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Winrevair

Winrevair

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Sotatercept
Indications/Uses
In combination w/ other pulmonary arterial HTN (PAH) therapies for the treatment of PAH in adults w/ WHO functional class II to III to improve exercise capacity.
Dosage/Direction for Use
Administer by SC inj. Obtain Hb & platelet count prior to the 1st dose. Initiate treatment w/ single dose of 0.3 mg/kg. Then 3 wk after starting dose, escalate to target dose of 0.7 mg/kg after verifying acceptable Hb & platelet count. Continue treatment at 0.7 mg/kg every 3 wk unless dose adjustments are required. Delay treatment for 3 wk (ie, 1 dose delay) if Hb increases >1.24 mmol/L (2 g/dL) from previous dose & is above ULN; Hb increases >2.48 mmol/L (4 g/dL) from baseline; Hb increases >1.24 mmol/L (2 g/dL) above ULN; platelet count decreases <50 x 109/L. Obtain Hb & platelet count before reinitiating treatment. For treatment delays lasting >9 wk, restart at 0.3 mg/kg, then escalate to 0.7 mg/kg after verifying acceptable Hb & platelet count. Re-evaluate benefit/risk before reinitiating treatment for delays lasting >9 wk due to platelet counts consistently <50 x 109/L.
Contraindications
Hypersensitivity. Patients w/ platelet counts consistently <50 x 109/L before initiating treatment.
Special Precautions
Risk of erythrocytosis, severe thrombocytopenia, & serious bleeding. Caution in patients w/ erythrocytosis who are at increased risk of thromboembolic events. Do not administer if patient is experiencing serious bleeding event. Monitor Hb & platelet count before each dose for the 1st 5 doses, or longer if values are unstable, & verify every 3-6 mth thereafter to determine if dose adjustments are required. Do not inj into sites that are scarred, tender, or bruised. Do not use same inj site on 2 consecutive inj. Contains polysorbate 80, which may cause allergic reactions. Clinical studies did not include participants w/ HIV-, portal HTN-, schistosomiasis-, or pulmonary veno occlusive disease-associated PAH. Has not been studied in patients w/ hepatic impairment (Child-Pugh class A to C); PAH patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2). Pregnancy testing is recommended for women of childbearing potential before starting treatment. Women of childbearing potential should use effective contraception during treatment & for at least 4 mth after the last dose if treatment is discontinued. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding during treatment & for 4 mth after the last dose of treatment. May impair female & male fertility. Safety & efficacy in childn & adolescents <18 yr have not yet been established.
Adverse Reactions
Thrombocytopenia, increased Hb; dizziness, headache; epistaxis; diarrhoea; telangiectasia, rash. Gingival bleeding; erythema; inj site pruritus; increased BP.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX06 - sotatercept ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Winrevair powd for inj 45 mg
Packing/Price
(+ solvent in pre-filled syringe) 1's
Form
Winrevair powd for inj 60 mg
Packing/Price
(+ solvent in pre-filled syringe) 1's
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