UDENYCA removal, place the used OBI for UDENYCA in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately.\nto remove the OBI for UDENYCA after the green light shines continuously and to place the used OBI for UDENYCA in a sharps disposal container (see the Patient Instructions for Use).\n\n", "Advise the patient:\n \ndo not reapply the OBI for UDENYCA if the OBI for UDENYCA comes off before full dose is\ndelivered and instead call their healthcare provider immediately, as they may need a replacement dose.\navoid bumping the OBI for UDENYCA or knocking the OBI for UDENYCA off the body.\ndo not use other materials to hold the on-body injector in place that could cover audio/visual\nindicators or compress the on-body injector against the patient’s skin, as this could dislodge the cannula and lead to a missed dose or incomplete dose of UDENYCA.\ndo not expose the OBI for UDENYCA to medical imaging studies (e.g., X-ray scan, MRI, CT\nscan and ultrasound), radiation treatment, and oxygen rich environments such as hyperbaric chambers to avoid OBI for UDENYCA damage and patient injury.\n\n", "Advise the patient to avoid:\n \nairport X-ray scans and request a manual pat down instead; remind patients who elect to request a\nmanual pat down to exercise care to avoid having the OBI for UDENYCA dislodged during the pat down process.\nsleeping on the OBI for UDENYCA or applying pressure on the OBI for UDENYCA as this may\naffect OBI for UDENYCA performance.\ngetting body lotions, creams, oils, and cleaning agents near the OBI for UDENYCA as these\nproducts may loosen the adhesive.\nuse of lotions, creams, or oils on their arms and abdomen prior to their next scheduled OBI for\nUDENYCA dose (to help with device adherence to the skin).\nusing bath tubs, hot tubs, whirlpools, or saunas and avoid exposing the OBI for UDENYCA to\ndirect sunlight as these may affect the drug.\npeeling off or disturbing the OBI for UDENYCA adhesive before delivery of full dose is complete.\n\n" ], "text": "" }

CoherusBioSciences

{ "type": "p", "children": [], "text": "\nCoherusBioSciences\n" }

UDENYCA® (pegfilgrastim-cbqv)

{ "type": "p", "children": [], "text": "UDENYCA® (pegfilgrastim-cbqv)" }

Manufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442U.S. License No. 2023

{ "type": "p", "children": [], "text": "\nManufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442U.S. License No. 2023" }

© 2021 Coherus BioSciences Inc. All rights reserved.

{ "type": "p", "children": [], "text": "© 2021 Coherus BioSciences Inc. All rights reserved." }

For more information, go to www.UDENYCA.com or call 1-800-4UDENYCA (1-800-483-3692)

{ "type": "p", "children": [], "text": "For more information, go to www.UDENYCA.com or call 1-800-4UDENYCA (1-800-483-3692)" }

