WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

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WINREVAIR is administered once every 3 weeks by subcutaneous injection according to patient body weight. The starting dose of WINREVAIR is 0.3 mg/kg.

Obtain hemoglobin (Hgb) and platelet count prior to the first dose of WINREVAIR. Do not initiate treatment if platelet count is <50,000/mm3 (<50 x 109/L) [see Dosage and Administration (2.3)].

Injection volume for starting dose is calculated based on patient weight as follows:

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="right" valign="middle" width="50%"/> <col align="left" valign="middle" width="50%"/> <tbody class="Headless"> <tr> <td align="right" rowspan="2"><span class="Italics">Injection Volume (mL)</span>  =</td><td align="left"> <span class="Italics Underline">Weight (kg) x 0.3 mg/kg</span></td> </tr> <tr> <td align="left">          <span class="Italics">50 mg/mL</span></td> </tr> </tbody> </table></div>

Injection volume should be rounded to the nearest 0.1 mL.

For example: (70 kg x 0.3 mg/kg) ÷ 50 mg/mL = 0.42 mL, rounds to 0.4 mL

See Table 1 for selecting the appropriate kit based on calculated injection volume for starting dose.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1: Kit Type Based on Injection Volume for Dose of 0.3 mg/kg</span> </caption> <col align="center" valign="top" width="40%"/> <col align="center" valign="top" width="60%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">     Injection Volume (mL)</th><th align="center" class="Botrule Rrule">Kit Type</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">0.2 to 0.9</td><td align="center" class="Rrule">45 mg kit (containing 1 x 45 mg vial)</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule">1 to 1.1</td><td align="center" class="Rrule">60 mg kit (containing 1 x 60 mg vial)</td> </tr> </tbody> </table></div>

After verifying acceptable Hgb and platelet count, increase to the target dose of 0.7 mg/kg. Continue treatment at 0.7 mg/kg every 3 weeks unless dosage adjustments are required [see Dosage and Administration (2.3)].

Injection volume for target dose is calculated based on patient weight as follows:

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="right" valign="middle" width="50%"/> <col align="left" valign="middle" width="50%"/> <tbody class="Headless"> <tr> <td align="right" rowspan="2"><span class="Italics">Injection Volume (mL)</span>  =</td><td align="left"> <span class="Italics Underline">Weight (kg) x 0.7 mg/kg</span></td> </tr> <tr> <td align="left">          <span class="Italics">50 mg/mL</span></td> </tr> </tbody> </table></div>

Injection volume should be rounded to the nearest 0.1 mL.

For example: (70 kg x 0.7 mg/kg) ÷ 50 mg/mL = 0.98 mL, rounds to 1 mL

See Table 2 for selecting the appropriate kit based on calculated injection volume for target dose.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2: Kit Type Based on Injection Volume for Dose of 0.7 mg/kg</span> </caption> <col align="center" valign="top" width="40%"/> <col align="center" valign="top" width="60%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">     Injection Volume (mL)</th><th align="center" class="Botrule Rrule">Kit Type</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">0.4 to 0.9</td><td align="center" class="Rrule">45 mg kit (containing 1 x 45 mg vial)</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1 to 1.2</td><td align="center" class="Rrule">60 mg kit (containing 1 x 60 mg vial)</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1.3 to 1.8</td><td align="center" class="Rrule">90 mg kit (containing 2 x 45 mg vials)</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule">1.9 to 2.4</td><td align="center" class="Rrule">120 mg kit (containing 2 x 60 mg vials)</td> </tr> </tbody> </table></div>

Missed Dose, Overdose, and Underdose

If a dose of WINREVAIR is missed, administer as soon as possible. If the missed dose of WINREVAIR is not administered within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals. In case of an overdose, monitor for erythrocytosis [see Overdosage (10)].

Check Hgb and platelet count before each dose for the first 5 doses, or longer if values are unstable. Thereafter, monitor Hgb and platelet count periodically [see Warnings and Precautions (5.1, 5.2)].

Delay treatment for at least 3 weeks if any of the following occur:

Recheck Hgb and platelet count before reinitiating treatment. For treatment delays lasting >9 weeks, restart treatment at 0.3 mg/kg, and escalate to 0.7 mg/kg after verifying acceptable Hgb and platelet count.

Administration is subject to monitoring of hemoglobin and platelet count [see Dosage and Administration (2.3), Warnings and Precautions (5.1, 5.2)].

WINREVAIR is intended for use under the guidance of a healthcare professional. Patients and caregivers may administer WINREVAIR when considered appropriate and when they receive training and follow-up from the healthcare provider (HCP) on how to reconstitute, prepare, measure, and inject WINREVAIR [see Patient Counseling Information (17)].

Confirm at subsequent visits that the patient and/or caregiver can correctly prepare and administer WINREVAIR, particularly if the dose changes or the patient requires a different kit [see Warnings and Precautions (5.1)].

Refer to the Instructions for Use (IFU) for detailed instructions on the proper preparation and administration of WINREVAIR.

Selecting the Appropriate Product Kit

If a patient’s body weight requires the use of two 45 mg vials or two 60 mg vials of lyophilized product, use a 2-vial kit instead of two individual 1-vial kits. A 2-vial kit includes instructions to combine the contents of two vials, which aids in measuring the proper dosage and eliminates the need for multiple injections [see How Supplied/Storage and Handling (16.1)].

Reconstitution Instructions

Syringe Preparation

Administration Instructions

WINREVAIR is for subcutaneous injection.

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None.

{ "type": "p", "children": [], "text": "None." }

WINREVAIR may increase hemoglobin. Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. In clinical studies, moderate elevations in Hgb (>2 g/dL above ULN) occurred in 15% of patients taking WINREVAIR while no elevations ≥4 g/dL above ULN were observed. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required [see Dosage and Administration (2.3), Adverse Reactions (6.1)].

WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. In clinical studies, severe thrombocytopenia (platelet count <50,000/mm3 [<50 x 109/L]) occurred in 3% of patients taking WINREVAIR. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion.

Do not initiate treatment if platelet count is <50,000/mm3 [see Dosage and Administration (2.3)].

Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. [see Dosage and Administration (2.3), Adverse Reactions (6.1)].

In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Evaluate and treat bleeding accordingly. Do not administer WINREVAIR if the patient is experiencing serious bleeding [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].

Based on findings in animal reproduction studies, WINREVAIR may cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of WINREVAIR to pregnant rats and rabbits during organogenesis resulted in adverse developmental outcomes, including increased embryo-fetal mortality, alterations to growth, and structural variations at exposures 4-fold and 0.6-fold (based on area under the curve [AUC]) those occurring at the maximum recommended human dose (MRHD), respectively. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose [see Use in Specific Populations (8.1, 8.3)].

Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

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

The following data reflect exposure to WINREVAIR in the STELLAR trial. Patients (n=323) were randomized in a 1:1 ratio to receive WINREVAIR or placebo in combination with background standard of care therapies. Patients received a starting dose of 0.3 mg/kg via SC injection and the dose was increased to the target dose of 0.7 mg/kg administered once every 3 weeks for 24 weeks. After completing the primary 24-week treatment phase, patients continued into a long-term double-blind (LTDB) treatment period, maintaining their randomized treatment assignment, until all patients completed the primary treatment period. The median duration of treatment was 273 days in the placebo group and 313 days in the WINREVAIR group [see Clinical Studies (14.1)].

The most common adverse reactions occurring in STELLAR (≥10% for WINREVAIR and at least 5% more than placebo) are shown in Table 3.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 3: Adverse Reactions ≥10% in Patients Receiving WINREVAIR and at least 5% More Than Placebo in STELLAR<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></span> </caption> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="30%"/> <col align="left" valign="top" width="30%"/> <thead> <tr class="Botrule First Last"> <th align="left" class="Lrule Rrule">     Adverse reaction</th><th align="left" class="Rrule">Placebo<br/>N=160</th><th align="left" class="Rrule">WINREVAIR<br/>N=163</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Double-blind placebo-controlled period + Long-term double-blind period of STELLAR</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Headache</td><td align="left" class="Rrule">28 (17.5)</td><td align="left" class="Rrule">40 (24.5)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Epistaxis</td><td align="left" class="Rrule">3 (1.9)</td><td align="left" class="Rrule">36 (22.1)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Rash</td><td align="left" class="Rrule">13 (8.1)</td><td align="left" class="Rrule">33 (20.2)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Telangiectasia</td><td align="left" class="Rrule">7 (4.4)</td><td align="left" class="Rrule">27 (16.6)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Diarrhea</td><td align="left" class="Rrule">16 (10.0)</td><td align="left" class="Rrule">25 (15.3)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Dizziness</td><td align="left" class="Rrule">10 (6.2)</td><td align="left" class="Rrule">24 (14.7)</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">Erythema</td><td align="left" class="Rrule">5 (3.1)</td><td align="left" class="Rrule">22 (13.5)</td> </tr> </tbody> </table></div>

Increased Hemoglobin

Increases in Hgb were managed by dose delays (10%), dose reductions (6%), or both (5%). Shifts in Hgb from normal to above normal levels occurred in 87 (53%) patients receiving WINREVAIR and in 23 (14%) patients receiving placebo.

Thrombocytopenia

Decreases in platelets were managed by dose delays (2%), dose reductions (2%), or both (2%). Shifts in platelet count from normal to below normal occurred in 40 (25%) patients receiving WINREVAIR and in 26 (16%) patients receiving placebo.

Telangiectasia

In patients exposed to WINREVAIR who experienced telangiectasia, the median time to onset was 47.1 weeks.

Increased Blood Pressure

In patients taking WINREVAIR, mean systolic/diastolic blood pressure increased from baseline by 2.2/4.9 mmHg at 24 weeks. In patients taking placebo, the change from baseline in mean blood pressure was -1.6/-0.6 mmHg.

Treatment Discontinuation

The incidences of treatment discontinuations due to an adverse reaction were 4% in the WINREVAIR group and 7% in the placebo group. No specific adverse reactions causing treatment discontinuations occurred with a frequency greater than 1% and more often in the WINREVAIR group.

Uncontrolled Long-term Safety Data

The safety profile in the long-term uncontrolled extension period of the PULSAR study was generally similar to that observed in the STELLAR study. Patients were treated with WINREVAIR 0.3 mg/kg or 0.7 mg/kg (n=104) and had a mean duration of exposure of 151 weeks (maximum 218 weeks).

In SOTERIA, an ongoing open-label study of the long-term safety and efficacy of WINREVAIR, right-to-left intrapulmonary shunting has been reported in 2 participants (<0.5%) who developed worsening hypoxemia despite improved PAH hemodynamics.

Risk Summary

Based on findings in animal reproduction studies, WINREVAIR may cause fetal harm when administered to a pregnant woman. There are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy (see Clinical Considerations). There are no available data on WINREVAIR use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, administration of WINREVAIR to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including embryo-fetal mortality, alterations to growth, and structural variations at exposures 4-fold and 0.6-fold (based on area under the curve [AUC]) above those occurring at the maximum recommended human dose (MRHD), respectively (see Data). Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.3)].

The background risk of major birth defects and miscarriage for the indicated population is not known. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Report exposure during pregnancy or lactation to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

In patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction, and premature labor.

Data

Animal Data

In embryo-fetal developmental toxicity studies, pregnant animals were dosed subcutaneously with sotatercept-csrk during the period of organogenesis. Sotatercept-csrk was administered to rats on gestation days 6 and 13 at doses of 5, 15, or 50 mg/kg and to rabbits on gestation days 7 and 14 at doses of 0.5, 1.5, or 5 mg/kg. Effects in both species included reductions in numbers of live fetuses and fetal body weights, delays in ossification, and increases in resorptions and post-implantation losses. In rats and rabbits, these effects were observed at exposures (based on area under the curve [AUC]) approximately 4-fold and 0.6-fold the maximum recommended human dose (MRHD), respectively. In rats only, skeletal variations (increased number of supernumerary ribs and changes in the number of thoracic or lumbar vertebrae) occurred at an exposure 15-fold the human exposure at the MRHD.

In a prenatal and postnatal development study in rats, sotatercept-csrk was administered subcutaneously at doses of 1.5 and 5 mg/kg on gestation days 6 and 13, or at dosages of 1.5, 5, or 10 mg/kg during lactation on days 1, 8, and 15. There were no adverse effects in first filial generation (F1) pups from dams dosed during gestation at estimated exposures up to 2-fold the MRHD. In F1 pups from dams dosed during lactation, decreases in pup weight correlated with delays in sexual maturation at estimated exposures (based on AUC) ≥2-fold the MRHD.

Risk Summary

There are no data on the presence of sotatercept-csrk in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

WINREVAIR may cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)].

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

Contraception

Females

Advise female patients of reproductive potential to use effective contraception during treatment with WINREVAIR and for at least 4 months after the final dose if treatment is discontinued [see Use in Specific Populations (8.1)].

Infertility

Based on findings in animals, sotatercept-csrk may impair female and male fertility [see Nonclinical Toxicology (13.1)]. In male rats, although adverse histologic changes in reproductive organs were not reversible after a 13-week period, functional fertility demonstrated reversibility.

The safety and effectiveness of WINREVAIR have not been established in patients less than 18 years of age.

A total of 81 patients ≥65 years of age participated in clinical studies for PAH, of which 52 (16%) were treated with WINREVAIR. No differences in efficacy of WINREVAIR were observed between the <65-year-old and ≥65-year-old subgroups.

With the exception of bleeding events (a collective group of adverse events of clinical interest), there were no differences in safety between the <65-year-old and ≥65-year-old subgroups. Bleeding events occurred more commonly in the older WINREVAIR subgroup, but with no imbalance between age subgroups for any specific bleeding event.

Clinical studies of WINREVAIR did not include sufficient numbers of patients aged 75 and older to determine whether they respond differently from younger patients.

In healthy volunteers, WINREVAIR dosed at 1 mg/kg resulted in increases in Hgb associated with hypertension; both improved with phlebotomy. In the event of overdose, monitor closely for increases in Hgb and blood pressure, and provide supportive care as appropriate. WINREVAIR is not dialyzable.

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Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer.

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Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution.

{ "type": "p", "children": [], "text": "Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution." }

Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL.

{ "type": "p", "children": [], "text": "Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL." }

Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL.

{ "type": "p", "children": [], "text": "Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL." }

Sotatercept-csrk, a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, is an activin signaling inhibitor that binds to activin A and other TGF- β superfamily ligands. As a result, sotatercept-csrk improves the balance between the pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signaling to modulate vascular proliferation. In rat models of PAH, a sotatercept-csrk analog reduced inflammation and inhibited proliferation of endothelial and smooth muscle cells in diseased vasculature. These cellular changes were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

PVR:

A statistically significantly greater decrease from baseline in PVR was observed in the WINREVAIR group compared to the placebo group in the Phase 3 STELLAR study. The median treatment difference in PVR between sotatercept-csrk and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p<0.001). Sotatercept-csrk steady state exposure at 0.7 mg/kg dose was associated with near maximal reduction in PVR based on exposure-response analysis.

NT-proBNP:

A statistically significantly greater decrease from baseline in NT-proBNP was observed in the WINREVAIR group compared to the placebo group in the Phase 3 STELLAR study. The median treatment difference in NT-proBNP between the sotatercept-csrk and placebo was -442 pg/mL (95% CI: -574, -310; p<0.001).

Following subcutaneous administration of 0.7 mg/kg WINREVAIR every three weeks to PAH patients, the steady state geometric mean (%CV) area under the time concentration curve (AUC) is 172 mcg×d/mL (34.2%), and peak concentration (Cmax) is 9.7 mcg/mL (30%). Sotatercept-csrk AUC and Cmax increased proportionally with dose. Steady state is achieved after approximately 15 weeks following initiation of multiple dosing. The accumulation ratio of sotatercept-csrk AUC is approximately 2.2.

Absorption

Following subcutaneous administration, the absolute bioavailability of sotatercept-csrk is approximately 66%. The sotatercept-csrk median time to peak drug concentration (Tmax) is approximately 7 days (range from 2 to 8 days) following multiple SC administration every 4 weeks.

Distribution

The population PK model estimated volume of distribution (%CV) of sotatercept-csrk at steady state is approximately 5.3 L (27.3%) in patients with PAH.

Elimination

The sotatercept-csrk effective half-life is approximately 24 days and its clearance is approximately 0.18 L/day.

Metabolism

Sotatercept-csrk is expected to be metabolized into small peptides by catabolic pathways.

Specific Populations

No clinically significant differences in sotatercept-csrk pharmacokinetics (PK) were observed based on age (18 to 81 years of age), sex, race, mild to moderate (eGFR ranging from 30 to 89 mL/min) renal impairment (PAH patients), or end-stage kidney disease (eGFR <15 mL/min) with dialysis. Severe renal impairment (eGFR ranging from 15 to 30 mL/min) is not expected to impact the PK of sotatercept-csrk. Sotatercept-csrk is not dialyzable. The effect of hepatic impairment on the PK of sotatercept-csrk has not been studied.

Body Weight

The clearance (CL) and central volume of distribution (Vc) increase with increase in body weight. This effect is not clinically significant when sotatercept-csrk is administered using weight-based dosing as recommended.

