Preparation and administration for WINREVAIR (sotatercept-csrk)
Administration is subject to monitoring of hemoglobin (Hgb) and platelet count.
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 on how to reconstitute, prepare, measure, and inject WINREVAIR.
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.
Refer to the Instructions for Use (IFU) for detailed instructions on the proper preparation and administration of WINREVAIR.
Access Instructions for Use (1-vial kit, 2-vial kit) videos
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.
1-vial kits

45 mg kit (containing 1 x 45 mg vial)

60 mg kit (containing 1 x 60 mg vial)
2-vial kits

90 mg kit (containing 2 x 45 mg vials)

120 mg kit (containing 2 x 60 mg vials)
Not actual size.
Reconstitution instructions
- Remove the injection kit from the refrigerator and wait 15 minutes to allow the pre-filled 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.