PMD-0212, Rev. 00

{ "type": "p", "children": [], "text": "PMD-0212, Rev. 00" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="60%"/> <col align="right" valign="bottom" width="40%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Patient Information</span> <br/>UDENYCA<span class="Sup">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>Injection</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">What is UDENYCA?</span> <br/>UDENYCA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.<br/>Acute Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied in animals, because it could not be studied in people.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Do not take UDENYCA</span>if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>have a sickle cell disorder.</li> <li>have kidney problems.</li> <li>are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.</li> </ul> <span class="Bold">Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">How will I receive UDENYCA?</span> <ul> <li> <span class="Bold">UDENYCA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "<a href="#ifu1">Instructions for Use</a>" that comes with your UDENYCA for information on how to prepare and inject a dose of UDENYCA.</span> </li> <li>You and your caregiver will be shown how to prepare and inject UDENYCA before you use it.</li> <li>UDENYCA comes in a prefilled syringe or a prefilled autoinjector. Your healthcare provider will prescribe the type of UDENYCA that is right for you.</li> <li>Only adults can self-inject UDENYCA with the prefilled autoinjector.</li> <li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled syringe. or prefilled autoinjector. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled syringe or prefilled autoinjector.</li> <li>If you are receiving UDENYCA because you are also receiving chemotherapy, the last dose of UDENYCA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li> <li>If you miss a dose of UDENYCA, talk to your healthcare provider about when you should give your next dose.</li> <li>When using the UDENYCA prefilled autoinjector:<br/> <ul> <li>You may miss your dose or may not receive your full dose if you lift the prefilled autoinjector before you hear the second "click" or if the orange indicator does not completely fill the viewing window.</li> <li>Call your healthcare provider right away if this happens, as you may need a replacement dose of UDENYCA.</li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">What are possible side effects of UDENYCA?<br/>UDENYCA may cause serious side effects, including:</span> <ul> <li> <span class="Bold">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.</li> <li> <span class="Bold">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li> <li> <span class="Bold">Serious allergic reactions.</span> UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away.</li> <li> <span class="Bold">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li> <li> <span class="Bold">Kidney injury (glomerulonephritis).</span> UDENYCA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:<ul> <li>swelling of your face or ankles</li> <li>blood in your urine or dark colored urine</li> <li>you urinate less than usual</li> </ul> </li> <li> <span class="Bold">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with UDENYCA.</li> <li> <span class="Bold">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li> <li> <span class="Bold">Capillary Leak Syndrome.</span> UDENYCA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul> <li>swelling or puffiness and are urinating less than usual</li> <li>trouble breathing</li> <li>swelling of your stomach-area (abdomen) and feeling of fullness</li> <li>dizziness or feeling faint</li> <li>a general feeling of tiredness</li> </ul> </li> <li> <span class="Bold">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when UDENYCA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML).Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.</li> <li> <span class="Bold">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.</li> </ul> <span class="Bold">The most common side effects of UDENYCA</span> are pain in the bones, arms, and legs.<br/>These are not all the possible side effects of UDENYCA.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">How should I store UDENYCA?</span> <ul> <li>Store UDENYCA in the refrigerator between 36°F to 46°F (2°C to 8°C).</li> <li> <span class="Bold">Do not</span> freeze. If UDENYCA is accidentally frozen, allow it to thaw in the refrigerator before injecting.</li> <li> <span class="Bold">Do not</span> use UDENYCA that has been frozen more than 1 time. Use a new UDENYCA prefilled syringe or prefilled autoinjector.</li> <li>Throw away (dispose of) any UDENYCA that has been left at room temperature, 68ºF to 77ºF (20ºC to 25ºC), for more than 48 hours or frozen more than 1 time.</li> <li>Keep UDENYCA in the original carton to protect from light.</li> <li>Do not shake UDENYCA.</li> <li>Take UDENYCA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.</li> </ul> <span class="Bold">Keep UDENYCA out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of UDENYCA.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a <a href="#ppi1">Patient Information</a> leaflet. Do not use UDENYCA for a condition for which it was not prescribed. Do not give UDENYCA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about UDENYCA that is written for health professionals.</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in UDENYCA?</span> <br/> <span class="Bold">Active ingredient: </span>pegfilgrastim-cbqv<br/> <span class="Bold">Inactive ingredients: </span>acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule"><span class="Bold">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City, California 94065-1442<br/>U.S. License No. 2023<br/>© 2023 Coherus BioSciences Inc. All rights reserved.<br/> <br/>For more Information go to <a href="#_Ref">www.UDENYCA.com</a> or call 1-800-4UDENYCA (1-800-483-3692)<br/>PMD-0006 Rev. 06</td><td align="right" class="Botrule Rrule"><span class="Bold">Coherus<br/>BioSciences</span></td> </tr> <tr class="Last"> <td align="left">This Patient Information has been approved by the U.S. Food and Drug Administration</td><td align="right">Revised: 03/2023</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"60%\"/>\n<col align=\"right\" valign=\"bottom\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Patient Information</span>\n<br/>UDENYCA<span class=\"Sup\">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>Injection</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is UDENYCA?</span>\n<br/>UDENYCA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.<br/>Acute Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied in animals, because it could not be studied in people.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Do not take UDENYCA</span>if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>have a sickle cell disorder.</li>\n<li>have kidney problems.</li>\n<li>are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How will I receive UDENYCA?</span>\n<ul>\n<li>\n<span class=\"Bold\">UDENYCA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed \"<a href=\"#ifu1\">Instructions for Use</a>\" that comes with your UDENYCA for information on how to prepare and inject a dose of UDENYCA.</span>\n</li>\n<li>You and your caregiver will be shown how to prepare and inject UDENYCA before you use it.</li>\n<li>UDENYCA comes in a prefilled syringe or a prefilled autoinjector. Your healthcare provider will prescribe the type\nof UDENYCA that is right for you.</li>\n<li>Only adults can self-inject UDENYCA with the prefilled autoinjector.</li>\n<li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled\nsyringe. or prefilled autoinjector. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the\nUDENYCA prefilled syringe or prefilled autoinjector.</li>\n<li>If you are receiving UDENYCA because you are also receiving chemotherapy, the last dose of UDENYCA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.</li>\n<li>If you miss a dose of UDENYCA, talk to your healthcare provider about when you should give your next dose.</li>\n<li>When using the UDENYCA prefilled autoinjector:<br/>\n<ul>\n<li>You may miss your dose or may not receive your full dose if you lift the prefilled autoinjector before you hear the second \"click\" or if the orange indicator does not completely fill the viewing window.</li>\n<li>Call your healthcare provider right away if this happens, as you may need a replacement dose of UDENYCA.</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are possible side effects of UDENYCA?<br/>UDENYCA may cause serious side effects, including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.</li>\n<li>\n<span class=\"Bold\">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away.</li>\n<li>\n<span class=\"Bold\">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.</li>\n<li>\n<span class=\"Bold\">Kidney injury (glomerulonephritis).</span> UDENYCA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:<ul>\n<li>swelling of your face or ankles</li>\n<li>blood in your urine or dark colored urine</li>\n<li>you urinate less than usual</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with UDENYCA.</li>\n<li>\n<span class=\"Bold\">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li>\n<li>\n<span class=\"Bold\">Capillary Leak Syndrome.</span> UDENYCA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called \"Capillary Leak Syndrome\" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:<ul>\n<li>swelling or puffiness and are urinating less than usual</li>\n<li>trouble breathing</li>\n<li>swelling of your stomach-area (abdomen) and feeling of fullness</li>\n<li>dizziness or feeling faint</li>\n<li>a general feeling of tiredness</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when UDENYCA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML).Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.</li>\n<li>\n<span class=\"Bold\">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.</li>\n</ul>\n<span class=\"Bold\">The most common side effects of UDENYCA</span> are pain in the bones, arms, and legs.<br/>These are not all the possible side effects of UDENYCA.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I store UDENYCA?</span>\n<ul>\n<li>Store UDENYCA in the refrigerator between 36°F to 46°F (2°C to 8°C).</li>\n<li>\n<span class=\"Bold\">Do not</span> freeze. If UDENYCA is accidentally frozen, allow it to thaw in the refrigerator before injecting.</li>\n<li>\n<span class=\"Bold\">Do not</span> use UDENYCA that has been frozen more than 1 time. Use a new UDENYCA prefilled syringe or prefilled autoinjector.</li>\n<li>Throw away (dispose of) any UDENYCA that has been left at room temperature, 68ºF to 77ºF (20ºC to 25ºC), for more than 48 hours or frozen more than 1 time.</li>\n<li>Keep UDENYCA in the original carton to protect from light.</li>\n<li>Do not shake UDENYCA.</li>\n<li>Take UDENYCA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.</li>\n</ul>\n<span class=\"Bold\">Keep UDENYCA out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of UDENYCA.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a <a href=\"#ppi1\">Patient Information</a> leaflet. Do not use UDENYCA for a condition for which it was not prescribed. Do not give UDENYCA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about UDENYCA that is written for health professionals.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in UDENYCA?</span>\n<br/>\n<span class=\"Bold\">Active ingredient: </span>pegfilgrastim-cbqv<br/>\n<span class=\"Bold\">Inactive ingredients: </span>acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"> <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\"><span class=\"Bold\">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City, California 94065-1442<br/>U.S. License No. 2023<br/>© 2023 Coherus BioSciences Inc. All rights reserved.<br/>\n<br/>For more Information go to <a href=\"#_Ref\">www.UDENYCA.com</a> or call 1-800-4UDENYCA (1-800-483-3692)<br/>PMD-0006 Rev. 06</td><td align=\"right\" class=\"Botrule Rrule\"><span class=\"Bold\">Coherus<br/>BioSciences</span></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\">This Patient Information has been approved by the U.S. Food and Drug Administration</td><td align=\"right\">Revised: 03/2023</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Instructions for Use<br/>UDENYCA<span class="Sup">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>Injection</span> <br/>Single-Dose Prefilled Syringe </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Guide to Parts</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">      Before Use</span></td> </tr> <tr> <td align="center" class="Lrule Rrule" colspan="2"><img alt="image of UDENYCA before use" src="/dailymed/image.cfm?name=udenyca-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Important: </span>The needle is covered by a needle cap before use </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">      After Use</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2"><img alt="image of UDENYCA after use" src="/dailymed/image.cfm?name=udenyca-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Important<br/>Read the Patient Information for important information you need to know about<br/>UDENYCA before using these Instructions for Use.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Storing the UDENYCA prefilled syringe</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> <ul> <li>Store UDENYCA prefilled syringes in the refrigerator between 36°F to 46° F (2°C to 8°C).</li> <li>Keep the UDENYCA prefilled syringe in the original carton to protect from light.</li> <li> <span class="Bold">Do not </span>freeze UDENYCA. <ul> <li>If UDENYCA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.</li> <li>Throw away (dispose of) any UDENYCA prefilled syringes that have been frozen more than 1 time.</li> </ul> </li> <li>Throw away (dispose of) any UDENYCA prefilled syringes that have been left out at room temperature for more than 48 hours.</li> <li>Keep the UDENYCA prefilled syringe out of the reach of children.</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of storage - instructions for use" src="/dailymed/image.cfm?name=udenyca-02a.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Using the prefilled syringe</span></td> </tr> <tr> <td align="left" class="Lrule Rrule"> <ul> <li> <span class="Bold">It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.</span> </li> <li>Make sure that the name UDENYCA appears on the carton and prefilled syringe label.</li> <li>Check the carton and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL.</li> <li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled syringe.</li> <li> <span class="Bold">Do not </span> use a prefilled syringe after the expiration date on the label.</li> <li> <span class="Bold">Do not </span>shake the prefilled syringe</li> <li> <span class="Bold">Do not </span>remove the needle cap from the prefilled syringe until you are ready to inject.</li> <li> <span class="Bold">Do not </span>use the prefilled syringe if the carton is open or damaged.</li> <li> <span class="Bold">Do not </span>use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.</li> <li> <span class="Bold">Do not </span>attempt to activate the needle safety guard prior to injection</li> </ul> </td><td align="center" class="Lrule Rrule">  </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Call your healthcare provider if you have any questions. </td><td align="center" class="Botrule Lrule Rrule">  </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Prepare the injection</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">1 - Remove carton from refrigerator and check expiration date</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">1A: Remove the carton from the refrigerator and check the expiration date printed on the carton. (See <a href="#fig-3">Figure 3</a>)<br/> <span class="Bold">Do not </span> use if the expiration date has passed. </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of removal from storage - instructions for use" src="/dailymed/image.cfm?name=udenyca-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">1B: Open the carton and remove the sealed syringe tray. (See <a href="#fig-4">Figure 4</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of opening UDENYCA - instructions for use" src="/dailymed/image.cfm?name=udenyca-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">2 - Allow UDENYCA to reach room temperature and gather supplies</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">2A: Place the sealed syringe tray on a flat, clean work surface and allow it to sit at room temperature for at least 30 minutes. (See <a href="#fig-5">Figure 5</a>)<br/> <br/> <span class="Bold">Do not </span>attempt to warm up the syringe in any other way, such as a microwave, hot water, or direct sunlight.</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of time to reach room temp - instructions for use" src="/dailymed/image.cfm?name=udenyca-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">2B: Gather the following supplies: (See <a href="#fig-6">Figure 6</a>) <ul> <li>Alcohol wipe</li> <li>Cotton ball or gauze</li> <li>1 adhesive bandage</li> <li>Sharps disposal container</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of gathering supplies - instructions for use" src="/dailymed/image.cfm?name=udenyca-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">3 - Wash your hands and remove syringe from tray</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">3A: Wash your hands well with soap and warm water. (See <a href="#fig-7">Figure 7</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of proper hand washing - instructions for use" src="/dailymed/image.cfm?name=udenyca-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">3B: Open the tray by peeling away the cover. Remove the prefilled syringe from the tray by grasping the middle of the syringe body and carefully pulling it out of the tray. (See <a href="#fig-8">Figure 8</a>)<br/> For Safety reasons:<ul> <li> <span class="Bold">Do not </span>grab the plunger or the plunger head.</li> <li> <span class="Bold">Do not </span>grab the needle cap.</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of removal of UDENYCA from tray - instructions of use" src="/dailymed/image.cfm?name=udenyca-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">4 - Inspect the syringe and medicine</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Check the medicine through the Inspection Window. The medicine should be clear and colorless. It is normal to see 1 or more air bubbles in the syringe. Removal of the air is not needed. (See <a href="#fig-9">Figure 9</a>)<br/> <br/> <span class="Bold">Do not </span> use the prefilled syringe if:<ul> <li>the medicine appears discolored or cloudy.</li> <li>the medicine contains lumps, flakes, or particles.</li> <li>it appears used or damaged.</li> <li>the needle cap is missing or not securely attached.</li> <li>the expiration date printed on the label has passed.</li> </ul>In all cases, use a new prefilled syringe and call your healthcare provider.</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of visual inspection - instructions for use" src="/dailymed/image.cfm?name=udenyca-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Select and clean injection site</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">5 - Select and clean the injection site</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">5A: Select the injection site. The recommended injection sites for a subcutaneous injection are the: (See <a href="#fig-10">Figure 10</a>)<ul> <li>Abdomen (except for a two-inch area surrounding the navel)</li> <li>Thighs</li> <li>Back of upper arms (only if someone else is giving you the injection)</li> <li>Upper outer area of the buttocks (only if someone else is giving you the injection)</li> </ul> <span class="Bold">Do not </span> inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.<br/>If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of injection site selection - instructions for use" src="/dailymed/image.cfm?name=udenyca-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">5B: Clean the injection site with an alcohol wipe. (See <a href="#fig-11">Figure 11</a>)<br/> <br/> <span class="Bold">Do not </span> touch this area again before injection.</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of cleaning injection site - instructions for use" src="/dailymed/image.cfm?name=udenyca-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Inject the dose</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">6 - Remove needle cap</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Remove the needle cap by pulling it straight off. (See <a href="#fig-12">Figure 12</a>)<br/> <br/> <ul> <li> <span class="Bold">Do not </span>remove the needle cap from the prefilled syringe until you are ready to inject.</li> <li> <span class="Bold">Do not </span>twist or bend the needle cap.</li> <li> <span class="Bold">Do not </span>hold the prefilled syringe by the plunger rod</li> <li> <span class="Bold">Do not </span>put the needle cap back onto the syringe. Dispose of (throw away) the needle cap in your household trash</li> <li> <span class="Bold">Do not </span>use the prefilled syringe if it has been dropped with the needle cap removed.</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of removal of needle cap - instructions for use" src="/dailymed/image.cfm?name=udenyca-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">7 – Position fingers</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Grasp the body of the syringe like a dart (just under the finger grips) with your thumb and index fingers. (See <a href="#fig-13">Figure 13</a>)<br/> <br/> <ul> <li> <span class="Bold">Do not </span>touch the plunger or grasp the syringe above the finger grips.</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of position of fingers - instructions for use" src="/dailymed/image.cfm?name=udenyca-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">8 – Pinch the skin and insert the needle</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">8A: Use your free hand to gently pinch the cleaned injection site to create a firm surface. (See <a href="#fig-14">Figure 14</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of pinching skin of injection site - instructions for use" src="/dailymed/image.cfm?name=udenyca-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">8B: Hold the pinch. Insert the needle into the skin at a 45 to 90-degree angle. (See <a href="#fig-15">Figure 15</a>)<br/> <br/> <ul> <li> <span class="Bold">Do not </span>touch the plunger head while inserting the needle into the skin.</li> <li> <span class="Bold">Do not </span>touch the cleaned area of the skin</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of proper needle insertion - instructions for use" src="/dailymed/image.cfm?name=udenyca-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">8C: After fully inserting the needle, release the pinched skin and use your free hand to stabilize the bottom of the syringe.<br/> <br/>Then move your other hand into injection position with your thumb on the plunger head. (See <a href="#fig-16">Figure 16</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of injection finger positioning - instructions for use" src="/dailymed/image.cfm?name=udenyca-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">9 – Push plunger head down to deliver dose</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">9A: Using slow and constant pressure, push the plunger head down until it reaches the bottom. This will help to ensure that you receive the full dose. (See <a href="#fig-17">Figure 17</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of plunger push - instructions for use" src="/dailymed/image.cfm?name=udenyca-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">9B: While the needle is still inserted, slowly move your thumb back, allowing the plunger to rise. This will release the needle safety guard to safely cover the needle. Then remove the syringe from the injection site. (See <a href="#fig-18">Figure 18</a>)<br/> <br/> <span class="Bold">Important:</span> When you remove the syringe, if it looks like the medicine is still in the syringe, this means you have not received a full dose. Call your healthcare provider right away.<br/> <br/> <ul> <li>If you see drops of blood at the injection site, treat by pressing a cotton ball or gauze to the site as needed.</li> </ul> </td><td align="center" class="Botrule Lrule Rrule"><img alt="image of needle retraction - instructions for use" src="/dailymed/image.cfm?name=udenyca-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Dispose</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">10 – Dispose of used prefilled syringes</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Put the used prefilled syringe into an FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not </span>throw away the syringe in the household trash. (See <a href="#fig-19">Figure 19</a>)</td><td align="center" class="Botrule Lrule Rrule"><img alt="image of disposal - instructions for use" src="/dailymed/image.cfm?name=udenyca-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"> <ul> <li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<ul> <li>made of a heavy-duty plastic</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out</li> <li>upright and stable during use</li> <li>leak-resistant</li> <li>properly labeled to warn of hazardous waste inside the container</li> </ul> </li> <li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.</li> <li> <span class="Bold">Do not </span>reuse the prefilled syringe.</li> <li> <span class="Bold">Do not </span>recycle prefilled syringes or sharps disposal container or throw them into household trash.</li> </ul> </td> </tr> <tr class="Last"> <td align="left">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</td><td align="right">Issued: 09/2019 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Instructions for Use<br/>UDENYCA<span class=\"Sup\">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>Injection</span>\n<br/>Single-Dose Prefilled Syringe\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Guide to Parts</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">      Before Use</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\"><img alt=\"image of UDENYCA before use\" src=\"/dailymed/image.cfm?name=udenyca-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Important: </span>The needle is covered by a needle cap before use\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">      After Use</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><img alt=\"image of UDENYCA after use\" src=\"/dailymed/image.cfm?name=udenyca-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Important<br/>Read the Patient Information for important information you need to know about<br/>UDENYCA before using these Instructions for Use.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Storing the UDENYCA prefilled syringe</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\n<ul>\n<li>Store UDENYCA prefilled syringes in the refrigerator between 36°F to 46° F (2°C to 8°C).</li>\n<li>Keep the UDENYCA prefilled syringe in the original carton to protect from light.</li>\n<li>\n<span class=\"Bold\">Do not </span>freeze UDENYCA.\n\t\t\t\t\t\t\t\t\t\t\t\t<ul>\n<li>If UDENYCA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.</li>\n<li>Throw away (dispose of) any UDENYCA prefilled syringes that have been frozen more than 1 time.</li>\n</ul>\n</li>\n<li>Throw away (dispose of) any UDENYCA prefilled syringes that have been left out at room temperature for more than 48 hours.</li>\n<li>Keep the UDENYCA prefilled syringe out of the reach of children.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of storage - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-02a.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Using the prefilled syringe</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\">\n<ul>\n<li>\n<span class=\"Bold\">It is important that you do not try to give the\ninjection unless you or your caregiver has received training from your healthcare provider.</span>\n</li>\n<li>Make sure that the name UDENYCA appears on the carton and prefilled syringe label.</li>\n<li>Check the carton and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL.</li>\n<li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled syringe.</li>\n<li>\n<span class=\"Bold\">Do not </span> use a prefilled syringe after the\nexpiration date on the label.</li>\n<li>\n<span class=\"Bold\">Do not </span>shake the prefilled syringe</li>\n<li>\n<span class=\"Bold\">Do not </span>remove the needle cap from the prefilled syringe until you are ready to inject.</li>\n<li>\n<span class=\"Bold\">Do not </span>use the prefilled syringe if the carton is open or damaged.</li>\n<li>\n<span class=\"Bold\">Do not </span>use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.</li>\n<li>\n<span class=\"Bold\">Do not </span>attempt to activate the needle safety guard prior to injection</li>\n</ul>\n</td><td align=\"center\" class=\"Lrule Rrule\"> \n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Call your healthcare provider if you have any\nquestions.\n\t\t\t\t\t\t\t\t\t</td><td align=\"center\" class=\"Botrule Lrule Rrule\"> \n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Prepare the injection</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">1 - Remove carton from refrigerator and check expiration date</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">1A: Remove the carton from the refrigerator and check the expiration date printed on the carton. (See <a href=\"#fig-3\">Figure 3</a>)<br/>\n<span class=\"Bold\">Do not </span> use if the expiration date has passed.\n </td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of removal from storage - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">1B: Open the carton and remove the sealed syringe tray. (See <a href=\"#fig-4\">Figure 4</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of opening UDENYCA - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">2 - Allow UDENYCA to reach room temperature and gather supplies</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">2A: Place the sealed syringe tray on a flat, clean work surface and allow it to sit at room temperature for at least 30 minutes. (See <a href=\"#fig-5\">Figure 5</a>)<br/>\n<br/>\n<span class=\"Bold\">Do not </span>attempt to warm up the syringe in any other way, such as a microwave, hot water, or direct sunlight.</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of time to reach room temp - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">2B: Gather the following supplies: (See <a href=\"#fig-6\">Figure 6</a>)\n<ul>\n<li>Alcohol wipe</li>\n<li>Cotton ball or gauze</li>\n<li>1 adhesive bandage</li>\n<li>Sharps disposal container</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of gathering supplies - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">3 - Wash your hands and remove syringe from tray</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">3A: Wash your hands well with soap and warm water. (See <a href=\"#fig-7\">Figure 7</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of proper hand washing - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">3B: Open the tray by peeling away the cover. Remove the prefilled syringe from the tray by grasping the middle of the syringe body and carefully pulling it out of the tray. (See <a href=\"#fig-8\">Figure 8</a>)<br/>\nFor Safety reasons:<ul>\n<li>\n<span class=\"Bold\">Do not </span>grab the plunger or the plunger head.</li>\n<li>\n<span class=\"Bold\">Do not </span>grab the needle cap.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of removal of UDENYCA from tray - instructions of use\" src=\"/dailymed/image.cfm?name=udenyca-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">4 - Inspect the syringe and medicine</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Check the medicine through the Inspection Window. The medicine should be clear and colorless. It is normal to see 1 or more air bubbles in the syringe. Removal of the air is not needed. (See <a href=\"#fig-9\">Figure 9</a>)<br/>\n<br/>\n<span class=\"Bold\">Do not </span> use the prefilled syringe if:<ul>\n<li>the medicine appears discolored or cloudy.</li>\n<li>the medicine contains lumps, flakes, or particles.</li>\n<li>it appears used or damaged.</li>\n<li>the needle cap is missing or not securely attached.</li>\n<li>the expiration date printed on the label has passed.</li>\n</ul>In all cases, use a new prefilled syringe and call your\nhealthcare provider.</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of visual inspection - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Select and clean injection site</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">5 - Select and clean the injection site</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">5A: Select the injection site. The recommended injection sites for a subcutaneous injection are the: (See <a href=\"#fig-10\">Figure 10</a>)<ul>\n<li>Abdomen (except for a two-inch area surrounding the navel)</li>\n<li>Thighs</li>\n<li>Back of upper arms (only if someone else is giving you the injection)</li>\n<li>Upper outer area of the buttocks (only if someone else is giving you the injection)</li>\n</ul>\n<span class=\"Bold\">Do not </span> inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.<br/>If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of injection site selection - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">5B: Clean the injection site with an alcohol wipe.\n(See <a href=\"#fig-11\">Figure 11</a>)<br/>\n<br/>\n<span class=\"Bold\">Do not </span> touch this area again before injection.</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of cleaning injection site - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Inject the dose</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">6 - Remove needle cap</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Remove the needle cap by pulling it straight off.\n(See <a href=\"#fig-12\">Figure 12</a>)<br/>\n<br/>\n<ul>\n<li>\n<span class=\"Bold\">Do not </span>remove the needle cap from the\nprefilled syringe until you are ready to inject.</li>\n<li>\n<span class=\"Bold\">Do not </span>twist or bend the needle cap.</li>\n<li>\n<span class=\"Bold\">Do not </span>hold the prefilled syringe by the\nplunger rod</li>\n<li>\n<span class=\"Bold\">Do not </span>put the needle cap back onto the\nsyringe. Dispose of (throw away) the needle\ncap in your household trash</li>\n<li>\n<span class=\"Bold\">Do not </span>use the prefilled syringe if it has\nbeen dropped with the needle cap removed.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of removal of needle cap - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">7 – Position fingers</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Grasp the body of the syringe like a dart (just under the finger grips) with your thumb and index fingers. (See <a href=\"#fig-13\">Figure 13</a>)<br/>\n<br/>\n<ul>\n<li>\n<span class=\"Bold\">Do not </span>touch the plunger or grasp the syringe above the finger grips.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of position of fingers - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">8 – Pinch the skin and insert the needle</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">8A: Use your free hand to gently pinch the cleaned injection site to create a firm surface. (See <a href=\"#fig-14\">Figure 14</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of pinching skin of injection site - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">8B: Hold the pinch. Insert the needle into the skin at a 45 to 90-degree angle. (See <a href=\"#fig-15\">Figure 15</a>)<br/>\n<br/>\n<ul>\n<li>\n<span class=\"Bold\">Do not </span>touch the plunger head while\ninserting the needle into the skin.</li>\n<li>\n<span class=\"Bold\">Do not </span>touch the cleaned area of the skin</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of proper needle insertion - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">8C: After fully inserting the needle, release the\npinched skin and use your free hand to stabilize the bottom of the syringe.<br/>\n<br/>Then move your other hand into injection position with your thumb on the plunger head. (See <a href=\"#fig-16\">Figure 16</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of injection finger positioning - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">9 – Push plunger head down to deliver dose</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">9A: Using slow and constant pressure, push the plunger head down until it reaches the bottom. This will help to ensure that you receive the full dose. (See <a href=\"#fig-17\">Figure 17</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of plunger push - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">9B: While the needle is still inserted, slowly move your thumb back, allowing the plunger to rise. This will release the needle safety guard to safely cover the needle. Then remove the syringe from the injection site. (See <a href=\"#fig-18\">Figure 18</a>)<br/>\n<br/>\n<span class=\"Bold\">Important:</span> When you remove the syringe, if it looks like the medicine is still in the syringe, this means you have not received a full dose. Call your healthcare provider right away.<br/>\n<br/>\n<ul>\n<li>If you see drops of blood at the injection site,\ntreat by pressing a cotton ball or gauze to\nthe site as needed.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of needle retraction - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Dispose</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">10 – Dispose of used prefilled syringes</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Put the used prefilled syringe into an FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not </span>throw away the syringe in the household trash. (See <a href=\"#fig-19\">Figure 19</a>)</td><td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of disposal - instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<ul>\n<li>If you do not have a FDA-cleared sharps disposal container, you may use a household\ncontainer that is:<ul>\n<li>made of a heavy-duty plastic</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out</li>\n<li>upright and stable during use</li>\n<li>leak-resistant</li>\n<li>properly labeled to warn of hazardous waste inside the container</li>\n</ul>\n</li>\n<li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.</li>\n<li>\n<span class=\"Bold\">Do not </span>reuse the prefilled syringe.</li>\n<li>\n<span class=\"Bold\">Do not </span>recycle prefilled syringes or sharps disposal container or throw them into household trash.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\">Issued: 09/2019\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n</tbody>\n</table></div>" }

CoherusBioSciences

{ "type": "p", "children": [], "text": "\nCoherusBioSciences\n" }

UDENYCA® (pegfilgrastim-cbqv) Manufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442U.S. License No. 2023© 2019 Coherus BioSciences Inc. All rights reserved.