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

During the 24-week treatment period in STELLAR, 27% (44/163) of sotatercept-csrk-treated patients developed anti-sotatercept-csrk antibodies (ADA). Among the 44 ADA-positive patients, 12 (27%) tested positive for neutralizing antibodies against sotatercept-csrk.

There were no identified clinical effects of anti-sotatercept-csrk antibodies on pharmacokinetics, pharmacodynamics, safety, or effectiveness of sotatercept-csrk over the treatment duration of 24 weeks at the recommended dosage.

No carcinogenicity or mutagenicity studies have been conducted with sotatercept-csrk.

In a fertility and early embryonic development study in female rats, sotatercept-csrk was administered SC once weekly at doses of 5, 15, and 50 mg/kg beginning 2 weeks prior to mating and through gestation day 7. At doses ≥15 mg/kg (≥9 fold the MRHD, based on estimated AUC), pregnancy rates were decreased and there were increases in preimplantation and postimplantation loss and reductions in live litter size. Increased estrous cycle duration occurred at 50 mg/kg only (21-fold the MRHD, based on estimated AUC).

In a fertility study in male rats, sotatercept-csrk was administered SC once weekly at doses of 0.3, 3, and 30 mg/kg for 13 weeks (beginning 10 weeks prior to mating). A subset of animals was examined after a 13-week recovery period. At ≥0.3 mg/kg (0.5-fold the MRHD, based on estimated AUC) there were non-reversible histologic changes in the efferent ducts, testes, and epididymides. Reversible decreases in functional fertility endpoints occurred at 30 mg/kg (20-fold the MRHD, based on estimated AUC).

The efficacy of WINREVAIR was evaluated in adult patients with PAH in the STELLAR trial (NCT04576988). STELLAR was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 323 patients with PAH (WHO Group 1 FC II or III) were randomized 1:1 to WINREVAIR (target dose 0.7 mg/kg) (n=163) or placebo (n=160) administered subcutaneously once every 3 weeks.

Participants were: 79% female; had a median age of 48 years (range: 18 to 82 years), and median body weight of 68 kg (range 38 to 141 kg); and 89% White/Caucasian, 2% Black/African American, 2% Asian, 0.3% American Indian or Alaska Native, 0.3% Native Hawaiian or Other Pacific Islander, 6% Missing/Other races. The most common PAH etiologies were idiopathic PAH (59%), heritable PAH (18%), and PAH associated with connective tissue diseases (CTD) (15%). STELLAR excluded patients with human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno occlusive disease. The mean time from PAH diagnosis to screening was 8.8 years. Most participants were receiving either three (61%) or two (35%) background drugs for PAH, and 40% were receiving prostacyclin infusions. Patients had a WHO FC II (49%) or III (51%) at baseline.

The primary efficacy endpoint was the change from baseline at Week 24 in 6-Minute Walk Distance (6 MWD). In the WINREVAIR group, the placebo-adjusted median increase in 6 MWD was 41 meters (95% CI: 28, 54; p<0.001). Figure 1 displays placebo-adjusted changes in 6 MWD at Week 24 in relevant subgroups.

<div class="scrollingtable"><table class="Noautorules" width="80%"> <caption> <span>Figure 1: Change from Baseline in 6-Minute Walk Distance (meters) at Week 24 in Subgroups </span> </caption> <col align="center" valign="top" width="100%"/> <tfoot> <tr> <td align="left"><span class="Sup">*</span>Hodges-Lehmann location shift from placebo estimate (median of all paired differences). ASE = asymptotic standard error.</td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center"><img alt="Figure 1" src="/dailymed/image.cfm?name=winrevair-01.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></td> </tr> </tbody> </table></div>

Change from baseline in 6 MWD at Week 24 for subjects who died was imputed to -2000 meters to receive the worst rank. Change from baseline in 6 MWD at Week 24 for subjects who had missing data due to a non-fatal clinical worsening event was imputed to -1000 meters to receive the next-worst rank.

Treatment with WINREVAIR led to an improvement from baseline by at least 1 WHO FC at Week 24 in 29% of patients compared to 14% of patients treated with placebo (p<0.001).

Treatment with WINREVAIR resulted in an 84% reduction in the occurrence of death from any cause or PAH clinical worsening events compared to placebo (see Table 4 and Figure 2). These outcomes were captured until the last patient completed the Week 24 visit (data up to the data cutoff; median duration of exposure 33.6 weeks).

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 4: Death from Any Cause or PAH Clinical Worsening Events</span> </caption> <col align="left" valign="middle" width="56%"/> <col align="center" valign="middle" width="13%"/> <col align="center" valign="middle" width="13%"/> <col align="center" valign="middle" width="18%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" valign="top">Placebo<br/>(N=160)<br/>n (%)</th><th align="center" class="Rrule" valign="top">WINREVAIR<br/>(N=163)<br/>n (%)</th><th align="center" class="Rrule" valign="middle">Hazard Ratio<br/>(95% CI)</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="4">N = number of subjects in the category.<br/>6 MWT = 6-Minute Walking Test</td> </tr> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>A subject can have more than one assessment recorded for their clinical worsening.</dd> <dt> <a href="#footnote-reference-3" name="footnote-3">†</a> </dt> <dd>There were no events of atrial septostomy.</dd> <dt> <a href="#footnote-reference-4" name="footnote-4">‡</a> </dt> <dd>Deterioration of PAH is defined by both of the following events occurring at any time, even if they began at different times, as compared to their baseline values: (a) Worsened WHO functional class (II to III, III to IV, II to IV, etc.); and (b) Decrease in 6 MWD by ≥15% (confirmed by two 6 MWTs at least 4 hours apart but no more than one week).</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Number of subjects who experienced death or at least one clinical worsening event</td><td align="center" class="Rrule">42 (26.3)</td><td align="center" class="Rrule">9 (5.5)</td><td align="center" class="Rrule">0.16 (0.08, 0.35)<br/>p&lt;0.001</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4">Assessment of clinical worsening events<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">      Death</td><td align="center" class="Rrule">7 (4.4)</td><td align="center" class="Rrule">2 (1.2)</td><td align="center" class="Rrule" rowspan="6"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">      Worsening-related listing for lung and/or heart transplant</td><td align="center" class="Rrule">2 (1.3)</td><td align="center" class="Rrule">1 (0.6)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">      Need to initiate rescue therapy with an approved PAH therapy or <br/>      the need to increase the dose of infusion prostacyclin by 10% or more</td><td align="center" class="Rrule">17 (10.6)</td><td align="center" class="Rrule">2 (1.2)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">      Need for atrial septostomy<a class="Sup" href="#footnote-3" name="footnote-reference-3">†</a></td><td align="center" class="Rrule">0 (0.0)</td><td align="center" class="Rrule">0 (0.0)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">      PAH-specific hospitalization (≥24 hours)</td><td align="center" class="Rrule">8 (5.0)</td><td align="center" class="Rrule">0 (0.0)</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">      Deterioration of PAH<a class="Sup" href="#footnote-4" name="footnote-reference-4">‡</a></td><td align="center" class="Rrule">15 (9.4)</td><td align="center" class="Rrule">4 (2.5)</td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="80%"> <caption> <span>Figure 2: Time to Death from Any Cause or First Occurrence of PAH Clinical Worsening Event Kaplan-Meier Plot</span> </caption> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><img alt="Figure 2" src="/dailymed/image.cfm?name=winrevair-02.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></td> </tr> </tbody> </table></div>

WINREVAIR (sotatercept-csrk) for injection is a white to off-white lyophilized cake or powder appearance supplied in single-dose vials (45 mg or 60 mg) packaged in kits that contain one measuring syringe and one safety needle. Each kit also contains Sterile Water for Injection in prefilled syringes necessary to reconstitute the product, vial adapter(s), and alcohol pads, as shown in Table 5.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 5: Kit Contents</span> </caption> <col align="center" valign="top" width="25%"/> <col align="center" valign="middle" width="10%"/> <col align="center" valign="middle" width="10%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="30%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" valign="bottom">Kit</th><th align="center" class="Rrule">Vial<br/>Adapters</th><th align="center" class="Rrule">Alcohol <br/>Pads</th><th align="center" class="Rrule">Sterile Water for Injection <br/>in prefilled syringes</th><th align="center" class="Rrule">NDC</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">(1) 45 mg vial</td><td align="center" class="Rrule">1</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">(1) 1 mL syringe</td><td align="center" class="Rrule">NDC # 0006-5090-01</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">(1) 60 mg vial</td><td align="center" class="Rrule">1</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">(1) 1.3 mL syringe</td><td align="center" class="Rrule">NDC # 0006-5091-01</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">(2) 45 mg vials</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">8</td><td align="center" class="Rrule">(2) 1 mL syringes</td><td align="center" class="Rrule">NDC # 0006-5087-01</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule">(2) 60 mg vials</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">8</td><td align="center" class="Rrule">(2) 1.3 mL syringes</td><td align="center" class="Rrule">NDC # 0006-5088-01</td> </tr> </tbody> </table></div>

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

The kit should remain in the refrigerator until ready for use. The unused kit can be out of the refrigerator for (up to 25°C/77°F) up to 24 hours. For additional information on temperature excursions, call Merck Sharp & Dohme LLC at 1-800-672-6372.

Advise patients to read the FDA-approved patient labeling (Patient Information and IFU).

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

Discuss the following with patients prior to and during treatment with WINREVAIR.

{ "type": "p", "children": [], "text": "Discuss the following with patients prior to and during treatment with WINREVAIR." }

Erythrocytosis

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

Caution patients that WINREVAIR may raise Hgb to levels that increase their risk of thrombotic events. Inform patients that Hgb levels will be assessed before at least the first 5 doses and then periodically, as dosage may need to be adjusted [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Caution patients that WINREVAIR may raise Hgb to levels that increase their risk of thrombotic events. Inform patients that Hgb levels will be assessed before at least the first 5 doses and then periodically, as dosage may need to be adjusted [see Warnings and Precautions (5.1)]." }

Severe Thrombocytopenia

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

Caution patients that WINREVAIR may cause platelet count to decrease, which if severe could cause bleeding. Inform patients that platelet count will be assessed before at least the first 5 doses and then periodically, as dosage may need to be adjusted [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Caution patients that WINREVAIR may cause platelet count to decrease, which if severe could cause bleeding. Inform patients that platelet count will be assessed before at least the first 5 doses and then periodically, as dosage may need to be adjusted [see Warnings and Precautions (5.2)]." }

Serious Bleeding

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

Inform patients of the possibility of serious bleeding, which is more likely to occur if they have low platelet counts or while on prostacyclin background therapy and/or antithrombotic agents. Advise patients to notify their healthcare provider about signs and symptoms of bleeding [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients of the possibility of serious bleeding, which is more likely to occur if they have low platelet counts or while on prostacyclin background therapy and/or antithrombotic agents. Advise patients to notify their healthcare provider about signs and symptoms of bleeding [see Warnings and Precautions (5.3)]." }

Embryo-Fetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryo-Fetal Toxicity\n" }

Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception while receiving WINREVAIR and for at least 4 months after the final dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected during treatment with WINREVAIR [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Report exposure during pregnancy or lactation to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231.

{ "type": "p", "children": [], "text": "Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception while receiving WINREVAIR and for at least 4 months after the final dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected during treatment with WINREVAIR [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Report exposure during pregnancy or lactation to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231." }

Lactation

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

Advise females not to breastfeed during treatment with WINREVAIR and for 4 months after the final dose [see Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "Advise females not to breastfeed during treatment with WINREVAIR and for 4 months after the final dose [see Use in Specific Populations (8.2)]." }

Females and Males of Reproductive Potential

{ "type": "p", "children": [], "text": "\nFemales and Males of Reproductive Potential\n" }

Advise females and males of reproductive potential that WINREVAIR may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

{ "type": "p", "children": [], "text": "Advise females and males of reproductive potential that WINREVAIR may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)]." }

Administration by Patient or Caregiver

{ "type": "p", "children": [], "text": "\nAdministration by Patient or Caregiver\n" }

Review the IFU with the patient or caregiver step-by-step. Provide training to the patient or caregiver regarding proper preparation and administration of WINREVAIR and decide whether a patient or caregiver is capable of preparing and administering WINREVAIR independently [see Dosage and Administration (2.4)].

{ "type": "p", "children": [], "text": "Review the IFU with the patient or caregiver step-by-step. Provide training to the patient or caregiver regarding proper preparation and administration of WINREVAIR and decide whether a patient or caregiver is capable of preparing and administering WINREVAIR independently [see Dosage and Administration (2.4)]." }

Make sure the patient or caregiver can do the following correctly:

{ "type": "p", "children": [], "text": "Make sure the patient or caregiver can do the following correctly:" }

{ "type": "ul", "children": [ "reconstitute the medicine,", "measure the correct amount of medicine according to the patient’s prescription,", "select and prepare a proper injection site, and", "inject the medicine subcutaneously." ], "text": "" }

Incorrect Dose or Missed Dose

{ "type": "p", "children": [], "text": "\nIncorrect Dose or Missed Dose\n" }

Inform patients to call their healthcare provider for further instruction if they take more than or less than the correct dose. Advise them about signs/symptoms to monitor for and what to do if any of these signs/symptoms should occur. Advise them that additional laboratory tests may be required prior to the next scheduled dose to ensure that the next dose can be safely administered.

{ "type": "p", "children": [], "text": "Inform patients to call their healthcare provider for further instruction if they take more than or less than the correct dose. Advise them about signs/symptoms to monitor for and what to do if any of these signs/symptoms should occur. Advise them that additional laboratory tests may be required prior to the next scheduled dose to ensure that the next dose can be safely administered." }

Instruct the patient that if they miss the prescribed dose of WINREVAIR, they should take it within 3 days and maintain the original schedule for the next dose. If not taken within 3 days, instruct them to call their healthcare provider for guidance [see Dosage and Administration (2.2)].

{ "type": "p", "children": [], "text": "Instruct the patient that if they miss the prescribed dose of WINREVAIR, they should take it within 3 days and maintain the original schedule for the next dose. If not taken within 3 days, instruct them to call their healthcare provider for guidance [see Dosage and Administration (2.2)]. " }

Manufactured by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA

{ "type": "p", "children": [], "text": "Manufactured by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA" }

U.S. license number 0002

{ "type": "p", "children": [], "text": "U.S. license number 0002" }

For patent information: www.msd.com/research/patent

{ "type": "p", "children": [], "text": "For patent information: www.msd.com/research/patent\n" }

Copyright © 2024-2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2024-2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.\n\t\t\t\t\t\t\tAll rights reserved." }

