WINREVAIR Aug 2025 Live
SELECTED SAFETY INFORMATION
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
WINREVAIR is not listed on the PBS.
Before prescribing, please review the Product Information available at: www.msdinfo.com.au/winrevairpi.
INDICATION:
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) in WHO Functional Class (FC) 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.
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION
CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS:
Erythrocytosis: Haemoglobin (Hgb) increases have been observed in patients during treatment with WINREVAIR. Severe erythrocytosis (high Hgb) may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable and periodically thereafter to determine if dose adjustments are required.
Severe Thrombocytopenia: Decreased platelet count has been observed in some patients taking WINREVAIR and severe thrombocytopenia [platelet count <50,000/mm3 (<50.0 x 109/L)] has been observed. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3 (<50 x 109/L). Monitor platelets before each dose for the first 5 doses, or longer if values are unstable and periodically thereafter to determine whether dose adjustments are required.
Serious Bleeding: In clinical studies, serious bleeding events (e.g., gastrointestinal, 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. Advise patients about signs and symptoms of blood loss. Evaluate and treat bleeding accordingly. Do not administer WINREVAIR if the patient is experiencing a serious bleeding event.
Embryofoetal Toxicity: Pregnancy category D. WINREVAIR may cause foetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a foetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting treatment.
Impaired Fertility: Based on findings in animals, WINREVAIR may impair female and male fertility.
Lactation: Since it is not known if WINREVAIR is excreted in human breast milk, breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.
ADVERSE EVENTS:
The most common treatment-emergent adverse events occurring with WINREVAIR in the phase 3 clinical trial (≥5% of participants) were headache, COVID-19, diarrhoea, epistaxis, fatigue, telangiectasia, dizziness, nausea, injection site pain, thrombocytopenia, hypokalaemia, rash, flushing, increased haemoglobin.
In long-term safety follow-up, right-to-left intrapulmonary shunting has been reported in 2 participants (<0.5%) who developed worsening hypoxemia despite improved PAH haemodynamics.
AU-SOT-00056 v1. Issued August 2025.
WINREVAIR is not listed on the PBS.
Before prescribing, please review the Product Information available at: www.msdinfo.com.au/winrevairpi.
INDICATION:
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) in WHO Functional Class (FC) 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.
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION
CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS:
Erythrocytosis: Haemoglobin (Hgb) increases have been observed in patients during treatment with WINREVAIR. Severe erythrocytosis (high Hgb) may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable and periodically thereafter to determine if dose adjustments are required.
Severe Thrombocytopenia: Decreased platelet count has been observed in some patients taking WINREVAIR and severe thrombocytopenia [platelet count <50,000/mm3 (<50.0 x 109/L)] has been observed. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3 (<50 x 109/L). Monitor platelets before each dose for the first 5 doses, or longer if values are unstable and periodically thereafter to determine whether dose adjustments are required.
Serious Bleeding: In clinical studies, serious bleeding events (e.g., gastrointestinal, 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. Advise patients about signs and symptoms of blood loss. Evaluate and treat bleeding accordingly. Do not administer WINREVAIR if the patient is experiencing a serious bleeding event.
Embryofoetal Toxicity: Pregnancy category D. WINREVAIR may cause foetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a foetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting treatment.
Impaired Fertility: Based on findings in animals, WINREVAIR may impair female and male fertility.
Lactation: Since it is not known if WINREVAIR is excreted in human breast milk, breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.
ADVERSE EVENTS:
The most common treatment-emergent adverse events occurring with WINREVAIR in the phase 3 clinical trial (≥5% of participants) were headache, COVID-19, diarrhoea, epistaxis, fatigue, telangiectasia, dizziness, nausea, injection site pain, thrombocytopenia, hypokalaemia, rash, flushing, increased haemoglobin.
In long-term safety follow-up, right-to-left intrapulmonary shunting has been reported in 2 participants (<0.5%) who developed worsening hypoxemia despite improved PAH haemodynamics.
AU-SOT-00056 v1. Issued August 2025.