AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

{ "type": "p", "children": [], "text": "AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.\n" }

AVONEX is administered intramuscularly.

The recommended dose is 30 micrograms once a week. To reduce the incidence and severity of flu-like symptoms that may occur when initiating AVONEX therapy at a dose of 30 micrograms, AVONEX may be started at a dose of 7.5 micrograms and the dose may be increased by 7.5 micrograms each week for the next three weeks until the recommended dose of 30 micrograms is achieved (see Table 1). An AVOSTARTGRIP™ kit containing 3 titration devices can be used for titration and is to be used only with AVONEX Prefilled Syringes.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 1: Schedule for Dose Titration </span> </caption> <col align="left" width="21.333%"/> <col align="left" width="35.633%"/> <col align="left" width="43.033%"/> <tfoot> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote"> <span class="Sup">1</span> Dosed once a week, intramuscularly </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="left" class="Botrule Rrule Toprule" valign="top">AVONEX Dose<span class="Sup">1</span></td><td align="left" class="Botrule Rrule Toprule" valign="top">Recommended Dose </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Week 1 </td><td align="left" class="Botrule Rrule" valign="top">7.5 micrograms </td><td align="left" class="Botrule Rrule" valign="top">1/4 dose </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Week 2 </td><td align="left" class="Botrule Rrule" valign="top">15 micrograms </td><td align="left" class="Botrule Rrule" valign="top">1/2 dose </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Week 3 </td><td align="left" class="Botrule Rrule" valign="top">22.5 micrograms </td><td align="left" class="Botrule Rrule" valign="top">3/4 dose </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Week 4+ </td><td align="left" class="Botrule Rrule" valign="top">30 micrograms </td><td align="left" class="Botrule Rrule" valign="top">full dose </td> </tr> </tbody> </table></div>

AVONEX dosage forms (prefilled syringe and prefilled autoinjector) are single-dose. See Patient's Instructions for Use for complete administration instructions.

The first AVONEX injection should be performed under the supervision of an appropriately qualified healthcare professional. If patients or caregivers are to administer AVONEX, train them in the proper intramuscular injection technique and assess their ability to inject intramuscularly to ensure the proper administration of AVONEX.

Advise patients and caregivers to:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

A 25 gauge, 1” needle for intramuscular injection with AVONEX prefilled syringe may be substituted for the 23 gauge, 1 ¼” needle by the healthcare provider, if deemed appropriate. A 25 gauge, 5/8” needle specific to the prefilled autoinjector is supplied with the AVONEX PEN® Administration Dose Pack. DO NOT use any other needle with the autoinjector.

Use safe disposal procedures for needles and syringes. DO NOT re-use needles, prefilled syringes, or autoinjectors. Following the administration of each titrated dose, discard any remaining product.

Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with AVONEX use.

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AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see Warnings and Precautions (5.3)].\n" }

The formerly available lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human).

{ "type": "p", "children": [], "text": "The formerly available lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human).\n" }

Patients treated with AVONEX and their caregivers should be advised to report immediately any symptoms of depression, suicidal ideation, and/or psychosis to their prescribing physicians. If a patient develops depression or other severe psychiatric symptoms, cessation of AVONEX therapy should be considered.

Depression and suicide have been reported to occur with increased frequency in patients receiving AVONEX. In Study 1, the incidence of depression was similar in placebo-treated and in AVONEX-treated patients, but suicidal tendency was seen more frequently in AVONEX-treated patients (4% in AVONEX group vs. 1% in placebo group). In Study 2, there was a greater incidence of depression in AVONEX-treated patients than in placebo-treated patients (20% in AVONEX group vs. 13% in placebo group) [see Clinical Studies (14)].

Additionally, there have been postmarketing reports of depression, suicidal ideation, and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis. For some of these patients, symptoms of depression improved upon cessation of AVONEX.

Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with AVONEX. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of AVONEX used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to starting AVONEX, or before starting hepatotoxic drugs. Patients should be monitored for signs of hepatic injury [see Warnings and Precautions (5.10)].

Anaphylaxis has been reported as a rare complication of AVONEX use. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria. Discontinue AVONEX if anaphylaxis or other allergic reactions occur.

Injection site reactions, including injection site necrosis, can occur with the use of interferon beta products, including AVONEX. In controlled clinical trials, injection site reactions (e.g., injection site pain, bruising or erythema) occurred in 18% of patients receiving AVONEX and 13% in the placebo group. These reactions included injection site inflammation (6%), injection site pain (8%), injection site mass (<1%), nonspecific reactions.

Injection site abscesses and cellulitis and injection site necrosis have been reported in the postmarketing setting with interferon beta products, including AVONEX. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics.

Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred. Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis. For patients who continue therapy with AVONEX after injection site necrosis has occurred, avoid administration of AVONEX into the affected area until it is fully healed. If multiple lesions occur, change injection site or discontinue therapy until healing occurs.

Patients with pre-existing congestive heart failure should be monitored for worsening of their cardiac condition during initiation of and continued treatment with AVONEX. While beta interferons do not have any known direct cardiac toxicity, during the postmarketing period cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other etiologies being established. In some cases, these events have been temporally related to the administration of AVONEX. In some of these instances recurrence upon rechallenge was observed.

Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from postmarketing experience in AVONEX-treated patients [see Adverse Reactions (6.2)]. In some cases, platelet counts were below 10,000/microliter. Some cases recurred with rechallenge [see Adverse Reactions (6.2)]. Patients should be monitored for symptoms or signs of decreased blood counts.

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products, including AVONEX. Cases have been reported several weeks to years after starting interferon beta products. Discontinue AVONEX if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including AVONEX. PAH has occurred in patients treated with interferon beta products in the absence of other contributory factors. Many of the reported cases required hospitalization, including one case with interferon beta in which the patient underwent a lung transplant. PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment.

Patients who develop unexplained symptoms (e.g., dyspnea, new or increasing fatigue) should be assessed for PAH. If alternative etiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.

Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance. In the two placebo-controlled studies in multiple sclerosis (Studies 1 and 2), 4 patients receiving AVONEX experienced seizures, while no seizures occurred in the placebo group [see Clinical Studies (14)]. Three of these 4 patients had no prior history of seizure [see Adverse Reactions (6.1)]. It is not known whether these events were related to the effects of multiple sclerosis alone, to AVONEX, or to a combination of both.

Postmarketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients included idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis. If AVONEX-treated patients develop a new autoimmune disorder, consider stopping the therapy.

In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests, are recommended during AVONEX therapy [see Warnings and Precautions (5.2, 5.6, 5.10)]. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Thyroid function should be monitored periodically. If patients have or develop symptoms of thyroid dysfunction (hypo- or hyperthyroidism), thyroid function tests should be performed according to standard medical practice.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AVONEX cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

Among 351 patients with relapsing forms of MS treated with AVONEX 30 micrograms (including 319 patients treated for 6 months and 288 patients treated for greater than one year) the most commonly reported adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms. Symptoms can include chills, fever, myalgia and asthenia occurring within hours to days following an injection. Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. For many people, these symptoms lessen or go away over time. The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of AVONEX or the need for concomitant medication to treat an adverse reaction symptom) were flu-like symptoms and depression.

Table 2 enumerates adverse reactions that occurred with AVONEX-treated patients at an incidence of at least 2% more than that observed in the placebo-treated patients in the pooled placebo-controlled studies in patients with relapsing forms of MS [see Clinical Studies (14)].

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 2: Adverse Reactions in the Placebo-Controlled Studies </span> </caption> <col align="left" width="53.300%"/> <col align="left" width="25.467%"/> <col align="left" width="21.233%"/> <tbody class="Headless"> <tr> <td align="left" class="Toprule" valign="middle"></td><td align="center" class="Toprule" valign="top">Placebo </td><td align="center" class="Toprule" valign="top">AVONEX </td> </tr> <tr> <td align="left" class="Botrule" valign="middle">Adverse Reaction </td><td align="center" class="Botrule" valign="top">(N = 333) </td><td align="center" class="Botrule" valign="top">(N = 351) </td> </tr> <tr> <td align="left" valign="middle">Body as a Whole </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Headache </td><td align="center" valign="top">55% </td><td align="center" valign="top">58% </td> </tr> <tr> <td align="left" valign="middle">       Flu-like symptoms (otherwise unspecified) </td><td align="center" valign="top">29% </td><td align="center" valign="top">49% </td> </tr> <tr> <td align="left" valign="middle">       Pain </td><td align="center" valign="top">21% </td><td align="center" valign="top">23% </td> </tr> <tr> <td align="left" valign="middle">       Asthenia </td><td align="center" valign="top">18% </td><td align="center" valign="top">24% </td> </tr> <tr> <td align="left" valign="middle">       Fever </td><td align="center" valign="top">9% </td><td align="center" valign="top">20% </td> </tr> <tr> <td align="left" valign="middle">       Chills </td><td align="center" valign="top">5% </td><td align="center" valign="top">19% </td> </tr> <tr> <td align="left" valign="middle">       Abdominal pain </td><td align="center" valign="top">6% </td><td align="center" valign="top">8% </td> </tr> <tr> <td align="left" valign="middle">       Injection site pain </td><td align="center" valign="top">6% </td><td align="center" valign="top">8% </td> </tr> <tr> <td align="left" valign="middle">       Infection </td><td align="center" valign="top">4% </td><td align="center" valign="top">7% </td> </tr> <tr> <td align="left" valign="middle">       Injection site inflammation </td><td align="center" valign="top">2% </td><td align="center" valign="top">6% </td> </tr> <tr> <td align="left" valign="middle">       Chest pain </td><td align="center" valign="top">2% </td><td align="center" valign="top">5% </td> </tr> <tr> <td align="left" valign="middle">       Injection site reaction </td><td align="center" valign="top">1% </td><td align="center" valign="top">3% </td> </tr> <tr> <td align="left" valign="middle">       Toothache </td><td align="center" valign="top">1% </td><td align="center" valign="top">3% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Nervous System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Depression </td><td align="center" valign="top">14% </td><td align="center" valign="top">18% </td> </tr> <tr> <td align="left" valign="middle">       Dizziness </td><td align="center" valign="top">12% </td><td align="center" valign="top">14% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Respiratory System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Upper respiratory tract infection </td><td align="center" valign="top">12% </td><td align="center" valign="top">14% </td> </tr> <tr> <td align="left" valign="middle">       Sinusitis </td><td align="center" valign="top">12% </td><td align="center" valign="top">14% </td> </tr> <tr> <td align="left" valign="middle">       Bronchitis </td><td align="center" valign="top">5% </td><td align="center" valign="top">8% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Digestive System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Nausea </td><td align="center" valign="top">19% </td><td align="center" valign="top">23% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Musculoskeletal System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Myalgia </td><td align="center" valign="top">22% </td><td align="center" valign="top">29% </td> </tr> <tr> <td align="left" valign="middle">       Arthralgia </td><td align="center" valign="top">6% </td><td align="center" valign="top">9% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Urogenital </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Urinary tract infection </td><td align="center" valign="top">15% </td><td align="center" valign="top">17% </td> </tr> <tr> <td align="left" valign="middle">       Urine constituents abnormal </td><td align="center" valign="top">0% </td><td align="center" valign="top">3% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Skin and Appendages </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Alopecia </td><td align="center" valign="top">2% </td><td align="center" valign="top">4% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Special Senses </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Eye disorder </td><td align="center" valign="top">2% </td><td align="center" valign="top">4% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Hemic and Lymphatic System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Injection site ecchymosis </td><td align="center" valign="top">4% </td><td align="center" valign="top">6% </td> </tr> <tr> <td align="left" valign="middle">       Anemia </td><td align="center" valign="top">1% </td><td align="center" valign="top">4% </td> </tr> <tr> <td align="left" valign="middle">        </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">Cardiovascular System </td><td align="center" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="middle">       Migraine </td><td align="center" valign="top">3% </td><td align="center" valign="top">5% </td> </tr> <tr> <td align="left" valign="middle">       Vasodilation </td><td align="center" valign="top">0% </td><td align="center" valign="top">2% </td> </tr> <tr> <td align="left" class="Botrule" valign="middle">        </td><td align="center" class="Botrule" valign="top"></td><td align="center" class="Botrule" valign="top"></td> </tr> </tbody> </table></div>

Immunogenicity

Anaphylaxis and other allergic reactions have occurred in AVONEX-treated patients [see Warnings and Precautions (5.3)]. As with all therapeutic proteins, there is a potential for immunogenicity. In studies assessing immunogenicity in multiple sclerosis patients administered AVONEX for at least 1 year, 5% (21 of 390 patients) showed the presence of neutralizing antibodies at one or more times.

These data reflect the percentage of patients whose test results were considered positive for antibodies to AVONEX using a two-tiered assay (ELISA binding assay followed by an antiviral cytopathic effect assay), and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of neutralizing activity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to AVONEX with the incidence of antibodies to other products may be misleading.

The following additional adverse reactions have been identified during post-approval use of AVONEX. 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

Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion at doses greater than those used clinically (see Data).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data

Human Data

The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.

In a population-based cohort study conducted in Finland and Sweden, data were collected from 1996--2014 in Finland and 2005--2014 in Sweden on 2,831 pregnancy outcomes from women with MS. 797 pregnancies were in women exposed to interferon beta only. No evidence was found of an increased risk of major birth defects among women with MS exposed to interferon beta products compared to women with MS that were unexposed to any non-steroid therapy for MS (n=1,647) within the study. No increased risks were observed for miscarriages and ectopic pregnancies, though there were limitations in obtaining complete data capture for these outcomes, making the interpretation of the findings more difficult.

Two small cohort studies that examined pregnancies exposed to interferon beta products (without differentiating between subtypes of interferon beta products) suggested that a decrease in mean birth weight may be associated with interferon beta exposure during pregnancy, but this finding was not confirmed in larger observational studies. Two small studies observed an increased prevalence of miscarriage, although the finding was only statistically significant in one study. Most studies enrolled patients later in pregnancy which made it difficult to ascertain the true percentage of miscarriages. In one small cohort study, a significantly increased risk of preterm birth following interferon beta exposure during pregnancy was observed.

Animal Data

In pregnant monkeys given interferon beta at 100 times the recommended weekly human dose (based upon a body surface area [mg/m2] comparison), no adverse effects on embryofetal development were observed. Abortifacient activity was evident following 3 to 5 doses at this level. No abortifacient effects were observed in monkeys treated at 2 times the recommended weekly human dose (based upon mg/m2).

Risk Summary

Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. There are no data on the effects of interferon beta-1a on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AVONEX and any potential adverse effects on the breastfed infant from AVONEX or from the underlying maternal condition.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of AVONEX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

Interferon beta-1a, an interferon beta, is a 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX is identical to that of natural human interferon beta.