uspi-mk7962-i-2505r001

{ "type": "p", "children": [], "text": "uspi-mk7962-i-2505r001" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="2%"/> <col align="left" valign="top" width="48%"/> <col align="left" valign="top" width="56%"/> <tfoot> <tr> <td align="left" colspan="2">This Patient Information has been approved by the U.S. Food and Drug Administration</td><td align="right">Issued: 3/2024</td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule"> <td align="center" class="Lrule Rrule Toprule" colspan="3"><span class="Bold">PATIENT INFORMATION</span> <br/> WINREVAIR™ (WIN-reh-vair)<br/>(sotatercept-csrk)<br/>for injection, for subcutaneous use</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">What is WINREVAIR?</span> </p> <p>WINREVAIR™ is a prescription medicine used to treat adults with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs.</p> <p>WINREVAIR can improve your ability to exercise, improve your ability to perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening.</p> <p>It is not known if WINREVAIR is safe and effective in children under 18 years of age.</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Bold">What should I tell my healthcare provider before taking WINREVAIR?</span> <br/> <ul class="Disc"> <li>Tell your healthcare provider about: <ul class="Circle"> <li> <span class="Bold">All of your medical conditions</span> </li> <li> <span class="Bold">All of the medicines you take, including:</span> <ul class="Square"> <li>Prescriptions</li> <li>Over-the-counter medicines</li> <li>Vitamins</li> <li>Herbal supplements</li> </ul> </li> </ul> </li> </ul> <p class="First"> <span class="Bold">If you are able to get pregnant:</span> </p> <ul class="Disc"> <li>WINREVAIR may harm your unborn baby. Tell your healthcare provider if you are pregnant or planning to get pregnant.</li> <li>Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with WINREVAIR.</li> <li>Your healthcare provider should do a pregnancy test before you start taking WINREVAIR.</li> <li>You should use effective birth control during treatment with WINREVAIR and for at least 4 months after your final dose. Ask your healthcare provider about birth control methods that may be right for you.</li> <li>You or your healthcare provider should report any exposure to WINREVAIR during pregnancy by calling 1-877-888-4231.</li> </ul> <p> <span class="Bold">If you are breastfeeding or planning to breastfeed:</span> </p> <ul class="Disc"> <li>Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if WINREVAIR passes into breast milk.</li> <li>Do not breastfeed during treatment with WINREVAIR and for 4 months after your final dose. Talk to your healthcare provider about the best way to feed your baby.</li> <li>You or your healthcare provider should report any exposure to WINREVAIR during breastfeeding by calling 1-877-888-4231.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Bold">Before you take WINREVAIR:</span> <ul class="Disc"> <li>If your healthcare provider decides that you or a caregiver can give your injections of WINREVAIR at home, you or your caregiver should receive training from your healthcare provider on the right way to prepare and inject WINREVAIR. Do not try to inject WINREVAIR until you have been shown how to inject WINREVAIR by your healthcare provider.</li> <li>Your healthcare provider will do a blood test before your first 5 doses of WINREVAIR, longer if needed, and then from time to time to check your levels of hemoglobin (a protein in red blood cells that carries oxygen) and platelets (blood cells that help blood clot). After each of these blood tests, your healthcare provider may delay treatment or change your dose if needed.</li> <li> <span class="Bold">See the detailed “<a href="#SIFU">Instructions for Use</a>” booklet that comes with WINREVAIR for information on how to prepare and inject a dose of WINREVAIR.</span> </li> </ul> <p class="First"> <span class="Bold">How should I take WINREVAIR?</span> </p> <ul class="Disc"> <li>Use WINREVAIR exactly as your healthcare provider tells you to.</li> <li>You will give WINREVAIR every 3 weeks as an injection just under your skin (subcutaneous) in your: <ul class="Circle"> <li> <span class="Bold">stomach</span> (abdomen) at least 2 inches away from the belly button, <span class="Bold">or</span> </li> <li> <span class="Bold">upper thigh</span> </li> </ul> </li> <li>You should inject WINREVAIR right away after mixing the medicine powder with the sterile water for injection, but no later than 4 hours after mixing.</li> </ul> <p> <span class="Bold">Your prescribed dose:</span> </p> <ul class="Disc"> <li>Your healthcare provider will tell you how much WINREVAIR to inject and when to inject it. This is because your prescribed dose depends on your body weight and blood tests.</li> <li>Do not change your dose or stop taking WINREVAIR without talking to your healthcare provider.</li> <li>Do not take WINREVAIR more often than your healthcare provider tells you to. If you are not sure when to take WINREVAIR, call your healthcare provider.</li> <li>Your healthcare provider may delay treatment, change your dose, or stop treatment depending on how you respond to WINREVAIR.</li> </ul> <p> <span class="Bold">What if I take the wrong dose or miss my dose?</span> </p> <ul class="Disc"> <li>If you give more than or less than your prescribed dose, call your healthcare provider right away.</li> <li>If you miss your dose of WINREVAIR: <ul class="Circle"> <li>If it has been 3 days or fewer, give it as soon as possible. You can then follow your usual schedule for your next dose.</li> <li>If it has been more than 3 days, call your healthcare provider for what to do.</li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">What are the possible side effects of WINREVAIR?</span> </p> <p> <span class="Bold">WINREVAIR may cause serious side effects including:</span> </p> <ul class="Disc"> <li> <span class="Bold">High level of hemoglobin in your blood.</span> High levels of hemoglobin can increase your risk for blood clots. Your healthcare provider will do blood tests to check your hemoglobin levels before starting and regularly during treatment with WINREVAIR.</li> <li> <span class="Bold">Severely low number of platelets in your blood.</span> Your healthcare provider will do blood tests to check your platelet levels before starting and regularly during treatment with WINREVAIR. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.</li> <li> <span class="Bold">Serious bleeding.</span> Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule"></td><td align="left"> <ul class="Circle"> <li>vomiting blood or your vomit looks like coffee-grounds</li> <li>pink or brown urine</li> <li>red or black stools that look like tar</li> <li>coughing up blood or blood clots</li> <li>persistent headaches</li> </ul> </td><td align="left" class="Rrule"> <ul class="Circle"> <li>nausea</li> <li>dizziness or feeling weak</li> <li>persistent abdominal cramps</li> <li>severe back pain</li> <li>abnormally heavy menstrual bleeding</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3"> <ul class="Disc"> <li> <span class="Bold">Decreased fertility:</span> WINREVAIR may affect female and male fertility, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">The most common side effects of WINREVAIR include:</span> </p> <ul class="Disc"> <li>headache</li> <li>nose bleeds</li> <li>rash</li> <li>tiny blood vessels that look like pink or red lines on the skin (spider veins)</li> <li>diarrhea</li> <li>dizziness</li> <li>redness</li> </ul> <p>These are not all the possible side effects of WINREVAIR.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">How should I store WINREVAIR?</span> </p> <ul class="Disc"> <li>Store WINREVAIR in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</li> <li>Store in the original carton to protect from light.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">Keep WINREVAIR and all medicines out of the reach of children and pets.</span> </p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">General information about the safe and effective use of WINREVAIR</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WINREVAIR for a condition for which it was not prescribed. Do not give WINREVAIR 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 WINREVAIR that is written for healthcare professionals.</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First"> <span class="Bold">What are the ingredients in WINREVAIR?</span> <br/> <span class="Bold">Active ingredient:</span> sotatercept-csrk<br/> <span class="Bold">Inactive ingredient(s):</span> citric acid monohydrate, polysorbate 80, sodium citrate, and sucrose.</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"> <p class="First">Manufactured by: Merck Sharp &amp; Dohme LLC, Rahway, NJ 07065, USA.<br/> <br/> US License Number 0002<br/> For patent information: <span class="Underline"><a href="http://www.msd.com/research/patent">www.msd.com/research/patent</a></span> <br/> Copyright © 2024 Merck &amp; Co., Inc., Rahway, NJ, USA, and its affiliates. <br/>All rights reserved.<br/> usppi-mk7962-i-2403r000<br/> For more information, call 1-877-888-4231, or go to <span class="Underline"><a href="http://www.WINREVAIR.com">www.WINREVAIR.com</a></span>.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"2%\"/>\n<col align=\"left\" valign=\"top\" width=\"48%\"/>\n<col align=\"left\" valign=\"top\" width=\"56%\"/>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"2\">This Patient Information has been approved by the U.S. Food and Drug Administration</td><td align=\"right\">Issued: 3/2024</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n WINREVAIR™ (WIN-reh-vair)<br/>(sotatercept-csrk)<br/>for injection, for subcutaneous use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">What is WINREVAIR?</span>\n</p>\n<p>WINREVAIR™ is a prescription medicine used to treat adults with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs.</p>\n<p>WINREVAIR can improve your ability to exercise, improve your ability to perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening.</p>\n<p>It is not known if WINREVAIR is safe and effective in children under 18 years of age.</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\"><span class=\"Bold\">What should I tell my healthcare provider before taking WINREVAIR?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Tell your healthcare provider about:\n\t\t\t\t\t\t\t <ul class=\"Circle\">\n<li>\n<span class=\"Bold\">All of your medical conditions</span>\n</li>\n<li>\n<span class=\"Bold\">All of the medicines you take, including:</span>\n<ul class=\"Square\">\n<li>Prescriptions</li>\n<li>Over-the-counter medicines</li>\n<li>Vitamins</li>\n<li>Herbal supplements</li>\n</ul>\n</li>\n</ul>\n</li>\n</ul>\n<p class=\"First\">\n<span class=\"Bold\">If you are able to get pregnant:</span>\n</p>\n<ul class=\"Disc\">\n<li>WINREVAIR may harm your unborn baby. Tell your healthcare provider if you are pregnant or planning to get pregnant.</li>\n<li>Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with WINREVAIR.</li>\n<li>Your healthcare provider should do a pregnancy test before you start taking WINREVAIR.</li>\n<li>You should use effective birth control during treatment with WINREVAIR and for at least 4 months after your final dose. Ask your healthcare provider about birth control methods that may be right for you.</li>\n<li>You or your healthcare provider should report any exposure to WINREVAIR during pregnancy by calling 1-877-888-4231.</li>\n</ul>\n<p>\n<span class=\"Bold\">If you are breastfeeding or planning to breastfeed:</span>\n</p>\n<ul class=\"Disc\">\n<li>Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if WINREVAIR passes into breast milk.</li>\n<li>Do not breastfeed during treatment with WINREVAIR and for 4 months after your final dose. Talk to your healthcare provider about the best way to feed your baby.</li>\n<li>You or your healthcare provider should report any exposure to WINREVAIR during breastfeeding by calling 1-877-888-4231.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\"><span class=\"Bold\">Before you take WINREVAIR:</span>\n<ul class=\"Disc\">\n<li>If your healthcare provider decides that you or a caregiver can give your injections of WINREVAIR at home, you or your caregiver should receive training from your healthcare provider on the right way to prepare and inject WINREVAIR. Do not try to inject WINREVAIR until you have been shown how to inject WINREVAIR by your healthcare provider.</li>\n<li>Your healthcare provider will do a blood test before your first 5 doses of WINREVAIR, longer if needed, and then from time to time to check your levels of hemoglobin (a protein in red blood cells that carries oxygen) and platelets (blood cells that help blood clot). After each of these blood tests, your healthcare provider may delay treatment or change your dose if needed.</li>\n<li>\n<span class=\"Bold\">See the detailed “<a href=\"#SIFU\">Instructions for Use</a>” booklet that comes with WINREVAIR for information on how to prepare and inject a dose of WINREVAIR.</span>\n</li>\n</ul>\n<p class=\"First\">\n<span class=\"Bold\">How should I take WINREVAIR?</span>\n</p>\n<ul class=\"Disc\">\n<li>Use WINREVAIR exactly as your healthcare provider tells you to.</li>\n<li>You will give WINREVAIR every 3 weeks as an injection just under your skin (subcutaneous) in your: <ul class=\"Circle\">\n<li>\n<span class=\"Bold\">stomach</span> (abdomen) at least 2 inches away from the belly button, <span class=\"Bold\">or</span>\n</li>\n<li>\n<span class=\"Bold\">upper thigh</span>\n</li>\n</ul>\n</li>\n<li>You should inject WINREVAIR right away after mixing the medicine powder with the sterile water for injection, but no later than 4 hours after mixing.</li>\n</ul>\n<p>\n<span class=\"Bold\">Your prescribed dose:</span>\n</p>\n<ul class=\"Disc\">\n<li>Your healthcare provider will tell you how much WINREVAIR to inject and when to inject it. This is because your prescribed dose depends on your body weight and blood tests.</li>\n<li>Do not change your dose or stop taking WINREVAIR without talking to your healthcare provider.</li>\n<li>Do not take WINREVAIR more often than your healthcare provider tells you to. If you are not sure when to take WINREVAIR, call your healthcare provider.</li>\n<li>Your healthcare provider may delay treatment, change your dose, or stop treatment depending on how you respond to WINREVAIR.</li>\n</ul>\n<p>\n<span class=\"Bold\">What if I take the wrong dose or miss my dose?</span>\n</p>\n<ul class=\"Disc\">\n<li>If you give more than or less than your prescribed dose, call your healthcare provider right away.</li>\n<li>If you miss your dose of WINREVAIR:\n <ul class=\"Circle\">\n<li>If it has been 3 days or fewer, give it as soon as possible. You can then follow your usual schedule for your next dose.</li>\n<li>If it has been more than 3 days, call your healthcare provider for what to do.</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of WINREVAIR?</span>\n</p>\n<p>\n<span class=\"Bold\">WINREVAIR may cause serious side effects including:</span>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">High level of hemoglobin in your blood.</span> High levels of hemoglobin can increase your risk for blood clots. Your healthcare provider will do blood tests to check your hemoglobin levels before starting and regularly during treatment with WINREVAIR.</li>\n<li>\n<span class=\"Bold\">Severely low number of platelets in your blood.</span> Your healthcare provider will do blood tests to check your platelet levels before starting and regularly during treatment with WINREVAIR. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.</li>\n<li>\n<span class=\"Bold\">Serious bleeding.</span> Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\"></td><td align=\"left\">\n<ul class=\"Circle\">\n<li>vomiting blood or your vomit looks like coffee-grounds</li>\n<li>pink or brown urine</li>\n<li>red or black stools that look like tar</li>\n<li>coughing up blood or blood clots</li>\n<li>persistent headaches</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\">\n<ul class=\"Circle\">\n<li>nausea</li>\n<li>dizziness or feeling weak</li>\n<li>persistent abdominal cramps</li>\n<li>severe back pain</li>\n<li>abnormally heavy menstrual bleeding</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Decreased fertility:</span> WINREVAIR may affect female and male fertility, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">The most common side effects of WINREVAIR include:</span>\n</p>\n<ul class=\"Disc\">\n<li>headache</li>\n<li>nose bleeds</li>\n<li>rash</li>\n<li>tiny blood vessels that look like pink or red lines on the skin (spider veins)</li>\n<li>diarrhea</li>\n<li>dizziness</li>\n<li>redness</li>\n</ul>\n<p>These are not all the possible side effects of WINREVAIR.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store WINREVAIR?</span>\n</p>\n<ul class=\"Disc\">\n<li>Store WINREVAIR in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</li>\n<li>Store in the original carton to protect from light.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Keep WINREVAIR and all medicines out of the reach of children and pets.</span>\n</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of WINREVAIR</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WINREVAIR for a condition for which it was not prescribed. Do not give WINREVAIR 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 WINREVAIR that is written for healthcare professionals.</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in WINREVAIR?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> sotatercept-csrk<br/>\n<span class=\"Bold\">Inactive ingredient(s):</span> citric acid monohydrate, polysorbate 80, sodium citrate, and sucrose.</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">Manufactured by: Merck Sharp &amp; Dohme LLC, Rahway, NJ 07065, USA.<br/>\n<br/>\n US License Number 0002<br/>\n For patent information: <span class=\"Underline\"><a href=\"http://www.msd.com/research/patent\">www.msd.com/research/patent</a></span>\n<br/> Copyright © 2024 Merck &amp; Co., Inc., Rahway, NJ, USA, and its affiliates.\n <br/>All rights reserved.<br/> usppi-mk7962-i-2403r000<br/>\n For more information, call 1-877-888-4231, or go to <span class=\"Underline\"><a href=\"http://www.WINREVAIR.com\">www.WINREVAIR.com</a></span>.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="center" valign="middle" width="70%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold">Important: Read this booklet first</span> </p> </td><td align="left" valign="top"> <p class="First">Important</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold"> <br/>INSTRUCTIONS FOR USE</span> </p> </td><td align="left" valign="top"> <p class="First"> <br/>Mix</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold"> <br/>WINREVAIR™ </span> (WIN-reh-vair)<br/>(sotatercept-csrk)<br/>for injection, for subcutaneous use <br/>How to use your WINREVAIR injection kit</p> </td><td align="left" valign="top"> <p class="First"> <br/>Withdraw</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-03.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>For package containing 1 vial<br/> <span class="Bold"> <br/>For subcutaneous injection only</span> (inject directly under the skin)</p> </td><td align="left" valign="top"> <p class="First"> <br/>Inject</p> </td> </tr> </tbody> </table></div>

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In this booklet:

{ "type": "p", "children": [], "text": "\nIn this booklet:\n" }

Before you start

{ "type": "p", "children": [], "text": "\nBefore you start\n" }

Important information for patients or caregivers

{ "type": "p", "children": [], "text": "\nImportant information for patients or caregivers\n" }

Get to know the parts of your kit

{ "type": "p", "children": [], "text": "\nGet to know the parts of your kit\n" }

Important information you need to know before injecting WINREVAIR

{ "type": "p", "children": [], "text": "\nImportant information you need to know before injecting WINREVAIR\n" }

Storing your injection kit

{ "type": "p", "children": [], "text": "\nStoring your injection kit\n" }

Get started

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

 Mix powdered medicine into liquid form

{ "type": "p", "children": [], "text": "\n Mix powdered medicine into liquid form\n" }

Withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\nWithdraw your prescribed dose\n" }

 Inject your medicine

{ "type": "p", "children": [], "text": "\n Inject your medicine\n" }

How to throw away WINREVAIR

{ "type": "p", "children": [], "text": "\nHow to throw away WINREVAIR\n" }

Frequently asked questions

{ "type": "p", "children": [], "text": "\nFrequently asked questions\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr> <td align="left" colspan="2"> <p class="First"> <a name="IFU1B"></a><span class="Bold">        Before you start:</span> </p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-07.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Read this booklet</span> <br/>Read this Instructions for Use from start to finish before using WINREVAIR and each time you get a refill. There may be new information.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-08.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Start with your healthcare provider</span> <br/>Do not use WINREVAIR until your healthcare provider has shown you or your caregiver the right way to prepare and inject it. Your healthcare provider should show you how to inject WINREVAIR before you use it for the first time.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-09.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Questions?</span> <br/>If you have questions about how to give WINREVAIR the right way or need more information, call your pharmacy or healthcare provider.<br/>For general product information visit <a href="http://www.WINREVAIR.com">www.WINREVAIR.com</a> or call Merck Sharp &amp; Dohme LLC at 1-800-672-6372.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" colspan=\"2\">\n<p class=\"First\">\n<a name=\"IFU1B\"></a><span class=\"Bold\">        Before you start:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-07.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Read this booklet</span>\n<br/>Read this Instructions for Use from start to finish before using WINREVAIR and each time you get a refill. There may be new information.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-08.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Start with your healthcare provider</span>\n<br/>Do not use WINREVAIR until your healthcare provider has shown you or your caregiver the right way to prepare and inject it. Your healthcare provider should show you how to inject WINREVAIR before you use it for the first time.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-09.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Questions?</span>\n<br/>If you have questions about how to give WINREVAIR the right way or need more information, call your pharmacy or healthcare provider.<br/>For general product information visit <a href=\"http://www.WINREVAIR.com\">www.WINREVAIR.com</a> or call Merck Sharp &amp; Dohme LLC at 1-800-672-6372.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="left" class="Lrule Rrule Toprule"> <p class="First"> <a name="IFU1I"></a><img alt="Figure" src="/dailymed/image.cfm?name=winrevair-10.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> <span class="Bold">Important information for patients or caregivers</span> </p> </td> </tr> </tbody> </table></div>

