WINREVAIR

Winrevair treatment should only be initiated and monitored by a physician experienced in the diagnosis and treatment of PAH. Posology Winrevair is administered once every 3 weeks as a single subcutaneous injection according to patient weight.

4). 3). 3 mg/kg (see Table 1). 2 “Dose adjustments due to increase in haemoglobin or decreased platelet count”). 7 mg/kg every 3 weeks unless dose adjustments are required. 6) Dose adjustments due to increase in haemoglobin or decreased platelet count Hgb and platelet count should be monitored for the first 5 doses, or longer if values are unstable.

8). 24 mmol/L (2 g/dL) from the previous dose and is above the ULN. 48 mmol/L (4 g/dL) from baseline. 24 mmol/L (2 g/dL) above ULN. • Platelet count decreases < 50 x 109/L. Hgb and platelet count should be obtained again before reinitiating treatment.

7 mg/kg after verifying acceptable Hgb and platelet count. For treatment delays lasting > 9 weeks due to platelet counts consistently < 50 x 109/L, the physician should carry out a benefit/risk re-evaluation for the patient before reinitiating treatment.

Missed dose If a dose is missed, administer as soon as possible. If the missed dose is not taken within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals. 2). 2). 73m2). Hepatic impairment No dose adjustment is required based on hepatic impairment (Child-Pugh Classification A to C).

2). Paediatric population The safety and efficacy of Winrevair in children and adolescents below 18 years of age have not yet been established. No data are available. Method of administration Winrevair is for single use only. It should be reconstituted before use.

The reconstituted medicinal product is a clear to opalescent and colourless to slightly brownish-yellow solution. Winrevair should be administered by subcutaneous injection in the abdomen (at least 5 cm away from navel), upper arm, or upper thigh.

It should not be injected into sites that are scarred, tender, or bruised. The same injection site should not be used on two consecutive injections. 6 for instructions on the proper preparation and administration of Winrevair.

4%). The most frequently reported serious adverse reactions were thrombocytopenia (< 1%) and epistaxis (< 1%). The most common adverse reactions leading to discontinuation were epistaxis and telangiectasia. 1). The median duration of treatment with sotatercept was 313 days.

The adverse reactions reported with sotatercept are listed in the table below by MedDRA system organ class and by frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), and very rare (< 1/10 000).

6% of patients taking sotatercept. 3% of patients taking sotatercept. 4). 4% of patients taking sotatercept. 5% of patients taking sotatercept. 1%). 4). 6% of patients taking sotatercept. 6 weeks. Discontinuations of treatment due to telangiectasia were 1% in the sotatercept group.

3% of patients taking sotatercept. 9 mmHg at 24 weeks. Elderly With the exception of bleeding events (a collective group of adverse events of clinical interest), there were no differences in safety between the < 65-year-old and ≥ 65-year- old subgroups.

9% in patients < 65-year-old); however, there was no notable imbalance between age categories for any specific bleeding event. 0% of patients ≥ 65-year-old taking sotatercept. Long-term safety data Long-term safety data are available from pooled phase 2 and phase 3 clinical studies (n=431).

The median duration of exposure was 657 days. The safety profile was generally similar to that observed in the pivotal STELLAR study. Right-to-left intrapulmonary shunting has been reported in participants who developed worsening hypoxemia despite improved PAH haemodynamics.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. 8). Severe thrombocytopenia Decreased platelet count has been observed in some patients taking sotatercept including severe thrombocytopenia (platelet count < 50 x 109/L).

8). Severe thrombocytopenia may increase the risk of bleeding events. 2). 8). 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’.

20 mg of polysorbate 80 in each mL of reconstituted solution. Polysorbates may cause allergic reactions.

1. Patients with platelet counts consistently < 50 x 109/L before initiating treatment.