{ "type": "p", "children": [], "text": "UDENYCA® (pegfilgrastim-cbqv)\nManufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442U.S. License No. 2023© 2019 Coherus BioSciences Inc. All rights reserved." }

For more Information go to www.UDENYCA.com or call 1-800-4UDENYCA (1-800-483-3692)

{ "type": "p", "children": [], "text": "For more Information go to www.UDENYCA.com or call 1-800-4UDENYCA (1-800-483-3692)" }

PMD-0005, Rev. 02

{ "type": "p", "children": [], "text": "PMD-0005, Rev. 02" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">INSTRUCTIONS FOR USE<br/>UDENYCA™ (yoo-den-i-kah)<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use<br/>Single-Dose Prefilled Autoinjector</span> <br/> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of before use and after use - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-p01-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Storing the UDENYCA prefilled autoinjector</span> <ul> <li>Store UDENYCA prefilled autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).</li> <li>Keep the UDENYCA prefilled autoinjector in the original carton to protect from light.</li> <li> <span class="Bold">Do not</span> freeze UDENYCA. <ul> <li>If UDENYCA is accidentally frozen, allow the prefilled autoinjector to thaw in the refrigerator before injecting.</li> <li>Throw away (dispose of) any UDENYCA prefilled autoinjectors that have been frozen more than 1 time.</li> </ul> </li> <li>Throw away (dispose of) any UDENYCA prefilled autoinjectors that have been left out at room temperature for more than 48 hours.</li> <li>Keep the UDENYCA prefilled autoinjector out of the reach of children.</li> </ul> <span class="Bold">Using the UDENYCA prefilled autoinjector</span> <ul> <li> <span class="Bold">It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.</span> </li> <li>Only adults can self-inject UDENYCA with the prefilled autoinjector.</li> <li>Make sure that the name UDENYCA appears on the carton and prefilled autoinjector label.</li> <li>Check the carton and prefilled autoinjector label to make sure the dose strength is 6 mg/0.6 mL.</li> <li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from an UDENYCA prefilled autoinjector. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled autoinjector.</li> <li> <span class="Bold">Do not</span> use a prefilled autoinjector after the expiration date on the label.</li> <li> <span class="Bold">Do not</span> shake the prefilled autoinjector.</li> <li> <span class="Bold">Do not</span> remove the clear cap from the prefilled autoinjector until you are ready to inject.</li> <li> <span class="Bold">Do not</span> use the prefilled autoinjector if the carton is open or damaged.</li> <li> <span class="Bold">Do not</span> use a prefilled autoinjector if it has been dropped on a hard surface. The prefilled autoinjector may be broken even if you cannot see the break. Use a new prefilled autoinjector.</li> </ul> Call your healthcare provider if you have any questions. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of removing UDENYCA from refrigeration - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Take</span> the UDENYCA carton out of the refrigerator. <ul> <li>Leave the prefilled autoinjector in the carton at room temperature for <span class="Bold">30 minutes</span> before injecting.</li> <li> <span class="Bold">Do not</span> remove the clear cap while allowing the prefilled autoinjector to reach room temperature.</li> <li> <span class="Bold">Do not</span> warm the prefilled autoinjector in any other way. For example, <span class="Bold">do not</span> warm it in a microwave, in hot water, or in direct sunlight.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of UDENYCA autoinjector status, sharps container and hand washing - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule">Check the expiration date on the prefilled autoinjector label. <span class="Bold">Do not</span> use the prefilled autoinjector if the expiration date has passed. Place the following supplies on a clean, flat surface: <ul> <li>1 single-dose UDENYCA prefilled autoinjector</li> <li>1 alcohol wipe (not included)</li> <li>1 cotton ball or gauze pad (not included)</li> <li>1 sharps disposal container (not included). See <span class="Bold">"How should I throw away (dispose of) the used UDENYCA prefilled autoinjector?"</span> in step 10.</li> <li></li> </ul> <span class="Bold">Wash and dry</span> your hands. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of choosing injection site - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-03a.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><br/> <img alt="image of choosing injection site - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-03b.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Choose</span> an injection site. <ul> <li>abdomen (except for a two-inch area surrounding the navel)</li> <li>thighs</li> </ul> <span class="Bold">If someone else is giving you the injection,</span> you can also use the: <ul> <li>back of upper arms</li> <li>upper outer area of the buttocks</li> <li> <span class="Bold">Do not</span> inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.</li> <li>Change (rotate) your injection site with each injection.</li> <li> <span class="Bold">Do not</span> inject through clothing. <span class="Bold">Clean</span> the injection site with an alcohol wipe. Let your skin air dry. <span class="Bold">Do not</span> touch this area again before injection.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of checking veiwing window - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Check the viewing window:</span> <ul> <li>Hold the prefilled autoinjector with the clear cap facing down.</li> <li>It is normal to see 1 or more air bubbles in the viewing window.</li> <li>Make sure the liquid is clear and colorless.</li> </ul> <span class="Bold">Do not</span> use the prefilled autoinjector if: <ul> <li>the medicine appears discolored or cloudy.</li> <li>the medicine contains lumps, flakes, or particles.</li> <li>if it has been dropped, crushed or damaged in any way.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of of removing the cap of the autoinjector - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Hold</span> the prefilled autoinjector with the clear cap facing up and <span class="Bold">pull</span> the clear cap straight off. <ul> <li>It is normal to see a few drops of liquid at the end of the needle.</li> <li>Throw away the clear cap.</li> <li> <span class="Bold">Do not</span> put the clear cap back on the prefilled autoinjector after it has been removed.</li> <li> <span class="Bold">Do not</span> touch the gray needle guard.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of of how to properly hold the autoinjector - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Hold</span> the body of the prefilled autoinjector in one hand so you can see the viewing window.<br/> <span class="Bold">Place</span> the gray needle guard against your skin at a 90-degree angle. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of press and first click - AI instructions of use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Press the prefilled autoinjector firmly</span> against the skin and you will hear the <span class="Bold">first "click"</span>.<br/> <br/> The orange indicator will start to move along the viewing window. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of after second click - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Keep holding the prefilled autoinjector firmly</span> against the skin until the orange indicator stops moving and you hear the <span class="Bold">second "click"</span>.<br/> <br/> <span class="Bold">After you hear the second "click"</span>, continue to hold the prefilled autoinjector in place and <span class="Bold">count to 5</span>.<br/> <br/> When the injection is complete, make sure the orange indicator completely fills the viewing window before <span class="Bold">slowly lifting the</span> prefilled autoinjector away from the skin. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of proper pull away of UDENYCA autoinjector post injection - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule">The gray needle guard will cover the needle tip.<br/> <span class="Bold">If the viewing window is not completely filled by the orange indicator or if there are more than a few drops of liquid on the injection site, contact your healthcare provider right away. You may not have received your full dose.</span> <br/> After completing the injection, place a cotton ball or gauze pad over the injection site. <ul> <li> <span class="Bold">Do not</span> rub the injection site.</li> <li>Slight bleeding at the injection site is normal.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><img alt="image of disposal of used UDENYCA autoinjector - AI instructions for use" src="/dailymed/image.cfm?name=udenyca-ai-ifu-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">How should I throw away (dispose of) the used UDENYCA prefilled autoinjector?</span> <ul> <li>Put your used prefilled autoinjector in a FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) prefilled autoinjectors in the household trash</span>.</li> <li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: <ul> <li>made of a heavy-duty plastic,</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li> <li>upright and stable during use,</li> <li>leak-resistant, and</li> <li>properly labeled to warn of hazardous waste inside the container.</li> </ul> </li> <li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used prefilled autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.</li> <li>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not reuse the prefilled autoinjector. Do not recycle your used sharps disposal container.</li> </ul> <span class="Bold">Important: Always keep the sharps disposal container out of reach of children.</span> <ul> <li>The clear cap, alcohol swab, cotton ball or gauze pad, and packaging may be placed in your household trash.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</td><td align="right" class="Rrule">Issued: 03/2023</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <br/> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule"><span class="Bold">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City California 94065-1442<br/>U.S. License No. 2023<br/>©2023 Coherus BioSciences, Inc. All rights reserved.<br/> <br/>For more information, go to <a href="#_Ref">www.UDENYCA.com</a>, or call 1-800-4UDENYCA (1-800-483-3692)<br/> <br/> <br/>PMD-0175 Rev. 00</td><td align="right" class="Botrule Rrule"><span class="Bold">Coherus<br/>BIOSCIENCES</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">INSTRUCTIONS FOR USE<br/>UDENYCA™ (yoo-den-i-kah)<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use<br/>Single-Dose Prefilled Autoinjector</span>\n<br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of before use and after use - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-p01-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Storing the UDENYCA prefilled autoinjector</span>\n<ul>\n<li>Store UDENYCA prefilled autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).</li>\n<li>Keep the UDENYCA prefilled autoinjector in the original carton to protect from light.</li>\n<li>\n<span class=\"Bold\">Do not</span> freeze UDENYCA.\n <ul>\n<li>If UDENYCA is accidentally frozen, allow the prefilled autoinjector to thaw in the refrigerator before injecting.</li>\n<li>Throw away (dispose of) any UDENYCA prefilled autoinjectors that have been frozen more than 1 time.</li>\n</ul>\n</li>\n<li>Throw away (dispose of) any UDENYCA prefilled autoinjectors that have been left out at room temperature for more than 48 hours.</li>\n<li>Keep the UDENYCA prefilled autoinjector out of the reach of children.</li>\n</ul>\n<span class=\"Bold\">Using the UDENYCA prefilled autoinjector</span>\n<ul>\n<li>\n<span class=\"Bold\">It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.</span>\n</li>\n<li>Only adults can self-inject UDENYCA with the prefilled autoinjector.</li>\n<li>Make sure that the name UDENYCA appears on the carton and prefilled autoinjector label.</li>\n<li>Check the carton and prefilled autoinjector label to make sure the dose strength is 6 mg/0.6 mL.</li>\n<li>You should not inject a dose of UDENYCA to children weighing less than 45 kg from an UDENYCA prefilled autoinjector. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled autoinjector.</li>\n<li>\n<span class=\"Bold\">Do not</span> use a prefilled autoinjector after the expiration date on the label.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the prefilled autoinjector.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the clear cap from the prefilled autoinjector until you are ready to inject.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the prefilled autoinjector if the carton is open or damaged.</li>\n<li>\n<span class=\"Bold\">Do not</span> use a prefilled autoinjector if it has been dropped on a hard surface. The prefilled autoinjector may be broken even if you cannot see the break. Use a new prefilled autoinjector.</li>\n</ul>\n Call your healthcare provider if you have any questions.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of removing UDENYCA from refrigeration - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Take</span> the UDENYCA carton out of the refrigerator.\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>Leave the prefilled autoinjector in the carton at room temperature for <span class=\"Bold\">30 minutes</span> before injecting.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the clear cap while allowing the prefilled autoinjector to reach room temperature.</li>\n<li>\n<span class=\"Bold\">Do not</span> warm the prefilled autoinjector in any other way. For example, <span class=\"Bold\">do not</span> warm it in a microwave, in hot water, or in direct sunlight.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of UDENYCA autoinjector status, sharps container and hand washing - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\">Check the expiration date on the prefilled autoinjector label. <span class=\"Bold\">Do not</span> use the prefilled autoinjector if the expiration date has passed. Place the following supplies on a clean, flat surface:\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>1 single-dose UDENYCA prefilled autoinjector</li>\n<li>1 alcohol wipe (not included)</li>\n<li>1 cotton ball or gauze pad (not included)</li>\n<li>1 sharps disposal container (not included). See <span class=\"Bold\">\"How should I throw away (dispose of) the used UDENYCA prefilled autoinjector?\"</span> in step 10.</li>\n<li></li>\n</ul>\n<span class=\"Bold\">Wash and dry</span> your hands.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of choosing injection site - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-03a.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><br/>\n<img alt=\"image of choosing injection site - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-03b.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Choose</span> an injection site.\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>abdomen (except for a two-inch area surrounding the navel)</li>\n<li>thighs</li>\n</ul>\n<span class=\"Bold\">If someone else is giving you the injection,</span> you can also use the:\n <ul>\n<li>back of upper arms</li>\n<li>upper outer area of the buttocks</li>\n<li>\n<span class=\"Bold\">Do not</span> inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.</li>\n<li>Change (rotate) your injection site with each injection.</li>\n<li>\n<span class=\"Bold\">Do not</span> inject through clothing. <span class=\"Bold\">Clean</span> the injection site with an alcohol wipe. Let your skin air dry. <span class=\"Bold\">Do not</span> touch this area again before injection.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of checking veiwing window - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Check the viewing window:</span>\n<ul>\n<li>Hold the prefilled autoinjector with the clear cap facing down.</li>\n<li>It is normal to see 1 or more air bubbles in the viewing window.</li>\n<li>Make sure the liquid is clear and colorless.</li>\n</ul>\n<span class=\"Bold\">Do not</span> use the prefilled autoinjector if:\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>the medicine appears discolored or cloudy.</li>\n<li>the medicine contains lumps, flakes, or particles.</li>\n<li>if it has been dropped, crushed or damaged in any way.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of of removing the cap of the autoinjector - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Hold</span> the prefilled autoinjector with the clear cap facing up and <span class=\"Bold\">pull</span> the clear cap straight off.\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>It is normal to see a few drops of liquid at the end of the needle.</li>\n<li>Throw away the clear cap.</li>\n<li>\n<span class=\"Bold\">Do not</span> put the clear cap back on the prefilled autoinjector after it has been removed.</li>\n<li>\n<span class=\"Bold\">Do not</span> touch the gray needle guard.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of of how to properly hold the autoinjector - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Hold</span> the body of the prefilled autoinjector in one hand so you can see the viewing window.<br/>\n<span class=\"Bold\">Place</span> the gray needle guard against your skin at a 90-degree angle.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of press and first click - AI instructions of use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Press the prefilled autoinjector firmly</span> against the skin and you will hear the <span class=\"Bold\">first \"click\"</span>.<br/>\n<br/>\n The orange indicator will start to move along the viewing window.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of after second click - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Keep holding the prefilled autoinjector firmly</span> against the skin until the orange indicator stops moving and you hear the <span class=\"Bold\">second \"click\"</span>.<br/>\n<br/>\n<span class=\"Bold\">After you hear the second \"click\"</span>, continue to hold the prefilled autoinjector in place and <span class=\"Bold\">count to 5</span>.<br/>\n<br/>\n When the injection is complete, make sure the orange indicator completely fills the viewing window before <span class=\"Bold\">slowly lifting the</span> prefilled autoinjector away from the skin.\n\t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of proper pull away of UDENYCA autoinjector post injection - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\">The gray needle guard will cover the needle tip.<br/>\n<span class=\"Bold\">If the viewing window is not completely filled by the orange indicator or if there are more than a few drops of liquid on the injection site, contact your healthcare provider right away. You may not have received your full dose.</span>\n<br/>\n After completing the injection, place a cotton ball or gauze pad over the injection site.\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> rub the injection site.</li>\n<li>Slight bleeding at the injection site is normal.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><img alt=\"image of disposal of used UDENYCA autoinjector - AI instructions for use\" src=\"/dailymed/image.cfm?name=udenyca-ai-ifu-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">How should I throw away (dispose of) the used UDENYCA prefilled autoinjector?</span>\n<ul>\n<li>Put your used prefilled autoinjector in a FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) prefilled autoinjectors in the household trash</span>.</li>\n<li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:\n <ul>\n<li>made of a heavy-duty plastic,</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li>\n<li>upright and stable during use,</li>\n<li>leak-resistant, and</li>\n<li>properly labeled to warn of hazardous waste inside the container.</li>\n</ul>\n</li>\n<li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used prefilled autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.</li>\n<li>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not reuse the prefilled autoinjector. Do not recycle your used sharps disposal container.</li>\n</ul>\n<span class=\"Bold\">Important: Always keep the sharps disposal container out of reach of children.</span>\n<ul>\n<li>The clear cap, alcohol swab, cotton ball or gauze pad, and packaging may be placed in your household trash.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\" class=\"Rrule\">Issued: 03/2023</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"> <br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule\"><span class=\"Bold\">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City California 94065-1442<br/>U.S. License No. 2023<br/>©2023 Coherus BioSciences, Inc. All rights reserved.<br/>\n<br/>For more information, go to <a href=\"#_Ref\">www.UDENYCA.com</a>, or call 1-800-4UDENYCA (1-800-483-3692)<br/>\n<br/>\n<br/>PMD-0175 Rev. 00</td><td align=\"right\" class=\"Botrule Rrule\"><span class=\"Bold\">Coherus<br/>BIOSCIENCES</span></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="60%"/> <col align="right" valign="bottom" width="40%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Patient Information</span> <br/>UDENYCA<span class="Sup">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>injection<br/>on-body injector for UDENYCA</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">What is the most important information I need to know about receiving UDENYCA with the on-body injector for UDENYCA?</span> <ul> <li> <span class="Bold">See the Instructions for Use for the on-body injector for UDENYCA for detailed information about the on-body injector for UDENYCA and important information about your dose delivery that has been written by your healthcare provider.</span> <ul> <li>Know the time that delivery of your dose of UDENYCA is expected to start.</li> <li>Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for UDENYCA is applied. Avoid activities and places that may interfere with monitoring during the <span class="Bold">5-minute</span> period that UDENYCA is expected to be delivered by the on-body injector for UDENYCA, and for 1 hour after delivery.</li> </ul> </li> <li>A caregiver should be with you the first time that you receive UDENYCA with the on-body injector for UDENYCA.</li> <li>Before your next scheduled UDENYCA dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin.</li> <li>If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector.</li> <li> <span class="Bold">If you have an allergic reaction during the delivery of UDENYCA, remove the on-body injector for UDENYCA by grabbing the edge of the adhesive pad and peeling off the on-body injector for UDENYCA. Get emergency medical help right away.</span> </li> <li> <span class="Bold">You should only receive a dose of UDENYCA on the day your healthcare provider tells you.</span> </li> <li> <span class="Bold">You should not receive your dose of UDENYCA any sooner than 24 hours after you finish receiving your chemotherapy.</span> The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider fills and places the on-body injector for UDENYCA on your skin.</li> <li> <span class="Bold">Do not</span> expose the on-body injector for UDENYCA to the following because the on-body injector for UDENYCA may be damaged, and you could be injured:<ul> <li>Diagnostic imaging (e.g., CT scan, MRI, Ultrasound, X-ray)</li> <li>Radiation treatment</li> <li>Oxygen rich environments, such as hyperbaric chambers</li> </ul> </li> <li>Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector for UDENYCA from being accidentally removed.</li> <li> <span class="Bold">Keep the on-body injector for UDENYCA at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances.</span> If the on-body injector for UDENYCA is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of UDENYCA.</li> <li>The on-body injector is for adult patients only.</li> <li> <span class="Bold">If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose of UDENYCA. If you miss your dose or do not receive your full dose of UDENYCA, you may have an increased risk of developing fever or infection.</span> </li> <li> <span class="Bold">Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:</span> <ul> <li>on-body injector for UDENYCA comes off before or during a dose delivery. Do not re-apply it.</li> <li>on-body injector for UDENYCA is leaking.</li> <li>adhesive on your on-body injector for UDENYCA becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that UDENYCA is leaking out of your on-body injector for UDENYCA. If this happens you may only receive some of your dose of UDENYCA, or you may not receive a dose at all.</li> <li>on-body injector for UDENYCA status light is flashing red.</li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">What is UDENYCA?</span> <br/>UDENYCA is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Do not take UDENYCA</span> if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>have a sickle cell disorder.</li> <li>have had severe skin reactions to acrylic adhesives.</li> <li>have kidney problems.</li> <li>are pregnant or plan to become pregnant. It is not known if UDENYCA may harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.</li> </ul> <span class="Bold">Tell your healthcare provider about all of the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">How will I receive UDENYCA?