Winrevair Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Erythrocytosis: Increases in Hgb have been observed in patients during treatment with sotatercept. Severe erythrocytosis may increase the risk of thromboembolic events and hyperviscosity syndrome. Use caution in patients with erythrocytosis who are at increased risk of thromboembolic events. Hgb should be monitored before each dose for the first 5 doses, or longer if values are unstable, and every 3 to 6 months thereafter to determine if dose adjustments are required (see Dosage & Administration and Adverse Reactions). If a patient develops erythrocytosis, HCP should consider re-evaluating the patient's or caregiver's administration technique.
Severe thrombocytopenia: Decreased platelet count has been observed in some patients taking sotatercept including severe thrombocytopenia (platelet count <50 x 10⁹/L). Thrombocytopenia was reported more frequently in patients also receiving prostacyclin infusion (21.5%) compared to patients not receiving prostacyclin infusion (3.1%) (see Adverse Reactions). Severe thrombocytopenia may increase the risk of bleeding events. Platelet count should be monitored before each dose for the first 5 doses, or longer if values are unstable, and every 3 to 6 months thereafter to determine whether dose adjustments are required (see Dosage & Administration).
Serious bleeding: In clinical studies, serious bleeding events (including gastrointestinal, intracranial haemorrhage) have been observed in 4.3% of patients during treatment with sotatercept (see Adverse Reactions).
Patients with serious bleeding events were more likely to be on prostacyclin background therapy and/or antithrombotic agents, have low platelet count, or be 65 years of age or older. Patients should be advised about any signs and symptoms of blood loss. A physician should evaluate and treat bleeding events accordingly. Sotatercept should not be administered if the patient is experiencing a serious bleeding event.
Limitation of the clinical data: The clinical studies did not include participants with human immunodeficiency virus (HIV)-, portal hypertension-, schistosomiasis-, or pulmonary veno occlusive disease (PVOD)-associated PAH.
Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.
This medicinal product contains 0.20 mg of polysorbate 80 in each mL of reconstituted solution. Polysorbates may cause allergic reactions.
Effects on ability to drive and use machines: Sotatercept has no or negligible influence on the ability to drive and use machines.