Winrevair Dosage/Direction for Use

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.
Recommended starting dose: Haemoglobin (Hgb) and platelet count should be obtained prior to the first dose (see Precautions). Initiation of treatment is contraindicated if platelet count is consistently <50 x 10⁹/L (see Contraindications).
Treatment is initiated with a single dose of 0.3 mg/kg (see Table 2).

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Recommended target dose: Three weeks after a single starting dose of 0.3 mg/kg, the dose should be escalated to the recommended target dose of 0.7 mg/kg after verifying acceptable Hgb and platelet count (see Dose adjustments due to increase in haemoglobin or decreased platelet count as follows). Treatment should be continued at 0.7 mg/kg every 3 weeks unless dose adjustments are required. (See Table 3.)

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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. Thereafter, Hgb and platelet count should be verified every 3 to 6 months and the dose adjusted if necessary (see Precautions and Adverse Reactions).
Treatment should be delayed for 3 weeks (i.e., one dose delay) if any of the following occur: Hgb increases >1.24 mmol/L (2 g/dL) from the previous dose and is above the ULN; Hgb increases >2.48 mmol/L (4 g/dL) from baseline; Hgb increases >1.24 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.
For treatment delays lasting >9 weeks, treatment should be restarted at 0.3 mg/kg, and the dose should be escalated to 0.7 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.
Elderly: No dose adjustment is required in elderly patients ≥65 years old (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required based on renal impairment (see Pharmacology: Pharmacokinetics under Actions). Sotatercept has not been studied in PAH patients with severe renal impairment (estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²).
Hepatic impairment: No dose adjustment is required based on hepatic impairment (Child-Pugh Classification A to C). Sotatercept has not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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.
Winrevair powder and solvent for solution for injection is intended for use under the guidance of a healthcare professional (HCP). Patients and caregivers may administer the medicinal product when considered appropriate and when they receive training from a HCP in how to reconstitute, prepare, measure and inject Winrevair powder and solvent for solution for injection. A HCP should confirm at a subsequent visit, soon after training, that the patient or caregiver can perform these steps correctly. A HCP should also consider reconfirming the patient's or caregiver's administration technique if the dose is adjusted, if the patient requires a different kit, if the patient develops erythrocytosis (see Precautions), or at any time at the discretion of the HCP.
Refer to Special precautions for disposal and other handling under Cautions for Usage for detailed instructions on the proper preparation and administration of Winrevair.