<br/>See the Instructions for Use for detailed information about how you will receive a dose of UDENYCA with the on-body injector for UDENYCA, and how to remove and dispose of the on-body injector for UDENYCA.</span> <ul> <li> <span class="Bold">See the section "What is the most important information I need to know about receiving UDENYCA with the on-body injector for UDENYCA?"</span> </li> <li>UDENYCA is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with UDENYCA to fill the on-body injector prior to applying it. The prefilled syringe with UDENYCA and the on-body injector are provided to your healthcare provider as part of UDENYCA ONBODY. The on-body injector for UDENYCA will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider. If the on-body injector for UDENYCA was placed on the back of your arm, a caregiver must be available to monitor the on-body injector for UDENYCA.</li> <li>Your healthcare provider should place the on-body injector for UDENYCA on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the on-body injector for UDENYCA application area after it has been applied.</li> <li>The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for UDENYCA on your skin.</li> <li>The dose of UDENYCA will be delivered over about 5 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the on-body injector for UDENYCA to make sure you receive your full dose of UDENYCA and watch for symptoms of an allergic reaction.</li> <li>Your healthcare provider will show you how to monitor the on-body injector for UDENYCA to make sure delivery has been completed.</li> <li>Keep the on-body injector for UDENYCA dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from the on-body injector for UDENYCA.</li> <li>Only expose the on-body injector for UDENYCA to temperatures between 41°F to 104°F (5°C to 40°C).</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">While the on-body injector for UDENYCA is in place you should avoid:</span> <ul> <li>traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for UDENYCA is applied.</li> <li>sleeping on the on-body injector for UDENYCA or applying pressure on the on-body injector for UDENYCA. The on-body injector for UDENYCA may not work properly.</li> <li>bumping the on-body injector for UDENYCA or knocking it off your body.</li> <li>using other materials to hold the on-body injector in place. Using other materials could cover audio or visual indicators or press the on-body injector against your skin, and lead to a missed dose or incomplete dose of UDENYCA.</li> <li>getting body lotion, creams, oils, and skin cleansing products near the on-body injector for UDENYCA. These products may loosen the adhesive that holds the on-body injector for UDENYCA onto your body.</li> <li>using bathtubs, hot tubs, whirlpools, or saunas, and direct sunlight. These may affect UDENYCA.</li> <li>peeling off or disturbing the on-body injector for UDENYCA adhesive before you receive your full dose of UDENYCA.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">What are the possible side effects of UDENYCA?<br/>UDENYCA may cause serious side effects, including:</span> <ul> <li> <span class="Bold">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder.</li> <li> <span class="Bold">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li> <li> <span class="Bold">Serious allergic reactions.</span> UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating.<br/> <span class="Bold">If you have an allergic reaction during the delivery of UDENYCA, remove the on-body injector for UDENYCA by grabbing the edge of the adhesive pad and peeling off the on-body injector for UDENYCA. Get emergency medical help right away.</span> </li> <li> <span class="Bold">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.</li> <li> <span class="Bold">Kidney injury (glomerulonephritis).</span> UDENYCA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: <ul> <li>swelling of your face or ankles</li> <li>blood in your urine or dark colored urine</li> <li>you urinate less than usual</li> </ul> </li> <li> <span class="Bold">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with UDENYCA.</li> <li> <span class="Bold">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li> <li> <span class="Bold">Capillary Leak Syndrome.</span> UDENYCA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms: <ul> <li>swelling or puffiness and are urinating less than usual</li> <li>trouble breathing</li> <li>swelling of your stomach-area (abdomen) and feeling of fullness</li> <li>dizziness or feeling faint</li> <li>a general feeling of tiredness</li> </ul> </li> <li> <span class="Bold">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when UDENYCA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.</li> <li> <span class="Bold">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.</li> </ul> The most common side effect of UDENYCA is pain in your bones, and in your arms, and legs. These are not all the possible side effects of UDENYCA. For more information, ask your healthcare provider or pharmacist.<br/> <br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of UDENYCA.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about UDENYCA, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about UDENYCA that is written for health professionals. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in UDENYCA?</span> <br/> <span class="Bold">Active ingredient: </span>pegfilgrastim-cbqv<br/> <span class="Bold">Inactive ingredients: </span>acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule"><span class="Bold">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City California 94065-1442<br/>U.S. License No. 2023<br/>©2021 Coherus BioSciences Inc. All rights reserved.<br/> <br/>For more information go to <a href="#_Ref">www.UDENYCA.com</a>, or call 1-800-4UDENYCA (1-800-483-3692)<br/>PMD-0213, Rev.00</td><td align="right" class="Botrule Rrule"><span class="Bold">Coherus<br/>BioSciences</span></td> </tr> <tr class="Last"> <td align="left">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align="right">Issued: 12/2023</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"60%\"/>\n<col align=\"right\" valign=\"bottom\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Patient Information</span>\n<br/>UDENYCA<span class=\"Sup\">®</span> (yoo-den-i-kah)<br/>(pegfilgrastim-cbqv)<br/>injection<br/>on-body injector for UDENYCA</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is the most important information I need to know about receiving UDENYCA with the on-body injector for UDENYCA?</span>\n<ul>\n<li>\n<span class=\"Bold\">See the Instructions for Use for the on-body injector for UDENYCA for detailed information about the on-body injector for UDENYCA and important information about your dose delivery that has been written by your healthcare provider.</span>\n<ul>\n<li>Know the time that delivery of your dose of UDENYCA is expected to start.</li>\n<li>Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for UDENYCA is applied. Avoid activities and places that may interfere with monitoring during the <span class=\"Bold\">5-minute</span> period that UDENYCA is expected to be delivered by the on-body injector for UDENYCA, and for 1 hour after delivery.</li>\n</ul>\n</li>\n<li>A caregiver should be with you the first time that you receive UDENYCA with the on-body injector for UDENYCA.</li>\n<li>Before your next scheduled UDENYCA dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin.</li>\n<li>If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector.</li>\n<li>\n<span class=\"Bold\">If you have an allergic reaction during the delivery of UDENYCA, remove the on-body injector for UDENYCA by grabbing the edge of the adhesive pad and peeling off the on-body injector for UDENYCA. Get emergency medical help right away.</span>\n</li>\n<li>\n<span class=\"Bold\">You should only receive a dose of UDENYCA on the day your healthcare provider tells you.</span>\n</li>\n<li>\n<span class=\"Bold\">You should not receive your dose of UDENYCA any sooner than 24 hours after you finish receiving your chemotherapy.</span> The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider fills and places the on-body injector for UDENYCA on your skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector for UDENYCA to the following because the on-body injector for UDENYCA may be damaged, and you could be injured:<ul>\n<li>Diagnostic imaging (e.g., CT scan, MRI, Ultrasound, X-ray)</li>\n<li>Radiation treatment</li>\n<li>Oxygen rich environments, such as hyperbaric chambers</li>\n</ul>\n</li>\n<li>Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector for UDENYCA from being accidentally removed.</li>\n<li>\n<span class=\"Bold\">Keep the on-body injector for UDENYCA at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances.</span> If the on-body injector for UDENYCA is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of UDENYCA.</li>\n<li>The on-body injector is for adult patients only.</li>\n<li>\n<span class=\"Bold\">If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose of UDENYCA. If you miss your dose or do not receive your full dose of UDENYCA, you may have an increased risk of developing fever or infection.</span>\n</li>\n<li>\n<span class=\"Bold\">Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:</span>\n<ul>\n<li>on-body injector for UDENYCA comes off before or during a dose delivery. Do not re-apply it.</li>\n<li>on-body injector for UDENYCA is leaking.</li>\n<li>adhesive on your on-body injector for UDENYCA becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that UDENYCA is leaking out of your on-body injector for UDENYCA. If this happens you may only receive some of your dose of UDENYCA, or you may not receive a dose at all.</li>\n<li>on-body injector for UDENYCA status light is flashing red.</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is UDENYCA?</span>\n<br/>UDENYCA is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Do not take UDENYCA</span> if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>have a sickle cell disorder.</li>\n<li>have had severe skin reactions to acrylic adhesives.</li>\n<li>have kidney problems.</li>\n<li>are pregnant or plan to become pregnant. It is not known if UDENYCA may harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all of the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n\t\t\t\t\t\t </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How will I receive UDENYCA?<br/>See the Instructions for Use for detailed information about how you will receive a dose of UDENYCA with the on-body injector for UDENYCA, and how to remove and dispose of the on-body injector for UDENYCA.</span>\n<ul>\n<li>\n<span class=\"Bold\">See the section \"What is the most important information I need to know about receiving UDENYCA with the on-body injector for UDENYCA?\"</span>\n</li>\n<li>UDENYCA is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with UDENYCA to fill the on-body injector prior to applying it. The prefilled syringe with UDENYCA and the on-body injector are provided to your healthcare provider as part of UDENYCA ONBODY. The on-body injector for UDENYCA will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider. If the on-body injector for UDENYCA was placed on the back of your arm, a caregiver must be available to monitor the on-body injector for UDENYCA.</li>\n<li>Your healthcare provider should place the on-body injector for UDENYCA on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the on-body injector for UDENYCA application area after it has been applied.</li>\n<li>The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for UDENYCA on your skin.</li>\n<li>The dose of UDENYCA will be delivered over about 5 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the on-body injector for UDENYCA to make sure you receive your full dose of UDENYCA and watch for symptoms of an allergic reaction.</li>\n<li>Your healthcare provider will show you how to monitor the on-body injector for UDENYCA to make sure delivery has been completed.</li>\n<li>Keep the on-body injector for UDENYCA dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from the on-body injector for UDENYCA.</li>\n<li>Only expose the on-body injector for UDENYCA to temperatures between 41°F to 104°F (5°C to 40°C).</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">While the on-body injector for UDENYCA is in place you should avoid:</span>\n<ul>\n<li>traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for UDENYCA is applied.</li>\n<li>sleeping on the on-body injector for UDENYCA or applying pressure on the on-body injector for UDENYCA. The on-body injector for UDENYCA may not work properly.</li>\n<li>bumping the on-body injector for UDENYCA or knocking it off your body.</li>\n<li>using other materials to hold the on-body injector in place. Using other materials could cover audio or visual indicators or press the on-body injector against your skin, and lead to a missed dose or incomplete dose of UDENYCA.</li>\n<li>getting body lotion, creams, oils, and skin cleansing products near the on-body injector for UDENYCA. These\nproducts may loosen the adhesive that holds the on-body injector for UDENYCA onto your body.</li>\n<li>using bathtubs, hot tubs, whirlpools, or saunas, and direct sunlight. These may affect UDENYCA.</li>\n<li>peeling off or disturbing the on-body injector for UDENYCA adhesive before you receive your full dose of UDENYCA.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the possible side effects of UDENYCA?<br/>UDENYCA may cause serious side effects, including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Spleen rupture.</span> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder.</li>\n<li>\n<span class=\"Bold\">A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).</span> Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating.<br/>\n<span class=\"Bold\">If you have an allergic reaction during the delivery of UDENYCA, remove the on-body injector for UDENYCA by grabbing the edge of the adhesive pad and peeling off the on-body injector for UDENYCA. Get emergency medical help right away.</span>\n</li>\n<li>\n<span class=\"Bold\">Sickle cell crises.</span> You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.</li>\n<li>\n<span class=\"Bold\">Kidney injury (glomerulonephritis).</span> UDENYCA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:\n <ul>\n<li>swelling of your face or ankles</li>\n<li>blood in your urine or dark colored urine</li>\n<li>you urinate less than usual</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Increased white blood cell count (leukocytosis).</span> Your healthcare provider will check your blood during treatment with UDENYCA.</li>\n<li>\n<span class=\"Bold\">Decreased platelet count (thrombocytopenia).</span> Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.</li>\n<li>\n<span class=\"Bold\">Capillary Leak Syndrome.</span> UDENYCA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:\n <ul>\n<li>swelling or puffiness and are urinating less than usual</li>\n<li>trouble breathing</li>\n<li>swelling of your stomach-area (abdomen) and feeling of fullness</li>\n<li>dizziness or feeling faint</li>\n<li>a general feeling of tiredness</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Myelodysplastic syndrome and acute myeloid leukemia.</span> If you have breast cancer or lung cancer, when UDENYCA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.</li>\n<li>\n<span class=\"Bold\">Inflammation of the aorta (aortitis).</span> Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.</li>\n</ul>\n The most common side effect of UDENYCA is pain in your bones, and in your arms, and legs. These are not all the possible side effects of UDENYCA. For more information, ask your healthcare provider or pharmacist.<br/>\n<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of UDENYCA.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about UDENYCA, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about UDENYCA that is written for health professionals.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in UDENYCA?</span>\n<br/>\n<span class=\"Bold\">Active ingredient: </span>pegfilgrastim-cbqv<br/>\n<span class=\"Bold\">Inactive ingredients: </span>acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"> <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\"><span class=\"Bold\">Manufactured by:</span> Coherus BioSciences, Inc., Redwood City California 94065-1442<br/>U.S. License No. 2023<br/>©2021 Coherus BioSciences Inc. All rights reserved.<br/>\n<br/>For more information go to <a href=\"#_Ref\">www.UDENYCA.com</a>, or call 1-800-4UDENYCA (1-800-483-3692)<br/>PMD-0213, Rev.00</td><td align=\"right\" class=\"Botrule Rrule\"><span class=\"Bold\">Coherus<br/>BioSciences</span></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\">Issued: 12/2023</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Healthcare Provider INSTRUCTIONS FOR USE<br/>UDENYCA</span> (yoo-den-i-kah) <span class="Bold">ONBODY™<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use</span> <br/> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Guide to Parts<br/> <br/>UDENYCA Prefilled Syringe</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2"><img alt="image 1 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">On-body Injector for UDENYCA</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2"><img alt="image 2 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Important<br/> <br/>READ THE FOLLOWING INSTRUCTIONS BEFORE USING UDENYCA ONBODY<br/> <br/>Prescribing Information</span> <ul> <li>See Prescribing Information for information on UDENYCA.</li> <li>The on-body injector is for adult patients only.</li> <li>The on-body injector is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.</li> <li>For patients who have had severe skin reactions to acrylic adhesives, consider the benefit-risk profile before administering pegfilgrastim via the on-body injector for UDENYCA.</li> </ul> <span class="Bold">Application Information</span> <ul> <li>The on-body injector should be applied to intact, non-irritated skin on the abdomen or back of the arm. The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector. </li> <li>The on-body injector has a self-adhesive backing to attach it to the skin, <span class="Bold">do not</span> use additional materials to hold it in place as this could lead to a missed or incomplete dose of UDENYCA.</li> </ul> <span class="Bold">Environmental Information</span> <ul> <li> <span class="Bold">Do not</span> expose the on-body injector for UDENYCA to the following environments as the on-body injector may be damaged and the patient could be injured: <ul> <li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li> <li>Radiation treatment</li> <li>Oxygen rich environments such as hyperbaric chambers.</li> </ul> </li> </ul> <span class="Bold">Cautions</span> <ul> <li> <span class="Bold">Do not</span> use UDENYCA ONBODY to deliver any other drug product.</li> <li> <span class="Bold">Do not</span> use the on-body injector if its packaging has been previously opened, or the expiration date on the carton or any components has passed.</li> <li> <span class="Bold">Do not</span> use if the name UDENYCA does not appear on UDENYCA ONBODY carton.</li> <li> <span class="Bold">Do not</span> modify the on-body injector.</li> <li> <span class="Bold">Do not</span> fill the UDENYCA on-body injector on the adhesive side. Use the metal medicine port.</li> <li> <span class="Bold">Do not</span> attempt to reapply the on-body injector.</li> <li> <span class="Bold">Do not</span> use if either the on-body injector or prefilled syringe is dropped. Start again with a new on-body injector or prefilled syringe.</li> </ul> <span class="Bold">Storage Information</span> <ul> <li>Store the ONBODY in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. If the ONBODY is stored at room temperature for more than 12 hours, <span class="Bold">do not</span> use. Start again with a new ONBODY.</li> <li>Keep the prefilled syringe in the carton until use to protect from light.</li> <li> <span class="Bold">Do not</span> freeze the ONBODY.</li> <li> <span class="Bold">Do not</span> separate the components of UDENYCA ONBODY until ready for use.</li> </ul> For all questions, call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). If a patient calls you regarding any on-body injector problems, call Coherus BioSciences at 1 800-4UDENYCA (1-800-483-3692).<br/> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 1: Prepare<br/> <br/>A| Remove ONBODY from the refrigerator and open carton.</span> <br/> Place the syringe tray and on-body injector tray on a clean, flat, well-lit work surface. Allow to come to room temperature for 30 minutes prior to use. <span class="Bold">Do not</span> warm the UDENYCA ONBODY components using a heat source.<br/> Check to make sure it contains: <ul> <li>One UDENYCA prefilled syringe</li> <li>One on-body injector for UDENYCA</li> <li>UDENYCA Patient Information</li> <li>UDENYCA Prescribing Information</li> <li>Instructions for Use for healthcare provider</li> <li>Instructions for Use for patient</li> </ul> Check the above listed items for damage and check the expiry date on the syringe tray and on-body injector tray.<br/> <span class="Bold">Do not</span> use the on-body injector: <ul> <li>if its packaging has been previously opened</li> <li>if the packaging or trays appear to be damaged or have been dropped</li> <li>if the expiry date on the syringe tray or on-body injector tray has passed.</li> </ul> <span class="Bold">B| Choose the patient’s injection site.</span> <br/> <br/> <img alt="image 3 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><br/> <br/> <span class="Bold">Choose the flattest site for the on-body injector application.<br/> Ask the patient about their ability to monitor and remove the on-body injector.</span> <ul> <li>You can use the left or right side of the abdomen, except for a two-inch area right around navel.</li> <li>You can use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector.</li> <li>Apply the on-body injector to intact, non-irritated skin.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on areas with scar tissue, moles, or excessive hair. In case of excessive hair, carefully trim hair to get the on-body injector close to the skin.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on surgical sites.</li> <li> <span class="Bold">Do not</span> apply the on-body injector on areas where the on-body injector will be affected by folds in the skin.</li> </ul> <span class="Bold">C| Clean an area on the injection site larger than the on-body injector adhesive backing.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule"> <ul> <li>Thoroughly clean the site with alcohol to enhance on-body injector‘s adherence to the skin. Only use alcohol to clean the skin.</li> <li>Make sure the skin is oil-free prior to applying the on-body injector.</li> <li>Allow the skin to completely dry on its own (e.g. without blowing on or fanning the area) before attaching the on-body injector.</li> <li> <span class="Bold">Do not</span> touch this area again before attaching the on-body injector.</li> </ul> </td><td align="center" class="Botrule Rrule"><img alt="image 4 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 2: Get ready<br/> <br/>A| Open on-body injector tray and remove plastic lid.</span></td> </tr> <tr> <td align="left" class="Lrule"> Wash your hands before use.<br/> Open the on-body injector tray by fully removing the tray cover and removing the plastic lid. <ul> <li> <span class="Bold">Do not</span> remove the on-body injector from the tray before filling it.</li> <li> <span class="Bold">Do not</span> remove the green fill guide.</li> </ul> </td><td align="center" class="Rrule"><img alt="image 5 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">B| Remove UDENYCA prefilled syringe from tray.</span> <br/> <br/> <img alt="image 6 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/> For safety reasons: <ul> <li> <span class="Bold">Do not</span> grasp the gray needle cap.</li> <li> <span class="Bold">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li> <li> <span class="Bold">Do not</span> grasp the plunger rod.</li> </ul> <span class="Bold">C| Inspect medicine and UDENYCA prefilled syringe. UDENYCA liquid should always be clear and colorless.</span> <br/> <br/> <img alt="image 7 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li> <span class="Bold">Do not</span> use if the liquid contains particulate matter or discoloration is observed prior to administration.</li> <li> <span class="Bold">Do not</span> use if any part appears to be damaged, cracked or broken.</li> <li> <span class="Bold">Do not</span> use if the gray needle cap is missing or not securely attached.</li> <li> <span class="Bold">Do not</span> use if the expiration date printed on the label has passed.</li> <li> <span class="Bold">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li> <li> <span class="Bold">Do not</span> shake the prefilled syringe.</li> </ul> In all the above cases, start again with a new UDENYCA ONBODY. Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).<br/> <span class="Bold">D| Remove air bubbles in prefilled syringe.</span><img alt="image 8 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><span class="Bold">E| Orient the syringe with the needle facing downwards. Center the needle directly over the metal medicine port at a 90-degree angle. Insert the needle all the way into the port, avoiding sides.</span></td> </tr> <tr> <td align="left" class="Lrule"> Insert needle into metal medicine port at a 90-degree angle only. <ul> <li> <span class="Bold">Do not</span> fill the UDENYCA on-body injector on the adhesive side. Use the metal medicine port.