WINREVAIR

What it is

Winrevair contains sotatercept, a recombinant activin receptor type IIA-Fc fusion protein. It is a sterile, preservative-free, white to off-white lyophilised powder available in 45 mg and 60 mg single-dose vials for subcutaneous administration after reconstitution.

Approved indications —

Adults with pulmonary arterial hypertension (PAH) in WHO Functional Class II or III, in combination with standard therapy. Efficacy has been shown in idiopathic and heritable PAH, PAH associated with connective tissue disease, drug or toxin-induced PAH and PAH associated with congenital heart disease with repaired shunts.

Dosing overview

Winrevair is administered once every three weeks by subcutaneous injection according to patient weight, with a starting dose of 0.3 mg/kg. Three weeks after the starting dose, the dose should be escalated to the recommended target dose of 0.7 mg/kg after verifying acceptable haemoglobin and platelet count. Treatment should be continued at 0.7 mg/kg every three weeks unless dose adjustments are required.

Key safety warnings

Haemoglobin increases have been observed during treatment with Winrevair. Severe erythrocytosis (high haemoglobin) may increase the risk of thromboembolic events or hyperviscosity syndrome. Haemoglobin and platelet count should be checked before each dose for the first five doses, or longer if values are unstable. Decreased platelet count has been observed in some patients taking Winrevair and severe thrombocytopenia (platelet count less than 50,000/mm³) has been observed, occurring more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is less than 50,000/mm³, and platelet count should be monitored before each dose for the first five doses, or longer if values are unstable and periodically thereafter. In clinical studies, serious bleeding events such as gastrointestinal and intracranial haemorrhage were reported in 4% of patients taking Winrevair and 1% of patients taking placebo. Patients with serious bleeding events were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Based on findings in animal reproduction studies, Winrevair may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with Winrevair and for at least four months after the final dose.

Contraindications

Winrevair is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Regulatory history

Winrevair was first registered on the ARTG on 8 November 2024, with both the 45 mg and 60 mg powder for injection vials listed in licence category RE. In March 2025, the PBAC recommended against listing for add-on therapy for the treatment of Group 1 pulmonary arterial hypertension. This medicinal product is subject to additional monitoring in Australia.