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Before you prepare and inject WINREVAIR, you must be:

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Before using WINREVAIR, make sure you are trained to do the following correctly:

{ "type": "p", "children": [], "text": "Before using WINREVAIR, make sure you are trained to do the following correctly:" }

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Get to know the parts of your kit

{ "type": "p", "children": [], "text": "\nGet to know the parts of your kit\n" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="middle" width="50%"/> <col align="center" valign="middle" width="50%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"> <p class="First"> <span class="Bold">Top Tray</span> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">Use to <span class="Bold">mix</span> the medicine </p> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="3"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-11.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule" valign="middle"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-12.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">1 Vial</span> of WINREVAIR <span class="Bold">medicine powder</span> </p> </td> </tr> <tr class="Botrule"> <td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-13.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">1 Prefilled syringe</span> with <span class="Bold">sterile water</span> <span class="Bold">for injection</span> to mix medicine powder into liquid form</p> </td> </tr> <tr class="Botrule Last"> <td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-14.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">1 Vial adapter</span> to connect the vial and syringe</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Top Tray</span>\n</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">Use to <span class=\"Bold\">mix</span> the medicine </p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"3\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-11.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-12.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">1 Vial</span> of WINREVAIR <span class=\"Bold\">medicine powder</span>\n</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-13.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">1 Prefilled syringe</span> with <span class=\"Bold\">sterile water</span> <span class=\"Bold\">for injection</span> to mix medicine powder into liquid form</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-14.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">1 Vial adapter</span> to connect the vial and syringe</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="middle" width="50%"/> <col align="center" valign="middle" width="50%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"> <p class="First"> <span class="Bold">Bottom Tray</span> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">Use to <span class="Bold">inject</span> the medicine</p> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-15.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-16.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Needle</span> for injection</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-17.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Empty dosing syringe</span> to measure, withdraw, and inject your medicine</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Bottom Tray</span>\n</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">Use to <span class=\"Bold\">inject</span> the medicine</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-15.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-16.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Needle</span> for injection</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-17.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Empty dosing syringe</span> to measure, withdraw, and inject your medicine</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Important information you need to know before injecting WINREVAIR

{ "type": "p", "children": [], "text": "\nImportant information you need to know before injecting WINREVAIR\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="60%"/> <col align="left" valign="middle" width="40%"/> <tbody class="Headless"> <tr> <td align="left"> <ul class="Disc"> <li>You must mix WINREVAIR before using it. Make sure the medicine powder in the vial is completely dissolved before you inject.</li> <li> <span class="Bold">Check your prescribed dose (amount in ‘mL’) each time you use WINREVAIR. Your prescribed dose may change.</span> Your prescribed dose is on the prescription label on your kit.</li> <li>Use only the supplies that are in the kit to prepare your prescribed dose.</li> <li>Do not open the package or mix the medicine until you are ready to use it.</li> <li> <span class="Bold">Do not reuse any of the supplies.</span> After your injection, throw away the used vials with any remaining WINREVAIR medicine, needle, caps, and syringes in a sharps container. See pages 36-37 for more information.</li> </ul> </td><td align="left" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-18.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<ul class=\"Disc\">\n<li>You must mix WINREVAIR before using it. Make sure the medicine powder in the vial is completely dissolved before you inject.</li>\n<li>\n<span class=\"Bold\">Check your prescribed dose (amount in ‘mL’) each time you use WINREVAIR. Your prescribed dose may change.</span> Your prescribed dose is on the prescription label on your kit.</li>\n<li>Use only the supplies that are in the kit to prepare your prescribed dose.</li>\n<li>Do not open the package or mix the medicine until you are ready to use it.</li>\n<li>\n<span class=\"Bold\">Do not reuse any of the supplies.</span> After your injection, throw away the used vials with any remaining WINREVAIR medicine, needle, caps, and syringes in a sharps container. See pages 36-37 for more information.</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-18.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr> <td align="left" colspan="2"> <p class="First"> <a name="IFU1S"></a>          <span class="Bold">Storing your injection kit</span> </p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-19.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Store WINREVAIR injection kit in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-20.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Store in the original carton to protect from light.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-21.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Keep injection kit out of the reach of children and pets.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" colspan=\"2\">\n<p class=\"First\">\n<a name=\"IFU1S\"></a>          <span class=\"Bold\">Storing your injection kit</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-19.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Store WINREVAIR injection kit in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-20.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Store in the original carton to protect from light.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-21.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Keep injection kit out of the reach of children and pets.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Get started

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

Before you can prepare and inject WINREVAIR, you must first be trained and determined to be capable of independent administration of WINREVAIR by a healthcare provider.

{ "type": "p", "children": [], "text": "Before you can prepare and inject WINREVAIR, you must first be trained and determined to be capable of independent administration of WINREVAIR by a healthcare provider." }

1 Check WINREVAIR injection kit and expiration date

{ "type": "p", "children": [], "text": "\n1 Check WINREVAIR injection kit and expiration date\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="top" width="80%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Rrule" colspan="2">Remove the WINREVAIR injection kit from the refrigerator.</td> </tr> <tr> <td align="center" class="Botrule Lrule" rowspan="2"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-22.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">Check the expiration date and look for any signs of damage</span> on the kit or on the supplies.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> If expired or damaged, do not use.<br/> Call your pharmacy to get a new kit.</p> </td> </tr> <tr class="Last"> <td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">Check that you have the medicine</span> that your healthcare provider prescribed.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">Remove the WINREVAIR injection kit from the refrigerator.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule\" rowspan=\"2\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-22.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">Check the expiration date and look for any signs of damage</span> on the kit or on the supplies.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> If expired or damaged, do not use.<br/> Call your pharmacy to get a new kit.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">Check that you have the medicine</span> that your healthcare provider prescribed.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2 Let your kit come to room temperature, gather supplies, and wash your hands

{ "type": "p", "children": [], "text": "\n2 Let your kit come to room temperature, gather supplies, and wash your hands\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="35%"/> <col align="left" valign="top" width="30%"/> <col align="left" valign="top" width="35%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Wait 15 minutes</span> to allow your kit to warm to room temperature.<br/>Cold medicine is more painful to inject.<br/>     <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-25.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left"> <p class="First">Along with your kit, gather these items and find a clean, flat surface where you will prepare and inject your dose.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>Sharps disposal container</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-27.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>Gauze, cotton ball, or bandage</p> </td><td align="left" class="Lrule Rrule" valign="top"> <p class="First">Wash your hands with soap and water.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-28.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"35%\"/>\n<col align=\"left\" valign=\"top\" width=\"30%\"/>\n<col align=\"left\" valign=\"top\" width=\"35%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Wait 15 minutes</span> to allow your kit to warm to room temperature.<br/>Cold medicine is more painful to inject.<br/>     <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-25.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">Along with your kit, gather these items and find a clean, flat surface where you will prepare and inject your dose.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/>Sharps disposal container</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-27.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/>Gauze, cotton ball, or bandage</p>\n</td><td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Wash your hands with soap and water.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-28.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Mix powdered medicine into liquid form

{ "type": "p", "children": [], "text": "\nMix powdered medicine into liquid form\n" }

Start with the Top Tray

{ "type": "p", "children": [], "text": "Start with the Top Tray\n" }

3 Remove medicine vial, prefilled syringe with sterile water for injection, alcohol wipes, and vial adapter from the kit.

{ "type": "p", "children": [], "text": "\n3 Remove medicine vial, prefilled syringe with sterile water for injection, alcohol wipes, and vial adapter from the kit.\n\n" }

4a Check medicine vial

{ "type": "p", "children": [], "text": "\n4a Check medicine vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-31.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> <p>Check the vial label to <span class="Bold">confirm the medicine is not expired.</span> </p> <p>Inspect the medicine powder.<br/>It should be white to off-white.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if expired, damaged, discolored, or you can see particles in it.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-31.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n<p>Check the vial label to <span class=\"Bold\">confirm the medicine is not expired.</span>\n</p>\n<p>Inspect the medicine powder.<br/>It should be white to off-white.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if expired, damaged, discolored, or you can see particles in it.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

4b Remove plastic cap and clean vial

{ "type": "p", "children": [], "text": "\n4b Remove plastic cap and clean vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-32.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Flip off the plastic cap and <span class="Bold">clean the rubber stopper on top of the vial</span> with an alcohol wipe.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if vial cap is missing.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the cleaned rubber stopper.</p> <p>Set vial aside on a clean, flat surface.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-32.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Flip off the plastic cap and <span class=\"Bold\">clean the rubber stopper on top of the vial</span> with an alcohol wipe.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if vial cap is missing.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the cleaned rubber stopper.</p>\n<p>Set vial aside on a clean, flat surface.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5a Align vial adapter to vial

{ "type": "p", "children": [], "text": "\n5a Align vial adapter to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="60%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-33.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Peel open the vial adapter package and remove vial adapter from its package.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-34.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Hold the blue neck of the vial adapter</span> and align the vial adapter on top of the vial.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the inside of the vial adapter.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-33.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Peel open the vial adapter package and remove vial adapter from its package.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-34.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Hold the blue neck of the vial adapter</span> and align the vial adapter on top of the vial.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the inside of the vial adapter.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5b Attach vial adapter to vial

{ "type": "p", "children": [], "text": "\n5b Attach vial adapter to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Lrule Rrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-35.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Hold the vial with one hand. <span class="Bold">Push down firmly</span> so it snaps in place (you may feel some resistance).</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-35.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Hold the vial with one hand. <span class=\"Bold\">Push down firmly</span> so it snaps in place (you may feel some resistance).</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5c Clean vial adapter

{ "type": "p", "children": [], "text": "\n5c Clean vial adapter\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Lrule Rrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-36.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Clean the top of the vial adapter with an alcohol wipe.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-36.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Clean the top of the vial adapter with an alcohol wipe.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

6 Check prefilled syringe

{ "type": "p", "children": [], "text": "\n6 Check prefilled syringe\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Confirm the sterile water inside the prefilled syringe is clear and the product is not expired or leaking.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-37.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if you see any clumps, particles, discoloration, or product is expired. You might see air bubbles. This is okay.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Confirm the sterile water inside the prefilled syringe is clear and the product is not expired or leaking.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-37.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if you see any clumps, particles, discoloration, or product is expired. You might see air bubbles. This is okay.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

7 Snap off prefilled syringe white cap

{ "type": "p", "children": [], "text": "\n7 Snap off prefilled syringe white cap\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Snap off the prefilled syringe cap along the perforation.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-38.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Snap off the prefilled syringe cap along the perforation.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-38.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

8 Connect prefilled syringe to vial adapter

{ "type": "p", "children": [], "text": "\n8 Connect prefilled syringe to vial adapter\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Rrule"> <p class="First">Pick up the vial with the vial adapter attached.<br/> <span class="Bold">Align the prefilled syringe tip on the blue circle of the vial adapter.</span> </p> <p> <span class="Bold">Push then twist the prefilled syringe onto the vial adapter until you cannot turn further.</span> While twisting, be sure to hold onto the vial adapter.</p> </td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule" valign="top"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-39.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">Pick up the vial with the vial adapter attached.<br/>\n<span class=\"Bold\">Align the prefilled syringe tip on the blue circle of the vial adapter.</span>\n</p>\n<p>\n<span class=\"Bold\">Push then twist the prefilled syringe onto the vial adapter until you cannot turn further.</span> While twisting, be sure to hold onto the vial adapter.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-39.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

9 Transfer sterile water from prefilled syringe to vial

{ "type": "p", "children": [], "text": "\n9 Transfer sterile water from prefilled syringe to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-40.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Italics">Slowly</span> push the plunger all the way down to transfer all the sterile water into the vial (the plunger will move up; this is normal).</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-40.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Italics\">Slowly</span> push the plunger all the way down to transfer all the sterile water into the vial (the plunger will move up; this is normal).</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

10 Swirl to mix medicine

{ "type": "p", "children": [], "text": "\n10 Swirl to mix medicine\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="34%"/> <col align="left" valign="middle" width="33%"/> <col align="left" valign="middle" width="33%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-41.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not shake the vial.​​<br/> <br/>Hold the prefilled syringe and <span class="Bold Italics">gently</span> <span class="Bold">swirl the vial in a circular motion</span> until the powder is fully dissolved. This may take up to <span class="Bold">2 minutes</span>.</p> </td><td align="left"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-42.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>When the medicine is mixed well, it should be clear. If not, repeat this step until it is clear.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-43.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Press the plunger down</span> to make sure all the liquid is in the vial (the plunger will move up; this is normal).</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"34%\"/>\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-41.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not shake the vial.​​<br/>\n<br/>Hold the prefilled syringe and <span class=\"Bold Italics\">gently</span> <span class=\"Bold\">swirl the vial in a circular motion</span> until the powder is fully dissolved. This may take up to <span class=\"Bold\">2 minutes</span>.</p>\n</td><td align=\"left\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-42.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>When the medicine is mixed well, it should be clear. If not, repeat this step until it is clear.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-43.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Press the plunger down</span> to make sure all the liquid is in the vial (the plunger will move up; this is normal).</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

11 Wait for large bubbles in the vial to go away

{ "type": "p", "children": [], "text": "\n11 Wait for large bubbles in the vial to go away\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="60%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-44.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>It is okay to have slight foam around edges of the vial</p> </td><td align="left" class="Rrule" valign="top"> <p class="First"> <span class="Bold">Set vial aside for large bubbles to go away.</span> <br/>This may take up to 3 minutes.</p> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-45.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-44.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>It is okay to have slight foam around edges of the vial</p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Set vial aside for large bubbles to go away.</span>\n<br/>This may take up to 3 minutes.</p>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-45.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></td>\n</tr>\n</tbody>\n</table></div>" }

12 Prepare vial by removing extra air

{ "type": "p", "children": [], "text": "\n12 Prepare vial by removing extra air\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-46.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>With the vial standing upright, <span class="Bold Italics">gently</span> <span class="Bold">pull the plunger upwards</span> to the top of the barrel. Do not to pull the plunger out of the syringe.<br/> <span class="Bold">Note:</span> Pulling extra air out of the vial will help to make sure you have the right dose.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-46.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>With the vial standing upright, <span class=\"Bold Italics\">gently</span> <span class=\"Bold\">pull the plunger upwards</span> to the top of the barrel. Do not to pull the plunger out of the syringe.<br/>\n<span class=\"Bold\">Note:</span> Pulling extra air out of the vial will help to make sure you have the right dose.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

13 Remove prefilled syringe from vial

{ "type": "p", "children": [], "text": "\n13 Remove prefilled syringe from vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="60%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-47.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Hold the vial adapter and unscrew the prefilled syringe from the vial.<br/>Throw away the prefilled syringe in the sharps container.</p> </td><td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-48.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>You should have a vial of medicine prepared and ready to be used in the next steps.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-47.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Hold the vial adapter and unscrew the prefilled syringe from the vial.<br/>Throw away the prefilled syringe in the sharps container.</p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-48.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>You should have a vial of medicine prepared and ready to be used in the next steps.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\nWithdraw your prescribed dose\n" }

For the next steps, you will need:

{ "type": "p", "children": [], "text": "For the next steps, you will need:" }

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

14 Clean top of vial adapter

{ "type": "p", "children": [], "text": "\n14 Clean top of vial adapter\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">With a new alcohol wipe from the bottom tray, clean the top of the vial adapter.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-50.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">With a new alcohol wipe from the bottom tray, clean the top of the vial adapter.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-50.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

15 Remove empty dosing syringe from its package

{ "type": "p", "children": [], "text": "\n15\tRemove empty dosing syringe from its package\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Toprule" valign="top"> <p class="First">Find the empty dosing syringe in the bottom tray and remove it from its package.</p> <p> <br/>You will use this dosing syringe to measure out the medicine you need (based on your prescribed dose).​</p> </td><td align="left" class="Rrule" valign="top"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-51.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Toprule\" valign=\"top\">\n<p class=\"First\">Find the empty dosing syringe in the bottom tray and remove it from its package.</p>\n<p>\n<br/>You will use this dosing syringe to measure out the medicine you need (based on your prescribed dose).​</p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-51.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

16 Pull air into the dosing syringe

{ "type": "p", "children": [], "text": "\n16 Pull air into the dosing syringe\n" }

 You must do this to make sure pressure in the vial is even and you get an accurate dose.