{ "type": "p", "children": [], "text": "Interferon beta-1a, an interferon beta, is a 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX is identical to that of natural human interferon beta.\n" }

Using the World Health Organization (WHO) International Standard for Interferon, AVONEX has a specific activity of approximately 200 million international units of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using lung carcinoma cells (A549) and Encephalomyocarditis virus (ECM). AVONEX 30 micrograms contains approximately 6 million international units of antiviral activity using this method. The activity against other standards is not known. Comparison of the activity of AVONEX with other interferon betas is not appropriate, because of differences in the reference standards and assays used to measure activity.

{ "type": "p", "children": [], "text": "Using the World Health Organization (WHO) International Standard for Interferon, AVONEX has a specific activity of approximately 200 million international units of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using lung carcinoma cells (A549) and Encephalomyocarditis virus (ECM). AVONEX 30 micrograms contains approximately 6 million international units of antiviral activity using this method. The activity against other standards is not known. Comparison of the activity of AVONEX with other interferon betas is not appropriate, because of differences in the reference standards and assays used to measure activity.\n" }

AVONEX (interferon beta-1a) injection is a sterile liquid for intramuscular injection available in a prefilled glass syringe or a prefilled glass syringe surrounded by an autoinjector. Each single-dose prefilled glass syringe or single-dose prefilled autoinjector delivers 0.5 mL of solution containing 30 micrograms of interferon beta-1a, arginine hydrochloride, USP (15.8 mg), glacial acetic acid, USP (0.25 mg), polysorbate 20 (0.025 mg), sodium acetate trihydrate, USP (0.79 mg), and Water for Injection, USP at a pH of approximately 4.8.

{ "type": "p", "children": [], "text": "AVONEX (interferon beta-1a) injection is a sterile liquid for intramuscular injection available in a prefilled glass syringe or a prefilled glass syringe surrounded by an autoinjector. Each single-dose prefilled glass syringe or single-dose prefilled autoinjector delivers 0.5 mL of solution containing 30 micrograms of interferon beta-1a, arginine hydrochloride, USP (15.8 mg), glacial acetic acid, USP (0.25 mg), polysorbate 20 (0.025 mg), sodium acetate trihydrate, USP (0.79 mg), and Water for Injection, USP at a pH of approximately 4.8.\n" }

The mechanism of action by which AVONEX exerts its effects in patients with multiple sclerosis is unknown.

Interferons (IFNs) are a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents. Three major types of interferons have been defined: type I (IFN-alpha, beta, epsilon, kappa and omega), type II (IFN–gamma) and type III (IFN-lambda). Interferon-beta is a member of the type I subset of interferons.  The type I interferons have considerably overlapping but also distinct biologic activities. The bioactivities of all IFNs, including IFN-beta, are induced via their binding to specific receptors on the membranes of human cells. Differences in the bioactivities induced by the three major subtypes of IFNs likely reflect differences in the signal transduction pathways induced by signaling through their cognate receptors.

Interferon beta exerts its biological effects by binding to specific receptors on the surface of human cells.  This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.  These include 2', 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.  These products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.

Clinical studies conducted in multiple sclerosis patients showed that interleukin 10 (IL-10) levels in cerebrospinal fluid were increased in patients treated with AVONEX compared to placebo.  Serum IL-10 levels maximally were increased by 48 hours after intramuscular injection of AVONEX and remained elevated for 1 week.  However, no relationship has been established between absolute levels of IL-10 and clinical outcome in multiple sclerosis.

Pharmacokinetics of AVONEX in multiple sclerosis patients have not been evaluated. The pharmacokinetic and pharmacodynamic profiles of AVONEX in healthy subjects following doses of 30 micrograms through 75 micrograms have been investigated. Serum levels of AVONEX as measured by antiviral activity are slightly above detectable limits following a 30 microgram intramuscular dose, and increase with higher doses.

After an intramuscular dose, serum levels of AVONEX generally peak at 15 hours post-dose (range: 6-36 hours) and then decline at a rate consistent with a 19 (range: 8-54) hour elimination half-life.

Subcutaneous administration of AVONEX should not be substituted for intramuscular administration as there is no data establishing that subcutaneous and intramuscular administration of AVONEX result in equivalent pharmacokinetic and pharmacodynamic parameters.

Biological response markers (e.g., neopterin and β2-microglobulin) are induced by AVONEX following parenteral doses of 15 micrograms through 75 micrograms in healthy subjects and treated patients. Biological response marker levels increase within 12 hours of dosing and remain elevated for at least 4 days. Peak biological response marker levels are typically observed 48 hours after dosing. The relationship of serum AVONEX levels or levels of these induced biological response markers to the mechanisms by which AVONEX exerts its effects in multiple sclerosis is unknown.

Carcinogenesis: The carcinogenic potential of AVONEX has not been tested in animals.

Mutagenesis: Interferon beta was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test or in an in vitro cytogenetic assay in human lymphocytes.

Impairment of Fertility: In monkeys administered interferon beta by subcutaneous injection (8 to 15 doses of 1.25 mcg/kg or 50 mcg/kg) over the course of one menstrual cycle, menstrual irregularities, anovulation, and decreased serum progesterone levels were observed at the higher dose. These effects were reversible after discontinuation of drug. The no-effect dose (1.25 mcg/kg) is approximately 2 times the recommended weekly dose in humans (30 mcg) on a mg/m2 basis.

Disability

The primary outcome assessment was time to progression in disability, measured as an increase in the EDSS score of at least 1 point that was sustained for at least 6 months. An increase in EDSS score reflects accumulation of disability. This endpoint was used to help distinguish permanent increase in disability from a transient increase due to an exacerbation.

As shown in Figure 1, the time to onset of sustained progression in disability was significantly longer in AVONEX-treated patients than in placebo-treated patients in Study 1 (p = 0.02). The percentage of patients progressing by the end of 2 years was 35% for placebo-treated patients and 22% for AVONEX-treated patients. This represents a 37% relative reduction in the risk of accumulating disability in the AVONEX-treated group compared to the placebo-treated group.

1Kaplan-Meier Methodology; Disability progression was defined as at least a 1 point increase in EDSS score sustained for at least 6 months.

The distribution of confirmed EDSS change from study entry (baseline) to the end of the study is shown in Figure 2. There was a statistically significant difference between the AVONEX and placebo groups in confirmed change for patients with at least 2 scheduled visits (p = 0.006).

Exacerbations

The rate and frequency of MS exacerbations were secondary outcomes. For all patients included in the study, irrespective of time on study, the annual exacerbation rate was 0.67 per year in the AVONEX-treated group and 0.82 per year in the placebo-treated group (p = 0.04).

AVONEX treatment significantly decreased the frequency of exacerbations in the subset of patients who were enrolled in the study for at least 2 years (87 placebo-treated patients and 85 AVONEX-treated patients; p = 0.03; see Table 3).

MRI Results

Gadolinium (Gd)-enhanced and T2-weighted magnetic resonance imaging (MRI) scans of the brain were obtained in most patients at baseline and at the end of 1 and 2 years of treatment. Secondary outcomes included Gd-enhanced lesion number and volume, and T2-weighted lesion volume. Gd-enhancing lesions seen on brain MRI scans represent areas of breakdown of the blood brain barrier thought to be secondary to inflammation. AVONEX-treated patients demonstrated significantly lower Gd-enhanced lesion number after 1 and 2 years of treatment than placebo-treated patients (p ≤ 0.05; see Table 3). The volume of Gd-enhanced lesions showed similar treatment effects in the AVONEX and placebo groups (p ≤ 0.03). Percentage change in T2-weighted lesion volume from study entry to Year 1 was significantly lower in AVONEX-treated than placebo-treated patients (p = 0.02). A significant difference in T2-weighted lesion volume change was not seen between study entry and Year 2 in the AVONEX and placebo groups.

Summary of Effects of Clinical and MRI Endpoints in Study 1

A summary of the effects of AVONEX on the clinical and MRI endpoints of this study is presented in Table 3.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 3: Clinical and MRI Endpoints in Patients with MS in Study 1 </span> </caption> <col align="left" width="31.000%"/> <col align="left" width="23.000%"/> <col align="left" width="23.000%"/> <col align="left" width="23.000%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Toprule" valign="bottom">Endpoint </td><td align="center" class="Botrule Toprule" valign="bottom">Placebo </td><td align="center" class="Botrule Toprule" valign="bottom">AVONEX </td><td align="center" class="Botrule Toprule" valign="bottom">P-Value </td> </tr> <tr> <td align="left" valign="bottom"> <br/> <span class="Underline">PRIMARY ENDPOINT</span>:<br/> <br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">Time to sustained progression in disability (N: 143, 158)<span class="Sup">1</span></td><td align="center" colspan="2" valign="bottom">--- See <a href="#f01">Figure 1</a> ---<br/> </td><td align="center" valign="bottom">0.02<span class="Sup">2</span></td> </tr> <tr> <td align="left" valign="bottom"> <br/>Percentage of patients progressing in disability at 2 years (Kaplan-Meier estimate)<span class="Sup">1</span></td><td align="center" valign="bottom">35% </td><td align="center" valign="bottom">22% </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom"> <br/> <span class="Underline">SECONDARY ENDPOINTS</span>:<br/> <span class="Underline">DISABILITY</span> <br/> <br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">Mean confirmed change in EDSS from study entry to end of study (N: 136, 150)<span class="Sup">1</span></td><td align="center" valign="bottom">0.50 </td><td align="center" valign="bottom">0.20 </td><td align="center" valign="bottom">0.006<span class="Sup">3</span></td> </tr> <tr> <td align="left" valign="bottom"> <br/> <span class="Underline">EXACERBATIONS</span> <br/> <br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">Number of exacerbations in subset completing 2 years (N: 87, 85) </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">      0 </td><td align="center" valign="bottom">26% </td><td align="center" valign="bottom">38% </td><td align="center" valign="bottom">0.03<span class="Sup">3</span></td> </tr> <tr> <td align="left" valign="bottom">      1 </td><td align="center" valign="bottom">30% </td><td align="center" valign="bottom">31% </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">      2 </td><td align="center" valign="bottom">11% </td><td align="center" valign="bottom">18% </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">      3 </td><td align="center" valign="bottom">14% </td><td align="center" valign="bottom">7% </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom">      ≥ 4 </td><td align="center" valign="bottom">18% </td><td align="center" valign="bottom">7% </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="bottom"> <br/>Percentage of patients exacerbation-free in subset completing 2 years (N: 87, 85) </td><td align="center" valign="bottom"> <br/>26% </td><td align="center" valign="bottom"> <br/>38% </td><td align="center" valign="bottom"> <br/>0.10<span class="Sup">4</span></td> </tr> <tr> <td align="left" valign="bottom"> <br/>Annual exacerbation rate (N: 143, 158)1 </td><td align="center" valign="bottom">0.82 </td><td align="center" valign="bottom">0.67 </td><td align="center" valign="bottom">0.04<span class="Sup">5</span></td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 3 (continued): Clinical and MRI Endpoints in Study 1 </span> </caption> <col align="left" width="31.000%"/> <col align="left" width="23.000%"/> <col align="left" width="23.000%"/> <col align="left" width="23.000%"/> <tfoot> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics">Note: (N: , ) denotes the number of evaluable placebo and AVONEX patients, respectively.</span> </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics"><span class="Sup">1</span></span><span class="Italics">Patient data included in this analysis represent variable periods of time on study.</span> </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics"><span class="Sup">2</span></span><span class="Italics">Analyzed by Mantel-Cox (logrank) test.</span> </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics"><span class="Sup">3</span></span><span class="Italics">Analyzed by Mann-Whitney rank-sum test.</span> </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics"><span class="Sup">4</span></span><span class="Italics">Analyzed by Cochran-Mantel-Haenszel test.</span> </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Italics"><span class="Sup">5</span></span><span class="Italics">Analyzed by likelihood ratio test.</span> </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left" class="Botrule Toprule" valign="top">Endpoint </td><td align="center" class="Botrule Toprule" valign="bottom">Placebo </td><td align="center" class="Botrule Toprule" valign="bottom">AVONEX </td><td align="center" class="Botrule Toprule" valign="bottom">P-Value </td> </tr> <tr> <td align="left" valign="top"><span class="Underline">MRI</span></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">  </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top"><span class="Underline">Number of Gd-enhanced lesions</span>:<br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">At study entry (N: 132, 141)<br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Mean (Median)<br/> </td><td align="center" valign="bottom">2.3 (1.0) </td><td align="center" valign="bottom">3.2 (1.0) </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Range<br/> </td><td align="center" valign="bottom">0-23 </td><td align="center" valign="bottom">0-56 </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">  </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">Year 1 (N: 123, 134)<br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Mean (Median) </td><td align="center" valign="bottom">1.6 (0) </td><td align="center" valign="bottom">1.0 (0) </td><td align="center" valign="bottom">0.02<span class="Sup">3</span></td> </tr> <tr> <td align="left" valign="top">     Range<br/> </td><td align="center" valign="bottom">0-22 </td><td align="center" valign="bottom">0-28 </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">  </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">Year 2 (N: 82, 83)<br/> </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Mean (Median) </td><td align="center" valign="bottom">1.6 (0) </td><td align="center" valign="bottom">0.8 (0) </td><td align="center" valign="bottom">0.05<span class="Sup">3</span></td> </tr> <tr> <td align="left" valign="top">     Range<br/> </td><td align="center" valign="bottom">0-34 </td><td align="center" valign="bottom">0-13 </td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">  </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top"><span class="Underline">T2 lesion volume</span>: </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">Percentage change from study entry to Year 1 (N: 116, 123) </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Median<br/> </td><td align="center" valign="bottom">-3.3% </td><td align="center" valign="bottom">-13.1% </td><td align="center" valign="bottom">0.02<span class="Sup">3</span></td> </tr> <tr> <td align="left" valign="top">Percentage change from study entry to Year 2 (N: 83, 81) </td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" valign="bottom"></td> </tr> <tr> <td align="left" valign="top">     Median </td><td align="center" valign="bottom">-6.5% </td><td align="center" valign="bottom">-13.2% </td><td align="center" valign="bottom">0.36<span class="Sup">3</span></td> </tr> </tbody> </table></div>

In Study 2, 383 patients who had recently experienced an isolated demyelinating event involving the optic nerve, spinal cord, or brainstem/cerebellum, and who had lesions typical of multiple sclerosis on brain MRI, received either 30 micrograms of AVONEX (n = 193) or placebo (n = 190) by intramuscular injection once weekly. Patients were enrolled into the study over a two-year period and followed for up to three years or until they developed a second clinical exacerbation in an anatomically distinct region of the central nervous system.

Exacerbations

In Study 2, the primary outcome measure was time to development of a second exacerbation in an anatomically distinct region of the central nervous system. Time to development of a second exacerbation was significantly delayed in AVONEX-treated compared to placebo-treated patients (p = 0.002). The Kaplan-Meier estimates of the percentage of patients developing an exacerbation within 24 months were 39% in the placebo group and 21% in the AVONEX group (see Figure 3). The relative rate of developing a second exacerbation in the AVONEX group was 0.56 of the rate in the placebo group (95% confidence interval 0.38 to 0.81).