</li> <li> <span class="Bold">Do not</span> touch the plunger until the needle is fully inserted into the metal medicine port.</li> <li> <span class="Bold">Do not</span> move the needle in the metal medicine port.</li> <li> <span class="Bold">Do not</span> insert the needle more than once.</li> <li> <span class="Bold">Do not</span> bend the needle. Avoid spilling the medicine.</li> <li> <span class="Bold">Do not</span> remove the green fill guide before filling the on-body injector.</li> </ul> </td><td align="center" class="Rrule"><img alt="image 9 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">F| Fully depress the plunger rod to expel entire contents of the prefilled syringe into the on-body injector.</span></td> </tr> <tr> <td align="left" class="Lrule"> After filling completely, you will hear two beeps. The status light will start to flash green.<br/> Remove the needle straight from the metal medicine port and dispose the empty syringe right away into a puncture proof container. <ul> <li> <span class="Bold">Do not</span> recap the needle.</li> </ul> </td><td align="center" class="Rrule"><img alt="image 10 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">G| Check to see if the on-body injector is full.</span></td> </tr> <tr> <td align="left" class="Lrule"> You should see the green status light flashing and a black line next to FULL on the fill indicator. If this is not the case, <span class="Bold">do not</span> use.<br/> Start again with a new UDENYCA ONBODY, and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). </td><td align="center" class="Rrule"><img alt="image 11 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">H| Remove on-body injector from tray, then firmly squeeze and lift the green fill guide away from the on-body injector.</span><img alt="image 12 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/> Dispose of green fill guide.<br/>A drop of medicine may be visible<br/>on the metal medicine port when the green fill<br/>guide is removed.<br/> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 3: Apply<br/> <br/>A| Peel away both pull tabs to show the adhesive. Never touch hands or gloves to the adhesive.</span> <br/>Make sure skin is dry prior to applying the on-body injector. <img alt="image 13 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li> <span class="Bold">Do not</span> touch or contaminate the automatic needle opening.</li> <li> <span class="Bold">Do not</span> pull off the adhesive pad or fold it.</li> <li> <span class="Bold">Do not place adhesive on skin that is damp.</span> </li> </ul> In all cases, start again with a new UDENYCA ONBODY.<br/> <br/> Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).<br/> <br/> <span class="Bold">B| Securely apply the on-body injector without folding and without wrinkling to the cleaned injection site so it is visible and can be monitored by the patient or caregiver.</span></td> </tr> <tr> <td align="left" class="Lrule"> <ul> <li> <span class="Bold">Do not</span> touch the adhesive.</li> <li>Grasp the on-body injector’s plastic case with your fingertips and only by sides, keeping fingers off of the adhesive.</li> <li> <span class="Bold">Do not</span> et the adhesive bend or curl while applying the on-body injector to skin.</li> </ul> </td><td align="center" class="Rrule"><img alt="image 14 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="center" class="Lrule Rrule" colspan="2"><img alt="image 15 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Back of upper arm (triceps)</span> <br/> Vertical with the light facing down toward the elbow </td><td align="center" class="Rrule"><img alt="image 16 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Abdomen</span> <br/> Horizontal with the light facing up and visible to the patient </td><td align="center" class="Rrule"><img alt="image 17 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><img alt="image 18 - UDENYCA ONBODY injector - OBI healthcare providerl instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><span class="Bold">If the adhesive is wrinkled or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new ONBODY and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).</span><img alt="image 19 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><br/> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Step 4: Finish<br/> <br/> A| Provide the Patient Instructions for Use Booklet for the patient to take home. Fill in the Dose Delivery information on the Patient Instructions for Use Booklet, and review the following instructions with your patient:</span> <ul> <li>The on-body injector will always flash a slow green light to let them know it is working properly.</li> <li>The patient should keep the on-body injector dry for at least 3 hours after it was placed on their skin.</li> <li>After approximately 27 hours the on-body injector will start to deliver the dose.</li> <li>Immediately before dose delivery starts the injection needle will be automatically inserted into the skin.</li> <li>When the dose delivery starts it will take about 5 minutes to complete. During this time, the on-body injector will flash a fast green light.</li> <li> <span class="Bold">When dose delivery is complete, the on-body injector will sound a long beep, and the status light will turn SOLID GREEN. The needle will retract automatically.</span> </li> <li> <span class="Bold">Do not remove the on-body injector until the status light is SOLID GREEN.</span> </li> <li>If the red error light is flashing, or the adhesive is noticeably wet (saturated), or the on-body injector is dislodged, the patient should contact their healthcare provider immediately as they may need a replacement dose.</li> <li>The patient should remain in a place where they can monitor the on-body injector for the entire dose delivery. The patient should avoid activities and settings that may interfere with wearing and monitoring during the dosing of UDENYCA administered by the on-body injector or could cause the OBI to fall off. For example, avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (this includes the approximately 5-minute delivery period plus an hour post-delivery).</li> <li>If the patient has an allergic reaction during the delivery of UDENYCA, the patient should remove the on-body injector and call his or her healthcare provider or seek emergency care right away.</li> <li>If placed on the back of the arm, remind the patient that a caregiver must be available to monitor the on-body injector.</li> <li>The on-body injector has a self-adhesive backing to attach it to the skin.</li> <li> <span class="Bold">Do not</span> use other materials to hold it in place as this could cover audio/visual indicators or compress the on-body injector against the patient’s skin, as this could lead to a missed or incomplete dose of UDENYCA.</li> <li>Always dispose of the empty on-body injector in a sharps disposal container as instructed by your healthcare provider or by state or local laws.</li> <li>Keep the on-body injector at least four inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA.</li> </ul> <img alt="image 20 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><br/> <br/> If at any time the on-body injector beeps continuously for five minutes, and the status light is flashing red, take the on-body injector off of the patient. <ul> <li> <span class="Bold">Do not</span> apply the on-body injector to the patient if red error light is on.</li> <li> <span class="Bold">Do not</span> leave the on-body injector on the patient if red error light is on.</li> </ul> In all cases, <span class="Bold">do not</span> use. Start over with a new UDENYCA ONBODY, and call 1-800-4UDENYCA (1-800-483-3692).<br/> <br/> If the patient reports the red status light is on, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). <img alt="image 21 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><br/> <br/> If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <br/> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Manufactured by:</span> <br/>Coherus BioSciences, Inc.<br/>Redwood City, CA 94065-1442<br/>US License No. 2023<br/> <br/>https://udenyca.com<br/>1-800-4UDENYCA (1-800-483-3692)<br/>Issued: 12/2023<br/>PMD-0214 Rev. 00 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Healthcare Provider INSTRUCTIONS FOR USE<br/>UDENYCA</span> (yoo-den-i-kah) <span class=\"Bold\">ONBODY™<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use</span>\n<br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Guide to Parts<br/>\n<br/>UDENYCA Prefilled Syringe</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><img alt=\"image 1 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">On-body Injector for UDENYCA</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><img alt=\"image 2 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Important<br/>\n<br/>READ THE FOLLOWING INSTRUCTIONS BEFORE USING UDENYCA ONBODY<br/>\n<br/>Prescribing Information</span>\n<ul>\n<li>See Prescribing Information for information on UDENYCA.</li>\n<li>The on-body injector is for adult patients only.</li>\n<li>The on-body injector is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.</li>\n<li>For patients who have had severe skin reactions to acrylic adhesives, consider the benefit-risk profile before administering pegfilgrastim via the on-body injector for UDENYCA.</li>\n</ul>\n<span class=\"Bold\">Application Information</span>\n<ul>\n<li>The on-body injector should be applied to intact, non-irritated skin on the abdomen or back of the arm. The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector.\n</li>\n<li>The on-body injector has a self-adhesive backing to attach it to the skin, <span class=\"Bold\">do not</span> use additional materials to hold it in place as this could lead to a missed or incomplete dose of UDENYCA.</li>\n</ul>\n<span class=\"Bold\">Environmental Information</span>\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector for UDENYCA to the following environments as the on-body injector may be damaged and the patient could be injured:\n <ul>\n<li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li>\n<li>Radiation treatment</li>\n<li>Oxygen rich environments such as hyperbaric chambers.</li>\n</ul>\n</li>\n</ul>\n<span class=\"Bold\">Cautions</span>\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> use UDENYCA ONBODY to deliver any other drug product.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the on-body injector if its packaging has been previously opened, or the expiration date on the carton or any components has passed.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if the name UDENYCA does not appear on UDENYCA ONBODY carton.</li>\n<li>\n<span class=\"Bold\">Do not</span> modify the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> fill the UDENYCA on-body injector on the adhesive side. Use the metal medicine port.</li>\n<li>\n<span class=\"Bold\">Do not</span> attempt to reapply the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if either the on-body injector or prefilled syringe is dropped. Start again with a new on-body injector or prefilled syringe.</li>\n</ul>\n<span class=\"Bold\">Storage Information</span>\n<ul>\n<li>Store the ONBODY in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. If the ONBODY is stored at room temperature for more than 12 hours, <span class=\"Bold\">do not</span> use. Start again with a new ONBODY.</li>\n<li>Keep the prefilled syringe in the carton until use to protect from light.</li>\n<li>\n<span class=\"Bold\">Do not</span> freeze the ONBODY.</li>\n<li>\n<span class=\"Bold\">Do not</span> separate the components of UDENYCA ONBODY until ready for use.</li>\n</ul>\n For all questions, call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). If a patient calls you regarding any on-body injector problems, call Coherus BioSciences at 1 800-4UDENYCA (1-800-483-3692).<br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 1: Prepare<br/>\n<br/>A| Remove ONBODY from the refrigerator and open carton.</span>\n<br/>\n Place the syringe tray and on-body injector tray on a clean, flat, well-lit work surface. Allow to come to room temperature for 30 minutes prior to use. <span class=\"Bold\">Do not</span> warm the UDENYCA ONBODY components using a heat source.<br/>\n Check to make sure it contains:\n <ul>\n<li>One UDENYCA prefilled syringe</li>\n<li>One on-body injector for UDENYCA</li>\n<li>UDENYCA Patient Information</li>\n<li>UDENYCA Prescribing Information</li>\n<li>Instructions for Use for healthcare provider</li>\n<li>Instructions for Use for patient</li>\n</ul>\n Check the above listed items for damage and check the expiry date on the syringe tray and on-body injector tray.<br/>\n<span class=\"Bold\">Do not</span> use the on-body injector:\n <ul>\n<li>if its packaging has been previously opened</li>\n<li>if the packaging or trays appear to be damaged or have been dropped</li>\n<li>if the expiry date on the syringe tray or on-body injector tray has passed.</li>\n</ul>\n<span class=\"Bold\">B| Choose the patient’s injection site.</span>\n<br/>\n<br/>\n<img alt=\"image 3 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><br/>\n<br/>\n<span class=\"Bold\">Choose the flattest site for the on-body injector application.<br/>\n Ask the patient about their ability to monitor and remove the on-body injector.</span>\n<ul>\n<li>You can use the left or right side of the abdomen, except for a two-inch area right around navel.</li>\n<li>You can use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector.</li>\n<li>Apply the on-body injector to intact, non-irritated skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on areas with scar tissue, moles, or excessive hair. In case of excessive hair, carefully trim hair to get the on-body injector close to the skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on surgical sites.</li>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector on areas where the on-body injector will be\naffected by folds in the skin.</li>\n</ul>\n<span class=\"Bold\">C| Clean an area on the injection site larger than the on-body injector adhesive backing.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\">\n<ul>\n<li>Thoroughly clean the site with alcohol to enhance on-body injector‘s adherence to the skin. Only use alcohol to clean the skin.</li>\n<li>Make sure the skin is oil-free prior to applying the on-body injector.</li>\n<li>Allow the skin to completely dry on its own (e.g. without blowing on or fanning the area) before attaching the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> touch this area again before attaching the on-body injector.</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 4 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 2: Get ready<br/>\n<br/>A| Open on-body injector tray and remove plastic lid.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n Wash your hands before use.<br/>\n Open the on-body injector tray by fully removing the tray cover and removing the plastic lid.\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> remove the on-body injector from the tray before filling it.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the green fill guide.</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule\"><img alt=\"image 5 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">B| Remove UDENYCA prefilled syringe from tray.</span>\n<br/>\n<br/>\n<img alt=\"image 6 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/>\n For safety reasons:\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> grasp the gray needle cap.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> grasp the plunger rod.</li>\n</ul>\n<span class=\"Bold\">C| Inspect medicine and UDENYCA prefilled syringe. UDENYCA liquid should always be clear and colorless.</span>\n<br/>\n<br/>\n<img alt=\"image 7 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>\n<span class=\"Bold\">Do not</span> use if the liquid contains particulate matter or discoloration is observed prior to administration.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if any part appears to be damaged, cracked or broken.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if the gray needle cap is missing or not securely attached.</li>\n<li>\n<span class=\"Bold\">Do not</span> use if the expiration date printed on the label has passed.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the gray needle cap until ready to fill the on-body injector.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the prefilled syringe.</li>\n</ul>\n In all the above cases, start again with a new UDENYCA ONBODY. Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).<br/>\n<span class=\"Bold\">D| Remove air bubbles in prefilled syringe.</span><img alt=\"image 8 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><span class=\"Bold\">E| Orient the syringe with the needle facing downwards. Center the needle directly over the metal medicine port at a 90-degree angle. Insert the needle all the way into the port, avoiding sides.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n Insert needle into metal medicine port at a 90-degree angle only.\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> fill the UDENYCA on-body injector on the adhesive side. Use the metal medicine port.</li>\n<li>\n<span class=\"Bold\">Do not</span> touch the plunger until the needle is fully inserted into the metal medicine port.</li>\n<li>\n<span class=\"Bold\">Do not</span> move the needle in the metal medicine port.</li>\n<li>\n<span class=\"Bold\">Do not</span> insert the needle more than once.</li>\n<li>\n<span class=\"Bold\">Do not</span> bend the needle. Avoid spilling the medicine.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the green fill guide before filling the on-body injector.</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule\"><img alt=\"image 9 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">F| Fully depress the plunger rod to expel entire contents of the prefilled syringe into the on-body injector.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n After filling completely, you will hear two beeps. The status light will start to flash green.<br/>\n Remove the needle straight from the metal medicine port and dispose the empty syringe right away into a puncture proof container.\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> recap the needle.</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule\"><img alt=\"image 10 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">G| Check to see if the on-body injector is full.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n You should see the green status light flashing and a black line next to FULL on the fill indicator. If this is not the case, <span class=\"Bold\">do not</span> use.<br/>\n Start again with a new UDENYCA ONBODY, and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).\n </td><td align=\"center\" class=\"Rrule\"><img alt=\"image 11 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">H| Remove on-body injector from tray, then firmly squeeze and lift the green fill guide away from the on-body injector.</span><img alt=\"image 12 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/>\n Dispose of green fill guide.<br/>A drop of medicine may be visible<br/>on the metal medicine port when the green fill<br/>guide is removed.<br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 3: Apply<br/>\n<br/>A| Peel away both pull tabs to show the adhesive. Never touch hands or gloves to the adhesive.</span>\n<br/>Make sure skin is dry prior to applying the on-body injector.\n <img alt=\"image 13 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>\n<span class=\"Bold\">Do not</span> touch or contaminate the automatic needle opening.</li>\n<li>\n<span class=\"Bold\">Do not</span> pull off the adhesive pad or fold it.</li>\n<li>\n<span class=\"Bold\">Do not place adhesive on skin that is damp.</span>\n</li>\n</ul>\n In all cases, start again with a new UDENYCA ONBODY.<br/>\n<br/>\n Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).<br/>\n<br/>\n<span class=\"Bold\">B| Securely apply the on-body injector without folding and without wrinkling to the cleaned injection site so it is visible and can be monitored by the patient or caregiver.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> touch the adhesive.</li>\n<li>Grasp the on-body injector’s plastic case with your fingertips and only by sides, keeping fingers off of the adhesive.</li>\n<li>\n<span class=\"Bold\">Do not</span> et the adhesive bend or curl while applying the on-body injector to skin.</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule\"><img alt=\"image 14 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\"><img alt=\"image 15 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\"><span class=\"Bold\">Back of upper arm (triceps)</span>\n<br/>\n Vertical with the light facing down toward the elbow \n </td><td align=\"center\" class=\"Rrule\"><img alt=\"image 16 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\"><span class=\"Bold\">Abdomen</span>\n<br/>\n Horizontal with the light facing up and visible to the patient \n </td><td align=\"center\" class=\"Rrule\"><img alt=\"image 17 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><img alt=\"image 18 - UDENYCA ONBODY injector - OBI healthcare providerl instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><span class=\"Bold\">If the adhesive is wrinkled or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new ONBODY and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).</span><img alt=\"image 19 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 4: Finish<br/>\n<br/>\n A| Provide the Patient Instructions for Use Booklet for the patient to take home. Fill in the Dose Delivery information on the Patient Instructions for Use Booklet, and review the following instructions with your patient:</span>\n<ul>\n<li>The on-body injector will always flash a slow green light to let them know it is working properly.</li>\n<li>The patient should keep the on-body injector dry for at least 3 hours after it was placed on their skin.</li>\n<li>After approximately 27 hours the on-body injector will start to deliver the dose.</li>\n<li>Immediately before dose delivery starts the injection needle will be automatically inserted into the skin.</li>\n<li>When the dose delivery starts it will take about 5 minutes to complete. During this time, the on-body injector will flash a fast green light.</li>\n<li>\n<span class=\"Bold\">When dose delivery is complete, the on-body injector will sound a long beep, and the status light will turn SOLID GREEN. The needle will retract automatically.</span>\n</li>\n<li>\n<span class=\"Bold\">Do not remove the on-body injector until the status light is SOLID GREEN.</span>\n</li>\n<li>If the red error light is flashing, or the adhesive is noticeably wet (saturated), or the on-body injector is dislodged, the patient should contact their healthcare provider immediately as they may need a replacement dose.</li>\n<li>The patient should remain in a place where they can monitor the on-body injector for the entire dose delivery. The patient should avoid activities and settings that may interfere with wearing and monitoring during the dosing of UDENYCA administered by the on-body injector or could cause the OBI to fall off. For example, avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (this includes the approximately 5-minute delivery period plus an hour post-delivery).</li>\n<li>If the patient has an allergic reaction during the delivery of UDENYCA, the patient should remove the on-body injector and call his or her healthcare provider or seek emergency care right away.</li>\n<li>If placed on the back of the arm, remind the patient that a caregiver must be available to monitor the on-body injector.</li>\n<li>The on-body injector has a self-adhesive backing to attach it to the skin.</li>\n<li>\n<span class=\"Bold\">Do not</span> use other materials to hold it in place as this could cover audio/visual indicators or compress the on-body injector against the patient’s skin, as this could lead to a missed or incomplete dose of UDENYCA.</li>\n<li>Always dispose of the empty on-body injector in a sharps disposal container as instructed by your healthcare provider or by state or local laws.</li>\n<li>Keep the on-body injector at least four inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA.</li>\n</ul>\n<img alt=\"image 20 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><br/>\n<br/>\n If at any time the on-body injector beeps continuously for five minutes, and the status light is flashing red, take the on-body injector off of the patient.\n <ul>\n<li>\n<span class=\"Bold\">Do not</span> apply the on-body injector to the patient if red error light is on.</li>\n<li>\n<span class=\"Bold\">Do not</span> leave the on-body injector on the patient if red error light is on.</li>\n</ul>\n In all cases, <span class=\"Bold\">do not</span> use. Start over with a new UDENYCA ONBODY, and call 1-800-4UDENYCA (1-800-483-3692).<br/>\n<br/>\n If the patient reports the red status light is on, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).\n <img alt=\"image 21 - UDENYCA ONBODY injector - OBI healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><br/>\n<br/>\n If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"> <br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Manufactured by:</span>\n<br/>Coherus BioSciences, Inc.<br/>Redwood City, CA 94065-1442<br/>US License No. 2023<br/>\n<br/>https://udenyca.com<br/>1-800-4UDENYCA (1-800-483-3692)<br/>Issued: 12/2023<br/>PMD-0214 Rev. 00\n </td>\n</tr>\n</tbody>\n</table></div>" }