{ "type": "p", "children": [], "text": "\n You must do this to make sure pressure in the vial is even and you get an accurate dose." }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Hold the dosing syringe upright and pull down the plunger to <span class="Bold">draw air into the dosing syringe. Stop when top rim of plunger is at the amount in ‘mL’ that matches your prescribed dose.</span> Your prescribed dose is on the prescription label on your kit.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-52.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Hold the dosing syringe upright and pull down the plunger to <span class=\"Bold\">draw air into the dosing syringe. Stop when top rim of plunger is at the amount in ‘mL’ that matches your prescribed dose.</span> Your prescribed dose is on the prescription label on your kit.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-52.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

17 Connect dosing syringe to the vial

{ "type": "p", "children": [], "text": "\n17 Connect dosing syringe to the vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">While holding the vial adapter, push then twist the dosing syringe onto the vial adapter until it stops.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-53.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">While holding the vial adapter, push then twist the dosing syringe onto the vial adapter until it stops.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-53.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

18 Push air into vial, then flip vial upside down

{ "type": "p", "children": [], "text": "\n18 Push air into vial, then flip vial upside down\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Push the plunger all the way down to transfer all the air into the vial.<br/>Then <span class="Bold">hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-54.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Push the plunger all the way down to transfer all the air into the vial.<br/>Then <span class=\"Bold\">hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-54.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

19 Pull plunger back to withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\n19 Pull plunger back to withdraw your prescribed dose\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">With the vial and dosing syringe upside down, <span class="Bold Italics">slowly</span> <span class="Bold">pull the plunger back</span>.<br/> Stop when you get to the <span class="Bold">amount in ‘mL’ that matches your prescribed dose</span>. <br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-55.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">With the vial and dosing syringe upside down, <span class=\"Bold Italics\">slowly</span> <span class=\"Bold\">pull the plunger back</span>.<br/>\n Stop when you get to the <span class=\"Bold\">amount in ‘mL’ that matches your prescribed dose</span>.\n <br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-55.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

20 Check for large air bubbles and air pockets

{ "type": "p", "children": [], "text": "\n20 Check for large air bubbles and air pockets\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">Check to see if there are large air bubbles or an air pocket in the syringe. You will remove extra air in the next steps.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-56.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">Check to see if there are large air bubbles or an air pocket in the syringe. You will remove extra air in the next steps.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-56.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

21 Remove air bubbles and air pockets from syringe

{ "type": "p", "children": [], "text": "\n21 Remove air bubbles and air pockets from syringe\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">If you see large air bubbles or an air pocket, tap the side of the dosing syringe to move the air to the top.</p> <p> <span class="Bold Italics">​Slowly</span> <span class="Bold">push the plunger up</span> to remove extra air.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-57.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">If you see large air bubbles or an air pocket, tap the side of the dosing syringe to move the air to the top.</p>\n<p>\n<span class=\"Bold Italics\">​Slowly</span> <span class=\"Bold\">push the plunger up</span> to remove extra air.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-57.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

22 Compare amount to prescribed dose

{ "type": "p", "children": [], "text": "\n22 Compare amount to prescribed dose\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="60%"/> <col align="left" valign="middle" width="40%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Toprule" valign="top"> <p class="First">After removing all extra air, <span class="Bold">compare the amount in your syringe to your prescribed dose.</span> <br/> <span class="Bold">If you do not have your prescribed dose in your syringe,</span> <span class="Bold Italics">slowly</span> pull the plunger back again to withdraw more medicine from the vial.<br/>Repeat Steps 19 to 21 until you get <span class="Bold">your prescribed dose</span> and no large bubbles or air pockets remain.</p> </td><td align="left" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-58.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Toprule\" valign=\"top\">\n<p class=\"First\">After removing all extra air, <span class=\"Bold\">compare the amount in your syringe to your prescribed dose.</span>\n<br/>\n<span class=\"Bold\">If you do not have your prescribed dose in your syringe,</span> <span class=\"Bold Italics\">slowly</span> pull the plunger back again to withdraw more medicine from the vial.<br/>Repeat Steps 19 to 21 until you get <span class=\"Bold\">your prescribed dose</span> and no large bubbles or air pockets remain.</p>\n</td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-58.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

23 Confirm your prescribed dose

{ "type": "p", "children": [], "text": "\n23 Confirm your prescribed dose\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Before you continue, check to make sure you have the prescribed dose in the dosing syringe.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-59.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> <span class="Bold">If the amount does not match your prescribed dose, repeat Steps 19 to 22.</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Before you continue, check to make sure you have the prescribed dose in the dosing syringe.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-59.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> <span class=\"Bold\">If the amount does not match your prescribed dose, repeat Steps 19 to 22.</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

24 Remove the dosing syringe from the vial and set dosing syringe aside

{ "type": "p", "children": [], "text": "\n24 Remove the dosing syringe from the vial and set dosing syringe aside\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-60.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Hold the plunger in place with one hand</span>. With the other hand, hold the vial adapter and unscrew the filled dosing syringe from the vial.</p> <p>Throw away the used vial into the sharps container.</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-61.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule"> <p class="First">Place the filled dosing syringe on a clean, flat surface.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the dosing syringe tip or let it to touch any surfaces.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-60.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Hold the plunger in place with one hand</span>. With the other hand, hold the vial adapter and unscrew the filled dosing syringe from the vial.</p>\n<p>Throw away the used vial into the sharps container.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-61.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">Place the filled dosing syringe on a clean, flat surface.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the dosing syringe tip or let it to touch any surfaces.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

25 Attach injection needle

{ "type": "p", "children": [], "text": "\n25 Attach injection needle\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="33%"/> <col align="left" valign="middle" width="34%"/> <col align="left" valign="middle" width="33%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-62.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Find the needle in the bottom tray and open its package.</p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-63.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>With the needle still in the package, <span class="Bold">grip the base of the needle</span> and <span class="Bold">twist on the dosing syringe</span> until it stops. Remove the needle package.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-64.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Move the safety shield away from the needle and toward the syringe. Place the dosing syringe on a clean, flat surface.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not uncap the needle.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<col align=\"left\" valign=\"middle\" width=\"34%\"/>\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-62.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Find the needle in the bottom tray and open its package.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-63.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>With the needle still in the package, <span class=\"Bold\">grip the base of the needle</span> and <span class=\"Bold\">twist on the dosing syringe</span> until it stops. Remove the needle package.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-64.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Move the safety shield away from the needle and toward the syringe. Place the dosing syringe on a clean, flat surface.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not uncap the needle.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

26 Choose and clean your injection site

{ "type": "p", "children": [], "text": "\n26 Choose and clean your injection site\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="30%"/> <col align="left" valign="top" width="70%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-65.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule Toprule"> <p class="First"> <span class="Bold">Select an injection site</span> on your stomach (abdomen) or your upper thigh. If injecting on your stomach, avoid a 2-inch area around your belly button.<br/> <br/>Choose a different site every time you inject. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not inject into skin that is damaged, sore, tender, bruised, or has red patches. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> ​Do not inject through clothes.</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-66.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule"> <p class="First"> <span class="Bold">Clean the injection site</span> with a new alcohol wipe. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the cleaned injection site again.​</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"30%\"/>\n<col align=\"left\" valign=\"top\" width=\"70%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-65.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Select an injection site</span> on your stomach (abdomen) or your upper thigh. If injecting on your stomach, avoid a 2-inch area around your belly button.<br/>\n<br/>Choose a different site every time you inject.\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not inject into skin that is damaged, sore, tender, bruised, or has red patches.\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> ​Do not inject through clothes.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-66.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Clean the injection site</span> with a new alcohol wipe.\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the cleaned injection site again.​</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Now, you are ready to inject the medicine.

{ "type": "p", "children": [], "text": "\nNow, you are ready to inject the medicine.\n" }

Inject your medicine

{ "type": "p", "children": [], "text": "\nInject your medicine\n" }

27 Inject your medicine

{ "type": "p", "children": [], "text": "\n27 Inject your medicine\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-67.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Pull the cap straight off the needle.<br/>Throw away the cap.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the plunger until ready to inject so you do not lose any medicine.<br/> </p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-68.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Gently <span class="Bold">pinch and hold a fold of skin</span> where you will inject. Insert the needle with a <span class="Bold">dartlike motion at a 45° to 90° angle.</span> </p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-69.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Push</span> the plunger with slow, steady pressure all the way down until the dosing syringe is empty. <span class="Bold">Confirm all the medicine has been injected.</span> You can let go of the skin fold now.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-67.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Pull the cap straight off the needle.<br/>Throw away the cap.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the plunger until ready to inject so you do not lose any medicine.<br/>\n</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-68.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Gently <span class=\"Bold\">pinch and hold a fold of skin</span> where you will inject. Insert the needle with a <span class=\"Bold\">dartlike motion at a 45° to 90° angle.</span>\n</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-69.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Push</span> the plunger with slow, steady pressure all the way down until the dosing syringe is empty. <span class=\"Bold\">Confirm all the medicine has been injected.</span> You can let go of the skin fold now.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="3"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Keep your fingers away from the needle at all times.</p> </td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-70.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>While keeping the plunger pushed in, <span class="Bold">remove the needle from your skin</span> at the same angle you inserted it.</p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-71.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>To reapply the safety shield, push the shield against a flat surface until you hear a “click” and see that the needle is covered.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-72.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Throw away the dosing syringe and used items in a sharps disposal container.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not remove the needle from the dosing syringe.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Keep your fingers away from the needle at all times.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-70.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>While keeping the plunger pushed in, <span class=\"Bold\">remove the needle from your skin</span> at the same angle you inserted it.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-71.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>To reapply the safety shield, push the shield against a flat surface until you hear a “click” and see that the needle is covered.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-72.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Throw away the dosing syringe and used items in a sharps disposal container.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not remove the needle from the dosing syringe.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <caption> <span>How to throw away WINREVAIR</span> </caption> <col align="left" valign="middle" width="55%"/> <col align="left" valign="middle" width="45%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"> <ul class="Disc"> <li>Throw away any used vials (including any remaining WINREVAIR liquid), needle, vial and needle caps, and used syringes in an FDA-cleared sharps disposal container.</li> <li>Do not throw away the WINREVAIR vials, syringes, or needle in your household trash.</li> <li> <span class="Bold">Do not reuse any of the supplies</span>. WINREVAIR is for one time use only.</li> <li> <span class="Bold">Important:</span> Always keep the sharps disposal container out of reach of children and pets.</li> </ul> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> <tr> <td align="left" valign="top"> <p class="First">If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p> <ul class="Disc"> <li>made of a heavy-duty plastic,</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out,</li> <li>upright and stable during use,</li> <li>leak resistant, and</li> <li>properly labeled to warn of hazardous waste inside the container.</li> </ul> </td><td align="left"> <p class="First">When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps disposal container. There may be state or local laws about how you should throw away used needles, dosing syringes, and prefilled syringes.</p> <p> <br/>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: <span class="Bold"><a href="http://www.fda.gov/safesharpsdisposal">http://www.fda.gov/safesharpsdisposal</a></span>.<br/> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not recycle your used sharps container.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<caption>\n<span>How to throw away WINREVAIR</span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"55%\"/>\n<col align=\"left\" valign=\"middle\" width=\"45%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>Throw away any used vials (including any remaining WINREVAIR liquid), needle, vial and needle caps, and used syringes in an FDA-cleared sharps disposal container.</li>\n<li>Do not throw away the WINREVAIR vials, syringes, or needle in your household trash.</li>\n<li>\n<span class=\"Bold\">Do not reuse any of the supplies</span>. WINREVAIR is for one time use only.</li>\n<li>\n<span class=\"Bold\">Important:</span> Always keep the sharps disposal container out of reach of children and pets.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\">\n<p class=\"First\">If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p>\n<ul class=\"Disc\">\n<li>made of a heavy-duty plastic,</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out,</li>\n<li>upright and stable during use,</li>\n<li>leak resistant, and</li>\n<li>properly labeled to warn of hazardous waste inside the container.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps disposal container. There may be state or local laws about how you should throw away used needles, dosing syringes, and prefilled syringes.</p>\n<p>\n<br/>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: <span class=\"Bold\"><a href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</a></span>.<br/>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not recycle your used sharps container.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Frequently asked questions

{ "type": "p", "children": [], "text": "\nFrequently asked questions\n" }

What should I do if I am bleeding at the injection site?

{ "type": "p", "children": [], "text": "\nWhat should I do if I am bleeding at the injection site?\n" }

Place a cotton ball or bandage on your skin right away and apply a small amount of pressure. If the bleeding does not stop, call your healthcare provider right away.

{ "type": "p", "children": [], "text": "Place a cotton ball or bandage on your skin right away and apply a small amount of pressure. If the bleeding does not stop, call your healthcare provider right away." }

Where can I find my prescribed dose?

{ "type": "p", "children": [], "text": "\nWhere can I find my prescribed dose?\n" }

Your prescribed dose in ‘mL’ is on your prescription label on your kit. Contact your healthcare provider if you cannot find your prescribed dose.

{ "type": "p", "children": [], "text": "Your prescribed dose in ‘mL’ is on your prescription label on your kit. Contact your healthcare provider if you cannot find your prescribed dose." }

What should I do if I accidentally get some medicine on my skin or my work surface?

{ "type": "p", "children": [], "text": "\nWhat should I do if I accidentally get some medicine on my skin or my work surface?\n" }

Wash the area thoroughly with soap and water right away.

{ "type": "p", "children": [], "text": "Wash the area thoroughly with soap and water right away." }

What should I do if I am not sure I administered my prescribed dose correctly?

{ "type": "p", "children": [], "text": "\nWhat should I do if I am not sure I administered my prescribed dose correctly?\n" }

Call your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "Call your pharmacy or healthcare provider." }

What should I do if the plunger of my dosing syringe moves automatically when I try to withdraw medicine from the vial?

{ "type": "p", "children": [], "text": "\nWhat should I do if the plunger of my dosing syringe moves automatically when I try to withdraw medicine from the vial?\n" }

Do not worry if your plunger moves slightly on its own when you are filling your dosing syringe with medicine.

{ "type": "p", "children": [], "text": "Do not worry if your plunger moves slightly on its own when you are filling your dosing syringe with medicine." }

With one hand, hold the plunger in place to stop the plunger from moving. With the other hand, unscrew the vial from the dosing syringe.

{ "type": "p", "children": [], "text": "With one hand, hold the plunger in place to stop the plunger from moving. With the other hand, unscrew the vial from the dosing syringe." }

After unscrewed, it is safe to let go of the plunger.

{ "type": "p", "children": [], "text": "After unscrewed, it is safe to let go of the plunger." }

You can avoid this automatic plunger movement by pushing air into the vial before filling your dosing syringe with medicine. Refer to Steps 16 to 23 for detailed instructions.

{ "type": "p", "children": [], "text": "You can avoid this automatic plunger movement by pushing air into the vial before filling your dosing syringe with medicine. Refer to Steps 16 to 23 for detailed instructions." }

What should I do if my kit parts are damaged or are discolored, cloudy, or have particles?

{ "type": "p", "children": [], "text": "\nWhat should I do if my kit parts are damaged or are discolored, cloudy, or have particles?\n" }

Do not use your kit. Call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use your kit. Call your pharmacy to get a new kit." }

What should I do if my medicine does not turn clear after mixing and swirling?

{ "type": "p", "children": [], "text": "\nWhat should I do if my medicine does not turn clear after mixing and swirling?\n" }

Do not use the medicine if you have swirled the medicine vial for about 2 minutes and let it stand for another 3 minutes but your medicine vial remains cloudy or has clumps, powder, or foreign particles. Call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use the medicine if you have swirled the medicine vial for about 2 minutes and let it stand for another 3 minutes but your medicine vial remains cloudy or has clumps, powder, or foreign particles. Call your pharmacy to get a new kit." }

What should I do if the sterile water will not come out of the prefilled syringe?

{ "type": "p", "children": [], "text": "\nWhat should I do if the sterile water will not come out of the prefilled syringe?\n" }

Check that the vial adapter is attached to the vial securely. If not, hold the vial and press the vial adapter down firmly to make sure the vial adapter punctures the vial rubber stopper.

{ "type": "p", "children": [], "text": "Check that the vial adapter is attached to the vial securely. If not, hold the vial and press the vial adapter down firmly to make sure the vial adapter punctures the vial rubber stopper." }

What should I do if I dropped my kit components?

{ "type": "p", "children": [], "text": "\nWhat should I do if I dropped my kit components?\n" }

Do not use if any items are damaged. If you are unsure, call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use if any items are damaged. If you are unsure, call your pharmacy to get a new kit." }

Can I use my kit that has been left out of the refrigerator?

{ "type": "p", "children": [], "text": "\nCan I use my kit that has been left out of the refrigerator?\n" }

Store the injection kit in the refrigerator until ready to use it. If the unused injection kit has been out of the refrigerator up to 77°F (25°C) for more than 24 hours, please contact your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "Store the injection kit in the refrigerator until ready to use it. If the unused injection kit has been out of the refrigerator up to 77°F (25°C) for more than 24 hours, please contact your pharmacy or healthcare provider." }

Do I need to use mixed medicine right away?

{ "type": "p", "children": [], "text": "\nDo I need to use mixed medicine right away?\n" }

We recommend you inject the medicine right away after mixing but no later than 4 hours after mixing. If it has been more than 4 hours, throw away unused mixed medicine. If you have questions, please contact your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "We recommend you inject the medicine right away after mixing but no later than 4 hours after mixing. If it has been more than 4 hours, throw away unused mixed medicine. If you have questions, please contact your pharmacy or healthcare provider." }

How can I get help preparing and giving my injection?

