Sotatercept
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for sotatercept. Take vial strength, diluent, and limits from the label below.
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Preparation and Administration Administration is subject to monitoring of hemoglobin and platelet count [see Dosage and Administration , 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 ] .
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 ] . 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 ] .
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.
| Injection Volume (mL) = | Weight (kg) x 0.3 mg/kg |
| 50 mg/mL |
| 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) |
| Injection Volume (mL) = | Weight (kg) x 0.7 mg/kg |
| 50 mg/mL |
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Sotatercept
Contraindications
None. None ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sotatercept. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy 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…
Breastfeeding (LactMed)
No information is available on the use of during breastfeeding. Because sotatercept is a large protein molecule with a molecular weight of 78,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. The manufacturer recommends that breastfeeding be discontinued during sotatercept therapy and for 4 months after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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