Electromagnetic Compatibility

{ "type": "p", "children": [], "text": "\nElectromagnetic Compatibility\n" }

The delivery system is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments.

{ "type": "p", "children": [], "text": "The delivery system is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments." }

To avoid electromagnetic interference (EMI) that may affect the performance of the delivery system [(i) Dose accuracy, (ii) treatment duration, (iii) Injection Depth, (iv) Visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (EMI), such as MRI, ionizing radiation, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. In addition, portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2- way radios, BluetoothTM devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness.

{ "type": "p", "children": [], "text": "To avoid electromagnetic interference (EMI) that may affect the performance of the delivery system [(i) Dose accuracy, (ii) treatment duration, (iii) Injection Depth, (iv) Visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (EMI), such as MRI, ionizing radiation, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. In addition, portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2- way radios, BluetoothTM devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness." }

If you identify or suspect that external RF sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the EMI source.

{ "type": "p", "children": [], "text": "If you identify or suspect that external RF sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the EMI source." }

Electromagnetic Emissions

{ "type": "p", "children": [], "text": "\nElectromagnetic Emissions\n" }

The delivery system has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

{ "type": "p", "children": [], "text": "The delivery system has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation." }

If this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician.

{ "type": "p", "children": [], "text": "If this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician." }

Electromagnetic Immunity

{ "type": "p", "children": [], "text": "\nElectromagnetic Immunity\n" }

The delivery system has been tested to comply in either a Home Healthcare Environment or Professional Healthcare Environment.

{ "type": "p", "children": [], "text": "The delivery system has been tested to comply in either a Home Healthcare Environment or Professional Healthcare Environment." }

Proximity fields from RF wireless communications equipment Immunity

{ "type": "p", "children": [], "text": "\nProximity fields from RF wireless communications equipment Immunity\n" }

The delivery system is tested per IEC 61000-4-3 at Frequencies and Levels as specified below to ensure Enclosure Port Immunity to RF wireless communications equipment.

{ "type": "p", "children": [], "text": "The delivery system is tested per IEC 61000-4-3 at Frequencies and Levels as specified below to ensure Enclosure Port Immunity to RF wireless communications equipment." }

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Delivery System. Otherwise, degradation of the performance of this equipment could result.

{ "type": "p", "children": [], "text": "\nWARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Delivery System. Otherwise, degradation of the performance of this equipment could result." }

WARNING: Use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

{ "type": "p", "children": [], "text": "\nWARNING: Use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally." }