{ "type": "p", "children": [], "text": "\nHow can I get help preparing and giving my injection?\n" }

If you have questions about how to give WINREVAIR the correct way or need more information, you can call your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "If you have questions about how to give WINREVAIR the correct way or need more information, you can call your pharmacy or healthcare provider." }

Call your doctor for advice about side effects.

{ "type": "p", "children": [], "text": "Call your doctor for advice about side effects." }

To report side effects or product quality complaints, please call Merck Sharp & Dohme LLC at 1-800-672-6372. You can also report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "To report side effects or product quality complaints, please call Merck Sharp & Dohme LLC at 1-800-672-6372. You can also report side effects to FDA at 1-800-FDA-1088." }

Manufactured by: Merck Sharp & Dohme LLCRahway, NJ 07065, USAU.S. License Number 0002

{ "type": "p", "children": [], "text": "Manufactured by: Merck Sharp & Dohme LLCRahway, NJ 07065, USAU.S. License Number 0002" }

Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.All rights reserved." }

usifu1-mk7962-i-2403r000

{ "type": "p", "children": [], "text": "usifu1-mk7962-i-2403r000" }

This Instructions for Use has been approved by the U.S. Food and Drug AdministrationApproved: March 2024

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug AdministrationApproved: March 2024" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="center" valign="middle" width="70%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold">Important: Read this booklet first</span> </p> </td><td align="left" valign="top"> <p class="First">Important</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold"> <br/>INSTRUCTIONS FOR USE</span> </p> </td><td align="left" valign="top"> <p class="First"> <br/>Mix</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold"> <br/>WINREVAIR™</span> (WIN-reh-vair)<br/>(sotatercept-csrk)<br/>for injection, for subcutaneous use <br/>How to use your WINREVAIR injection kit</p> </td><td align="left" valign="top"> <p class="First"> <br/>Combine</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-73.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>     For package containing 2 vials</p> </td><td align="left" valign="top"> <p class="First">Withdraw</p> </td> </tr> <tr> <td align="center" valign="top"> <p class="First"> <span class="Bold"> <br/>For subcutaneous injection only</span> (inject directly under the skin)</p> </td><td align="left" valign="top"> <p class="First"> <br/>Inject</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"70%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important: Read this booklet first</span>\n</p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">Important</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">\n<br/>INSTRUCTIONS FOR USE</span>\n</p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<br/>Mix</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">\n<br/>WINREVAIR™</span> (WIN-reh-vair)<br/>(sotatercept-csrk)<br/>for injection, for subcutaneous use\n <br/>How to use your WINREVAIR injection kit</p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<br/>Combine</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-73.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/>     For package containing 2 vials</p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">Withdraw</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">\n<br/>For subcutaneous injection only</span> (inject directly under the skin)</p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<br/>Inject</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

In this booklet:

{ "type": "p", "children": [], "text": "\nIn this booklet:\n" }

Important information for patients or caregivers

{ "type": "p", "children": [], "text": "\nImportant information for patients or caregivers\n" }

Before you start

{ "type": "p", "children": [], "text": "\nBefore you start\n" }

Get to know the parts of your kit

{ "type": "p", "children": [], "text": "\nGet to know the parts of your kit\n" }

Important information you need to know before injecting WINREVAIR

{ "type": "p", "children": [], "text": "\nImportant information you need to know before injecting WINREVAIR\n" }

Storing your injection kit

{ "type": "p", "children": [], "text": "\nStoring your injection kit\n" }

Get started

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

 Mix powdered medicine into liquid form

{ "type": "p", "children": [], "text": "\n Mix powdered medicine into liquid form\n" }

 Combine medicine from both vials

{ "type": "p", "children": [], "text": "\n Combine medicine from both vials\n" }

Withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\nWithdraw your prescribed dose\n" }

 Inject your medicine

{ "type": "p", "children": [], "text": "\n Inject your medicine\n" }

How to throw away WINREVAIR

{ "type": "p", "children": [], "text": "\nHow to throw away WINREVAIR\n" }

Frequently asked questions

{ "type": "p", "children": [], "text": "\nFrequently asked questions\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="left" class="Lrule Rrule Toprule"> <p class="First"> <a name="IFU2IH"></a><img alt="Figure" src="/dailymed/image.cfm?name=winrevair-10.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">Important information for patients or caregivers</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">\n<a name=\"IFU2IH\"></a><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-10.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">Important information for patients or caregivers</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Before you prepare and inject WINREVAIR, you must be:

{ "type": "p", "children": [], "text": "Before you prepare and inject WINREVAIR, you must be:" }

{ "type": "ul", "children": [ "trained by a healthcare provider following this Instructions for Use booklet step-by-step, and", "capable of independent administration of WINREVAIR as determined by a healthcare provider" ], "text": "" }

Before using WINREVAIR, make sure you are trained to do the following correctly:

{ "type": "p", "children": [], "text": "Before using WINREVAIR, make sure you are trained to do the following correctly:" }

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

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr> <td align="left" colspan="2"> <p class="First"> <a name="IFU2B"></a><span class="Bold">        Before you start:</span> </p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-07.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Read this booklet</span> <br/>Read this Instructions for Use from start to finish before using WINREVAIR and each time you get a refill. There may be new information.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-08.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Start with your healthcare provider</span> <br/>Do not use WINREVAIR until your healthcare provider has shown you or your caregiver the right way to prepare and inject it. Your healthcare provider should show you how to inject WINREVAIR before you use it for the first time.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-09.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="top"> <p class="First"> <span class="Bold">Questions?</span> <br/>If you have questions about how to give WINREVAIR the right way or need more information, call your pharmacy or healthcare provider.<br/>For general product information visit <a href="http://www.WINREVAIR.com">www.WINREVAIR.com</a> or call Merck Sharp &amp; Dohme LLC at 1-800-672-6372.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" colspan=\"2\">\n<p class=\"First\">\n<a name=\"IFU2B\"></a><span class=\"Bold\">        Before you start:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-07.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Read this booklet</span>\n<br/>Read this Instructions for Use from start to finish before using WINREVAIR and each time you get a refill. There may be new information.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-08.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Start with your healthcare provider</span>\n<br/>Do not use WINREVAIR until your healthcare provider has shown you or your caregiver the right way to prepare and inject it. Your healthcare provider should show you how to inject WINREVAIR before you use it for the first time.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-09.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Questions?</span>\n<br/>If you have questions about how to give WINREVAIR the right way or need more information, call your pharmacy or healthcare provider.<br/>For general product information visit <a href=\"http://www.WINREVAIR.com\">www.WINREVAIR.com</a> or call Merck Sharp &amp; Dohme LLC at 1-800-672-6372.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

How to use WINREVAIR

{ "type": "p", "children": [], "text": "\nHow to use WINREVAIR\n" }

Before injecting WINREVAIR, make sure you read the full instructions in this booklet to get your prescribed dose.

{ "type": "p", "children": [], "text": "Before injecting WINREVAIR, make sure you read the full instructions in this booklet to get your prescribed dose." }

 Mix medicine in vial 1

{ "type": "p", "children": [], "text": "\n Mix medicine in vial 1" }

 Mix medicine in vial 2

{ "type": "p", "children": [], "text": "\n Mix medicine in vial 2" }

 Combine medicine mixture from vial 1 to vial 2

{ "type": "p", "children": [], "text": "\n Combine medicine mixture from vial 1 to vial 2" }

Withdraw your prescribed dose from vial 2

{ "type": "p", "children": [], "text": "\nWithdraw your prescribed dose from vial 2" }

 Then, inject your medicine

{ "type": "p", "children": [], "text": "\n Then, inject your medicine" }

Proceed to the next pages for step-by-step directions.

{ "type": "p", "children": [], "text": "Proceed to the next pages for step-by-step directions." }

Get to know the parts of your kit

{ "type": "p", "children": [], "text": "\nGet to know the parts of your kit\n" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="middle" width="60%"/> <col align="center" valign="middle" width="40%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"> <p class="First"> <span class="Bold">Top Tray</span> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">Use to <span class="Bold">mix</span> the medicine</p> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="3"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-75.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-76.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">2 Vials</span> of WINREVAIR <span class="Bold">medicine powder</span> </p> </td> </tr> <tr class="Botrule"> <td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-77.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">2 Prefilled syringes</span> with <span class="Bold">sterile water for injection</span> to mix medicine powder into liquid form</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-78.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">2 Vial adapters</span> to connect the vial and syringe</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"60%\"/>\n<col align=\"center\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Top Tray</span>\n</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">Use to <span class=\"Bold\">mix</span> the medicine</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"3\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-75.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-76.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">2 Vials</span> of WINREVAIR <span class=\"Bold\">medicine powder</span>\n</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-77.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">2 Prefilled syringes</span> with <span class=\"Bold\">sterile water for injection</span> to mix medicine powder into liquid form</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-78.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">2 Vial adapters</span> to connect the vial and syringe</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="center" valign="middle" width="60%"/> <col align="center" valign="middle" width="40%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"> <p class="First"> <span class="Bold">Bottom Tray</span> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">Use to <span class="Bold">inject</span> the medicine</p> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-79.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-80.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Needle</span> for injection</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-81.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Empty dosing syringe</span> to measure, withdraw, and inject your medicine</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"center\" valign=\"middle\" width=\"60%\"/>\n<col align=\"center\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Bottom Tray</span>\n</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">Use to <span class=\"Bold\">inject</span> the medicine</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-79.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-80.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Needle</span> for injection</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-81.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Empty dosing syringe</span> to measure, withdraw, and inject your medicine</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Important information you need to know before injecting WINREVAIR

{ "type": "p", "children": [], "text": "\nImportant information you need to know before injecting WINREVAIR\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="60%"/> <col align="left" valign="middle" width="40%"/> <tbody class="Headless"> <tr> <td align="left"> <ul class="Disc"> <li>You must mix WINREVAIR before using it. Make sure the medicine powder in the vial is completely dissolved before you inject.</li> <li> <span class="Bold">Check your prescribed dose (amount in ‘mL’) each time you use WINREVAIR. Your prescribed dose may change.</span> Your prescribed dose is on the prescription label on your kit.</li> <li>Use only the supplies that are in the kit to prepare your prescribed dose.</li> <li>Do not open the package or mix the medicine until you are ready to use it.</li> <li> <span class="Bold">Do not reuse any of the supplies.</span> After your injection, throw away the used vials with any remaining WINREVAIR medicine, needle, caps, and syringes in a sharps container. See pages 38-39 for more information.</li> </ul> </td><td align="left" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-82.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<ul class=\"Disc\">\n<li>You must mix WINREVAIR before using it. Make sure the medicine powder in the vial is completely dissolved before you inject.</li>\n<li>\n<span class=\"Bold\">Check your prescribed dose (amount in ‘mL’) each time you use WINREVAIR. Your prescribed dose may change.</span> Your prescribed dose is on the prescription label on your kit.</li>\n<li>Use only the supplies that are in the kit to prepare your prescribed dose.</li>\n<li>Do not open the package or mix the medicine until you are ready to use it.</li>\n<li>\n<span class=\"Bold\">Do not reuse any of the supplies.</span> After your injection, throw away the used vials with any remaining WINREVAIR medicine, needle, caps, and syringes in a sharps container. See pages 38-39 for more information.</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-82.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr> <td align="left" colspan="2"> <p class="First"> <a name="IFU2S"></a>          <span class="Bold">Storing your injection kit</span> </p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-19.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Store WINREVAIR injection kit in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-20.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Store in the original carton to protect from light.</p> </td> </tr> <tr> <td align="center"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-21.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" valign="middle"> <p class="First">Keep injection kit out of the reach of children and pets.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" colspan=\"2\">\n<p class=\"First\">\n<a name=\"IFU2S\"></a>          <span class=\"Bold\">Storing your injection kit</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-19.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Store WINREVAIR injection kit in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-20.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Store in the original carton to protect from light.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-21.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" valign=\"middle\">\n<p class=\"First\">Keep injection kit out of the reach of children and pets.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Get started

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

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left">Before you can prepare and inject WINREVAIR, you must first be trained and determined to be capable of independent administration of WINREVAIR by a healthcare provider.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">Before you can prepare and inject WINREVAIR, you must first be trained and determined to be capable of independent administration of WINREVAIR by a healthcare provider.</td>\n</tr>\n</tbody>\n</table></div>" }

1 Check WINREVAIR injection kit and expiration date

{ "type": "p", "children": [], "text": "\n1 Check WINREVAIR injection kit and expiration date\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="30%"/> <col align="left" valign="top" width="70%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Rrule" colspan="2">Remove the WINREVAIR injection kit from the refrigerator.</td> </tr> <tr> <td align="left" class="Botrule Lrule" rowspan="2"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-83.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">Check the expiration date and look for any signs of damage</span> on the kit or on the supplies.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> If expired or damaged, do not use. <br/>Call your pharmacy to get a new kit.</p> </td> </tr> <tr class="Last"> <td align="left" class="Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><span class="Bold">Check that you have the medicine</span> that your healthcare provider prescribed.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"top\" width=\"70%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">Remove the WINREVAIR injection kit from the refrigerator.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\" rowspan=\"2\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-83.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">Check the expiration date and look for any signs of damage</span> on the kit or on the supplies.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> If expired or damaged, do not use. <br/>Call your pharmacy to get a new kit.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-23.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><span class=\"Bold\">Check that you have the medicine</span> that your healthcare provider prescribed.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2 Let your kit come to room temperature, gather supplies, and wash your hands

{ "type": "p", "children": [], "text": "\n2 Let your kit come to room temperature, gather supplies, and wash your hands\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="35%"/> <col align="left" valign="top" width="30%"/> <col align="left" valign="top" width="35%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Wait 15 minutes</span> to allow your kit to warm to room temperature. <br/>Cold medicine is more painful to inject. <br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-25.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left"> <p class="First">Along with your kit, gather these items and find a clean, flat surface where you will prepare and inject your dose.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>Sharps disposal container</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-27.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/>Gauze, cotton ball, or bandage</p> </td><td align="left" class="Lrule Rrule" valign="top"> <p class="First">Wash your hands with soap and water.<br/> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-28.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"35%\"/>\n<col align=\"left\" valign=\"top\" width=\"30%\"/>\n<col align=\"left\" valign=\"top\" width=\"35%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Wait 15 minutes</span> to allow your kit to warm to room temperature. <br/>Cold medicine is more painful to inject.\n <br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-25.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">Along with your kit, gather these items and find a clean, flat surface where you will prepare and inject your dose.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/>Sharps disposal container</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-27.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/>Gauze, cotton ball, or bandage</p>\n</td><td align=\"left\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Wash your hands with soap and water.<br/>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-28.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Mix powdered medicine into liquid form

{ "type": "p", "children": [], "text": "\nMix powdered medicine into liquid form\n" }

Start with the Top Tray

{ "type": "p", "children": [], "text": "Start with the Top Tray\n" }

3 Remove medicine vial 1, prefilled syringe with sterile water for injection 1, alcohol wipes, and vial adapter 1 from the kit.