1 Kaplan-Meier Methodology

MRI Findings

Secondary outcomes were brain MRI measures, including the cumulative increase in the number of new or enlarging T2 lesions, T2 lesion volume at baseline compared to results at 18 months, and the number of Gd-enhancing lesions at 6 months. See Table 4 for the MRI results.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 4: Brain MRI Results in Study 2 </span> </caption> <col align="left" width="48.487%"/> <col align="left" width="24.631%"/> <col align="left" width="10%"/> <col align="left" width="26.507%"/> <tfoot> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Sup">1</span> P value &lt;0.001 </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote"> <span class="Sup">2</span> P value &lt;0.03 </p> </td> </tr> <tr> <td align="left" colspan="4" valign="top"> <p class="First Footnote">* P value from a Mann-Whitney rank-sum test </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center" class="Botrule Toprule" valign="top"></td><td align="center" class="Botrule Toprule" valign="top">AVONEX </td><td align="center" class="Botrule Toprule" colspan="2" valign="top">Placebo </td> </tr> <tr> <td align="left" valign="top"><span class="Underline">CHANGE FROM BASELINE IN T2 VOLUME OF LESIONS AT 18 MONTHS:</span></td><td align="center" valign="top">N = 119 </td><td align="center" colspan="2" valign="top">N = 109 </td> </tr> <tr> <td align="center" valign="top"></td><td align="center" valign="top"></td><td align="center" colspan="2" valign="top"></td> </tr> <tr> <td align="center" valign="top">Actual Change (mm<span class="Sup">3</span>)<span class="Sup">1*</span> <br/>Median (25<span class="Sup">th</span>%, 75<span class="Sup">th</span>%) </td><td align="center" valign="top"> <br/>28 (-576, 397) </td><td align="center" colspan="2" valign="top"> <br/>313 (5, 1140)<br/> </td> </tr> <tr> <td align="left" valign="top"> Percentage Change<span class="Sup">1*</span> <br/>Median (25<span class="Sup">th</span>%, 75<span class="Sup">th</span>%) </td><td align="center" valign="top"> <br/>1 (-24, 29) </td><td align="center" colspan="2" valign="top"> <br/>16 (0, 53) </td> </tr> <tr> <td align="center" colspan="4" valign="top"></td> </tr> <tr> <td align="left" valign="top"><span class="Underline">NUMBER OF NEW OR ENLARGING T2 LESIONS AT 18 MONTHS</span><span class="Underline"><span class="Sup">1*</span></span>: </td><td align="center" colspan="2" valign="top">N = 132<br/>N (%) </td><td align="center" valign="top">N = 119<br/>N (%) </td> </tr> <tr> <td align="center" colspan="4" valign="top"></td> </tr> <tr> <td align="center" valign="top">0 </td><td align="center" valign="top">62 (47) </td><td align="center" colspan="2" valign="top">22 (18) </td> </tr> <tr> <td align="center" valign="top">1-3 </td><td align="center" valign="top">41 (31) </td><td align="center" colspan="2" valign="top">47 (40) </td> </tr> <tr> <td align="center" valign="top">≥4 </td><td align="center" valign="top">29 (22) </td><td align="center" colspan="2" valign="top">50 (42) </td> </tr> <tr> <td align="center" valign="top">Mean (SD) </td><td align="center" valign="top">2.13 (3.2) </td><td align="center" colspan="2" valign="top">4.97 (7.7) </td> </tr> <tr> <td align="center" colspan="4" valign="top"></td> </tr> <tr> <td align="left" valign="top"><span class="Underline">NUMBER OF GD-ENHANCING LESIONS AT 6 MONTHS</span><span class="Underline"><span class="Sup">2*</span></span>: </td><td align="center" colspan="2" valign="top">N = 165<br/>N (%) </td><td align="center" valign="top">N = 152<br/>N (%) </td> </tr> <tr> <td align="center" valign="top"></td><td align="center" colspan="3" valign="top"></td> </tr> <tr> <td align="center" valign="top">0 </td><td align="center" valign="top">115 (70) </td><td align="center" colspan="2" valign="top">93 (61) </td> </tr> <tr> <td align="center" valign="top">1 </td><td align="center" valign="top">27 (16) </td><td align="center" colspan="2" valign="top">16 (11) </td> </tr> <tr> <td align="center" valign="top">&gt;1 </td><td align="center" valign="top">23 (14) </td><td align="center" colspan="2" valign="top">43 (28) </td> </tr> <tr> <td align="center" class="Botrule" valign="top">Mean (SD) </td><td align="center" class="Botrule" valign="top">0.87 (2.3) </td><td align="center" class="Botrule" colspan="2" valign="top">1.49 (3.1)<br/> </td> </tr> </tbody> </table></div>

AVONEX (interferon beta-1a) injection is a clear, colorless solution in a single-dose prefilled glass syringe or a single-dose prefilled autoinjector for intramuscular injection available in the following packaging configurations:

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="42.500%"/> <col align="left" width="57.500%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">NDC number</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Contents</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">NDC 59627-002-06 </td><td align="left" class="Botrule Rrule" valign="top">one single-dose prefilled AVONEX syringe<br/>one 23-gauge, 1¼-inch needle </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">NDC 59627-222-05 </td><td align="left" class="Botrule Rrule" valign="top">four single-dose prefilled AVONEX syringes<br/>four 23-gauge, 1¼-inch needles<br/>four alcohol wipes<br/>four gauze pads<br/>four adhesive bandages </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">NDC 59627-003-01 </td><td align="left" class="Botrule Rrule" valign="top">one single-dose prefilled autoinjector (AVONEX Pen)<br/>one 25-gauge, 5/8-inch needle<br/>one AVONEX Pen cover </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">NDC 59627-333-04 </td><td align="left" class="Botrule Rrule" valign="top">four single-dose prefilled autoinjector (AVONEX Pens)<br/>four 25-gauge, 5/8-inch needles<br/>four AVONEX Pen covers<br/>four alcohol wipes<br/>four gauze pads<br/>four adhesive bandages </td> </tr> </tbody> </table></div>

Refrigerate AVONEX prefilled syringes and autoinjectors at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. DO NOT FREEZE. Once removed from the refrigerator, allow prefilled syringes and autoinjectors to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX.

Should refrigeration be unavailable, a prefilled syringe or autoinjector may be stored at room temperature up to 25°C (77°F) for a period up to 7 days. DO NOT EXPOSE TO HIGH TEMPERATURES. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE.

Do not use beyond the expiration date.

AVONEX Prefilled Syringe and AVONEX PEN contain natural rubber latex which may cause allergic reactions.

Instruction on Self-injection Technique and Procedures

Provide appropriate instruction for methods of self-injection of AVONEX, including careful review of the AVONEX Medication Guide. Instruct patients in the use of aseptic technique when administering AVONEX.

Inform patients that an appropriately qualified healthcare professional should show them or their caregiver how to prepare and inject AVONEX before administering the first dose. An appropriately qualified healthcare professional should watch the first AVONEX injection given. Tell patients not to re-use needles or syringes and instruct patients on safe disposal procedures. Inform patients to dispose of used needles and syringes in a puncture-resistant container and instruct the patient regarding safe disposal of full containers.

Advise patients:

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)].

Depression

Advise patients of the symptoms of depression, suicidal ideation, or psychotic disorders as they have been reported with the use of AVONEX and instruct patients to report them immediately to their physician [see Warnings and Precautions (5.1)].

Liver Disease

Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of AVONEX. Advise patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their physician [see Warnings and Precautions (5.2)].

Allergic Reactions and Anaphylaxis

Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur [see Warnings and Precautions (5.3)].

Injection Site Reactions Including Necrosis

Advise patients that injection site reactions can occur and that the reactions can include injection site necrosis. Instruct patients to report promptly any break in the skin that is associated with blue-black discoloration, swelling, or drainage of fluid from the injection site [see Warnings and Precautions (5.4)].

Congestive Heart Failure

Advise patients that worsening of pre-existing congestive heart failure has been reported in patients using AVONEX. Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their physician [see Warnings and Precautions (5.5)].

Pulmonary Arterial Hypertension

Inform patients that PAH has occurred in patients treated with interferon beta products, including AVONEX. Instruct patients to promptly report any new symptoms such as new or increasing fatigue or shortness of breath to their healthcare provider [see Warnings and Precautions (5.8)].

Seizures

Advise patients that seizures have been reported in patients using AVONEX. Instruct patients to report seizures immediately to their physician [see Warnings and Precautions (5.9)].

Flu-like Symptoms

Inform patients that flu-like symptoms are common following initiation of therapy with AVONEX [see Dosage and Administration (2.3) and Adverse Reactions (6)]. Advise patients that starting with a lower dose than 30 micrograms and increasing the dose over 3 weeks reduces the incidence and severity of flu-like symptoms.

41613-07

Manufactured by:

Biogen Inc.

Cambridge, MA 02142 USA

U.S. License #1697

1-800-456-2255

AVONEX is a registered trademark of Biogen.

