Winrevair

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• The recommended starting dose is 0.3 mg/kg by subcutaneous injection.
• ( 2.1 ) The recommended target dose is 0.7 mg/kg every 3 weeks by subcutaneous injection.
• ( 2.2 ) Dosage modifications due to increased hemoglobin (Hgb) and decreased platelets may be necessary.
• Check Hgb and platelets before each dose for the first 5 doses, or longer if values are unstable, and monitor periodically thereafter.
• ( 2.3 ) See full prescribing information for preparation and administration instructions.
• ( 2.4 )
• 2.1 Recommended Starting Dosage 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/mm 3 (<50 x 10 9 /L) [see Dosage and Administration (2.3) ] .
• Injection volume for starting dose is calculated based on patient weight as follows:
• Injection Volume (mL) = Weight (kg) x 0.3 mg/kg 50 mg/mL 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.
• Table 1:
• Kit Type Based on Injection Volume for Dose of 0.3 mg/kg Injection Volume (mL) Kit Type 0.2 to 0.9 45 mg kit (containing 1 x 45 mg vial) 1 to 1.1 60 mg kit (containing 1 x 60 mg vial)
• 2.2 Recommended Target Dosage 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:
• Injection Volume (mL) = Weight (kg) x 0.7 mg/kg 50 mg/mL 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.
• Table 2:
• Kit Type Based on Injection Volume for Dose of 0.7 mg/kg Injection Volume (mL) Kit Type 0.4 to 0.9 45 mg kit (containing 1 x 45 mg vial) 1 to 1.2 60 mg kit (containing 1 x 60 mg vial) 1.3 to 1.8 90 mg kit (containing 2 x 45 mg vials) 1.9 to 2.4 120 mg kit (containing 2 x 60 mg vials) 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) ] .
• 2.3 Dosage Modifications Due to Hemoglobin Increase or Platelet Count Decrease 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:
• Hgb increases >2.0 g/dL from the previous dose and is above ULN.
• Hgb increases >4.0 g/dL from baseline.
• Hgb increases >2.0 g/dL above ULN.
• Platelet count decreases to <50,000/mm 3 (<50 x 10 9 /L).
• 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.
• 2.4 Preparation and Administration 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 Remove the injection kit from the refrigerator and wait 15 minutes to allow the prefilled syringe(s) and drug product to come to room temperature prior to preparation.
• Attach the vial adapter to the vial.
• Visually inspect the pre-filled syringe for any damage or leaks and the Sterile Water for Injection inside to ensure there are no visible particles.
• Snap off the cap of the pre-filled syringe and attach the syringe to the vial adapter.
• Inject all of the Sterile Water for Injection from the attached syringe into the vial containing the lyophilized powder.
• This will provide a final concentration of 50 mg/mL.
• Gently swirl the vial to reconstitute the drug product.
• DO NOT shake or vigorously agitate.
• Allow the vial to stand for up to 3 minutes to allow bubbles to disappear.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• When properly mixed, WINREVAIR should be clear to opalescent and colorless to slightly brownish-yellow and does not have clumps or powder.
• If prescribed a 2-vial presentation, repeat the steps within this section to prepare the second vial.
• Use the reconstituted solution as soon as possible, but no later than 4 hours after reconstitution.
• Discard unused reconstituted solution.
• Syringe Preparation Turn the syringe and vial upside-down and withdraw the appropriate volume for injection, based on the patient’s weight.
• If the dose amount requires the use of two vials, withdraw the entire contents of the first vial and slowly transfer full contents into the second vial.
• Turn the syringe and vial upside-down and withdraw the required amount of drug product.
• If necessary, remove excess drug product.
• If necessary, remove excess air from the syringe.
• Administration Instructions WINREVAIR is for subcutaneous injection.
• Select the injection site on the abdomen (at least 2 inches away from navel), upper thigh, or upper arm, and swab with an alcohol wipe.
• Select a new site for each injection that is not scarred, tender, or bruised.
• For administration by the patient or caregiver, use only the abdomen and upper thigh (see IFU ).
• Perform subcutaneous injection.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

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

Quoted from the official label, section “Pediatric Use”.