{ "type": "p", "children": [], "text": "\n3 Remove medicine vial 1, prefilled syringe with sterile water for injection 1, alcohol wipes, and vial adapter 1 from the kit.\n\n\n" }

4a Check medicine vial

{ "type": "p", "children": [], "text": "\n4a Check medicine vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-86.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> <p>Check the vial label to <span class="Bold">confirm the medicine is not expired.</span> </p> <p>Inspect the medicine powder.<br/>It should be white to off-white.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if expired, damaged, discolored, or you can see particles in it.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-86.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n<p>Check the vial label to <span class=\"Bold\">confirm the medicine is not expired.</span>\n</p>\n<p>Inspect the medicine powder.<br/>It should be white to off-white.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if expired, damaged, discolored, or you can see particles in it.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

4b Remove plastic cap and clean vial

{ "type": "p", "children": [], "text": "\n4b Remove plastic cap and clean vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-87.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Flip off the plastic cap and <span class="Bold">clean the rubber stopper on top of the vial</span> with an alcohol wipe.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if vial cap is missing.</p> <p> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the cleaned rubber stopper.</p> <p>Set vial aside on a clean, flat surface.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-87.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Flip off the plastic cap and <span class=\"Bold\">clean the rubber stopper on top of the vial</span> with an alcohol wipe.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if vial cap is missing.</p>\n<p>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the cleaned rubber stopper.</p>\n<p>Set vial aside on a clean, flat surface.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5a Align vial adapter to vial

{ "type": "p", "children": [], "text": "\n5a Align vial adapter to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="60%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-88.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Peel open the vial adapter package and remove vial adapter from its package.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-89.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Hold the blue neck of the vial adapter</span> and align the vial adapter on top of the vial.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the inside of the vial adapter.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-88.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Peel open the vial adapter package and remove vial adapter from its package.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-89.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Hold the blue neck of the vial adapter</span> and align the vial adapter on top of the vial.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the inside of the vial adapter.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5b Attach vial adapter to vial

{ "type": "p", "children": [], "text": "\n5b Attach vial adapter to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-90.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Hold the vial with one hand. <span class="Bold">Push down firmly</span> so it snaps in place (you may feel some resistance).</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-90.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Hold the vial with one hand. <span class=\"Bold\">Push down firmly</span> so it snaps in place (you may feel some resistance).</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

5c Clean vial adapter

{ "type": "p", "children": [], "text": "\n5c Clean vial adapter\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-91.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Clean the top of the vial adapter with an alcohol wipe.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-91.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Clean the top of the vial adapter with an alcohol wipe.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

6 Check prefilled syringe

{ "type": "p", "children": [], "text": "\n6 Check prefilled syringe\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Confirm the sterile water inside the prefilled syringe is clear and the product is not expired or leaking.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-92.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not use if you see any clumps, particles, discoloration, or product is expired. You might see air bubbles. This is okay.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Confirm the sterile water inside the prefilled syringe is clear and the product is not expired or leaking.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-92.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not use if you see any clumps, particles, discoloration, or product is expired. You might see air bubbles. This is okay.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

7 Snap off prefilled syringe white cap

{ "type": "p", "children": [], "text": "\n7 Snap off prefilled syringe white cap\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Snap off the prefilled syringe cap along the perforation.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-93.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Snap off the prefilled syringe cap along the perforation.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-93.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

8 Connect prefilled syringe to vial adapter

{ "type": "p", "children": [], "text": "\n8 Connect prefilled syringe to vial adapter\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Lrule Rrule"> <p class="First">Pick up the vial with the vial adapter attached.<br/> <span class="Bold">Align the prefilled syringe tip on the blue circle of the vial adapter.</span> <br/> <span class="Bold">Push then twist the prefilled syringe onto the vial adapter until you cannot turn further.</span> While twisting, be sure to hold onto the vial adapter.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-94.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">Pick up the vial with the vial adapter attached.<br/>\n<span class=\"Bold\">Align the prefilled syringe tip on the blue circle of the vial adapter.</span>\n<br/>\n<span class=\"Bold\">Push then twist the prefilled syringe onto the vial adapter until you cannot turn further.</span> While twisting, be sure to hold onto the vial adapter.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-94.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

9 Transfer sterile water from prefilled syringe to vial

{ "type": "p", "children": [], "text": "\n9 Transfer sterile water from prefilled syringe to vial\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="50%"/> <col align="left" valign="middle" width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-95.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-96.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule"><span class="Italics">Slowly</span> push the plunger all the way down to transfer all the sterile<br/> water into the vial (the plunger will move up; this is normal).</td><td align="left" class="Rrule">Leave the prefilled syringe attached to the vial and set aside on a flat surface.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-95.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-96.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule\"><span class=\"Italics\">Slowly</span> push the plunger all the way down to transfer all the sterile<br/> water into the vial (the plunger will move up; this is normal).</td><td align=\"left\" class=\"Rrule\">Leave the prefilled syringe attached to the vial and set aside on a flat surface.</td>\n</tr>\n</tbody>\n</table></div>" }

10 Prepare vial 2, prefilled syringe 2, and vial adapter 2

{ "type": "p", "children": [], "text": "\n10 Prepare vial 2, prefilled syringe 2, and vial adapter 2\n" }

<div class="scrollingtable"><table class="Noautorules" width="40%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <tbody class="Headless"> <tr> <td align="left" rowspan="2"><img alt="Figure" src="/dailymed/image.cfm?name=winrevair-98.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></td><td align="left"><span class="Bold">Stop and check to make sure you have both vial 1 and vial 2 prepared.</span></td> </tr> <tr> <td align="left">You need both vials prepared before you can continue to Step 11.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"40%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" rowspan=\"2\"><img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-98.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></td><td align=\"left\"><span class=\"Bold\">Stop and check to make sure you have both vial 1 and vial 2 prepared.</span></td>\n</tr>\n<tr>\n<td align=\"left\">You need both vials prepared before you can continue to Step 11.</td>\n</tr>\n</tbody>\n</table></div>" }

11 Swirl to mix medicine

{ "type": "p", "children": [], "text": "\n11 Swirl to mix medicine\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="34%"/> <col align="left" valign="top" width="33%"/> <col align="left" valign="top" width="33%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-99.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not shake the vials.<br/> <br/>Hold 1 prefilled syringe in each hand and <span class="Bold Italics">gently</span> <span class="Bold">swirl both vials in a circular motion</span> until the powder is fully dissolved. This may take up to <span class="Bold">2 minutes.</span> </p> </td><td align="left"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-100.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>When the medicine is mixed well, it should be clear. If not, repeat this step until it is clear.</p> </td><td align="left" class="Lrule Rrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-101.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>For each vial, <span class="Bold">press the plunger down</span> to make sure all the liquid is in the vial (the plunger will move up; this is normal).</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"34%\"/>\n<col align=\"left\" valign=\"top\" width=\"33%\"/>\n<col align=\"left\" valign=\"top\" width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-99.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not shake the vials.<br/>\n<br/>Hold 1 prefilled syringe in each hand and <span class=\"Bold Italics\">gently</span> <span class=\"Bold\">swirl both vials in a circular motion</span> until the powder is fully dissolved. This may take up to <span class=\"Bold\">2 minutes.</span>\n</p>\n</td><td align=\"left\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-100.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>When the medicine is mixed well, it should be clear. If not, repeat this step until it is clear.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-101.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>For each vial, <span class=\"Bold\">press the plunger down</span> to make sure all the liquid is in the vial (the plunger will move up; this is normal).</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

12 Wait for large bubbles in the vials to go away

{ "type": "p", "children": [], "text": "\n12 Wait for large bubbles in the vials to go away\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="60%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Lrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-102.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>It is okay to have slight foam around edges of the vials</p> </td><td align="left" class="Rrule" valign="top"> <p class="First"> <span class="Bold">Set both vials aside for large bubbles to go away.</span> <br/>This may take up to 3 minutes.</p> <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-103.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Lrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-102.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>It is okay to have slight foam around edges of the vials</p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Set both vials aside for large bubbles to go away.</span>\n<br/>This may take up to 3 minutes.</p>\n<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-103.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></td>\n</tr>\n</tbody>\n</table></div>" }

13 Prepare vials by removing extra air

{ "type": "p", "children": [], "text": "\n13 Prepare vials by removing extra air\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="60%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Lrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-104.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule" valign="top"> <p class="First">Start with either vial. With the vial standing upright, <span class="Bold Italics">gently</span> <span class="Bold">pull the plunger upwards</span> to the top of the barrel. Do not pull the plunger out of the syringe.</p> <p> <span class="Bold">Note:</span> Pulling extra air out of the vials will help to make sure you have the right dose.</p> </td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-105.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"40%\"/>\n<col align=\"left\" valign=\"top\" width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-104.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">Start with either vial. With the vial standing upright, <span class=\"Bold Italics\">gently</span> <span class=\"Bold\">pull the plunger upwards</span> to the top of the barrel. Do not pull the plunger out of the syringe.</p>\n<p>\n<span class=\"Bold\">Note:</span> Pulling extra air out of the vials will help to make sure you have the right dose.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-105.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

14 Remove prefilled syringes from vials

{ "type": "p", "children": [], "text": "\n14 Remove prefilled syringes from vials\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="50%"/> <col align="left" valign="middle" width="50%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Toprule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-106.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Hold the vial adapters and unscrew <span class="Bold">both</span> prefilled syringes from the vials.<br/> Throw away <span class="Bold">both</span> prefilled syringes in the sharps container.<br/> </p> </td><td align="left" class="Rrule"> <p class="First">        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-107.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>​You should have 2 vials of medicine prepared and ready to be combined in the next steps.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Toprule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-106.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Hold the vial adapters and unscrew <span class=\"Bold\">both</span> prefilled syringes from the vials.<br/> Throw away <span class=\"Bold\">both</span> prefilled syringes in the sharps container.<br/>\n</p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-107.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>​You should have 2 vials of medicine prepared and ready to be combined in the next steps.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Combine medicine from both vials

{ "type": "p", "children": [], "text": "\nCombine medicine from both vials\n" }

For the next steps, you will need:

{ "type": "p", "children": [], "text": "For the next steps, you will need:" }

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

15 Clean top of both vial adapters

{ "type": "p", "children": [], "text": "\n15 Clean top of both vial adapters\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">With 2 alcohol wipes from the bottom tray, clean the top of the vial adapters. Use a new wipe for each vial adapter.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-109.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">With 2 alcohol wipes from the bottom tray, clean the top of the vial adapters. Use a new wipe for each vial adapter.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-109.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

16 Remove empty dosing syringe from its package

{ "type": "p", "children": [], "text": "\n16 Remove empty dosing syringe from its package\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Toprule" valign="top"> <p class="First">Find the empty dosing syringe in the bottom tray and remove it from its package.</p> <p> <br/>You will use this dosing syringe to combine medicine from both vials and measure out the medicine you need (based on your prescribed dose).​ </p> </td><td align="left" class="Rrule" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-110.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Toprule\" valign=\"top\">\n<p class=\"First\">Find the empty dosing syringe in the bottom tray and remove it from its package.</p>\n<p>\n<br/>You will use this dosing syringe to combine medicine from both vials and measure out the medicine you need (based on your prescribed dose).​ </p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-110.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

17 Pull air into the dosing syringe

{ "type": "p", "children": [], "text": "\n17 Pull air into the dosing syringe\n" }

 You must do this to make sure pressure in the vial is even and you get an accurate dose.

{ "type": "p", "children": [], "text": "\n You must do this to make sure pressure in the vial is even and you get an accurate dose." }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Hold the dosing syringe upright and pull down the plunger to <span class="Bold">draw in 1.5 mL of air.</span> <br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-111.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Hold the dosing syringe upright and pull down the plunger to <span class=\"Bold\">draw in 1.5 mL of air.</span>\n<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-111.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

18 Connect dosing syringe to one of the vials

{ "type": "p", "children": [], "text": "\n18 Connect dosing syringe to one of the vials\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">While holding the vial adapter, push then twist the dosing syringe onto the vial adapter until it stops.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-112.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">While holding the vial adapter, push then twist the dosing syringe onto the vial adapter until it stops.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-112.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

19 Push air into vial, then flip upside down

{ "type": "p", "children": [], "text": "\n19 Push air into vial, then flip upside down\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Push the plunger all the way down to transfer all the air into the vial.<br/>Then <span class="Bold">hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>         <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-113.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Push the plunger all the way down to transfer all the air into the vial.<br/>Then <span class=\"Bold\">hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>\n         <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-113.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

20 Withdraw all the medicine from 1st vial

{ "type": "p", "children": [], "text": "\n20 Withdraw all the medicine from 1st vial\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">With the vial and dosing syringe upside down, slowly pull the plunger back. <span class="Bold">Stop at 1.5 mL</span>.<br/>This will make sure all the medicine from the vial is in the dosing syringe.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-114.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">With the vial and dosing syringe upside down, slowly pull the plunger back. <span class=\"Bold\">Stop at 1.5 mL</span>.<br/>This will make sure all the medicine from the vial is in the dosing syringe.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-114.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

21 Remove 1st vial from the dosing syringe

{ "type": "p", "children": [], "text": "\n21 Remove 1st vial from the dosing syringe\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Hold the vial adapter and unscrew the filled dosing syringe from the vial.<br/>Throw away the <span class="Bold">empty</span> vial into the sharps container.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-115.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Hold the vial adapter and unscrew the filled dosing syringe from the vial.<br/>Throw away the <span class=\"Bold\">empty</span> vial into the sharps container.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-115.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

22 Connect the dosing syringe to the 2nd vial

{ "type": "p", "children": [], "text": "\n22 Connect the dosing syringe to the 2nd vial\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">While holding the vial adapter of the 2<span class="Sup">nd</span> vial, push then twist the partially filled dosing syringe onto the vial adapter until it stops.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-116.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">While holding the vial adapter of the 2<span class=\"Sup\">nd</span> vial, push then twist the partially filled dosing syringe onto the vial adapter until it stops.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-116.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

23 Push all the medicine into the 2nd vial, then flip vial upside down

{ "type": "p", "children": [], "text": "\n23 Push all the medicine into the 2nd vial, then flip vial upside down\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Italics">Slowly</span> push the plunger all the way down to transfer <span class="Bold">all of the medicine into the vial</span>. This combines the medicine from both vials.<br/> <span class="Bold">Hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-117.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Slowly</span> push the plunger all the way down to transfer <span class=\"Bold\">all of the medicine into the vial</span>. This combines the medicine from both vials.<br/>\n<span class=\"Bold\">Hold the plunger in place</span> with your thumb and flip the vial upside down.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-117.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\nWithdraw your prescribed dose\n" }

24 Pull plunger back to withdraw your prescribed dose

{ "type": "p", "children": [], "text": "\n24 Pull plunger back to withdraw your prescribed dose\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">With the vial and dosing syringe upside down, <span class="Bold Italics">slowly</span> <span class="Bold">pull the plunger back</span>.<br/>Stop when you get to the <span class="Bold">amount in ‘mL’ that matches your prescribed dose.</span> <br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-118.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">With the vial and dosing syringe upside down, <span class=\"Bold Italics\">slowly</span> <span class=\"Bold\">pull the plunger back</span>.<br/>Stop when you get to the <span class=\"Bold\">amount in ‘mL’ that matches your prescribed dose.</span>\n<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-118.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

25 Check for large bubbles and air pockets

{ "type": "p", "children": [], "text": "\n25 Check for large bubbles and air pockets\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Check to see if there are large air bubbles or an air pocket in the syringe. You will remove extra air in the next steps.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-119.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Check to see if there are large air bubbles or an air pocket in the syringe. You will remove extra air in the next steps.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-119.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

26 Remove air bubbles and air pockets from syringe

{ "type": "p", "children": [], "text": "\n26 Remove air bubbles and air pockets from syringe\n" }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">If you see large air bubbles or an air pocket, tap the side of the dosing syringe to move the air to the top.<br/> <span class="Bold Italics">​Slowly</span> <span class="Bold">push the plunger up</span> to remove extra air.<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-120.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">If you see large air bubbles or an air pocket, tap the side of the dosing syringe to move the air to the top.<br/>\n<span class=\"Bold Italics\">​Slowly</span> <span class=\"Bold\">push the plunger up</span> to remove extra air.<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-120.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

27 Compare amount to prescribed dose

{ "type": "p", "children": [], "text": "\n27 Compare amount to prescribed dose\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="60%"/> <col align="left" valign="middle" width="40%"/> <tbody class="Headless"> <tr class="First Last"> <td align="left" class="Botrule Lrule Toprule" valign="top"> <p class="First">After removing all extra air, <span class="Bold">compare the amount in your syringe to your prescribed dose.</span> <br/> <span class="Bold">If you do not have your prescribed dose in your syringe,</span> <span class="Bold Italics">slowly</span> pull the plunger back again to withdraw more medicine from the vial. <br/>Repeat Steps 24 to 26 until you get <span class="Bold">your prescribed dose</span> and no large bubbles or air pockets are visible.</p> </td><td align="left" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-121.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"60%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule Lrule Toprule\" valign=\"top\">\n<p class=\"First\">After removing all extra air, <span class=\"Bold\">compare the amount in your syringe to your prescribed dose.</span>\n<br/>\n<span class=\"Bold\">If you do not have your prescribed dose in your syringe,</span> <span class=\"Bold Italics\">slowly</span> pull the plunger back again to withdraw more medicine from the vial.\n <br/>Repeat Steps 24 to 26 until you get <span class=\"Bold\">your prescribed dose</span> and no large bubbles or air pockets are visible.</p>\n</td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-121.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

28 Confirm your prescribed dose

{ "type": "p", "children": [], "text": "\n28 Confirm your prescribed dose\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="100%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule Toprule"> <p class="First">Before you continue, check to make sure you have the prescribed dose in the dosing syringe.​<br/>        <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-122.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> <span class="Bold">If the amount does not match your prescribed dose, repeat Steps 24 to 27.</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\">\n<p class=\"First\">Before you continue, check to make sure you have the prescribed dose in the dosing syringe.​<br/>        <img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-122.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> <span class=\"Bold\">If the amount does not match your prescribed dose, repeat Steps 24 to 27.</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

29 Remove the dosing syringe from the vial and set dosing syringe aside

{ "type": "p", "children": [], "text": "\n29 Remove the dosing syringe from the vial and set dosing syringe aside\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="80%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-123.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule Toprule"> <p class="First"> <span class="Bold">Hold the plunger in place with one hand</span>. With the other hand, hold the vial adapter and unscrew the filled dosing syringe from the vial.<br/>Throw away the used vial into the sharps container.</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-124.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule" valign="middle"> <p class="First">Place the filled dosing syringe on a clean, flat surface.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the dosing syringe tip or let it to touch any surfaces.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"80%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-123.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Hold the plunger in place with one hand</span>. With the other hand, hold the vial adapter and unscrew the filled dosing syringe from the vial.<br/>Throw away the used vial into the sharps container.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-124.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">Place the filled dosing syringe on a clean, flat surface.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the dosing syringe tip or let it to touch any surfaces.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

30 Attach injection needle to dosing syringe

{ "type": "p", "children": [], "text": "\n30 Attach injection needle to dosing syringe\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="33%"/> <col align="left" valign="middle" width="34%"/> <col align="left" valign="middle" width="33%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-125.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Find the needle in the bottom tray and open its package.</p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-126.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>With the needle still in the package, <span class="Bold">grip the base of the needle</span> and <span class="Bold">twist on the dosing syringe</span> until it stops. Remove the needle package.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-127.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Move the safety shield away from the needle</span> and toward the syringe. Place the dosing syringe on a clean, flat surface.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not uncap the needle.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<col align=\"left\" valign=\"middle\" width=\"34%\"/>\n<col align=\"left\" valign=\"middle\" width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-125.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Find the needle in the bottom tray and open its package.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-126.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>With the needle still in the package, <span class=\"Bold\">grip the base of the needle</span> and <span class=\"Bold\">twist on the dosing syringe</span> until it stops. Remove the needle package.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-127.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Move the safety shield away from the needle</span> and toward the syringe. Place the dosing syringe on a clean, flat surface.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not uncap the needle.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

31 Choose and clean your injection site

{ "type": "p", "children": [], "text": "\n31 Choose and clean your injection site\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="top" width="30%"/> <col align="left" valign="top" width="70%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-65.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule Toprule"> <p class="First"> <span class="Bold">Select an injection site</span> on your stomach (abdomen) or your upper thigh. If injecting on your stomach, avoid a 2-inch area around your belly button.<br/>Choose a different site every time you inject. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> ​Do not inject into skin that is damaged, sore, tender, bruised, or has red patches.​ <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> ​Do not inject through clothes.</p> </td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-66.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td><td align="left" class="Rrule"> <p class="First"> <span class="Bold">Clean the injection site</span> with a new alcohol wipe. <br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the cleaned injection site again.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"30%\"/>\n<col align=\"left\" valign=\"top\" width=\"70%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-65.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Select an injection site</span> on your stomach (abdomen) or your upper thigh. If injecting on your stomach, avoid a 2-inch area around your belly button.<br/>Choose a different site every time you inject.\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> ​Do not inject into skin that is damaged, sore, tender, bruised, or has red patches.​\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> ​Do not inject through clothes.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-66.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td><td align=\"left\" class=\"Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Clean the injection site</span> with a new alcohol wipe.\n <br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the cleaned injection site again.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Now, you are ready to inject the medicine.