© Biogen 1996-2023. All rights reserved.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="25.000%"/> <col align="left" width="25.000%"/> <col align="left" width="25.000%"/> <col align="left" width="25.000%"/> <tfoot> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote"> This Medication Guide has been approved by the U.S. Food and Drug Administration. </p> </td><td align="right" valign="top"> <p class="First Footnote">Revised: 7/2023 </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"><span class="Bold">MEDICATION GUIDE</span> <br/> <span class="Bold">AVONEX</span><span class="Bold"><span class="Sup">® </span></span><span class="Bold">(a-vuh-necks)</span> <br/> <span class="Bold">(interferon beta-1a) Injection for intramuscular use</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top">Read this Medication Guide before you start using AVONEX, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"> <p class="First"> <a name="p01"></a><span class="Bold">What is the most important information I should know about AVONEX?</span> <br/> <span class="Bold">AVONEX can cause serious side effects.</span> Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.<br/>1. <span class="Bold">Depression, suicidal thoughts, hallucinations or other behavioral health problems.</span> Some people taking AVONEX may develop mood or behavior problems including:<br/> </p> <ul class="Disc"> <li>irritability (getting upset easily) </li> <li>depression (feeling hopeless or feeling bad about yourself) </li> <li>nervousness </li> <li>anxiety </li> <li>aggressive behavior </li> <li>thoughts of hurting yourself or suicide </li> <li>hearing or seeing things that others do not hear or see (hallucinations) </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top">If you have any of these mood or behavior problems, your healthcare provider may tell you to stop taking AVONEX.<br/> <span class="Bold">2. Liver problems, or worsening of liver problems including liver failure and death. Tell your healthcare provider right away if you have any of these symptoms:</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> <ul class="Disc"> <li>nausea </li> <li>loss of appetite </li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>tiredness </li> <li>dark colored urine and pale stools </li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>yellowing of your skin or the white part of your eye </li> <li>bleeding more easily than normal </li> </ul> </td><td align="left" class="Rrule" valign="top"> <ul class="Disc"> <li>confusion </li> <li>sleepiness </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top">During your treatment with AVONEX you will need to see your healthcare provider regularly and have regular blood tests to check for side effects. Tell your healthcare provider about all the medicines you take and if you drink alcohol before you start taking AVONEX.<br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">3. Serious allergic and skin reactions.</span> Serious allergic and skin reactions can happen when you take AVENOX. <span class="Bold">Symptoms of serious allergic and skin reactions may include:</span> <br/> <ul class="Disc"> <li>itching </li> <li>swelling of the face, eyes, lips, tongue or throat </li> <li>trouble breathing </li> <li>anxiousness </li> <li>feeling faint </li> <li>skin rash, hives, sores in your mouth, or your skin blisters and peels </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top">Get emergency help right away if you have any of these symptoms. Talk to your healthcare provider before taking another dose of AVONEX.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top"><span class="Bold">What is AVONEX?</span> <br/>AVONEX is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.<br/>It is not known if AVONEX is safe and effective in children. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top"><span class="Bold">Do not take AVONEX if you:</span> <br/> <ul class="Disc"> <li>are allergic to interferon beta or any of the ingredients in AVONEX. See the end of this Medication Guide for a complete list of ingredients in AVONEX. </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">Before taking AVONEX, tell your healthcare provider about all of your medical conditions, including if you:</span> <br/> <ul class="Disc"> <li>are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. </li> <li>have or had bleeding problems or blood clots. </li> <li>have or had low blood cell counts. </li> <li>have or had liver problems. </li> <li>have or had seizures. (epilepsy). </li> <li>have or had heart problems. </li> <li>have or had thyroid problems. </li> <li>have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells). </li> <li>drink alcohol. </li> <li>have or have had an allergic reaction to rubber or latex. The tip cap of the AVONEX prefilled syringe and prefilled autoinjector Pen contain natural rubber latex. </li> <li>are pregnant or plan to become pregnant. It is not known if AVONEX can harm your unborn baby. </li> <li>are breastfeeding or plan to breastfeed. AVONEX may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take AVONEX. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top">Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">How should I use AVONEX?</span> <br/> <ul class="Disc"> <li>See the <span class="Bold">Instructions for Use</span> for detailed instructions for preparing and injecting your dose of AVONEX. </li> <li>A healthcare provider should show you how to prepare your dose of AVONEX and how to inject your AVONEX before you use it for the first time. </li> <li>A healthcare provider or nurse should watch the first AVONEX injection you give yourself. </li> <li>AVONEX is given 1 time each week by injection into the muscle (intramuscular injection). </li> <li>Inject AVONEX exactly as your healthcare provider tells you. </li> <li>Your healthcare provider will tell you how much AVONEX to inject and how often to inject AVONEX. <span class="Bold">Do not</span> inject more than your healthcare provider tells you to. </li> <li> <span class="Bold">Do not</span> change your dose unless your healthcare provider tells you to. </li> <li>Change (rotate) your injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction. </li> <li> <span class="Bold">Do not</span> inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. </li> <li>AVONEX comes as a:<ul class="Circle"> <li>Single-dose prefilled syringe (can be used with the AVOSTARTGRIP™ titration kit) </li> <li>Single-dose prefilled autoinjector Pen (AVONEX PEN<span class="Sup">®</span>) </li> </ul> </li> <li>After 2 hours check your injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.<br/> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top">Your healthcare provider will decide which one is best for you.<br/>Always use a new, unopened AVONEX single-dose prefilled syringe or single-dose prefilled autoinjector pen for each intramuscular injection. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">What are the possible side effects of AVONEX?</span> <br/> <span class="Bold">AVONEX can cause serious side effects including:</span> <br/> <ul class="Disc"> <li> <span class="Bold">See “<a href="#p01">What is the most important information I should know about AVONEX?</a>”</span> </li> <li> <span class="Bold">Injection site reactions. </span>AVONEX may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider. </li> <li> <span class="Bold">Heart problems, including heart failure.</span> Some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX. If you already have heart failure, AVONEX may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using AVONEX.<ul class="Circle"> <li>Some people using AVONEX may have other heart problems including:<ul class="Square"> <li>low blood pressure </li> <li>fast or abnormal heart beat </li> <li>chest pain </li> <li>heart attack or a heart muscle problem (cardiomyopathy) </li> </ul> </li> </ul> </li> <li> <span class="Bold">Blood problems.</span> AVONEX can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. </li> <li> <span class="Bold">Thrombotic microangiopathy (TMA).</span> TMA is a condition that involves injury to the smallest blood vessels in your body. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking AVONEX if you develop TMA. </li> <li> <span class="Bold">Pulmonary arterial hypertension.</span> Pulmonary arterial hypertension can occur with interferon beta products, including AVONEX. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms. </li> <li> <span class="Bold">Seizures.</span> Some people have had seizures while taking AVONEX, including people who have never had seizures before. Tell your healthcare provider right away if you have a seizure. </li> <li> <span class="Bold">Autoimmune diseases.</span> Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use AVONEX.<br/> <br/> </li> </ul> </td> </tr> <tr> <td align="justify" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">The most common side effects of AVONEX include:</span> <br/> <ul class="Disc"> <li> <span class="Bold">Flu-like symptoms.</span> Most people who take AVONEX have flu-like symptoms especially early during the course of therapy. Usually, these symptoms last for a day after the injection. Symptoms may include: <ul class="Circle"> <li>muscle aches </li> <li>fever </li> <li>tiredness </li> <li>chills<br/> </li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top">You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. Talk with your healthcare provider about ways to help if you develop flu-like symptoms while taking AVONEX.<br/> <br/>These are not all of the possible side effects of AVONEX.<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="4" valign="top"><span class="Bold">How should I store AVONEX?</span> <ul class="Disc"> <li>Store AVONEX in the refrigerator between 36°F to 46°F (2°C to 8°C). </li> <li> <span class="Bold">Do not</span> freeze AVONEX. <span class="Bold">Do not</span> use AVONEX that has been frozen. </li> <li>If you cannot refrigerate your AVONEX PEN and AVONEX prefilled syringes, you can store your AVONEX PEN and AVONEX prefilled syringes at room temperature up to 77°F (25°C) for up to 7 days. </li> <li> <span class="Bold">Do not</span> store AVONEX above 77°F (25°C). <span class="Bold">Do not use</span> AVONEX that is stored at temperatures higher than 77°F (25°C). Throw it away in a FDA-cleared sharps disposal container. </li> <li>Keep AVONEX in the original carton to protect it from light. </li> <li> <span class="Bold">Do not</span> use AVONEX past the expiration date. </li> </ul> <br/> <span class="Bold">Keep AVONEX prefilled syringes, pens, and all other medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top"><span class="Bold">General information about the safe and effective use of AVONEX.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVONEX for a condition for which it was not prescribed. Do not give AVONEX 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 AVONEX that is written for health professionals. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="4" valign="top"><span class="Bold">What are the ingredients in AVONEX?</span> <br/> <span class="Bold">Active ingredient:</span> interferon beta-1a<br/> <span class="Bold">Inactive ingredients:</span> <br/> <ul class="Disc"> <li> <span class="Bold">Single-Dose Prefilled Syringe:</span> arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for inject]tion. </li> <li> <span class="Bold">Single-Dose Prefilled Autoinjector Pen:</span> arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.<br/> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="4" valign="top"> <br/>Manufactured by:<br/>Biogen Inc. Cambridge, MA 02142 USA<br/>U.S. License #1697<br/>AVONEX is a registered trademark of Biogen. © Biogen 1996-2023. All rights reserved.<br/>For more information, call 1-1-800-456-2255. </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"25.000%\"/>\n<col align=\"left\" width=\"25.000%\"/>\n<col align=\"left\" width=\"25.000%\"/>\n<col align=\"left\" width=\"25.000%\"/>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"3\" valign=\"top\">\n<p class=\"First Footnote\"> This Medication Guide has been approved by the U.S. Food and Drug Administration.\n</p>\n</td><td align=\"right\" valign=\"top\">\n<p class=\"First Footnote\">Revised: 7/2023\n</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>\n<span class=\"Bold\">AVONEX</span><span class=\"Bold\"><span class=\"Sup\">®\n</span></span><span class=\"Bold\">(a-vuh-necks)</span>\n<br/>\n<span class=\"Bold\">(interferon beta-1a) Injection for intramuscular use</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">Read this Medication Guide before you start using AVONEX, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<a name=\"p01\"></a><span class=\"Bold\">What is the most important information I should know about AVONEX?</span>\n<br/>\n<span class=\"Bold\">AVONEX can cause serious side effects.</span> Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.<br/>1. <span class=\"Bold\">Depression, suicidal thoughts, hallucinations or other behavioral health problems.</span> Some people taking AVONEX may develop mood or behavior problems including:<br/>\n</p>\n<ul class=\"Disc\">\n<li>irritability (getting upset easily)\n</li>\n<li>depression (feeling hopeless or feeling bad about yourself)\n</li>\n<li>nervousness\n</li>\n<li>anxiety\n</li>\n<li>aggressive behavior\n</li>\n<li>thoughts of hurting yourself or suicide\n</li>\n<li>hearing or seeing things that others do not hear or see (hallucinations)\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\">If you have any of these mood or behavior problems, your healthcare provider may tell you to stop taking AVONEX.<br/>\n<span class=\"Bold\">2. Liver problems, or worsening of liver problems including liver failure and death. Tell your healthcare provider right away if you have any of these symptoms:</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>nausea\n</li>\n<li>loss of appetite\n</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>tiredness\n</li>\n<li>dark colored urine and pale stools\n</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>yellowing of your skin or the white part of your eye\n</li>\n<li>bleeding more easily than normal\n</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>confusion\n</li>\n<li>sleepiness\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\">During your treatment with AVONEX you will need to see your healthcare provider regularly and have regular blood tests to check for side effects. Tell your healthcare provider about all the medicines you take and if you drink alcohol before you start taking AVONEX.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">3. Serious allergic and skin reactions.</span> Serious allergic and skin reactions can happen when you take AVENOX. <span class=\"Bold\">Symptoms of serious allergic and skin reactions may include:</span>\n<br/>\n<ul class=\"Disc\">\n<li>itching\n</li>\n<li>swelling of the face, eyes, lips, tongue or throat\n</li>\n<li>trouble breathing\n</li>\n<li>anxiousness\n</li>\n<li>feeling faint\n</li>\n<li>skin rash, hives, sores in your mouth, or your skin blisters and peels\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">Get emergency help right away if you have any of these symptoms. Talk to your healthcare provider before taking another dose of AVONEX.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">What is AVONEX?</span>\n<br/>AVONEX is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.<br/>It is not known if AVONEX is safe and effective in children.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">Do not take AVONEX if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>are allergic to interferon beta or any of the ingredients in AVONEX. See the end of this Medication Guide for a complete list of ingredients in AVONEX.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">Before taking AVONEX, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior.\n</li>\n<li>have or had bleeding problems or blood clots.\n</li>\n<li>have or had low blood cell counts.\n</li>\n<li>have or had liver problems.\n</li>\n<li>have or had seizures. (epilepsy).\n</li>\n<li>have or had heart problems.\n</li>\n<li>have or had thyroid problems.\n</li>\n<li>have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells).\n</li>\n<li>drink alcohol.\n</li>\n<li>have or have had an allergic reaction to rubber or latex. The tip cap of the AVONEX prefilled syringe and prefilled autoinjector Pen contain natural rubber latex.\n</li>\n<li>are pregnant or plan to become pregnant. It is not known if AVONEX can harm your unborn baby.\n</li>\n<li>are breastfeeding or plan to breastfeed. AVONEX may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take AVONEX.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">How should I use AVONEX?</span>\n<br/>\n<ul class=\"Disc\">\n<li>See the <span class=\"Bold\">Instructions for Use</span> for detailed instructions for preparing and injecting your dose of AVONEX.\n</li>\n<li>A healthcare provider should show you how to prepare your dose of AVONEX and how to inject your AVONEX before you use it for the first time.\n</li>\n<li>A healthcare provider or nurse should watch the first AVONEX injection you give yourself.\n</li>\n<li>AVONEX is given 1 time each week by injection into the muscle (intramuscular injection).\n</li>\n<li>Inject AVONEX exactly as your healthcare provider tells you.\n</li>\n<li>Your healthcare provider will tell you how much AVONEX to inject and how often to inject AVONEX. <span class=\"Bold\">Do not</span> inject more than your healthcare provider tells you to.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> change your dose unless your healthcare provider tells you to.\n</li>\n<li>Change (rotate) your injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.\n</li>\n<li>AVONEX comes as a:<ul class=\"Circle\">\n<li>Single-dose prefilled syringe (can be used with the AVOSTARTGRIP™ titration kit)\n</li>\n<li>Single-dose prefilled autoinjector Pen (AVONEX PEN<span class=\"Sup\">®</span>)\n</li>\n</ul>\n</li>\n<li>After 2 hours check your injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">Your healthcare provider will decide which one is best for you.<br/>Always use a new, unopened AVONEX single-dose prefilled syringe or single-dose prefilled autoinjector pen for each intramuscular injection.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">What are the possible side effects of AVONEX?</span>\n<br/>\n<span class=\"Bold\">AVONEX can cause serious side effects including:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">See “<a href=\"#p01\">What is the most important information I should know about AVONEX?</a>”</span>\n</li>\n<li>\n<span class=\"Bold\">Injection site reactions. </span>AVONEX may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.\n\t\t\t\t\t\t\t\t\t\t\t</li>\n<li>\n<span class=\"Bold\">Heart problems, including heart failure.</span> Some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX. If you already have heart failure, AVONEX may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using AVONEX.<ul class=\"Circle\">\n<li>Some people using AVONEX may have other heart problems including:<ul class=\"Square\">\n<li>low blood pressure\n</li>\n<li>fast or abnormal heart beat\n</li>\n<li>chest pain\n</li>\n<li>heart attack or a heart muscle problem (cardiomyopathy)\n</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Blood problems.</span> AVONEX can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising.\n</li>\n<li>\n<span class=\"Bold\">Thrombotic microangiopathy (TMA).</span> TMA is a condition that involves injury to the smallest blood vessels in your body. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking AVONEX if you develop TMA.\n</li>\n<li>\n<span class=\"Bold\">Pulmonary arterial hypertension.</span> Pulmonary arterial hypertension can occur with interferon beta products, including AVONEX. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.\n</li>\n<li>\n<span class=\"Bold\">Seizures.</span> Some people have had seizures while taking AVONEX, including people who have never had seizures before. Tell your healthcare provider right away if you have a seizure. \n</li>\n<li>\n<span class=\"Bold\">Autoimmune diseases.</span> Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use AVONEX.<br/>\n<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"justify\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">The most common side effects of AVONEX include:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Flu-like symptoms.</span> Most people who take AVONEX have flu-like symptoms especially early during the course of therapy. Usually, these symptoms last for a day after the injection. Symptoms may include: <ul class=\"Circle\">\n<li>muscle aches\n</li>\n<li>fever\n</li>\n<li>tiredness\n</li>\n<li>chills<br/>\n</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. Talk with your healthcare provider about ways to help if you develop flu-like symptoms while taking AVONEX.<br/>\n<br/>These are not all of the possible side effects of AVONEX.<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=\"4\" valign=\"top\"><span class=\"Bold\">How should I store AVONEX?</span>\n<ul class=\"Disc\">\n<li>Store AVONEX in the refrigerator between 36°F to 46°F (2°C to 8°C).\n</li>\n<li>\n<span class=\"Bold\">Do not</span> freeze AVONEX. <span class=\"Bold\">Do not</span> use AVONEX that has been frozen.\n</li>\n<li>If you cannot refrigerate your AVONEX PEN and AVONEX prefilled syringes, you can store your AVONEX PEN and AVONEX prefilled syringes at room temperature up to 77°F (25°C) for up to 7 days.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> store AVONEX above 77°F (25°C). <span class=\"Bold\">Do not use</span> AVONEX that is stored at temperatures higher than 77°F (25°C). Throw it away in a FDA-cleared sharps disposal container.\n</li>\n<li>Keep AVONEX in the original carton to protect it from light.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> use AVONEX past the expiration date.\n</li>\n</ul>\n<br/>\n<span class=\"Bold\">Keep AVONEX prefilled syringes, pens, and all other medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">General information about the safe and effective use of AVONEX.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVONEX for a condition for which it was not prescribed. Do not give AVONEX 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 AVONEX that is written for health professionals.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\"><span class=\"Bold\">What are the ingredients in AVONEX?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> interferon beta-1a<br/>\n<span class=\"Bold\">Inactive ingredients:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Single-Dose Prefilled Syringe:</span> arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for inject]tion.\n</li>\n<li>\n<span class=\"Bold\">Single-Dose Prefilled Autoinjector Pen:</span> arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<br/>Manufactured by:<br/>Biogen Inc. Cambridge, MA 02142 USA<br/>U.S. License #1697<br/>AVONEX is a registered trademark of Biogen. © Biogen 1996-2023. All rights reserved.<br/>For more information, call 1-1-800-456-2255.\n</td>\n</tr>\n</tbody>\n</table></div>" }

INSTRUCTIONS FOR USE

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

AVONEX PEN® (a-vuh-necks)

{ "type": "p", "children": [], "text": "\nAVONEX PEN®\n(a-vuh-necks)\n" }

(interferon beta-1a)

{ "type": "p", "children": [], "text": "\n(interferon beta-1a)\n" }

injection for intramuscular use

{ "type": "p", "children": [], "text": "\ninjection for intramuscular use\n" }

single-dose prefilled autoinjector pen

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

Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.\n" }

Your healthcare provider should show you or your caregiver how to prepare the dose of AVONEX and how to inject your AVONEX PEN the right way before AVONEX PEN is used for the first time.  Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX PEN is used.

{ "type": "p", "children": [], "text": "Your healthcare provider should show you or your caregiver how to prepare the dose of AVONEX and how to inject your AVONEX PEN the right way before AVONEX PEN is used for the first time.  Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX PEN is used.\n" }

Important information: The tip of the cap of the AVONEX PEN is made of natural rubber latex. Tell your healthcare provider if you are allergic to rubber or latex.

{ "type": "p", "children": [], "text": "\nImportant information: The tip of the cap of the AVONEX PEN is made of natural rubber latex. Tell your healthcare provider if you are allergic to rubber or latex.\n" }

How should I store AVONEX?

