Winlebrio Injection 60 mg (Sotatercept)

Adult administration

This drug should be initiated and monitored for treatment by a physician experienced in treating pulmonary arterial hypertension. Recommended starting dose: 0.3 mg/kg administered subcutaneously (SC) every 3 weeks based on the patient's weight. Recommended target dose: After 3 weeks of starting dose, check hemoglobin and platelet counts, and continue administering 0.7 mg/kg every 3 weeks. If a dose is missed, it should be administered as soon as possible, and within 3 days.

This drug should not be used in patients who are allergic to this drug or any of its components. Pregnant women should not use this drug as it may harm the fetus. Caution is required when used in patients with a tendency to bleed or at high risk of bleeding, and in those taking medications that may affect blood coagulation. Elderly patients may have a higher risk of bleeding and should be monitored closely. During the use of this drug, side effects such as headache, epistaxis, diarrhea, dizziness, skin rash, and thrombocytopenia may occur, so the symptoms should be carefully monitored. If the platelet count is very low, the risk of bleeding increases, so platelet levels must be confirmed before administration. This drug may increase blood pressure, so blood pressure should be measured and managed regularly. There is a risk of increased hemoglobin levels leading to increased blood viscosity, thus regular blood tests should be conducted. Women of childbearing potential should use effective contraception during and for at least 4 months after treatment, and pregnancy testing is recommended. This drug is not recommended for breastfeeding women, and it is advisable to avoid breastfeeding. After reconstitution, it should be used as soon as possible, and not exceed 4 hours. This drug must be prepared and administered accurately by healthcare professionals, and the injection site should be varied each time.

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

This drug should be stored in a sealed container to prevent exposure to air or light, at a refrigerator temperature between 2 to 8 degrees Celsius. Additionally, care should be taken not to freeze the drug.

Appearance

The injection is a freeze-dried cake or powder that appears white to off-white, contained in a colorless transparent vial, and when dissolved with sterile water for injection, should be free of particulate matter and results in a clear or slightly opalescent colorless to pale yellow solution.

Package unit

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