WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)

Patheon Italia S.p.A (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Sep 20, 2024
Approval ID: 67a52791efc59198
Company: Patheon Italia S.p.A (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 67a52791efc59198
Drug Name: WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)
Product Name: WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)
Approval Number: SIN17093P
Approval Date: 2024-09-20
Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
Licence Holder: MSD PHARMA (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Dosage: 2. DOSAGE 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)]. <img src="/TGIF/WinrevairVial-Table1.png" alt="Winrevair Vial Dosage Table 1" /> 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)]. <img src="/TGIF/WinrevairVial-Table2.png" alt="Winrevair Vial Dosage Table 2" /> Missed Dose or Overdose 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, 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: <ul> <li>Hgb increases >2.0 g/dL from the previous dose and is above ULN.</li> <li>Hgb increases >4.0 g/dL from baseline.</li> <li>Hgb increases >2.0 g/dL above ULN.</li> <li>Platelet count decreases to <50,000/mm3 (<50.0 x 109/L).</li> </ul> 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].
Route Of Administration: SUBCUTANEOUS
Indication Info: 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.
Contraindications: 4. CONTRAINDICATIONS None.
Atc Code: C02KX06
Pharma Manufacturer Name: MSD PHARMA (SINGAPORE) PTE. LTD.

Active Ingredients

sotatercept

45mg

sotatercept

45mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 20, 2024

Approval ID

67a52791efc59198

Type

Therapeutic

Back to HSA Approvals