{ "type": "p", "children": [], "text": "\nHow should I store AVONEX?\n" }

{ "type": "ul", "children": [ "Store AVONEX in the refrigerator between 36°F to 46°F (2°C to 8°C).\n", "\nDo not freeze AVONEX. Do not use AVONEX that has been frozen.\n", "If you cannot refrigerate your AVONEX PEN, you can store your AVONEX PEN at room temperature up to 77°F (25°C) for up to 7 days.\n", "\nDo not store AVONEX above 77°F (25°C). Do not use AVONEX that is stored at temperatures higher than 77°F (25°C).\n", "Throw AVONEX away in an FDA-cleared sharps disposal container if it has not been stored as stated above. (See After the AVONEX injection section at the end of this Instructions for Use.)\n", "Keep AVONEX in the original carton to protect it from light.\n" ], "text": "" }

Preparing the AVONEX PEN:

{ "type": "p", "children": [], "text": "\nPreparing the AVONEX PEN:\n" }

{ "type": "ul", "children": [ "Find a well lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.\n", "Take 1 AVONEX PEN Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature. Do not use external heat sources such as hot water to warm the AVONEX PEN.\n", "Check the expiration date printed on the AVONEX PEN, AVONEX PEN Administration Dose Pack carton, and the outer carton. Do not use the AVONEX PEN past the expiration date.\n", "Wash your hands with soap and water.\n" ], "text": "" }

Supplies you will need to give the AVONEX PEN injection:

{ "type": "p", "children": [], "text": "\nSupplies you will need to give the AVONEX PEN injection:\n" }

{ "type": "ul", "children": [ "1 AVONEX Administration Dose Pack that contains:\n1 AVONEX PEN\n\na 25 gauge, 5/8 inch long sterile needle\n\n1 AVONEX PEN cover\n\n\n", "1 alcohol wipe\n", "1 gauze pad\n", "1 adhesive bandage\n", "a puncture resistant container for disposal of used AVONEX PEN and needle\n" ], "text": "" }

Identifying parts of the AVONEX PEN (See Figure A).

{ "type": "p", "children": [], "text": "\nIdentifying parts of the AVONEX PEN (See Figure A).\n" }

Single-Dose Administration Dose Pack Contents – AVONEX PEN, Supplied Needle and AVONEX PEN Cover

{ "type": "p", "children": [], "text": "\nSingle-Dose Administration Dose Pack Contents – AVONEX PEN, Supplied Needle and AVONEX PEN Cover\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="100.000%"/> <tbody class="Headless"> <tr> <td align="center" valign="top"><a name="f04"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-04.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/></td> </tr> <tr> <td align="center" valign="top">(Figure A) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"100.000%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" valign=\"top\"><a name=\"f04\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-04.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/></td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">(Figure A)\n</td>\n</tr>\n</tbody>\n</table></div>" }

Preparing the AVONEX PEN injection:

{ "type": "p", "children": [], "text": "\nPreparing the AVONEX PEN injection:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="50.000%"/> <col align="left" width="50.000%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 1:</span> Hold the AVONEX PEN with the white tamper-evident cap (cap) pointing up (See <a href="#f05">Figure B</a>).<br/> <ul class="Disc"> <li>Check that the cap is intact and has not been removed. If the cap has been removed or is not tightly attached, <span class="Bold">do not</span> use it. Throw it away and get a new AVONEX PEN. (See <span class="Bold"><a href="#p02">After the AVONEX injection</a></span> section at the end of this Instructions for Use.)<br/> <br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <br/> <a name="f05"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-05.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure B) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 2:</span> With your other hand, grasp the cap and bend it at a 90° angle until the cap snaps off (See <a href="#f06">Figure C</a>).<br/> <ul class="Disc"> <li>After the cap comes off, you will see the glass tip of the syringe. <span class="Bold">Do not</span> touch the glass tip of the syringe (See <a href="#f07">Figure D</a>).<br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f06"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-06.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure C)<br/> <br/> <a name="f07"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-07.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure D) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 3:</span> Place the AVONEX PEN down on a flat work surface.<br/> </td><td align="center" class="Botrule Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 4:</span> Pull off the sterile foil from the needle cover (See <a href="#f08">Figure E</a>).<br/> <ul class="Disc"> <li>Only use the needle that comes with your AVONEX PEN.<br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f08"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-08.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure E) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 5:</span> Hold the AVONEX PEN with the glass syringe tip pointing up. Press the needle onto the AVONEX PEN glass syringe tip (See <a href="#f09">Figure F</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f09"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-09.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure F) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 6:</span> Gently turn the needle to the right (clockwise) until it is firmly attached (See <a href="#f10">Figure G</a>).<br/> <ul class="Disc"> <li>If the needle is not firmly attached, it may leak, and you may not get your full dose of AVONEX.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f10"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-10.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure G) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <ul class="Disc"> <li> <span class="Bold">Do not</span> remove the plastic cover from the needle (See <a href="#f11">Figure H</a>).<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f11"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-11.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure H)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 7:</span> Hold the body of the AVONEX PEN in 1 hand with the needle and needle cover pointing away from you and other people. <span class="Bold">Do not</span> remove the plastic cover from the needle (See <a href="#f12">Figure I</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f12"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-12.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure I)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 8:</span> Using your other hand, hold onto the injector shield (grooved area) tightly and quickly pull up on the injector shield until the injector shield covers the needle all the way.<br/> <ul class="Disc"> <li>The plastic needle cover will “pop” off after the injector shield has been fully extended (See <a href="#f13">Figure J</a>).<br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f13"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-13.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure J) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <ul class="Disc"> <li>When the injector shield is extended the right way, you will see a small blue rectangular area next to the oval medicine display window (See <a href="#f14">Figure K</a>).<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <br/> <a name="f14"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-14.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure K) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 9:</span> Check the oval medicine display window and make sure the AVONEX is clear and colorless (See <a href="#f15">Figure L</a>).<br/>You might see air bubbles in the oval medicine display window. This is normal and will not affect your dose.<br/> <ul class="Disc"> <li> <span class="Bold">Do not</span> use AVONEX PEN if the liquid is colored, cloudy, or contains any lumps or particles. Throw away the AVONEX PEN in an FDA-cleared sharps container and get a new one, then repeat steps 1 to 9. (See <span class="Bold"><a href="#p02">After the AVONEX injection</a></span> section at the end of this Instructions for Use .) </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f15"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-15.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure L) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"50.000%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 1:</span> Hold the AVONEX PEN with the white tamper-evident cap (cap) pointing up (See <a href=\"#f05\">Figure B</a>).<br/>\n<ul class=\"Disc\">\n<li>Check that the cap is intact and has not been removed. If the cap has been removed or is not tightly attached, <span class=\"Bold\">do not</span> use it. Throw it away and get a new AVONEX PEN. (See <span class=\"Bold\"><a href=\"#p02\">After the AVONEX injection</a></span> section at the end of this Instructions for Use.)<br/>\n<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<br/>\n<a name=\"f05\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-05.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure B)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 2:</span> With your other hand, grasp the cap and bend it at a 90° angle until the cap snaps off (See <a href=\"#f06\">Figure C</a>).<br/>\n<ul class=\"Disc\">\n<li>After the cap comes off, you will see the glass tip of the syringe. <span class=\"Bold\">Do not</span> touch the glass tip of the syringe (See <a href=\"#f07\">Figure D</a>).<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f06\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-06.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure C)<br/>\n<br/>\n<a name=\"f07\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-07.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure D)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 3:</span> Place the AVONEX PEN down on a flat work surface.<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 4:</span> Pull off the sterile foil from the needle cover (See <a href=\"#f08\">Figure E</a>).<br/>\n<ul class=\"Disc\">\n<li>Only use the needle that comes with your AVONEX PEN.<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f08\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-08.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure E)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 5:</span> Hold the AVONEX PEN with the glass syringe tip pointing up. Press the needle onto the AVONEX PEN glass syringe tip (See <a href=\"#f09\">Figure F</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f09\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-09.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure F)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 6:</span> Gently turn the needle to the right (clockwise) until it is firmly attached (See <a href=\"#f10\">Figure G</a>).<br/>\n<ul class=\"Disc\">\n<li>If the needle is not firmly attached, it may leak, and you may not get your full dose of AVONEX.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f10\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-10.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure G)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> remove the plastic cover from the needle (See <a href=\"#f11\">Figure H</a>).<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f11\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-11.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure H)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 7:</span> Hold the body of the AVONEX PEN in 1 hand with the needle and needle cover pointing away from you and other people. <span class=\"Bold\">Do not</span> remove the plastic cover from the needle (See <a href=\"#f12\">Figure I</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f12\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-12.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure I)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 8:</span> Using your other hand, hold onto the injector shield (grooved area) tightly and quickly pull up on the injector shield until the injector shield covers the needle all the way.<br/>\n<ul class=\"Disc\">\n<li>The plastic needle cover will “pop” off after the injector shield has been fully extended (See <a href=\"#f13\">Figure J</a>).<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f13\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-13.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure J)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>When the injector shield is extended the right way, you will see a small blue rectangular area next to the oval medicine display window (See <a href=\"#f14\">Figure K</a>).<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f14\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-14.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure K)\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 9:</span> Check the oval medicine display window and make sure the AVONEX is clear and colorless (See <a href=\"#f15\">Figure L</a>).<br/>You might see air bubbles in the oval medicine display window. This is normal and will not affect your dose.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> use AVONEX PEN if the liquid is colored, cloudy, or contains any lumps or particles. Throw away the AVONEX PEN in an FDA-cleared sharps container and get a new one, then repeat steps 1 to 9. (See <span class=\"Bold\"><a href=\"#p02\">After the AVONEX injection</a></span> section at the end of this Instructions for Use .)\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f15\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-15.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure L)\n</td>\n</tr>\n</tbody>\n</table></div>" }

Giving the AVONEX injection:

{ "type": "p", "children": [], "text": "\nGiving the AVONEX injection:\n" }

{ "type": "ul", "children": [ "Your healthcare provider should show you or your caregiver how to prepare the dose of AVONEX and how to inject your AVONEX PEN the right way before AVONEX PEN is used for the first time. Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX PEN is used.\n", "Inject your AVONEX PEN exactly as your healthcare provider has shown you.\n", "AVONEX PEN is injected into the muscle (intramuscularly).\n", "AVONEX PEN should be injected into the upper, outer thigh (See Figure M).\n", "Change (rotate) injection sites for each dose. Do not use the same injection site for each injection.\n", "\nDo not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.\n", "\nDo not push down on the injector shield and the blue activation button at the same time until you are ready to give your injection.\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="100.000%"/> <tbody class="Headless"> <tr> <td align="center" valign="top"><a name="f16"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-16.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/></td> </tr> <tr> <td align="center" valign="top">Figure M </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"100.000%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" valign=\"top\"><a name=\"f16\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-16.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/></td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">Figure M\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="50.000%"/> <col align="left" width="50.000%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 10:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href="#f17">Figure N</a>). Let the injection site dry before injecting the dose.<br/> <ul class="Disc"> <li> <span class="Bold">Do not</span> touch this area again before giving the injection.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <br/> <a name="f17"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-17.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/><br/>(Figure N) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 11:</span> Place the AVONEX PEN on the injection site (See <a href="#f18">Figure O</a>). </td><td align="center" class="Botrule Rrule" valign="top"><a name="f18"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-18.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/><br/>(Figure O) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 12:</span> Hold the body of the AVONEX PEN at a 90º angle to the injection site, and make sure you can see the window (See <a href="#f19">Figure P</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f19"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-19.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure P) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 13:</span> Keeping your fingers away from the blue activation button, firmly push the body of the AVONEX PEN down against the thigh to release the safety lock (See <a href="#f20">Figure Q</a>). <span class="Bold">Do not</span> lift the AVONEX PEN off the injection site.<br/> <ul class="Disc"> <li>Check to make sure the safety lock has been released. You will know the safety lock is released when the small blue rectangular area above the oval medicine display window is gone (See <a href="#f21">Figure R</a>).<br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f20"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-20.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure Q)<br/> <br/> <br/> <a name="f21"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-21.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure R) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 14:</span> Continue to firmly maintain pressure and push down on the AVONEX PEN against the injection site, then push down on the blue activation button with your thumb (See <a href="#f22">Figure S</a>). Keep the AVONEX PEN pushed down against the injection site and slowly count to 10.<br/> <ul class="Disc"> <li> <span class="Bold">You will hear a “click” when the injection starts.</span> If you <span class="Bold">do not</span> hear a “click”, your injection was not given the right way. </li> <li>If this happens, make sure that the injector shield is extended, the safety lock is completely released, and that you are firmly maintaining pressure and pushing down against the injection site. Press the blue activation button with your thumb again. If you still <span class="Bold">do not</span> hear a “click”, call Biogen at 1-800-456-2255.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f22"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-22.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure S)<br/> <br/> <br/> <a name="f23"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-23.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 15:</span> After you count to 10, pull the AVONEX PEN straight out of the skin (See <a href="#f24">Figure T</a>). Use the gauze pad to apply pressure to the injection site for a few seconds or rub gently in a circular motion.<br/>• If you see blood after you press the injection site for a few seconds, wipe it off with the gauze pad and apply an adhesive bandage. </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f24"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-24.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure T) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 16:</span> Check the circular display window on the AVONEX PEN to make sure that it is yellow. This is to be sure that you have been given your full dose (See <a href="#f25">Figure U</a>).<br/> <ul class="Disc"> <li>If you did not receive your full dose of AVONEX, throw away the AVONEX PEN in a FDA-cleared sharps disposal container and call your healthcare provider. <span class="Bold">Do not</span> re-use the AVONEX PEN.<br/> <br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f25"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-25.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure U) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 17: Do not</span> hold the AVONEX PEN cover with your hands. Place the AVONEX PEN cover on a flat work surface. <span class="Bold">Line up the exposed needle with the hole of the AVONEX PEN cover</span>, and insert directly into the opening (See <a href="#f26">Figure V</a>). </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f26"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-26.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure V)<br/> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 18:</span> Firmly press the AVONEX PEN down until you hear a “click” to seal the needle (See <a href="#f27">Figure W</a>). You may need to hold both hands around the AVONEX PEN body to snap the AVONEX PEN cover into place. </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f27"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-27.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure W)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"50.000%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 10:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href=\"#f17\">Figure N</a>). Let the injection site dry before injecting the dose.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> touch this area again before giving the injection.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<br/>\n<a name=\"f17\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-17.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/><br/>(Figure N)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 11:</span> Place the AVONEX PEN on the injection site (See <a href=\"#f18\">Figure O</a>).\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"><a name=\"f18\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-18.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/><br/>(Figure O)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 12:</span> Hold the body of the AVONEX PEN at a 90º angle to the injection site, and make sure you can see the window (See <a href=\"#f19\">Figure P</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f19\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-19.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure P)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 13:</span> Keeping your fingers away from the blue activation button, firmly push the body of the AVONEX PEN down against the thigh to release the safety lock (See <a href=\"#f20\">Figure Q</a>). <span class=\"Bold\">Do not</span> lift the AVONEX PEN off the injection site.<br/>\n<ul class=\"Disc\">\n<li>Check to make sure the safety lock has been released. You will know the safety lock is released when the small blue rectangular area above the oval medicine display window is gone (See <a href=\"#f21\">Figure R</a>).<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f20\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-20.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure Q)<br/>\n<br/>\n<br/>\n<a name=\"f21\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-21.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure R)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 14:</span> Continue to firmly maintain pressure and push down on the AVONEX PEN against the injection site, then push down on the blue activation button with your thumb (See <a href=\"#f22\">Figure S</a>). Keep the AVONEX PEN pushed down against the injection site and slowly count to 10.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">You will hear a “click” when the injection starts.</span> If you <span class=\"Bold\">do not</span> hear a “click”, your injection was not given the right way.\n</li>\n<li>If this happens, make sure that the injector shield is extended, the safety lock is completely released, and that you are firmly maintaining pressure and pushing down against the injection site. Press the blue activation button with your thumb again. If you still <span class=\"Bold\">do not</span> hear a “click”, call Biogen at 1-800-456-2255.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f22\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-22.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure S)<br/>\n<br/>\n<br/>\n<a name=\"f23\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-23.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 15:</span> After you count to 10, pull the AVONEX PEN straight out of the skin (See <a href=\"#f24\">Figure T</a>). Use the gauze pad to apply pressure to the injection site for a few seconds or rub gently in a circular motion.<br/>• If you see blood after you press the injection site for a few seconds, wipe it off with the gauze pad and apply an adhesive bandage.\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f24\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-24.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure T)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 16:</span> Check the circular display window on the AVONEX PEN to make sure that it is yellow. This is to be sure that you have been given your full dose (See <a href=\"#f25\">Figure U</a>).<br/>\n<ul class=\"Disc\">\n<li>If you did not receive your full dose of AVONEX, throw away the AVONEX PEN in a FDA-cleared sharps disposal container and call your healthcare provider. <span class=\"Bold\">Do not</span> re-use the AVONEX PEN.<br/>\n<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f25\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-25.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure U)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 17: Do not</span> hold the AVONEX PEN cover with your hands. Place the AVONEX PEN cover on a flat work surface. <span class=\"Bold\">Line up the exposed needle with the hole of the AVONEX PEN cover</span>, and insert directly into the opening (See <a href=\"#f26\">Figure V</a>).\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f26\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-26.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure V)<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 18:</span> Firmly press the AVONEX PEN down until you hear a “click” to seal the needle (See <a href=\"#f27\">Figure W</a>). You may need to hold both hands around the AVONEX PEN body to snap the AVONEX PEN cover into place.\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f27\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-27.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure W)<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