{ "type": "p", "children": [], "text": "\nNow, you are ready to inject the medicine.\n" }

Inject your medicine

{ "type": "p", "children": [], "text": "\nInject your medicine\n" }

32 Inject your medicine

{ "type": "p", "children": [], "text": "\n32 Inject your medicine\n" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr class="Botrule First Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-128.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Pull the cap straight off the needle.<br/>Throw away the cap.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not touch the plunger until ready to inject so you do not lose any medicine.<br/> </p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-129.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Gently <span class="Bold">pinch and hold a fold of skin</span> where you will inject. Insert the needle with a <span class="Bold">dartlike motion at a 45° to 90° angle.</span> </p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-130.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/> <span class="Bold">Push</span> the plunger with slow, steady pressure all the way down until the dosing syringe is empty. <br/> <span class="Bold">Confirm all the medicine has been injected.</span> <br/>You can let go of the skin fold now.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-128.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Pull the cap straight off the needle.<br/>Throw away the cap.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not touch the plunger until ready to inject so you do not lose any medicine.<br/>\n</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-129.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Gently <span class=\"Bold\">pinch and hold a fold of skin</span> where you will inject. Insert the needle with a <span class=\"Bold\">dartlike motion at a 45° to 90° angle.</span>\n</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-130.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>\n<span class=\"Bold\">Push</span> the plunger with slow, steady pressure all the way down until the dosing syringe is empty. <br/>\n<span class=\"Bold\">Confirm all the medicine has been injected.</span>\n<br/>You can let go of the skin fold now.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="30%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="3"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Keep your fingers away from the needle at all times.</p> </td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-131.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>While keeping the plunger pushed in, <span class="Bold">remove the needle from your skin</span> at the same angle you inserted it.</p> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-132.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>To reapply the safety shield, push the shield against a flat surface until you hear a “click” and see that the needle is covered.</p> </td><td align="left" class="Lrule Rrule"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-133.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/><br/>Throw away the dosing syringe and used items in a sharps container.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not remove the needle from the dosing syringe.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"middle\" width=\"40%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Keep your fingers away from the needle at all times.</p>\n</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-131.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>While keeping the plunger pushed in, <span class=\"Bold\">remove the needle from your skin</span> at the same angle you inserted it.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-132.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>To reapply the safety shield, push the shield against a flat surface until you hear a “click” and see that the needle is covered.</p>\n</td><td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-133.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/><br/>Throw away the dosing syringe and used items in a sharps container.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not remove the needle from the dosing syringe.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <caption> <span>How to throw away WINREVAIR</span> </caption> <col align="left" valign="middle" width="55%"/> <col align="left" valign="middle" width="45%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"> <ul class="Disc"> <li>Throw away any used vials (including any remaining WINREVAIR liquid), needle, vial and needle caps, and used syringes in an FDA-cleared sharps disposal container.</li> <li>Do not throw away the WINREVAIR vials, syringes, or needle in your household trash.</li> <li> <span class="Bold">Do not reuse any of the supplies</span>.<br/>WINREVAIR is for one time use only.</li> <li> <span class="Bold">Important:</span> Always keep the sharps disposal container out of reach of children and pets.</li> </ul> </td><td align="left"> <p class="First"> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/></p> </td> </tr> <tr> <td align="left" valign="top"> <p class="First">If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p> <ul class="Disc"> <li>made of a heavy-duty plastic,</li> <li>can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out,</li> <li>upright and stable during use,</li> <li>leak resistant, and</li> <li>properly labeled to warn of hazardous waste inside the container.</li> </ul> </td><td align="left"> <p class="First">When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps container. There may be state or local laws about how you should throw away used needles, dosing syringes, and prefilled syringes.</p> <p>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: <span class="Bold"><a href="http://www.fda.gov/safesharpsdisposal">http://www.fda.gov/safesharpsdisposal</a></span>.<br/> <img alt="Figure" src="/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7"/> Do not recycle your used sharps container.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<caption>\n<span>How to throw away WINREVAIR</span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"55%\"/>\n<col align=\"left\" valign=\"middle\" width=\"45%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>Throw away any used vials (including any remaining WINREVAIR liquid), needle, vial and needle caps, and used syringes in an FDA-cleared sharps disposal container.</li>\n<li>Do not throw away the WINREVAIR vials, syringes, or needle in your household trash.</li>\n<li>\n<span class=\"Bold\">Do not reuse any of the supplies</span>.<br/>WINREVAIR is for one time use only.</li>\n<li>\n<span class=\"Bold\">Important:</span> Always keep the sharps disposal container out of reach of children and pets.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-26.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\">\n<p class=\"First\">If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p>\n<ul class=\"Disc\">\n<li>made of a heavy-duty plastic,</li>\n<li>can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out,</li>\n<li>upright and stable during use,</li>\n<li>leak resistant, and</li>\n<li>properly labeled to warn of hazardous waste inside the container.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps container. There may be state or local laws about how you should throw away used needles, dosing syringes, and prefilled syringes.</p>\n<p>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: <span class=\"Bold\"><a href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</a></span>.<br/>\n<img alt=\"Figure\" src=\"/dailymed/image.cfm?name=winrevair-24.jpg&amp;setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7\"/> Do not recycle your used sharps container.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Frequently asked questions

{ "type": "p", "children": [], "text": "\nFrequently asked questions\n" }

What should I do if I am bleeding at the injection site?

{ "type": "p", "children": [], "text": "\nWhat should I do if I am bleeding at the injection site?\n" }

Place a cotton ball or bandage on your skin right away and apply a small amount of pressure. If the bleeding does not stop, call your healthcare provider right away.

{ "type": "p", "children": [], "text": "Place a cotton ball or bandage on your skin right away and apply a small amount of pressure. If the bleeding does not stop, call your healthcare provider right away." }

Where can I find my prescribed dose?

{ "type": "p", "children": [], "text": "\nWhere can I find my prescribed dose?\n" }

Your prescribed dose in ‘mL’ is on your prescription label on your kit. Contact your healthcare provider if you cannot find your prescribed dose.

{ "type": "p", "children": [], "text": "Your prescribed dose in ‘mL’ is on your prescription label on your kit. Contact your healthcare provider if you cannot find your prescribed dose." }

What should I do if I accidentally get some medicine on my skin or my work surface?

{ "type": "p", "children": [], "text": "\nWhat should I do if I accidentally get some medicine on my skin or my work surface?\n" }

Wash the area thoroughly with soap and water right away.

{ "type": "p", "children": [], "text": "Wash the area thoroughly with soap and water right away." }

What should I do if I am not sure I administered my prescribed dose correctly?

{ "type": "p", "children": [], "text": "\nWhat should I do if I am not sure I administered my prescribed dose correctly?\n" }

Call your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "Call your pharmacy or healthcare provider." }

What should I do if the plunger of my dosing syringe moves automatically when I try to withdraw medicine from the vial?

{ "type": "p", "children": [], "text": "\nWhat should I do if the plunger of my dosing syringe moves automatically when I try to withdraw medicine from the vial?\n" }

Do not worry if your plunger moves slightly on its own when you are filling your dosing syringe with medicine.

{ "type": "p", "children": [], "text": "Do not worry if your plunger moves slightly on its own when you are filling your dosing syringe with medicine." }

With one hand, hold the plunger in place to stop the plunger from moving. With the other hand, unscrew the vial from the dosing syringe.

{ "type": "p", "children": [], "text": "With one hand, hold the plunger in place to stop the plunger from moving. With the other hand, unscrew the vial from the dosing syringe. " }

After unscrewed, it is safe to let go of the plunger.

{ "type": "p", "children": [], "text": "After unscrewed, it is safe to let go of the plunger." }

You can avoid this automatic plunger movement by pushing air into the vial before filling your dosing syringe with medicine. Refer to Steps 17 to 28 for detailed instructions.

{ "type": "p", "children": [], "text": "You can avoid this automatic plunger movement by pushing air into the vial before filling your dosing syringe with medicine. Refer to Steps 17 to 28 for detailed instructions." }

What should I do if my kit parts are damaged or are discolored, cloudy, or have particles?

{ "type": "p", "children": [], "text": "\nWhat should I do if my kit parts are damaged or are discolored, cloudy, or have particles?\n" }

Do not use your kit. Call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use your kit. Call your pharmacy to get a new kit." }

What should I do if my medicine does not turn clear after mixing and swirling?

{ "type": "p", "children": [], "text": "\nWhat should I do if my medicine does not turn clear after mixing and swirling?\n" }

Do not use the medicine if you have swirled the medicine vial for about 2 minutes and let it stand for another 3 minutes but your medicine vial remains cloudy or has clumps, powder, or foreign particles. Call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use the medicine if you have swirled the medicine vial for about 2 minutes and let it stand for another 3 minutes but your medicine vial remains cloudy or has clumps, powder, or foreign particles. Call your pharmacy to get a new kit." }

What should I do if the sterile water will not come out of the prefilled syringe?

{ "type": "p", "children": [], "text": "\nWhat should I do if the sterile water will not come out of the prefilled syringe?\n" }

Check that the vial adapter is attached to the vial securely. If not, hold the vial and press the vial adapter down firmly to make sure the vial adapter punctures the vial rubber stopper.

{ "type": "p", "children": [], "text": "Check that the vial adapter is attached to the vial securely. If not, hold the vial and press the vial adapter down firmly to make sure the vial adapter punctures the vial rubber stopper." }

What should I do if I dropped my kit components?

{ "type": "p", "children": [], "text": "\nWhat should I do if I dropped my kit components?\n" }

Do not use if any items are damaged. If you are unsure, call your pharmacy to get a new kit.

{ "type": "p", "children": [], "text": "Do not use if any items are damaged. If you are unsure, call your pharmacy to get a new kit." }

Can I use my kit that has been left out of the refrigerator?

{ "type": "p", "children": [], "text": "\nCan I use my kit that has been left out of the refrigerator?\n" }

Store the injection kit in the refrigerator until ready to use it. If the unused injection kit has been out of the refrigerator up to 77°F (25°C) for more than 24 hours, please contact your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "Store the injection kit in the refrigerator until ready to use it. If the unused injection kit has been out of the refrigerator up to 77°F (25°C) for more than 24 hours, please contact your pharmacy or healthcare provider." }

Do I need to use mixed medicine right away?

{ "type": "p", "children": [], "text": "\nDo I need to use mixed medicine right away?\n" }

We recommend you inject the medicine right away after mixing but no later than 4 hours after mixing. If it has been more than 4 hours, throw away unused mixed medicine. If you have questions, please contact your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "We recommend you inject the medicine right away after mixing but no later than 4 hours after mixing. If it has been more than 4 hours, throw away unused mixed medicine. If you have questions, please contact your pharmacy or healthcare provider." }

How can I get help preparing and giving my injection?

{ "type": "p", "children": [], "text": "\nHow can I get help preparing and giving my injection?\n" }

If you have questions about how to give WINREVAIR the correct way or need more information, you can call your pharmacy or healthcare provider.

{ "type": "p", "children": [], "text": "If you have questions about how to give WINREVAIR the correct way or need more information, you can call your pharmacy or healthcare provider." }

Call your doctor for advice about side effects.

{ "type": "p", "children": [], "text": "Call your doctor for advice about side effects." }

To report side effects or product quality complaints, please call Merck Sharp & Dohme LLC at 1-800-672-6372. You can also report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "To report side effects or product quality complaints, please call Merck Sharp & Dohme LLC at 1-800-672-6372. You can also report side effects to FDA at 1-800-FDA-1088." }

Manufactured by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USAU.S. License Number 0002

{ "type": "p", "children": [], "text": "Manufactured by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USAU.S. License Number 0002" }

Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved." }

usifu2-mk7962-i-2403r000

{ "type": "p", "children": [], "text": "usifu2-mk7962-i-2403r000" }

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" }

Approved: March 2024

{ "type": "p", "children": [], "text": "Approved: March 2024" }

NDC 0006-5090-01

{ "type": "p", "children": [], "text": "NDC 0006-5090-01" }

WINREVAIR™ (sotatercept-csrk) for injection

{ "type": "p", "children": [], "text": "\nWINREVAIR™\n\n(sotatercept-csrk) for injection\n" }

45 mg/vial

{ "type": "p", "children": [], "text": "\n45 mg/vial\n" }

Packagecontains1 Vial

{ "type": "p", "children": [], "text": "Packagecontains1 Vial" }

Dosebased onpatientweight

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

For Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration

{ "type": "p", "children": [], "text": "\nFor Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration\n" }

1 Single-Dose VialDiscard unused portion

{ "type": "p", "children": [], "text": "1 Single-Dose VialDiscard unused portion" }

Rx only

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

NDC 0006-5091-01

{ "type": "p", "children": [], "text": "NDC 0006-5091-01" }

WINREVAIR™ (sotatercept-csrk) for injection

{ "type": "p", "children": [], "text": "\nWINREVAIR™\n\n(sotatercept-csrk) for injection\n" }

60 mg/vial

{ "type": "p", "children": [], "text": "\n60 mg/vial\n" }

Packagecontains1 Vial

{ "type": "p", "children": [], "text": "Packagecontains1 Vial" }

Dosebased onpatientweight

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

For Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration

{ "type": "p", "children": [], "text": "\nFor Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration\n" }

1 Single-Dose VialDiscard unused portion

{ "type": "p", "children": [], "text": "1 Single-Dose VialDiscard unused portion" }

Rx only

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

NDC 0006-5087-01

{ "type": "p", "children": [], "text": "NDC 0006-5087-01" }

WINREVAIR™ (sotatercept-csrk) for injection

{ "type": "p", "children": [], "text": "\nWINREVAIR™\n\n(sotatercept-csrk) for injection\n" }

45 mg/vial

{ "type": "p", "children": [], "text": "\n45 mg/vial\n" }

Packagecontains2 Vials

{ "type": "p", "children": [], "text": "Packagecontains2 Vials" }

Dosebased onpatientweight

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

For Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration

{ "type": "p", "children": [], "text": "\nFor Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration\n" }

2 Single-Dose VialsDiscard unused portion

{ "type": "p", "children": [], "text": "2 Single-Dose VialsDiscard unused portion" }

Rx only

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

NDC 0006-5088-01

{ "type": "p", "children": [], "text": "NDC 0006-5088-01" }

WINREVAIR™ (sotatercept-csrk) for injection

{ "type": "p", "children": [], "text": "\nWINREVAIR™\n\n(sotatercept-csrk) for injection\n" }

60 mg/vial

{ "type": "p", "children": [], "text": "\n60 mg/vial\n" }

Packagecontains2 Vials

{ "type": "p", "children": [], "text": "Packagecontains2 Vials" }

Dosebased onpatientweight

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

For Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration

{ "type": "p", "children": [], "text": "\nFor Subcutaneous Use OnlyMust be reconstituted with diluent providedprior to administration\n" }

2 Single-Dose VialsDiscard unused portion

{ "type": "p", "children": [], "text": "2 Single-Dose VialsDiscard unused portion" }

Rx only

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