Winlebe Air Kit Injection 45 mg (Sotatercept)

Adult administration

This medication should be initiated and monitored by a physician with experience in treating pulmonary arterial hypertension. Subcutaneous injection (SC) is administered every 3 weeks according to the patient's weight. The starting dose is 0.3 mg/kg, which can be increased to the target dose of 0.7 mg/kg after 3 weeks. Hemoglobin and platelet counts should be checked before each administration, and if no dose adjustments are needed, 0.7 mg/kg should be given every 3 weeks.

This drug should not be used in patients who are allergic to this drug or its ingredients or in pregnant women. Caution should be exercised in patients at risk of bleeding or with a tendency to bleed, as well as those taking anticoagulants. While it can be used in the elderly without special dose adjustments, careful monitoring is needed due to a higher risk of bleeding. Common side effects during use may include headache, epistaxis, skin rash, diarrhea, dizziness, and thrombocytopenia. During treatment, hemoglobin levels and platelet counts should be regularly monitored to check for abnormalities. If platelet counts are very low, this medication should not be initiated, and it should be discontinued immediately if significant bleeding occurs. It should not be administered during pregnancy due to potential harm to the fetus, and women of childbearing age should ensure effective contraception during and for some time after treatment. This drug is not recommended for lactating women due to insufficient safety data. Safety and efficacy have not been established for pediatric patients, and its use in children is not advised. In patients with impaired kidney function, dose adjustments are not generally needed, but studies in severe renal impairment are lacking. There is also a lack of studies in patients with impaired liver function, but since it is metabolized in the liver, it is expected to have minimal impact. In the event of overdose, blood pressure and blood levels should be closely monitored, and necessary treatment should be provided. This drug must be prepared and administered correctly under the guidance of healthcare professionals, and patients or guardians should be thoroughly educated on its use. The reconstituted solution should be used as soon as possible and discarded if not used within 4 hours. This drug should be stored in a refrigerator and kept out of reach of children.

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

This medication should be stored in a sealed container to prevent air and moisture ingress. It is advisable to keep it away from direct sunlight and in a location that is shielded from light. Additionally, it should be stored at refrigeration temperatures between 2 degrees and 8 degrees Celsius, making sure not to freeze it.

Appearance

The injection is a white to off-white freeze-dried cake or powder contained in a colorless and transparent vial, as well as a colorless and transparent prefilled syringe containing a solvent. When reconstituted, it should be free of visible particles and appear clear or opalescent.

Package unit

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