After the AVONEX injection:

{ "type": "p", "children": [], "text": "\nAfter the AVONEX injection:\n" }

Throw Away your AVONEX:

{ "type": "p", "children": [], "text": "\nThrow Away your AVONEX:\n" }

{ "type": "ul", "children": [ "Put your used needles and PENS in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.\n", "If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:\nmade of a heavy-duty plastic,\n\ncan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,\n\nupright and stable during use,\n\nleak-resistant, and\n\nproperly labeled to warn of hazardous waste inside the container.\n\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\n", "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.\n" ], "text": "" }

Check Your Injection Site:

{ "type": "p", "children": [], "text": "\nCheck Your Injection Site:\n" }

{ "type": "ul", "children": [ "After 2 hours, check the injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.\n" ], "text": "" }

General information about the safe and effective use of AVONEX PEN

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of AVONEX PEN\n" }

{ "type": "ul", "children": [ "Always use a new AVONEX PEN and needle for each injection. Do not re-use your AVONEX PEN or needle.\n", "\nDo not share your AVONEX PEN or needles.\n", "Keep AVONEX PEN and needles and all medicines out of the reach of children.\n" ], "text": "" }

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.\n" }

Manufactured by:

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

Biogen Inc.

{ "type": "p", "children": [], "text": "Biogen Inc.\n" }

Cambridge, MA 02142 USA

{ "type": "p", "children": [], "text": "Cambridge, MA 02142 USA\n" }

U.S. License # 1697

{ "type": "p", "children": [], "text": "U.S. License # 1697\n" }

1-800-456-2255

{ "type": "p", "children": [], "text": "1-800-456-2255\n" }

AVONEX is a registered trademark of Biogen.

{ "type": "p", "children": [], "text": "AVONEX is a registered trademark of Biogen.\n" }

©Biogen 1996-2020. All rights reserved.

{ "type": "p", "children": [], "text": "©Biogen 1996-2020. All rights reserved.\n" }

Revised: 03/2020

{ "type": "p", "children": [], "text": "Revised: 03/2020\n" }

41610-03

{ "type": "p", "children": [], "text": "41610-03\n" }

INSTRUCTIONS FOR USE

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

AVONEX® (a-vuh-necks)

{ "type": "p", "children": [], "text": "\nAVONEX®\n(a-vuh-necks)\n" }

(interferon beta-1a)

{ "type": "p", "children": [], "text": "\n(interferon beta-1a)\n" }

injection for intramuscular use

{ "type": "p", "children": [], "text": "\ninjection for intramuscular use\n" }

single-dose prefilled syringe

{ "type": "p", "children": [], "text": "\nsingle-dose prefilled syringe\n" }

Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.\n" }

Important information: The tip of the cap of the AVONEX prefilled syringe is made of natural rubber latex. Tell your healthcare provider if you are allergic to rubber or latex.

{ "type": "p", "children": [], "text": "\nImportant information: The tip of the cap of the AVONEX prefilled syringe is made of natural rubber latex. Tell your healthcare provider if you are allergic to rubber or latex.\n" }

How should I store AVONEX?

{ "type": "p", "children": [], "text": "\nHow should I store AVONEX?\n" }

{ "type": "ul", "children": [ "Store AVONEX in the refrigerator between 36°F to 46°F (2°C to 8°C).\n", "\nDo not freeze AVONEX. Do not use AVONEX that has been frozen.\n", "If you cannot refrigerate your AVONEX prefilled syringes, you can store your AVONEX prefilled syringes at room temperature up to 77°F (25°C) for up to 7 days.\n", "\nDo not store AVONEX above 77°F (25°C). Do not use AVONEX that is stored at temperatures higher than 77°F (25°C).\n", "Throw AVONEX away in an FDA-cleared sharps disposal container if it has not been stored as stated above. (See After the AVONEX injection section at the end of this Instructions for Use.)\n", "Keep AVONEX in the original carton to protect it from light.\n" ], "text": "" }

Supplies you will need for the AVONEX injection:

{ "type": "p", "children": [], "text": "\nSupplies you will need for the AVONEX injection:\n" }

{ "type": "ul", "children": [ "1 AVONEX Administration Dose Pack that contains:\n1 AVONEX prefilled syringe\n\n23 gauge, 1¼ inch long sterile needle\n\n\n", "1 alcohol wipe\n", "1 gauze pad\n", "1 adhesive bandage\n", "a puncture resistant container for disposal of used syringes and needles\n" ], "text": "" }

Preparing the dose of AVONEX:

{ "type": "p", "children": [], "text": "\nPreparing the dose of AVONEX:\n" }

{ "type": "ul", "children": [ "Find a well-lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.\n", "Take 1 AVONEX Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature. Do not use external heat sources such as hot water to warm the AVONEX prefilled syringe.\n", "Check the expiration date printed on AVONEX prefilled syringe, AVONEX Administration Dose Pack, and the outer carton. Do not use AVONEX prefilled syringe past the expiration date.\n", "Wash your hands with soap and water.\n" ], "text": "" }

Identifying parts of the AVONEX prefilled syringe (See Figure A):

{ "type": "p", "children": [], "text": "\nIdentifying parts of the AVONEX prefilled syringe (See Figure A):\n" }

Preparing the AVONEX injection:

{ "type": "p", "children": [], "text": "\nPreparing the AVONEX injection:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="50.000%"/> <col align="left" width="50.000%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 1:</span> Hold the AVONEX prefilled syringe with the cap pointing down and with the 0.5 mL mark at eye level (See <a href="#f28">Figure A</a>).<br/> <ul class="Disc"> <li>Check the syringe:<ul class="Disc"> <li>The syringe should not have any cracks or damage. </li> <li>Check that the cap is intact and has not been removed. </li> <li>The amount of liquid in the syringe should be at or very close to the 0.5 mL mark. </li> <li>AVONEX should look clear, colorless, and should not have any particles in it. </li> </ul> </li> <li> <span class="Bold">Do not</span> use the AVONEX prefilled syringe if:<ul class="Disc"> <li>the syringe is cracked or damaged </li> <li>the solution is cloudy, colored, or has lumps or particles in it </li> <li>the cap has been removed or is not tightly attached or </li> <li>there is not enough liquid in the syringe </li> </ul>If you cannot use that syringe, you will need to get a new syringe. Contact Biogen at 1-800-456-2255.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <br/> <a name="f28"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-28.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure A) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 2:</span> With 1 hand, hold the AVONEX prefilled syringe right under the cap and with the cap pointing up (See <a href="#f29">Figure B</a>).<br/> <ul class="Disc"> <li>Make sure you are holding the AVONEX prefilled syringe by the ridged part, directly under the cap.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f29"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-29.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure B) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 3:</span> With the other hand, grasp the cap and bend it at a 90º angle until the cap snaps off (See <a href="#f30">Figure C</a> and <a href="#f31">Figure D</a>). </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f30"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-30.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure C)<br/> <br/> <a name="f31"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-31.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure D) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 4:</span> Open the sterile needle package and take out the covered needle. Hold the AVONEX prefilled syringe with the glass syringe tip pointing up. Press the needle on the AVONEX prefilled syringe glass tip (See <a href="#f32">Figure E</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f32"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-32.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure E) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 5:</span> Gently turn the needle to the right (clockwise) until it is tight and firmly attached (See <a href="#f33">Figure F</a>).<br/> <ul class="Disc"> <li>If the needle is not firmly attached, it may leak and you may not get your full dose of AVONEX. </li> <li> <span class="Bold">Do not</span> remove the plastic cover from the needle. </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f33"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-33.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure F) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"50.000%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 1:</span> Hold the AVONEX prefilled syringe with the cap pointing down and with the 0.5 mL mark at eye level (See <a href=\"#f28\">Figure A</a>).<br/>\n<ul class=\"Disc\">\n<li>Check the syringe:<ul class=\"Disc\">\n<li>The syringe should not have any cracks or damage.\n</li>\n<li>Check that the cap is intact and has not been removed.\n</li>\n<li>The amount of liquid in the syringe should be at or very close to the 0.5 mL mark.\n</li>\n<li>AVONEX should look clear, colorless, and should not have any particles in it.\n</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Do not</span> use the AVONEX prefilled syringe if:<ul class=\"Disc\">\n<li>the syringe is cracked or damaged\n</li>\n<li>the solution is cloudy, colored, or has lumps or particles in it\n</li>\n<li>the cap has been removed or is not tightly attached or\n</li>\n<li>there is not enough liquid in the syringe\n</li>\n</ul>If you cannot use that syringe, you will need to get a new syringe. Contact Biogen at 1-800-456-2255.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<br/>\n<a name=\"f28\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-28.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure A)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 2:</span> With 1 hand, hold the AVONEX prefilled syringe right under the cap and with the cap pointing up (See <a href=\"#f29\">Figure B</a>).<br/>\n<ul class=\"Disc\">\n<li>Make sure you are holding the AVONEX prefilled syringe by the ridged part, directly under the cap.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f29\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-29.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure B)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 3:</span> With the other hand, grasp the cap and bend it at a 90º angle until the cap snaps off (See <a href=\"#f30\">Figure C</a> and <a href=\"#f31\">Figure D</a>).\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f30\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-30.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure C)<br/>\n<br/>\n<a name=\"f31\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-31.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure D)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 4:</span> Open the sterile needle package and take out the covered needle. Hold the AVONEX prefilled syringe with the glass syringe tip pointing up. Press the needle on the AVONEX prefilled syringe glass tip (See <a href=\"#f32\">Figure E</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f32\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-32.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure E)\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 5:</span> Gently turn the needle to the right (clockwise) until it is tight and firmly attached (See <a href=\"#f33\">Figure F</a>).<br/>\n<ul class=\"Disc\">\n<li>If the needle is not firmly attached, it may leak and you may not get your full dose of AVONEX.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the plastic cover from the needle.\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f33\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-33.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure F)\n</td>\n</tr>\n</tbody>\n</table></div>" }

Giving the AVONEX injection:

{ "type": "p", "children": [], "text": "\nGiving the AVONEX injection:\n" }

{ "type": "ul", "children": [ "Your healthcare provider should show you or a caregiver how to prepare and inject the dose of AVONEX before AVONEX prefilled syringe is used for the first time. Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX prefilled syringe is used.\n", "Inject your AVONEX exactly as your healthcare provider has shown you.\n", "AVONEX is injected into the muscle (intramuscularly).\n", "AVONEX should be injected into the thigh or upper arm (See Figures G and H).\n", "Change (rotate) your injection sites for each dose. Do not use the same injection site for each injection.\n", "\nDo not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.\n" ], "text": "" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="50.000%"/> <col align="left" width="25.000%"/> <col align="left" width="25.000%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 6:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href="#f34">Figures G</a> and <a href="#f35">H</a>). Let the injection site dry before injecting the dose.<br/> <ul class="Disc"> <li> <span class="Bold">Do not</span> touch this area again before giving the injection. </li> </ul> </td><td align="center" class="Botrule Toprule" valign="top"><a name="f34"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-34.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure G) </td><td align="center" class="Botrule Rrule Toprule" valign="top"><a name="f35"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-35.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure H) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 7:</span> Pull the protective cover straight off the needle (See <a href="#f36">Figure I</a>). <span class="Bold">Do not</span> twist the cover off. </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <br/> <a name="f36"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-36.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure I) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 8:</span> With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90 degree angle, through the skin and into the muscle (See <a href="#f37">Figure J</a>). After the needle is in, let go of the skin. </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <br/> <a name="f37"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-37.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure J) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">  </td><td align="left" class="Botrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 9:</span> Slowly push the plunger down until the syringe is empty (See <a href="#f38">Figure K</a>).<br/> <br/> <br/> <br/> <br/> <br/> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <br/> <a name="f38"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-38.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure K)<br/> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 10:</span> Pull the needle out of the skin (See <a href="#f39">Figure L</a>). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion.<br/> <ul class="Disc"> <li>If you see blood after you press the injection site for a few seconds, wipe it off with the gauze pad and apply an adhesive bandage. </li> </ul> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <br/> <a name="f39"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-39.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure L) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"25.000%\"/>\n<col align=\"left\" width=\"25.000%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 6:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href=\"#f34\">Figures G</a> and <a href=\"#f35\">H</a>). Let the injection site dry before injecting the dose.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> touch this area again before giving the injection.\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Toprule\" valign=\"top\"><a name=\"f34\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-34.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure G)\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\"><a name=\"f35\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-35.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure H)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 7:</span> Pull the protective cover straight off the needle (See <a href=\"#f36\">Figure I</a>). <span class=\"Bold\">Do not</span> twist the cover off.\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f36\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-36.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure I)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 8:</span> With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90 degree angle, through the skin and into the muscle (See <a href=\"#f37\">Figure J</a>). After the needle is in, let go of the skin.\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f37\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-37.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure J)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> \n</td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 9:</span> Slowly push the plunger down until the syringe is empty (See <a href=\"#f38\">Figure K</a>).<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f38\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-38.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure K)<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 10:</span> Pull the needle out of the skin (See <a href=\"#f39\">Figure L</a>). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion.<br/>\n<ul class=\"Disc\">\n<li>If you see blood after you press the injection site for a few seconds, wipe it off with the gauze pad and apply an adhesive bandage.\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f39\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-39.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure L)\n</td>\n</tr>\n</tbody>\n</table></div>" }

After the AVONEX injection:

{ "type": "p", "children": [], "text": "\nAfter the AVONEX injection:\n" }

{ "type": "ul", "children": [ "\nDo not recap the needle. Recapping the needle can lead to a needle stick injury.\n", "Put your used needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.\n", "If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:\nmade of a heavy-duty plastic,\n\ncan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,\n\nupright and stable during use,\n\nleak-resistant, and\n\nproperly labeled to warn of hazardous waste inside the container.\n\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\n", "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.\n" ], "text": "" }

Check Your Injection Site:

{ "type": "p", "children": [], "text": "\nCheck Your Injection Site:\n" }

{ "type": "ul", "children": [ "After 2 hours, check the injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.\n" ], "text": "" }

General information about the safe and effective use of AVONEX

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of AVONEX\n" }

{ "type": "ul", "children": [ "Always use a new AVONEX prefilled syringe and needle for each injection. Do not re-use your AVONEX prefilled syringe or needles.\n", "\nDo not share your AVONEX prefilled syringe or needles.\n", "Keep the AVONEX prefilled syringe and needles and all medicines out of the reach of children.\n" ], "text": "" }

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.\n" }

Manufactured by:

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

Biogen Inc.