Use in older people

• A total of 127 patients ≥65 years of age participated in clinical studies for PAH, of which 99 (78%) 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in the labeling:
• Erythrocytosis [see Warnings and Precautions (5.1) ] Severe Thrombocytopenia [see Warnings and Precautions (5.2) ] Serious Bleeding [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Impaired Fertility [see Warnings and Precautions (5.5) ] The most common (≥10% in patients receiving WINREVAIR and 5% more than placebo) adverse reactions were infections, epistaxis, telangiectasia, diarrhea, headache, rash, increased hemoglobin, dizziness, erythema, and gingival bleeding.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Trials Experience 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.
• STELLAR The following data reflect exposure to WINREVAIR in the STELLAR trial.
• Adult PAH patients with WHO FC II or III (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 .
• Table 3:
• Adverse Reactions ≥10% in Patients Receiving WINREVAIR and at least 5% More Than Placebo in STELLAR Double-blind placebo-controlled period + Long-term double-blind period of STELLAR Adverse reaction WINREVAIR N=163 Placebo N=160 Headache 40 (24.5) 28 (17.5) Epistaxis 36 (22.1) 3 (1.9) Rash 33 (20.2) 13 (8.1) Telangiectasia 27 (16.6) 7 (4.4) Diarrhea 25 (15.3) 16 (10.0) Dizziness 24 (14.7) 10 (6.3) Erythema 22 (13.5) 5 (3.1) 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 36.1 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.
• ZENITH The following data reflect exposure to WINREVAIR in the ZENITH trial.
• Adult PAH patients with WHO FC III or IV at high risk of mortality (n=172) were randomized in a 1:1 ratio to treatment with WINREVAIR or placebo in combination with background standard of care therapies.
• Patients who did not experience a primary endpoint event remained in the Double-Blind Placebo-Controlled (DBPC) Treatment Period, while patients who experienced an event of PAH worsening-related hospitalization of ≥24 hours were eligible to enroll into the open-label, long-term follow-up (LTFU) study SOTERIA.
• The median duration of exposure was longer in the WINREVAIR group (435 days) than in the placebo group (268 days) [see Clinical Studies (14.1) ].
• The overall incidences of adverse reactions in both arms were higher in the ZENITH trial than in the STELLAR trial.
• Severe reduction in platelet count <50,000/mm 3 (<50.0 x 10 9 /L) occurred in 6% of patients taking WINREVAIR.
• In the WINREVAIR group, 1 patient (1%) discontinued study intervention due to an adverse event, compared with 4 patients (5%) in the placebo group.
• Table 4:
• Adverse Reactions ≥10% in Patients Receiving WINREVAIR and at least 5% More Than Placebo in ZENITH Adverse reaction WINREVAIR N=86 Placebo N=86 Infections 58 (67.4) 38 (44.2) Epistaxis 39 (45.3) 8 (9.3) Diarrhea 22 (25.6) 15 (17.4) Telangiectasia 22 (25.6) 3 (3.5) Increased hemoglobin 13 (15.1) 1 (1.2) Rash 9 (10.5) 4 (4.7) Erythema 9 (10.5) 3 (3.5) Gingival bleeding 9 (10.5) 2 (2.3) Uncontrolled Long-term Safety Data Pooled long-term safety data are available from 431 patients who participated in multicenter phase 2 (PULSAR, SPECTRA) and phase 3 (STELLAR) clinical trials.
• A majority of these patients continued in SOTERIA, an ongoing, open-label follow-up study of the long-term safety and efficacy of WINREVAIR.
• The safety profile with long-term exposure was generally similar to that observed in the STELLAR study.
• The mean duration of exposure to WINREVAIR was 173 weeks with a maximum exposure of 335 weeks.
• Intrapulmonary Right-to-Left Shunting:
• Cases of intrapulmonary right-to-left shunting have been reported in a clinical trial with WINREVAIR.
• In SOTERIA, right-to-left intrapulmonary shunting has been reported in 3 participants (<0.7%) who developed worsening hypoxemia despite improved PAH hemodynamics.
• Post-marketing cases have also been reported.
• Partial to complete improvement in oxygenation has been observed following discontinuation of WINREVAIR.
• Additional Adverse Reactions from Clinical Trials The following adverse reactions were reported in at least one adult patient receiving treatment with WINREVAIR.
• These adverse reactions are presented by system organ class and are ranked by frequency.
• Skin and Subcutaneous Tissue Disorders:
• 1% and less than 10%:
• skin hypopigmentation Gastrointestinal Disorders:
• 1% and less than 10% :
• gastrointestinal tract bleeding (including gastrointestinal hemorrhage, upper gastrointestinal hemorrhage, hematemesis, lower gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, melaena, gastritis hemorrhagic), colonic angioectasia
• 6.2 Post-marketing Experience The following adverse reaction has been reported during post-approval use of WINREVAIR.
• Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Cardiac disorders:
• pericardial effusion General disorders and administration site conditions:
• injection site reactions

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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.
• Erythrocytosis 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 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 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 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 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 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 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:
• 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.
• Incorrect Dose or Missed Dose 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) ] .
• Manufactured by:
• Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA U.S. license number 0002 For patent information:
• www.msd.com/research/patent Copyright © 2024-2026 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.
• All rights reserved. uspi-mk7962-i-2608r006

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS For injection:
• 45 mg white to off-white lyophilized cake or powder appearance in a single-dose vial.
• For injection:
• 60 mg white to off-white lyophilized cake or powder appearance in a single-dose vial.
• For injection:
• 45 mg lyophilized cake or powder in a single-dose vial ( 3 ) For injection:
• 60 mg lyophilized cake or powder in a single-dose vial ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied 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 7 .
• Table 7:
• Kit Contents Kit Vial Adapters Alcohol Pads Sterile Water for Injection in prefilled syringes NDC (1) 45 mg vial 1 4 (1) 1 mL syringe NDC # 0006-5090-01 (1) 60 mg vial 1 4 (1) 1.3 mL syringe NDC # 0006-5091-01 (2) 45 mg vials 2 8 (2) 1 mL syringes NDC # 0006-5087-01 (2) 60 mg vials 2 8 (2) 1.3 mL syringes NDC # 0006-5088-01
• 16.2 Storage and Handling 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.
• 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 7 .
• Table 7:
• Kit Contents Kit Vial Adapters Alcohol Pads Sterile Water for Injection in prefilled syringes NDC (1) 45 mg vial 1 4 (1) 1 mL syringe NDC # 0006-5090-01 (1) 60 mg vial 1 4 (1) 1.3 mL syringe NDC # 0006-5091-01 (2) 45 mg vials 2 8 (2) 1 mL syringes NDC # 0006-5087-01 (2) 60 mg vials 2 8 (2) 1.3 mL syringes NDC # 0006-5088-01

Quoted from the official label, section “How Supplied”.

How to store it

• 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.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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.
• 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.
• 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.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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