Winlev Air Kit Injection 60 mg (Sotatercept)

Adult administration

This drug must be initiated and monitored by a physician experienced in treating pulmonary arterial hypertension. It is administered subcutaneously (SC) every 3 weeks based on the patient's weight. The starting dose is 0.3 mg/kg, which is increased to the target dose of 0.7 mg/kg after 3 weeks. Before administration, hemoglobin and platelet counts should be checked, and if the platelet count is below 50,000/mm3, administration should not commence.

This drug should not be administered to certain patients. Patients with hypersensitivity to this drug or its ingredients or pregnant women should not use it. Caution should be exercised when administering this drug to patients with a tendency to bleed or at high risk of bleeding, as well as to patients taking anticoagulants or prostacyclin. The most common side effects associated with this drug include headache, nosebleed, skin vasodilation, diarrhea, dizziness, rash, and thrombocytopenia. Since a decrease in platelet count may increase the risk of bleeding, platelet levels should be monitored and managed regularly. Additionally, a rise in hemoglobin levels may be observed during the administration of this medication, which may thicken the blood and increase the risk of thrombosis, thus requiring caution. Serious bleeding may occur, so patients should be educated about bleeding symptoms and should inform healthcare providers immediately if bleeding is suspected. Use during pregnancy may harm the fetus, so pregnant women should not take this medication, and women of reproductive age should use effective contraception during and for a period of time after treatment. The safety and efficacy of this drug in pediatric patients have not been established, so it should not be used in those under 18 years of age. For elderly patients (aged 65 years and older), no special dosage adjustments are needed; however, there may be an increased risk of bleeding, so caution is warranted. No special dosage adjustment is necessary for patients with impaired renal or hepatic function, but studies on severely impaired renal patients are limited. In cases of overdose, blood pressure and hemoglobin levels may rise, so care should be taken not to exceed dosages, and any abnormal signs should prompt immediate consultation with a healthcare provider. This drug must be prepared and administered precisely according to the instructions of a healthcare professional, and the syringe should not be reused but disposed of safely after use. Store in a sealed container to prevent air from entering, and keep it in a light-protective container at refrigeration temperatures of 2 to 8 degrees. Also, ensure the drug is not frozen. The reconstituted solution should be used as soon as possible and administered within 4 hours, with any unused solution disposed of.

• headache
• epistaxis
• capillary dilation
• diarrhea
• dizziness
• rash
• thrombocytopenia
• increased hemoglobin
• gingival bleeding
• erythema

This drug should be stored in a sealed container to prevent air entry and should be kept in a light-resistant container at refrigeration temperatures between 2 and 8 degrees. Additionally, care should be taken not to freeze the drug.

Appearance

Injectable product in a colorless transparent vial containing a white to whitish lyophilized cake or powder, and a pre-filled syringe containing colorless transparent injection water, which shows no particles and is clear or pale opalescent when dissolved with the diluent.

Package unit

1 vial/box - 1 vial/box [vial (60 mg)], 2 vials/box - 2 vials/box [vial (60 mg)]