{ "type": "p", "children": [], "text": "Biogen Inc.\n" }

Cambridge, MA 02142 USA

{ "type": "p", "children": [], "text": "Cambridge, MA 02142 USA\n" }

U.S. License # 1697

{ "type": "p", "children": [], "text": "U.S. License # 1697\n" }

1-800-456-2255

{ "type": "p", "children": [], "text": "1-800-456-2255\n" }

AVONEX is a registered trademark of Biogen.

{ "type": "p", "children": [], "text": "AVONEX is a registered trademark of Biogen.\n" }

©Biogen 1996-2020. All rights reserved.

{ "type": "p", "children": [], "text": "©Biogen 1996-2020. All rights reserved.\n" }

Revised: 03/2020

{ "type": "p", "children": [], "text": "Revised: 03/2020\n" }

41611-03

{ "type": "p", "children": [], "text": "41611-03\n" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

AVOSTARTGRIP®Titration Kit

{ "type": "p", "children": [], "text": "\nAVOSTARTGRIP®Titration Kit\n" }

Use with AVONEX®(interferon beta-1a) Prefilled Syringe Only

{ "type": "p", "children": [], "text": "\nUse with AVONEX®(interferon beta-1a) Prefilled Syringe Only\n" }

Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.\n" }

Preparing the AVONEX Prefilled Syringe:

{ "type": "p", "children": [], "text": "\nPreparing the AVONEX Prefilled Syringe:\n" }

{ "type": "ul", "children": [ "Find a well lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.\n", "Take 1 AVONEX Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature. Do not use external heat sources such as hot water to warm the AVONEX prefilled syringe.\n", "Check the expiration date printed on the AVONEX prefilled syringe, AVONEX prefilled syringe Administration Dose Package carton, and the outer carton. Do not use the AVONEX prefilled syringe past the expiration date.\n", "Wash your hands with soap and water.\n" ], "text": "" }

Supplies you will need for the AVONEX injection:

{ "type": "p", "children": [], "text": "\nSupplies you will need for the AVONEX injection:\n" }

{ "type": "ul", "children": [ "1 AVONEX Administration Dose Pack that contains:\n1 AVONEX prefilled syringe\n\n23 gauge, 1¼ inch long sterile needle\n\n\n", "1 alcohol wipe\n", "1 gauze pad\n", "1 adhesive bandage\n", "a puncture resistant container for disposal of used syringes and needles\n" ], "text": "" }

Identifying parts of the AVONEX prefilled syringe (See Figure A):

{ "type": "p", "children": [], "text": "\nIdentifying parts of the AVONEX prefilled syringe (See Figure A):\n" }

Preparing the AVONEX injection:

{ "type": "p", "children": [], "text": "\nPreparing the AVONEX injection:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="50.700%"/> <col align="left" width="49.300%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 1:</span> Hold the AVONEX prefilled syringe with the cap pointing down and with the 0.5 mL mark at eye level (See <a href="#f40">Figure A</a>).<br/> <ul class="Disc"> <li>Check the syringe:<ul class="Disc"> <li>The syringe should not have any cracks or damage. </li> <li>Check that the cap is intact and has not been removed. </li> <li>The amount of liquid in the syringe should be at or very close to the 0.5 mL mark. </li> <li>AVONEX should look clear, colorless, and should not have any particles in it. </li> </ul> </li> <li> <span class="Bold">Do not</span> use the AVONEX prefilled syringe if:<ul class="Disc"> <li>the syringe is cracked or damaged </li> <li>the solution is cloudy, colored, or has lumps or particles in it </li> <li>the cap has been removed or is not tightly attached or </li> <li>there is not enough liquid in the syringe<br/> </li> </ul> </li> </ul> <span class="Bold">Do not</span> use that syringe. Get a new syringe. Contact MS ACTIVESOURCE at 1-800-456-2255.<br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <br/> <br/> <a name="f40"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-40.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure A) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 2:</span> With 1 hand, hold the AVONEX prefilled syringe right under the cap and with the cap pointing up (See <a href="#f41">Figure B</a>).<br/> <ul class="Disc"> <li>Make sure you are holding the AVONEX prefilled syringe by the ridged part, directly under the cap.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f41"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-41.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure B) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 3:</span> With the other hand, grasp the cap and bend it at a 90º angle until the cap snaps off (See <a href="#f42">Figure C</a> and <a href="#f43">Figure D</a>).<br/> <br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f42"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-42.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure C)<br/> <br/> <a name="f43"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-43.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure D) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 4:</span> Open the sterile needle package and take out the covered needle. Hold the AVONEX prefilled syringe with the glass syringe tip pointing up. Press the needle on the AVONEX prefilled syringe glass tip (See <a href="#f44">Figure E</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <br/> <a name="f44"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-44.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure E) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 5:</span> Gently turn the needle forward (clockwise) until it is tight and firmly attached (See <a href="#f45">Figure F</a>).<br/> <ul class="Disc"> <li>If the needle is not firmly attached, it may leak and you may not get your full dose of AVONEX. </li> <li> <span class="Bold">Do not</span> remove the plastic cover from the needle.<br/> </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f45"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-45.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure F) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"50.700%\"/>\n<col align=\"left\" width=\"49.300%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 1:</span> Hold the AVONEX prefilled syringe with the cap pointing down and with the 0.5 mL mark at eye level (See <a href=\"#f40\">Figure A</a>).<br/>\n<ul class=\"Disc\">\n<li>Check the syringe:<ul class=\"Disc\">\n<li>The syringe should not have any cracks or damage.\n</li>\n<li>Check that the cap is intact and has not been removed.\n</li>\n<li>The amount of liquid in the syringe should be at or very close to the 0.5 mL mark.\n</li>\n<li>AVONEX should look clear, colorless, and should not have any particles in it.\n</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Do not</span> use the AVONEX prefilled syringe if:<ul class=\"Disc\">\n<li>the syringe is cracked or damaged\n</li>\n<li>the solution is cloudy, colored, or has lumps or particles in it\n</li>\n<li>the cap has been removed or is not tightly attached or\n</li>\n<li>there is not enough liquid in the syringe<br/>\n</li>\n</ul>\n</li>\n</ul>\n<span class=\"Bold\">Do not</span> use that syringe. Get a new syringe. Contact MS ACTIVESOURCE at 1-800-456-2255.<br/>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f40\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-40.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure A)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 2:</span> With 1 hand, hold the AVONEX prefilled syringe right under the cap and with the cap pointing up (See <a href=\"#f41\">Figure B</a>).<br/>\n<ul class=\"Disc\">\n<li>Make sure you are holding the AVONEX prefilled syringe by the ridged part, directly under the cap.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f41\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-41.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure B)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 3:</span> With the other hand, grasp the cap and bend it at a 90º angle until the cap snaps off (See <a href=\"#f42\">Figure C</a> and <a href=\"#f43\">Figure D</a>).<br/>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f42\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-42.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure C)<br/>\n<br/>\n<a name=\"f43\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-43.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure D)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 4:</span> Open the sterile needle package and take out the covered needle. Hold the AVONEX prefilled syringe with the glass syringe tip pointing up. Press the needle on the AVONEX prefilled syringe glass tip (See <a href=\"#f44\">Figure E</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<br/>\n<a name=\"f44\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-44.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure E)\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 5:</span> Gently turn the needle forward (clockwise) until it is tight and firmly attached (See <a href=\"#f45\">Figure F</a>).<br/>\n<ul class=\"Disc\">\n<li>If the needle is not firmly attached, it may leak and you may not get your full dose of AVONEX.\n</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the plastic cover from the needle.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f45\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-45.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure F)\n</td>\n</tr>\n</tbody>\n</table></div>" }

Using the AVONEX prefilled syringe with the AVOSTARTGRIP titration kit:

{ "type": "p", "children": [], "text": "\nUsing the AVONEX prefilled syringe with the AVOSTARTGRIP titration kit:\n" }

{ "type": "ul", "children": [ "Your AVONEX dose may be titrated over 3 weeks by using AVONEX prefilled syringe with the AVOSTARTGRIP titration kit. The AVOSTARTGRIP is used for giving the week 1, 2, and 3 (¼, ½, ¾) injections.\n\nWeek 1: ¼ dose (white device)\n\n\nWeek 2: ½ dose (yellow device)\n\n\nWeek 3: ¾ dose (purple device)\n\n\nWeek 4: a full dose\n\n\n", "The 3 AVOSTARTGRIP devices are for single-use only with the AVONEX prefilled syringe. Do not re-use the AVONEX prefilled syringe and AVOSTARTGRIP devices.\n", "You must prepare the AVONEX prefilled syringe and needle before you put it into the AVOSTARTGRIP device. Follow steps 1 to 5 above to prepare the AVONEX prefilled syringe.\n" ], "text": "" }

Identifying the parts of AVOSTARTGRIP titration kit (See Figure G):

{ "type": "p", "children": [], "text": "\nIdentifying the parts of AVOSTARTGRIP titration kit (See Figure G):\n" }

                                                                                                                                    (Figure G)

{ "type": "p", "children": [], "text": "                                                                                                                                    (Figure G)\n" }

{ "type": "ul", "children": [ "AVOSTARTGRIP has a “collar” on top of the device that will stop the syringe from injecting a full dose (See Figure H). The “collar” makes sure that you do not get the full dose of AVONEX.\t\t\t\t\t\t\t\n" ], "text": "" }

                                                                                                                                    (Figure H)

{ "type": "p", "children": [], "text": "                                                                                                                                    (Figure H)\n" }

Attaching the AVOSTARTGRIP device:

{ "type": "p", "children": [], "text": "\nAttaching the AVOSTARTGRIP device:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="48.450%"/> <col align="left" width="51.550%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Rrule Toprule" valign="top"><span class="Bold">Step 6:</span> Choose the right AVOSTARTGRIP titration device for your weekly dose.<br/> <ul class="Disc"> <li> <span class="Bold">Week 1 Injection:</span> Choose the <span class="Bold">white</span> device to give ¼ dose (See <a href="#f48">Figure I</a>).<br/> </li> </ul> </td><td align="center" class="Rrule Toprule" valign="top"> <br/> <a name="f48"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-48.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure I)<br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"> <ul class="Disc"> <li> <span class="Bold">Week 2 Injection:</span> Choose the <span class="Bold">yellow</span> device to give ½ dose (See <a href="#f49">Figure J</a>).<br/> </li> </ul> </td><td align="center" class="Rrule" valign="top"><a name="f49"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-49.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure J)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <ul class="Disc"> <li> <span class="Bold">Week 3 Injection:</span> Choose the <span class="Bold">purple</span> device to give ¾ dose (See <a href="#f50">Figure K</a>). </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"><a name="f50"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-50.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure K) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 7:</span> Put the right AVOSTARTGRIP device on a flat surface with the door open (See <a href="#f51">Figure L</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f51"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-51.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure L) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 8:</span> Line up the AVONEX prefilled syringe over the AVOSTARTGRIP device with the plunger pointing to the left and the needle pointing to the right (See <a href="#f52">Figure M</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f52"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-52.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure M) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 9:</span> Push the AVONEX prefilled syringe down into the AVOSTARTGRIP device until both ends “snap” into place (See <a href="#f53">Figure N</a>).<br/> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f53"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-53.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure N) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 10:</span> Using two fingers, push the door down until it closes over the AVONEX prefilled syringe (See <a href="#f54">Figure O</a>).<br/> <ul class="Disc"> <li>You will hear a “snap” when the door is closed the right way. <span class="Bold">Do not</span> open door after it is closed. </li> </ul> </td><td align="center" class="Botrule Rrule" valign="top"> <br/> <a name="f54"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-54.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure O) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 11:</span> Check to make sure that the AVONEX prefilled syringe is in the AVOSTARTGRIP device the right way and that the door is tightly closed. </td><td align="center" class="Botrule Rrule" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"48.450%\"/>\n<col align=\"left\" width=\"51.550%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 6:</span> Choose the right AVOSTARTGRIP titration device for your weekly dose.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Week 1 Injection:</span> Choose the <span class=\"Bold\">white</span> device to give ¼ dose (See <a href=\"#f48\">Figure I</a>).<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule Toprule\" valign=\"top\">\n<br/>\n<a name=\"f48\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-48.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure I)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Week 2 Injection:</span> Choose the <span class=\"Bold\">yellow</span> device to give ½ dose (See <a href=\"#f49\">Figure J</a>).<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\"><a name=\"f49\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-49.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure J)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Week 3 Injection:</span> Choose the <span class=\"Bold\">purple</span> device to give ¾ dose (See <a href=\"#f50\">Figure K</a>).\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"><a name=\"f50\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-50.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure K)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 7:</span> Put the right AVOSTARTGRIP device on a flat surface with the door open (See <a href=\"#f51\">Figure L</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f51\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-51.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure L)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 8:</span> Line up the AVONEX prefilled syringe over the AVOSTARTGRIP device with the plunger pointing to the left and the needle pointing to the right (See <a href=\"#f52\">Figure M</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f52\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-52.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure M)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 9:</span> Push the AVONEX prefilled syringe down into the AVOSTARTGRIP device until both ends “snap” into place (See <a href=\"#f53\">Figure N</a>).<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f53\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-53.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure N)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 10:</span> Using two fingers, push the door down until it closes over the AVONEX prefilled syringe (See <a href=\"#f54\">Figure O</a>).<br/>\n<ul class=\"Disc\">\n<li>You will hear a “snap” when the door is closed the right way. <span class=\"Bold\">Do not</span> open door after it is closed.\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<br/>\n<a name=\"f54\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-54.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure O)\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 11:</span> Check to make sure that the AVONEX prefilled syringe is in the AVOSTARTGRIP device the right way and that the door is tightly closed.\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