Symbols Glossary

{ "type": "p", "children": [], "text": "\nSymbols Glossary\n" }

<div class="scrollingtable"><table width="95%"> <col align="left" valign="middle" width="50%"/> <col align="center" valign="middle" width="50%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule">Description</th><th align="center" class="Botrule Rrule">Symbol/Sub clause</th> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Botrule Lrule Rrule">Name or trade mark of the product</td><td align="center" class="Botrule Rrule"><img alt="image 1 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Part number</td><td align="center" class="Botrule Rrule"><img alt="image 2 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Name or trade name and address of the manufacturer</td><td align="center" class="Botrule Rrule"><img alt="image 3 - UDENYCA ONBODY injector - OBI patient and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Serial number or batch code, preceded by the word 'LOT', or the serial number/NDC number;</td><td align="center" class="Botrule Rrule"><img alt="image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare providerinstructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Warnings and/or precautions to take (in text format)</td><td align="center" class="Botrule Rrule"><img alt="image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Storage temperature and any other special storage and/or handling conditions (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 6 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Humidity limitation (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 7 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Pressure limitation (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 8 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Do not use if package is damaged</td><td align="center" class="Botrule Rrule"><img alt="image 9 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Keep away from sunlight</td><td align="center" class="Botrule Rrule"><img alt="image 10 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Keep dry</td><td align="center" class="Botrule Rrule"><img alt="image 11 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">For electrical devices - Water and dust ingress rating</td><td align="center" class="Botrule Rrule"><img alt="image 12 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">For electrical devices – refer to instruction for use</td><td align="center" class="Botrule Rrule"><img alt="image 13 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">"Rx only" labeling of prescription devices</td><td align="center" class="Botrule Rrule"><img alt="image 14 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Sterile &amp; Sterilization by EO</td><td align="center" class="Botrule Rrule"><img alt="image 15 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Expiration date (Use by)</td><td align="center" class="Botrule Rrule"><img alt="image 16 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">The device is for single use</td><td align="center" class="Botrule Rrule"><img alt="image 17 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Should not enter the MRI scanner room</td><td align="center" class="Botrule Rrule"><img alt="image 18 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Type BF applied parts</td><td align="center" class="Botrule Rrule"><img alt="image 19 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">CSA Certificate</td><td align="center" class="Botrule Rrule"><img alt="image 20 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Battery specification Li-MnO2 Battery 3V/850mAH (CR14250)</td><td align="center" class="Botrule Rrule">N/A</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">WEEE directive compliance</td><td align="center" class="Botrule Rrule"><img alt="image 21 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">UDENYCA® (pegfilgrastim-cbqv) prefilled syringe</td><td align="center" class="Botrule Rrule"><img alt="image 22 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-22.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule">On-body injector for UDENYCA® (pegfilgrastim-cbqv)</td><td align="center" class="Botrule Rrule"><img alt="image 23 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-23.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"95%\">\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Botrule Lrule Rrule\">Description</th><th align=\"center\" class=\"Botrule Rrule\">Symbol/Sub clause</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Name or trade mark of the product</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 1 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Part number</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 2 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Name or trade name and address of the manufacturer</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 3 - UDENYCA ONBODY injector - OBI patient and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Serial number or batch code, preceded by the word 'LOT', or the serial number/NDC number;</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare providerinstructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Warnings and/or precautions to take (in text format)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Storage temperature and any other special storage and/or handling conditions (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 6 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Humidity limitation (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 7 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Pressure limitation (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 8 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Do not use if package is damaged</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 9 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Keep away from sunlight</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 10 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Keep dry</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 11 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">For electrical devices - Water and dust ingress rating</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 12 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">For electrical devices – refer to instruction for use</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 13 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\"Rx only\" labeling of prescription devices</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 14 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Sterile &amp; Sterilization by EO</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 15 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Expiration date (Use by)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 16 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">The device is for single use</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 17 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Should not enter the MRI scanner room</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 18 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Type BF applied parts</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 19 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">CSA Certificate</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 20 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Battery specification Li-MnO2 Battery 3V/850mAH (CR14250)</td><td align=\"center\" class=\"Botrule Rrule\">N/A</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">WEEE directive compliance</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 21 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">UDENYCA® (pegfilgrastim-cbqv) prefilled syringe</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 22 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-22.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\">On-body injector for UDENYCA® (pegfilgrastim-cbqv)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 23 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-23.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Patient INSTRUCTIONS FOR USE<br/>UDENYCA</span> (yoo-den-i-kah) <span class="Bold">ONBODY™<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use</span> <br/> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Dose Delivery Information</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2"><img alt="image 1 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Get to Know Your On-body Injector</span></td> </tr> <tr> <td align="center" class="Botrule Lrule"><img alt="image 2 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td><td align="left" class="Botrule Rrule"><span class="Bold">Flashing Green:</span> The on-body injector is working properly. <span class="Bold">Do not</span> remove the on-body injector if the status light is flashing green.<br/> <br/> <br/> <br/> <br/> <span class="Bold">Solid Green (or off):</span> Signals dose delivery is complete. Check to see if fill indicator reads empty.<br/> <br/> <br/> <br/> <br/> <span class="Bold">Flashing Red:</span> On-body injector error. If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away as you may need a replacement dose.<br/> <br/> <br/> <br/> <br/> <br/> <br/> <br/> <br/> <br/> <span class="Bold">Fill indicator:</span> Black line shows how much UDENYCA is in the on-body injector. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Important Information<br/> <br/>On-body Injector for UDENYCA Description</span> <ul> <li>The on-body injector for UDENYCA is intended for delivery of UDENYCA. This on-body injector delivers UDENYCA with an injection under-the-skin (subcutaneous). See the Patient Information that comes with your on-body injector for important information.</li> <li>Your healthcare provider will use a prefilled syringe with UDENYCA to fill the on-body injector prior to applying it. The prefilled syringe with UDENYCA and the on-body injector are provided to your healthcare provider as part of UDENYCA ONBODY. The on-body injector is applied directly to your skin using a self- adhesive backing. The on-body injector lets you know its status with sounds and lights.</li> </ul> <span class="Bold">Warnings</span> <ul> <li>You should only receive a dose of UDENYCA on the day your healthcare provider tells you.</li> <li>You should not receive your dose of UDENYCA any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin.</li> <li>If you have concerns about your medicine, call your healthcare provider right away. Serious allergic reactions can happen with UDENYCA. Ask your caregiver to be nearby for the first use. Plan to be in a place where you or your caregiver can closely monitor the on-body injector for UDENYCA for about 5-minutes during UDENYCA delivery and for an hour after the delivery.</li> <li> <span class="Bold">Do not</span> take UDENYCA if you have had a serious allergic reaction to pegfilgrastim products or to filgrastim products.</li> <li>Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.</li> <li>If you have an allergic reaction during the delivery of UDENYCA, remove the on- body injector by grabbing the edge of the adhesive pad and peeling off the on- body injector. Get emergency medical help right away. <span class="Bold">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away.</li> <li>Call your healthcare provider right away if you have severe pain or skin discomfort around your on-body injector.</li> <li>Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. This pain could mean your spleen is enlarged or ruptured.</li> <li>Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ARDS): fever, shortness of breath, trouble breathing, or a fast rate of breathing.</li> <li>Call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.</li> <li>Call your healthcare provider if you have persistent or worsening redness or tenderness at the application site (may be a sign of infection).</li> <li>The on-body injector is for adult patients only.</li> </ul> <span class="Bold">Wearing the On-body Injector</span> <ul> <li>This on-body injector delivers UDENYCA with an under-the-skin (subcutaneous) injection.</li> <li>The on-body injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 5 feet (1.5 meters) for 1 hour.</li> <li>The on-body injector can be worn in a shower. After showering, check the on- body injector to make sure it has not become loose (dislodged).</li> <li>Avoid getting body lotions, creams, oils or cleaning agents near the on-body injector as these products may loosen the adhesive. Before your next scheduled UDENYCA dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen).</li> <li>Only expose the on-body injector to temperatures between 41°F and 104°F (5°C and 40°C).</li> <li> <span class="Bold">Do not</span> use bathtubs, hot tubs, whirlpools, or saunas while wearing the on-body injector. This may affect your medicine.</li> <li> <span class="Bold">Do not</span> expose the on-body injector to direct sunlight. If the on-body injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the on-body injector under clothing.</li> <li> <span class="Bold">Do not</span> sleep on the on-body injector or apply pressure during wear, especially during dose delivery. This may affect on-body injector performance.</li> <li> <span class="Bold">Do not</span> peel off or disturb the on-body injector adhesive before your full dose is complete. This may result in a missed or incomplete dose of UDENYCA.</li> </ul> <span class="Bold">Environmental Precautions</span> <ul> <li> <span class="Bold">Do not</span> expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: <ul> <li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li> <li>Radiation treatment</li> <li>Oxygen rich environments, such as hyperbaric chambers.</li> </ul> </li> <li>Keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA.</li> <li>Avoid activities and places that may interfere with monitoring during the dosing of UDENYCA administered by the on-body injector. For example, <span class="Bold">avoid</span> traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector for UDENYCA (this includes the 5-minute dose delivery period plus an hour post-delivery).</li> <li>If you must travel by airplane <span class="Bold">before</span> the approximately 5-minute dose delivery period with the on-body injector, avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector from being accidentally removed. For more information go to: <span class="Bold">http://www.tsa.gov/travelerinformation/travelers-disabilities-and-medical-conditions</span> </li> </ul> A healthcare provider who is familiar with UDENYCA should answer your questions. For general questions or support call <span class="Bold">1-800-4UDENYCA (1-800-483-3692)</span> or visit <span class="Bold">www.udenyca.com</span>. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Step 1: Monitor On-body Injector<br/> <br/> A| For the next 27 hours, occasionally check the status light for at least 10 seconds. If the status light is flashing green, it is okay.</span><img alt="image 3 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>Keep the on-body injector and adhesive backing dry for at least 3 hours after it was placed on your skin, and for 3 hours prior to dose delivery.</li> <li>Be careful not to bump the on-body injector, or knock the on-body injector off your body.</li> <li>The on-body injector has a self-adhesive backing to attach it to the skin. <span class="Bold">Do not</span> add other materials to hold it in place as this could lead to a missed or incomplete dose of UDENYCA.</li> </ul> <img alt="image 4 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor the status of the on-body injector.</li> <li>If the on-body injector comes away from your skin at any time, <span class="Bold">do not</span> reapply it. Call your healthcare provider right away as you may need a replacement dose. <span class="Bold">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away.</li> <li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Step 2: Observe Dose Delivery<br/> <br/> A| After about 27 hours, your on-body injector will begin to deliver your dose of UDENYCA.</span> <ul> <li>Right before the injection starts the injection needle will be automatically inserted into the skin.</li> <li>Dose delivery will take around 5-minutes to complete. The on-body injector will flash a fast, green light.</li> <li>You may hear the pump working. This is okay.</li> </ul> <img alt="image 5 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>When dose delivery is complete, a long beep will sound and the status light will turn solid green.</li> <li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> <img alt="iimage 6 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>If the adhesive is noticeably wet or dripping with medicine, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Step 3: Verify Dose Complete<br/> <br/> A| After the beep, check the color of the status light.</span><img alt="image 7 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><span class="Bold">B| Grab the edge of the adhesive pad. Slowly peel off the on-body injector.</span><img alt="image 8 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li> <span class="Bold">Do not</span> grasp the on-body injector itself to try to pull it off of your body.</li> <li>If medicine has leaked or the adhesive is noticeably wet or dripping, call your healthcare provider right away, as you may not have received your full dose and you may need a replacement dose.</li> <li>Remove any extra adhesive using soap and water.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 4: Finish</span><img alt="image 9 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>Check your status light. Watch for at least 10 seconds. If the status light is solid green or it has switched off, it is okay.</li> <li>You should see a black line next to the EMPTY indicator. If the on-body injector is not empty, call your healthcare provider right away, as you may need a replacement dose.</li> </ul> <img alt="image 10 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>If you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider right away.</li> <li>If the needle is exposed, call your healthcare provider right away.</li> </ul> <span class="Bold">A| Check off the box below to record how your on-body injector looks after use.</span><img alt="image 11 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><span class="Bold">B| Properly dispose of the on-body injector.</span> <ul> <li>After on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not.</li> <li>The on-body injector contains batteries, electronics, and a needle. Put the on-body injector in a FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) the on-body injector in your household trash.</span> </li> <li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: <ul> <li>made of a heavy-duty plastic,</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li> <li>upright and stable during use,</li> <li>leak-resistant, and</li> <li>properly labeled to warn of hazardous waste inside the container.</li> </ul> </li> <li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule"> <ul> <li> <span class="Bold">Do not</span> dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. <span class="Bold">Do not</span> recycle your used sharps disposal container.</li> <li>For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA's website at: <span class="Bold">http://www.fda.gov/safesharpsdisposal.</span> </li> <li> <span class="Bold">Keep the used on-body injector and sharps disposal container away from children.</span> </li> </ul> </td><td align="center" class="Botrule Rrule"><img alt="image 12 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Frequently Asked Questions<br/> <br/> How do I know it is safe to remove the on-body injector?</span><img alt="image 13 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><span class="Bold">It is safe to remove the on-body injector after checking the following:</span> <ul> <li>The status light should be solid green.</li> <li>If the status light is flashing green, the dose delivery is not complete. Wait until you hear a long beep and the status light turns solid green before removing your on-body injector.</li> <li>The status light turns off 1 hour after delivery completion.</li> <li>The fill indicator should have a black line next to EMPTY.</li> </ul> <img alt="image 14 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><ul> <li>If the status light is flashing red, you may not have received your full dose and may need a replacement dose. Call your healthcare provider right away.</li> </ul> <img alt="image 15 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/><img alt="image 16 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/> Call your healthcare provider right away if the on-body injector at any time comes away from your skin before your full dose delivery, as you may need a replacement dose.<br/> <span class="Bold">Do not</span> reapply it. <span class="Bold">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away. <img alt="image 17 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/> If there is blood, press a clean cotton ball or gauze pad on the application site. Apply an adhesive bandage if needed. <img alt="image 18 - UDENYCA ONBODY injector - OBI paitent instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/> Call your healthcare provider right away if you experience persistent or worsening redness or tenderness at the application site, as this can be a sign of infection. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <br/> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" colspan="2"><span class="Bold">Manufactured by:</span> <br/>Coherus BioSciences, Inc.<br/>Redwood City, CA 94065-1442<br/>US License No. 2023<br/> <br/>https://udenyca.com<br/>1-800-4UDENYCA (1-800-483-3692)<br/>Issued: 12/2023<br/>PMD-0215 Rev. 00 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"center\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Patient INSTRUCTIONS FOR USE<br/>UDENYCA</span> (yoo-den-i-kah) <span class=\"Bold\">ONBODY™<br/> (pegfilgrastim-cbqv)<br/>injection, for subcutaneous use</span>\n<br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Dose Delivery Information</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><img alt=\"image 1 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Get to Know Your On-body Injector</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule\"><img alt=\"image 2 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">Flashing Green:</span> The on-body injector is working properly. <span class=\"Bold\">Do not</span> remove the on-body injector if the status light is flashing green.<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<span class=\"Bold\">Solid Green (or off):</span> Signals dose delivery is complete. Check to see if fill indicator reads empty.<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<span class=\"Bold\">Flashing Red:</span> On-body injector error. If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away as you may need a replacement dose.<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<span class=\"Bold\">Fill indicator:</span> Black line shows how much UDENYCA is in the on-body injector. \n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Important Information<br/>\n<br/>On-body Injector for UDENYCA Description</span>\n<ul>\n<li>The on-body injector for UDENYCA is intended for delivery of UDENYCA. This on-body injector delivers UDENYCA with an injection under-the-skin (subcutaneous). See the Patient Information that comes with your on-body injector for important information.</li>\n<li>Your healthcare provider will use a prefilled syringe with UDENYCA to fill the on-body injector prior to applying it. The prefilled syringe with UDENYCA and the on-body injector are provided to your healthcare provider as part of UDENYCA ONBODY. The on-body injector is applied directly to your skin using a self- adhesive backing. The on-body injector lets you know its status with sounds and lights.</li>\n</ul>\n<span class=\"Bold\">Warnings</span>\n<ul>\n<li>You should only receive a dose of UDENYCA on the day your healthcare provider tells you.</li>\n<li>You should not receive your dose of UDENYCA any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for UDENYCA is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin.</li>\n<li>If you have concerns about your medicine, call your healthcare provider right away. Serious allergic reactions can happen with UDENYCA. Ask your caregiver to be nearby for the first use. Plan to be in a place where you or your caregiver can closely monitor the on-body injector for UDENYCA for about 5-minutes during UDENYCA delivery and for an hour after the delivery.</li>\n<li>\n<span class=\"Bold\">Do not</span> take UDENYCA if you have had a serious allergic reaction to pegfilgrastim products or to filgrastim products.</li>\n<li>Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.</li>\n<li>If you have an allergic reaction during the delivery of UDENYCA, remove the on- body injector by grabbing the edge of the adhesive pad and peeling off the on- body injector. Get emergency medical help right away. <span class=\"Bold\">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away.</li>\n<li>Call your healthcare provider right away if you have severe pain or skin discomfort around your on-body injector.</li>\n<li>Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. This pain could mean your spleen is enlarged or ruptured.</li>\n<li>Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ARDS): fever, shortness of breath, trouble breathing, or a fast rate of breathing.</li>\n<li>Call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.</li>\n<li>Call your healthcare provider if you have persistent or worsening redness or tenderness at the application site (may be a sign of infection).</li>\n<li>The on-body injector is for adult patients only.</li>\n</ul>\n<span class=\"Bold\">Wearing the On-body Injector</span>\n<ul>\n<li>This on-body injector delivers UDENYCA with an under-the-skin (subcutaneous) injection.</li>\n<li>The on-body injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 5 feet (1.5 meters) for 1 hour.</li>\n<li>The on-body injector can be worn in a shower. After showering, check the on- body injector to make sure it has not become loose (dislodged).</li>\n<li>Avoid getting body lotions, creams, oils or cleaning agents near the on-body injector as these products may loosen the adhesive. Before your next scheduled UDENYCA dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen).</li>\n<li>Only expose the on-body injector to temperatures between 41°F and 104°F (5°C and 40°C).</li>\n<li>\n<span class=\"Bold\">Do not</span> use bathtubs, hot tubs, whirlpools, or saunas while wearing the on-body injector. This may affect your medicine.</li>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector to direct sunlight. If the on-body injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the on-body injector under clothing.</li>\n<li>\n<span class=\"Bold\">Do not</span> sleep on the on-body injector or apply pressure during wear, especially during dose delivery. This may affect on-body injector performance.</li>\n<li>\n<span class=\"Bold\">Do not</span> peel off or disturb the on-body injector adhesive before your full dose is complete. This may result in a missed or incomplete dose of UDENYCA.</li>\n</ul>\n<span class=\"Bold\">Environmental Precautions</span>\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> expose the on-body injector to the following because the on-body injector may be damaged and you could be injured:\n <ul>\n<li>Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray)</li>\n<li>Radiation treatment</li>\n<li>Oxygen rich environments, such as hyperbaric chambers.</li>\n</ul>\n</li>\n<li>Keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA.</li>\n<li>Avoid activities and places that may interfere with monitoring during the dosing of UDENYCA administered by the on-body injector. For example, <span class=\"Bold\">avoid</span> traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector for UDENYCA (this includes the 5-minute dose delivery period plus an hour post-delivery).</li>\n<li>If you must travel by airplane <span class=\"Bold\">before</span> the approximately 5-minute dose delivery period with the on-body injector, avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector from being accidentally removed. For more information go to: <span class=\"Bold\">http://www.tsa.gov/travelerinformation/travelers-disabilities-and-medical-conditions</span>\n</li>\n</ul>\n A healthcare provider who is familiar with UDENYCA should answer your questions. For general questions or support call <span class=\"Bold\">1-800-4UDENYCA (1-800-483-3692)</span> or visit <span class=\"Bold\">www.udenyca.com</span>.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 1: Monitor On-body Injector<br/>\n<br/>\nA| For the next 27 hours, occasionally check the status light for at least 10 seconds. If the status light is flashing green, it is okay.</span><img alt=\"image 3 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>Keep the on-body injector and adhesive backing dry for at least 3 hours after it was placed on your skin, and for 3 hours prior to dose delivery.</li>\n<li>Be careful not to bump the on-body injector, or knock the on-body injector off your body.</li>\n<li>The on-body injector has a self-adhesive backing to attach it to the skin. <span class=\"Bold\">Do not</span> add other materials to hold it in place as this could lead to a missed or incomplete dose of UDENYCA.</li>\n</ul>\n<img alt=\"image 4 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor the status of the on-body injector.</li>\n<li>If the on-body injector comes away from your skin at any time, <span class=\"Bold\">do not</span> reapply it. Call your healthcare provider right away as you may need a replacement dose. <span class=\"Bold\">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away.</li>\n<li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 2: Observe Dose Delivery<br/>\n<br/>\nA| After about 27 hours, your on-body injector will begin to deliver your dose of UDENYCA.</span>\n<ul>\n<li>Right before the injection starts the injection needle will be automatically inserted into the skin.</li>\n<li>Dose delivery will take around 5-minutes to complete. The on-body injector will flash a fast, green light.</li>\n<li>You may hear the pump working. This is okay.</li>\n</ul>\n<img alt=\"image 5 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>When dose delivery is complete, a long beep will sound and the status light will turn solid green.</li>\n<li>If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n<img alt=\"iimage 6 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>If the adhesive is noticeably wet or dripping with medicine, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 3: Verify Dose Complete<br/>\n<br/>\nA| After the beep, check the color of the status light.</span><img alt=\"image 7 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><span class=\"Bold\">B| Grab the edge of the adhesive pad. Slowly peel off the on-body injector.</span><img alt=\"image 8 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>\n<span class=\"Bold\">Do not</span> grasp the on-body injector itself to try to pull it off of your body.</li>\n<li>If medicine has leaked or the adhesive is noticeably wet or dripping, call your healthcare provider right away, as you may not have received your full dose and you may need a replacement dose.</li>\n<li>Remove any extra adhesive using soap and water.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Step 4: Finish</span><img alt=\"image 9 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>Check your status light. Watch for at least 10 seconds. If the status light is solid green or it has switched off, it is okay.</li>\n<li>You should see a black line next to the EMPTY indicator. If the on-body injector is not empty, call your healthcare provider right away, as you may need a replacement dose.</li>\n</ul>\n<img alt=\"image 10 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>If you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider right away.</li>\n<li>If the needle is exposed, call your healthcare provider right away.</li>\n</ul>\n<span class=\"Bold\">A| Check off the box below to record how your on-body injector looks after use.</span><img alt=\"image 11 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><span class=\"Bold\">B| Properly dispose of the on-body injector.</span>\n<ul>\n<li>After on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not.</li>\n<li>The on-body injector contains batteries, electronics, and a needle. Put the on-body injector in a FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) the on-body injector in your household trash.</span>\n</li>\n<li>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:\n <ul>\n<li>made of a heavy-duty plastic,</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</li>\n<li>upright and stable during use,</li>\n<li>leak-resistant, and</li>\n<li>properly labeled to warn of hazardous waste inside the container.</li>\n</ul>\n</li>\n<li>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\">\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. <span class=\"Bold\">Do not</span> recycle your used sharps disposal container.</li>\n<li>For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA's website at: <span class=\"Bold\">http://www.fda.gov/safesharpsdisposal.</span>\n</li>\n<li>\n<span class=\"Bold\">Keep the used on-body injector and sharps disposal container away from children.</span>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 12 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Frequently Asked Questions<br/>\n<br/>\nHow do I know it is safe to remove the on-body injector?</span><img alt=\"image 13 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><span class=\"Bold\">It is safe to remove the on-body injector after checking the following:</span>\n<ul>\n<li>The status light should be solid green.</li>\n<li>If the status light is flashing green, the dose delivery is not complete. Wait until you hear a long beep and the status light turns solid green before removing your on-body injector.</li>\n<li>The status light turns off 1 hour after delivery completion.</li>\n<li>The fill indicator should have a black line next to EMPTY.</li>\n</ul>\n<img alt=\"image 14 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><ul>\n<li>If the status light is flashing red, you may not have received your full dose and may need a replacement dose. Call your healthcare provider right away.</li>\n</ul>\n<img alt=\"image 15 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/><img alt=\"image 16 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/>\n Call your healthcare provider right away if the on-body injector at any time comes away from your skin before your full dose delivery, as you may need a replacement dose.<br/>\n<span class=\"Bold\">Do not</span> reapply it. <span class=\"Bold\">Caution the needle may be exposed.</span> Dispose of the on-body injector into a sharps disposal container right away.\n <img alt=\"image 17 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/>\n If there is blood, press a clean cotton ball or gauze pad on the application site. Apply an adhesive bandage if needed.\n <img alt=\"image 18 - UDENYCA ONBODY injector - OBI paitent instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/>\n Call your healthcare provider right away if you experience persistent or worsening redness or tenderness at the application site, as this can be a sign of infection.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"> <br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Manufactured by:</span>\n<br/>Coherus BioSciences, Inc.<br/>Redwood City, CA 94065-1442<br/>US License No. 2023<br/>\n<br/>https://udenyca.com<br/>1-800-4UDENYCA (1-800-483-3692)<br/>Issued: 12/2023<br/>PMD-0215 Rev. 00\n </td>\n</tr>\n</tbody>\n</table></div>" }

