WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG [SIN17091P]

Product Info

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG

[SIN17091P]

1. INDICATIONS AND USAGE

WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1; Functional Class [FC] II to III) to increase exercise capacity, improve WHO functional class, and delay disease progression.

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Starting Dosage in Adults
WINREVAIR is administered once every 3 weeks by subcutaneous (SC) injection according to patient weight. The starting dose of WINREVAIR is 0.3 mg/kg (see Table 1).

Obtain hemoglobin (Hgb) and platelet count prior to the first dose of WINREVAIR. Rapid increases in Hgb of more than 2 g/dL have been observed after initiating treatment. It is not recommended to initiate treatment if platelet count is <50,000/mm³ (<50.0 x 10⁹/L) [see Dosage and Administration (2.3)].

2.2 Recommended Target Dosage in Adults
The target dose of WINREVAIR is 0.7 mg/kg (see Table 2) administered every 3 weeks.

Obtain and review hemoglobin (Hgb) and platelet count prior to increasing to the target dose. Continue treatment at 0.7 mg/kg every 3 weeks unless dosage adjustments are required [see Dosage and Administration (2.3)].

Missed Dose, Overdose, or Underdose
If a dose of WINREVAIR is missed, administer as soon as possible. If the missed dose of WINREVAIR is not taken within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals. In case of an overdose or underdose, consider retraining the patient or caregiver on proper administration as appropriate. In case of an overdose, monitor for erythrocytosis [see Overdosage (9) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.3 Dosage Modifications in Adults Due to Hemoglobin Increase or Platelet Count Decrease
Increases in Hgb to levels greater than 2 g/dL above the upper limit of normal (ULN) and decreases in platelet count <50,000/mm³ (<50.0 x 10⁹/L) have been observed. 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. Consider assessment of benefit-risk for the individual patient in determining whether dose modification is appropriate [see Warnings and Precautions (5.1, 5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Delay treatment for 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 (<50.0 x 10⁹/L).

For treatment delays lasting >9 weeks, restart treatment at 0.3 mg/kg.

2.4 Pediatric Patients
Safety and efficacy of WINREVAIR have not been established in patients less than 18 years of age.

2.5 Geriatric Patients
No dose adjustment of WINREVAIR is required based on age [see 7. Use in Specific Populations (7.5) and Clinical Pharmacology (11.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.6 Renal Impairment
No dose adjustment of WINREVAIR is required based on renal impairment. Sotatercept has not been studied in PAH patients with severe renal impairment (eGFR <30 mL/min/1.73m²) [see 7. Use in Specific Populations (7.6) and Clinical Pharmacology (11.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.7 Hepatic Impairment
WINREVAIR use has not been studied in patients with hepatic impairment (Child-Pugh Classification A to C). Hepatic impairment is not expected to influence sotatercept metabolism since sotatercept is metabolized via cellular catabolism [see 7. Use in Specific Populations (7.7) and Clinical Pharmacology (11.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.8 Preparation and Administration
WINREVAIR is intended for use under the guidance of a health care professional. Patients and caregivers may administer WINREVAIR when considered appropriate and when they receive training and follow-up from the doctor in how to reconstitute, prepare, measure, and inject WINREVAIR.

Consider confirming at subsequent visits that the patient or caregiver can prepare and administer WINREVAIR correctly:

• if the dose changes or the patient requires a different kit

• if the patient develops erythrocytosis [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

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 weight requires the use of two 45 mg vials or two 60 mg vials of lyophilized product, a 2-vial kit should be used 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 Pharmaceutical Particulars (15.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

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.

• Check the vial to ensure the product is not expired. The powder should be white to off-white and may look like a whole or fragmented cake.

• Remove the lid from the vial containing the WINREVAIR lyophilized powder and swab the rubber stopper with an alcohol wipe.

• Attach the vial adapter to the vial.

• Visually inspect the pre-filled syringe for any damage or leaks and the sterile water 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 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.

• Visually inspect the reconstituted solution. When properly mixed, WINREVAIR should be clear to opalescent and colorless to slightly brownish-yellow and does not have clumps or powder.

• Unscrew the syringe from the vial adapter and discard the emptied syringe into a sharps container.

• 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.

Syringe Preparation

• Swab the vial adapter with an alcohol wipe.

• Remove dosing syringe from packaging and attach the syringe to the vial adapter.

• 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, push plunger in to remove excess drug product or air from the syringe.

• Remove the syringe from the vial and attach the needle.

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.

• Discard the emptied syringe into a sharps container. Do not reuse the syringe.

4. CONTRAINDICATIONS

None.