Winlevair Injection 45 mg (Sotatercept)

Adult administration

This drug is administered as a subcutaneous injection (SC) every 3 weeks, based on the patient's weight. The starting dose is 0.3 mg/kg, with the dose increased to the target dosage of 0.7 mg/kg after 3 weeks. Before the initiation of treatment and prior to dose increase, hemoglobin and platelet counts should be checked. If a dose is missed, it should be administered as soon as possible, and if not administered within 3 days, the dosing schedule should be adjusted to maintain the 3-week interval. Administer the first 5 doses.

This drug should not be used in individuals with known allergies to this drug or any of its components. It should not be administered to pregnant women as it may harm the fetus. Caution should be exercised in patients with a tendency for bleeding or at high risk of bleeding. Care should be taken if used in combination with anticoagulants. Elderly patients over the age of 65 may have an increased risk of bleeding, necessitating careful observation. Common side effects during treatment may include headache, nosebleed, skin rash, diarrhea, dizziness, among others. Periodic blood tests are necessary as platelet counts may decrease, raising bleeding risks. Hemoglobin levels may increase, resulting in symptoms of blood thickening, so regular monitoring is required. Blood pressure may rise, thus blood pressure should be monitored. Serious bleeding may occur during treatment, and any signs of bleeding should be reported to healthcare professionals immediately. Women of childbearing potential should implement effective contraception during and for at least 4 months after using this drug. Safety and efficacy have not been established for this medication in children under 18 years of age. Patients with impaired renal function can use this drug without special dosing adjustments, though there is insufficient research for those with severe renal impairment. No specific dosing adjustments are indicated for patients with liver dysfunction, but caution is advised. In cases of overdose, blood pressure and hemoglobin levels may increase, thus careful monitoring and appropriate treatment should be administered. This drug must be prepared and administered precisely by healthcare professionals, and it should be used within 4 hours after reconstitution. Storage should be at 2–8 degrees Celsius in a refrigerator, avoiding freezing, and kept out of reach of children.

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

This drug should be stored in a sealed container to protect it from air and light exposure, maintaining a temperature between 2 and 8 degrees Celsius in a refrigerated state. Additionally, care should be taken to avoid freezing the medication.

Appearance

The injection is a white to off-white freeze-dried cake or powder contained in a colorless, transparent vial, and when reconstituted with sterile water for injection, it forms a clear or slightly opalescent, colorless to pale yellowish-brown solution without any particulates.

Package unit

1 vial/box - 1 vial/box [vial (45 mg)], 2 vials/box - 2 vials/box [vial (45 mg)]