Electromagnetic Compatibility

{ "type": "p", "children": [], "text": "\nElectromagnetic Compatibility\n" }

The delivery system is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments.

{ "type": "p", "children": [], "text": "The delivery system is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments." }

To avoid electromagnetic interference (EMI) that may affect the performance of the delivery system [(i) Dose accuracy, (ii) treatment duration, (iii) Injection Depth, (iv) Visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (EMI), such as MRI, ionizing radiation, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. In addition, portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2- way radios, BluetoothTM devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness.

{ "type": "p", "children": [], "text": "To avoid electromagnetic interference (EMI) that may affect the performance of the delivery system [(i) Dose accuracy, (ii) treatment duration, (iii) Injection Depth, (iv) Visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (EMI), such as MRI, ionizing radiation, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. In addition, portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2- way radios, BluetoothTM devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness." }

If you identify or suspect that external RF sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the EMI source.

{ "type": "p", "children": [], "text": "If you identify or suspect that external RF sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the EMI source." }

Electromagnetic Emissions

{ "type": "p", "children": [], "text": "\nElectromagnetic Emissions\n" }

The delivery system has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

{ "type": "p", "children": [], "text": "The delivery system has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation." }

If this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician.

{ "type": "p", "children": [], "text": "If this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician." }

Electromagnetic Immunity

{ "type": "p", "children": [], "text": "\nElectromagnetic Immunity\n" }

The delivery system has been tested to comply in either a Home Healthcare Environment or Professional Healthcare Environment.

{ "type": "p", "children": [], "text": "The delivery system has been tested to comply in either a Home Healthcare Environment or Professional Healthcare Environment." }

Proximity fields from RF wireless communications equipment Immunity

{ "type": "p", "children": [], "text": "\nProximity fields from RF wireless communications equipment Immunity\n" }

The delivery system is tested per IEC 61000-4-3 at Frequencies and Levels as specified below to ensure Enclosure Port Immunity to RF wireless communications equipment.

{ "type": "p", "children": [], "text": "The delivery system is tested per IEC 61000-4-3 at Frequencies and Levels as specified below to ensure Enclosure Port Immunity to RF wireless communications equipment." }

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Delivery System. Otherwise, degradation of the performance of this equipment could result.

{ "type": "p", "children": [], "text": "\nWARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Delivery System. Otherwise, degradation of the performance of this equipment could result." }

WARNING: Use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

{ "type": "p", "children": [], "text": "\nWARNING: Use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally." }

Symbols Glossary

{ "type": "p", "children": [], "text": "\nSymbols Glossary\n" }

<div class="scrollingtable"><table width="95%"> <col align="left" valign="middle" width="50%"/> <col align="center" valign="middle" width="50%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule">Description</th><th align="center" class="Botrule Rrule">Symbol/Sub clause</th> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Botrule Lrule Rrule">Name or trade mark of the product</td><td align="center" class="Botrule Rrule"><img alt="image 1 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Part number</td><td align="center" class="Botrule Rrule"><img alt="image 2 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Name or trade name and address of the manufacturer</td><td align="center" class="Botrule Rrule"><img alt="image 3 - UDENYCA ONBODY injector - OBI patient and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Serial number or batch code, preceded by the word ‘LOT’, or the serial number/NDC number;</td><td align="center" class="Botrule Rrule"><img alt="image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare providerinstructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Warnings and/or precautions to take (in text format)</td><td align="center" class="Botrule Rrule"><img alt="image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Storage temperature and any other special storage and/or handling conditions (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 6 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Humidity limitation (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 7 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Pressure limitation (for the combination)</td><td align="center" class="Botrule Rrule"><img alt="image 8 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Do not use if package is damaged</td><td align="center" class="Botrule Rrule"><img alt="image 9 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Keep away from sunlight</td><td align="center" class="Botrule Rrule"><img alt="image 10 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Keep dry</td><td align="center" class="Botrule Rrule"><img alt="image 11 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">For electrical devices - Water and dust ingress rating</td><td align="center" class="Botrule Rrule"><img alt="image 12 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">For electrical devices – refer to instruction for use</td><td align="center" class="Botrule Rrule"><img alt="image 13 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">"Rx only" labeling of prescription devices</td><td align="center" class="Botrule Rrule"><img alt="image 14 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Sterile &amp; Sterilization by EO</td><td align="center" class="Botrule Rrule"><img alt="image 15 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Expiration date (Use by)</td><td align="center" class="Botrule Rrule"><img alt="image 16 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">The device is for single use</td><td align="center" class="Botrule Rrule"><img alt="image 17 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Should not enter the MRI scanner room</td><td align="center" class="Botrule Rrule"><img alt="image 18 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Type BF applied parts</td><td align="center" class="Botrule Rrule"><img alt="image 19 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">CSA Certificate</td><td align="center" class="Botrule Rrule"><img alt="image 20 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Battery specification Li-MnO2 Battery 3V/850mAH (CR14250)</td><td align="center" class="Botrule Rrule">N/A</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">WEEE directive compliance</td><td align="center" class="Botrule Rrule"><img alt="image 21 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">UDENYCA® (pegfilgrastim-cbqv) prefilled syringe</td><td align="center" class="Botrule Rrule"><img alt="image 22 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-22.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule">On-body injector for UDENYCA® (pegfilgrastim-cbqv)</td><td align="center" class="Botrule Rrule"><img alt="image 23 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use" src="/dailymed/image.cfm?name=ifu-obi-pt-hcp-23.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"95%\">\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Botrule Lrule Rrule\">Description</th><th align=\"center\" class=\"Botrule Rrule\">Symbol/Sub clause</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Name or trade mark of the product</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 1 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-01.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Part number</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 2 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-02.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Name or trade name and address of the manufacturer</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 3 - UDENYCA ONBODY injector - OBI patient and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-03.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Serial number or batch code, preceded by the word ‘LOT’, or the serial number/NDC number;</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare providerinstructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-04.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Warnings and/or precautions to take (in text format)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 4 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-05.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Storage temperature and any other special storage and/or handling conditions (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 6 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-06.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Humidity limitation (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 7 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-07.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Pressure limitation (for the combination)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 8 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-08.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Do not use if package is damaged</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 9 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-09.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Keep away from sunlight</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 10 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-10.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Keep dry</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 11 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-11.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">For electrical devices - Water and dust ingress rating</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 12 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-12.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">For electrical devices – refer to instruction for use</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 13 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-13.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\"Rx only\" labeling of prescription devices</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 14 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-14.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Sterile &amp; Sterilization by EO</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 15 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-15.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Expiration date (Use by)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 16 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-16.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">The device is for single use</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 17 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-17.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Should not enter the MRI scanner room</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 18 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-18.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Type BF applied parts</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 19 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-19.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">CSA Certificate</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 20 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-20.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">Battery specification Li-MnO2 Battery 3V/850mAH (CR14250)</td><td align=\"center\" class=\"Botrule Rrule\">N/A</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">WEEE directive compliance</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 21 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-21.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">UDENYCA® (pegfilgrastim-cbqv) prefilled syringe</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 22 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-22.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\">On-body injector for UDENYCA® (pegfilgrastim-cbqv)</td><td align=\"center\" class=\"Botrule Rrule\"><img alt=\"image 23 - UDENYCA ONBODY injector - OBI paitent and healthcare provider instructions for use\" src=\"/dailymed/image.cfm?name=ifu-obi-pt-hcp-23.jpg&amp;setid=a8c290ee-b699-4395-a596-1453d4a4b4eb\"/></td>\n</tr>\n</tbody>\n</table></div>" }

Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled Syringe - UDENYCA

{ "type": "p", "children": [], "text": "\n\nCarton Label - One 6 mg/0.6 mL Single-Dose Prefilled Syringe - UDENYCA\n" }

PRINCIPAL DISPLAY PANEL

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL\n\n\n" }

CoherusBioSciences

{ "type": "p", "children": [], "text": "\nCoherusBioSciences\n" }

6 mg/0.6 mL

{ "type": "p", "children": [], "text": "\n6 mg/0.6 mL\n" }

NDC 70114-101-01

{ "type": "p", "children": [], "text": "NDC 70114-101-01\n " }

UDENYCA® pegfilgrastim-cbqvInjection

{ "type": "p", "children": [], "text": "\nUDENYCA®\npegfilgrastim-cbqvInjection\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

6 mg in 0.6 mL Single-Dose PrefilledSyringeFor Subcutaneous UseSterile Solution - No Preservative

{ "type": "p", "children": [], "text": "\n6 mg in 0.6 mL Single-Dose PrefilledSyringeFor Subcutaneous UseSterile Solution - No Preservative\n" }

Pegylated RecombinantMethionyl Human GranulocyteColony-Stimulating Factor (PEG-r-metHuG-CSF) derivedfrom E. coli

{ "type": "p", "children": [], "text": "Pegylated RecombinantMethionyl Human GranulocyteColony-Stimulating Factor (PEG-r-metHuG-CSF) derivedfrom E. coli\n" }

One 6 mg/0.6 mL single-dosePrefilled Syringe

{ "type": "p", "children": [], "text": "One 6 mg/0.6 mL single-dosePrefilled Syringe" }

Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled AUTOINJECTOR - UDENYCA

{ "type": "p", "children": [], "text": "\n\nCarton Label - One 6 mg/0.6 mL Single-Dose Prefilled AUTOINJECTOR - UDENYCA\n" }

PRINCIPAL DISPLAY PANEL

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL\n\n\n" }

NDC 70114-120-01

{ "type": "p", "children": [], "text": "NDC 70114-120-01\n " }

UDENYCA® pegfilgrastim-cbqvInjection

{ "type": "p", "children": [], "text": "\nUDENYCA®\npegfilgrastim-cbqvInjection\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

6 mg in 0.6 mL Single-Dose Prefilled AUTOINJECTORFor Subcutaneous Use Sterile Solution - No Preservative

{ "type": "p", "children": [], "text": "\n6 mg in 0.6 mL Single-Dose Prefilled AUTOINJECTORFor Subcutaneous Use Sterile Solution - No Preservative\n" }

One 6 mg/0.6 mL Single-Dose Prefilled Autoinjector

{ "type": "p", "children": [], "text": "One 6 mg/0.6 mL Single-Dose Prefilled Autoinjector\n" }

Pegylated Recombinant Methionyl HumanGranulocyte Colony-Stimulating Factor(PEG-r-metHuG-CSF) derived from E. coli

{ "type": "p", "children": [], "text": "Pegylated Recombinant Methionyl HumanGranulocyte Colony-Stimulating Factor(PEG-r-metHuG-CSF) derived from E. coli\n" }

Coherus™

{ "type": "p", "children": [], "text": "Coherus™" }

6 mg/0.6 mL

{ "type": "p", "children": [], "text": "\n6 mg/0.6 mL\n" }

Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled On-body Injector (OBI) - UDENYCA

{ "type": "p", "children": [], "text": "\n\nCarton Label - One 6 mg/0.6 mL Single-Dose Prefilled On-body Injector (OBI) - UDENYCA\n" }

PRINCIPAL DISPLAY PANEL

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL\n\n\n" }

Coherus®

{ "type": "p", "children": [], "text": "Coherus®\n" }

6 mg/0.6 mL*

{ "type": "p", "children": [], "text": "\n6 mg/0.6 mL*\n" }

See package insert for fullPrescribing Informationand Instructions for Use.

{ "type": "p", "children": [], "text": "\nSee package insert for fullPrescribing Informationand Instructions for Use.\n" }

RxOnly

{ "type": "p", "children": [], "text": "\nRxOnly\n" }

1 - Single-Dose UDENYCA Prefilled Syringe1 - Sterile On-body Injector for UDENYCA

{ "type": "p", "children": [], "text": "1 - Single-Dose UDENYCA Prefilled Syringe1 - Sterile On-body Injector for UDENYCA" }

NDC 70114-130-01

{ "type": "p", "children": [], "text": "NDC 70114-130-01" }

UDENYCA® ONBODY™(pegfilgrastim-cbqv)

{ "type": "p", "children": [], "text": "\nUDENYCA® ONBODY™(pegfilgrastim-cbqv)\n" }

Injection

{ "type": "p", "children": [], "text": "\nInjection\n" }

Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli

{ "type": "p", "children": [], "text": "Pegylated Recombinant Methionyl Human Granulocyte\nColony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli\n" }

*Prefilled syringe contains 0.67 mL to deliver 6 mg/0.6 mL when used with On-bodv Injector.

{ "type": "p", "children": [], "text": "\n*Prefilled syringe contains 0.67 mL to deliver 6 mg/0.6 mL\nwhen used with On-bodv Injector.\n" }

For Subcutaneous Use Only

{ "type": "p", "children": [], "text": "\nFor Subcutaneous Use Only\n" }

Carton Contents (intended to be dispensed as a unit):

{ "type": "p", "children": [], "text": "\nCarton Contents (intended to be dispensed as a unit):\n" }

{ "type": "ul", "children": [ "1 Sterile On-body Injector for UDENYCA", "1 UDENYCA Prefilled Syringe Labeled for Use With\nOn-body Injector Only", "1 Prescribing Information and 1 Patient information", "1 Patient Instructions for Use", "1 Healthcare Provider Instructions for Use" ], "text": "" }

{ "type": "ul", "children": [ "\nStore refrigerated at 2°C to 8°C\n(36°F to 46°F)\n", "\nKeep in carton to protect from light\n", "\nDo not freeze. Do not shake\n" ], "text": "" }