Winrevair Dosage
Generic name: SOTATERCEPT 45mg in 1mL; WATER 1mL in 1mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Agents for pulmonary hypertension
Medically reviewed by Drugs.com. Last updated on Mar 26, 2024.
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/mm3 (<50 x 109/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.
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) |
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.
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)].
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/mm3 (<50 x 109/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.
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.
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