Giving the AVONEX injection:

{ "type": "p", "children": [], "text": "\nGiving the AVONEX injection:\n" }

{ "type": "ul", "children": [ "Your healthcare provider should show you or a caregiver how to prepare and inject the dose of AVONEX before AVONEX prefilled syringe is used for the first time. Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX prefilled syringe is used.\n", "Inject your AVONEX exactly as your healthcare provider has shown you.\n", "AVONEX is injected into the muscle (intramuscularly).\n", "AVONEX should be injected into the thigh or upper arm (See Figures P and Q).\n", "Change (rotate) your injection sites for each dose. Do not use the same injection site for each injection.\n", "\nDo not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.\n" ], "text": "" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="47.182%"/> <col align="left" width="26.409%"/> <col align="left" width="26.409%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Step 12:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href="#f55">Figures P</a> and <a href="#f56">Q</a>). Let the injection site dry before injecting the dose.<br/> <ul class="Disc"> <li> <span class="Bold">Do not</span> touch this area again before giving the injection.<br/> </li> </ul> </td><td align="center" class="Botrule Toprule" valign="bottom"><a name="f55"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-55.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure P) </td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><a name="f56"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-56.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure Q) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 13:</span> Pull the protective cover straight off the needle (See <a href="#f57">Figure R</a>). <span class="Bold">Do not</span> twist the cover off.<br/> <br/> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <a name="f57"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-57.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure R) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 14:</span> With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90º angle, through the skin and into the muscle (See <a href="#f58">Figure S</a>). Once the needle is in, let go of the skin. </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <a name="f58"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-58.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure S) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 15:</span> Make sure that you push the plunger all the way down until it touches the collar (See <a href="#f59">Figure T</a>). </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <a name="f59"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-59.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure T) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Step 16:</span> Pull the needle out of the skin (See <a href="#f60">Figure U</a>). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion.<br/> <ul class="Disc"> <li>If you see blood after you press the injection site for a few seconds, wipe it off with gauze and apply an adhesive bandage. </li> </ul> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <br/> <a name="f60"></a><img alt="Figure " src="/dailymed/image.cfm?name=avo08-0025-60.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1"/>(Figure U) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"47.182%\"/>\n<col align=\"left\" width=\"26.409%\"/>\n<col align=\"left\" width=\"26.409%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Step 12:</span> Choose an injection site and wipe the skin with an alcohol wipe (See <a href=\"#f55\">Figures P</a> and <a href=\"#f56\">Q</a>). Let the injection site dry before injecting the dose.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> touch this area again before giving the injection.<br/>\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Toprule\" valign=\"bottom\"><a name=\"f55\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-55.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure P)\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"bottom\"><a name=\"f56\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-56.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure Q)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 13:</span> Pull the protective cover straight off the needle (See <a href=\"#f57\">Figure R</a>). <span class=\"Bold\">Do not</span> twist the cover off.<br/>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<a name=\"f57\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-57.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure R)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 14:</span> With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90º angle, through the skin and into the muscle (See <a href=\"#f58\">Figure S</a>). Once the needle is in, let go of the skin.\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<a name=\"f58\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-58.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure S)\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 15:</span> Make sure that you push the plunger all the way down until it touches the collar (See <a href=\"#f59\">Figure T</a>).\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<a name=\"f59\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-59.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure T)\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Step 16:</span> Pull the needle out of the skin (See <a href=\"#f60\">Figure U</a>). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion.<br/>\n<ul class=\"Disc\">\n<li>If you see blood after you press the injection site for a few seconds, wipe it off with gauze and apply an adhesive bandage.\n</li>\n</ul>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<br/>\n<a name=\"f60\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=avo08-0025-60.jpg&amp;setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1\"/>(Figure U)\n</td>\n</tr>\n</tbody>\n</table></div>" }

After the AVONEX injection:

{ "type": "p", "children": [], "text": "\nAfter the AVONEX injection:\n" }

Do not recap the needle. Recapping the needle can lead to a needle stick injury.

{ "type": "p", "children": [], "text": "\nDo not recap the needle. Recapping the needle can lead to a needle stick injury.\n" }

{ "type": "ul", "children": [ "Throw away the used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles in a sharps container or some type of hard plastic or metal container with a screw cap such as a detergent bottle or coffee can. Check with your healthcare provider about the right way to throw away the container. There may be local or state laws about how to throw away used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles. Do not throw away used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles in household trash or recycling bins.\n", "After 2 hours, check the injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.\n" ], "text": "" }

General information about the safe and effective use of AVONEX

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of AVONEX\n" }

{ "type": "ul", "children": [ "Always use a new AVONEX prefilled syringe, AVOSTARTGRIP device, and needle for each injection. Do not re-use your AVONEX prefilled syringe, AVOSTARTGRIP device, or needles.\n", "\nDo not share your AVONEX prefilled syringe, AVOSTARTGRIP device, or needles.\n", "Keep the AVONEX prefilled syringe, AVOSTARTGRIP device, and needles out of the reach of children.\n", "You can use the table below to keep track of your weekly injections.\t\t\t\t\t\t\t\n" ], "text": "" }

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.\n" }

Revised 09/2016Manufactured for: Biogen Inc.250 Binney StreetCambridge, MA 02142 USA©2012-2016 Biogen. All rights reserved.1-800-456-2255

{ "type": "p", "children": [], "text": "Revised 09/2016Manufactured for: Biogen Inc.250 Binney StreetCambridge, MA 02142 USA©2012-2016 Biogen. All rights reserved.1-800-456-2255\n" }

I11073-05

{ "type": "p", "children": [], "text": "I11073-05\n" }

Principal Display Panel - 30 mcg Carton Label

{ "type": "p", "children": [], "text": "\nPrincipal Display Panel - 30 mcg Carton Label\n" }

NDC 59627-003-01

{ "type": "p", "children": [], "text": "\nNDC 59627-003-01\n" }

Avonex Pen®

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

(interferon beta-1a)

{ "type": "p", "children": [], "text": "(interferon beta-1a)\n" }

Injection

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

30 mcg/0.5 mL Single-Use Prefilled Autoinjector

{ "type": "p", "children": [], "text": "30 mcg/0.5 mL Single-Use Prefilled Autoinjector\n" }

For Intramuscular Injection

{ "type": "p", "children": [], "text": "For Intramuscular Injection\n" }

Once a Week

{ "type": "p", "children": [], "text": "\nOnce a Week\n" }

Avonex Pen® Administration Dose Pack

{ "type": "p", "children": [], "text": "Avonex Pen® Administration Dose Pack\n" }

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

{ "type": "p", "children": [], "text": "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.\n" }

Store refrigerated at 2-8°C (36-46°F).

{ "type": "p", "children": [], "text": "Store refrigerated at 2-8°C (36-46°F).\n" }

Do not freeze or expose to high temperatures. Protect from light.

{ "type": "p", "children": [], "text": "Do not freeze or expose to high temperatures. Protect from light.\n" }

The recommended dosage of Avonex® is 30 mcg injected intramuscularlyonce weekly. See package insert for full prescribing information.

{ "type": "p", "children": [], "text": "The recommended dosage of Avonex® is 30 mcg injected intramuscularlyonce weekly. See package insert for full prescribing information.\n" }

This Product Contains Dry Natural Rubber.

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

Rx only

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

Principal Display Panel - 30 mcg Carton Label

{ "type": "p", "children": [], "text": "\nPrincipal Display Panel - 30 mcg Carton Label\n" }

NDC 59627-002-06

{ "type": "p", "children": [], "text": "\nNDC 59627-002-06\n" }

Avonex® (interferon beta-1a) Injection

{ "type": "p", "children": [], "text": "\nAvonex®\n\n(interferon beta-1a)\nInjection\n" }

30 mcg/0.5 mL Single-Use Prefilled Syringe

{ "type": "p", "children": [], "text": "30 mcg/0.5 mL Single-Use Prefilled Syringe\n" }

For Intramuscular Injection

{ "type": "p", "children": [], "text": "For Intramuscular Injection\n" }

Once a Week

{ "type": "p", "children": [], "text": "\nOnce a Week\n" }

Avonex® Administration Dose Pack

{ "type": "p", "children": [], "text": "Avonex® Administration Dose Pack\n" }

ATTENTION PHARMACIST: Each patient is requiredto receive the enclosed Medication Guide.

{ "type": "p", "children": [], "text": "ATTENTION PHARMACIST: Each patient is requiredto receive the enclosed Medication Guide.\n" }

Store refrigerated at 2-8°C (36-46°F)

{ "type": "p", "children": [], "text": "Store refrigerated at 2-8°C (36-46°F)\n" }

Do not freeze or expose to high temperatures.

{ "type": "p", "children": [], "text": "Do not freeze or expose to high temperatures.\n" }

Protect from light.

{ "type": "p", "children": [], "text": "Protect from light.\n" }

See package insert for dosage and administration.

{ "type": "p", "children": [], "text": "See package insert for dosage and administration.\n" }

This Product Contains Dry Natural Rubber.

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

Rx only

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

Principal Display Panel - Carton Label

{ "type": "p", "children": [], "text": "\nPrincipal Display Panel - Carton Label\n" }

NDC 59627-333-04

{ "type": "p", "children": [], "text": "\nNDC 59627-333-04\n" }

Avonex Pen® (interferon beta-1a) Injection

{ "type": "p", "children": [], "text": "\nAvonex Pen®\n\n(interferon beta-1a)\n\nInjection\n" }

30 mcg/0.5 mL Single-Use Prefilled Autoinjector

{ "type": "p", "children": [], "text": "30 mcg/0.5 mL Single-Use Prefilled Autoinjector\n" }

For Intramuscular Injection

{ "type": "p", "children": [], "text": "For Intramuscular Injection\n" }

Once a Week

{ "type": "p", "children": [], "text": "Once a Week\n" }

Contents:

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

4 Avonex Pen® Administration Dose Packs

{ "type": "p", "children": [], "text": "4 Avonex Pen® Administration Dose Packs\n" }

Store refrigerated at 2-8°C (36-46°F)

{ "type": "p", "children": [], "text": "Store refrigerated at 2-8°C (36-46°F)\n" }

Do not freeze or expose to high temperatures. Protect from light.

{ "type": "p", "children": [], "text": "Do not freeze or expose to high temperatures. Protect from light.\n" }

The recommended dosage of Avonex® is 30 mcg injected intramuscularlyonce weekly. See package insert for full prescribing information.

{ "type": "p", "children": [], "text": "The recommended dosage of Avonex® is 30 mcg injected intramuscularlyonce weekly. See package insert for full prescribing information.\n" }

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

{ "type": "p", "children": [], "text": "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.\n" }

Principal Display Panel - Carton Label

{ "type": "p", "children": [], "text": "\nPrincipal Display Panel - Carton Label\n" }

NDC 59627-222-05

{ "type": "p", "children": [], "text": "\nNDC 59627-222-05\n" }

Avonex® (interferon beta-1a) Injection

{ "type": "p", "children": [], "text": "\nAvonex®\n\n(interferon beta-1a)\n\nInjection\n" }

30 mcg/0.5 mL Single-Use Prefilled Syringe

{ "type": "p", "children": [], "text": "30 mcg/0.5 mL Single-Use Prefilled Syringe\n" }

For Intramuscular Injection

{ "type": "p", "children": [], "text": "For Intramuscular Injection\n" }

Once a Week

{ "type": "p", "children": [], "text": "Once a Week\n" }

Contents:

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

4 Avonex®Administration Dose Packs

{ "type": "p", "children": [], "text": "\n4 Avonex®Administration Dose Packs\n" }

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

{ "type": "p", "children": [], "text": "\nATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.\n" }

This Product Contains Dry Natural Rubber.

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

Rx only

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

Store refrigerated at 2-8°C (36-46°F).

{ "type": "p", "children": [], "text": "Store refrigerated at 2-8°C (36-46°F).\n" }

Do not freeze or expose to high temperatures.

{ "type": "p", "children": [], "text": "Do not freeze or expose to high temperatures.\n" }

Protect from light.

{ "type": "p", "children": [], "text": "Protect from light.\n" }

See package insert for dosage and administration.

{ "type": "p", "children": [], "text": "See package insert for dosage and administration.\n" }

Principal Display Panel - Tray Lid Label

{ "type": "p", "children": [], "text": "\nPrincipal Display Panel - Tray Lid Label\n" }

Avonex®(interferon beta-1a)

{ "type": "p", "children": [], "text": "\nAvonex®(interferon beta-1a)\n" }

30 mcg/0.5 mL Single-Use Prefilled Syringe

{ "type": "p", "children": [], "text": "\n30 mcg/0.5 mL Single-Use Prefilled Syringe\n" }

For Intramuscular Injection

{ "type": "p", "children": [], "text": "\nFor Intramuscular Injection\n" }

Store refrigerated at 2-8°C (36-46°F). Do not freeze or expose to high temperatures.

{ "type": "p", "children": [], "text": "Store refrigerated at 2-8°C (36-46°F). Do not freeze or expose to high temperatures.\n" }

Protect from light. Contents: 1 single-use prefilled syringe of Avonex® and 1, 23G, 1 1/4" needle. See package insert for dosage and administration. This Product Contains Dry Natural Rubber. ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. U.S. License# 1697

{ "type": "p", "children": [], "text": "Protect from light. Contents: 1 single-use prefilled syringe of Avonex® and 1, 23G, 1 1/4\" needle. See package insert for dosage and administration. This Product Contains Dry Natural Rubber. ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. U.S. License# 1697\n" }

Biogen Inc., Cambridge, MA 02142 1-800-456-2255 Rx only 46043 -02

{ "type": "p", "children": [], "text": "Biogen Inc., Cambridge, MA 02142 1-800-456-2255 Rx only 46043 -02\n" }

NDC 59627-002-07

{ "type": "p", "children": [], "text": "NDC 59627-002-07\n" }