Indications for XYNTHA SOLOFUSE:
In Hemophilia A: for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.
Adults and Children:
Individualize and titrate. Give by IV infusion over several minutes. One IU of factor VIII per kg raises the plasma factor VIII activity by about 2 IU/dL. Dose (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Bleeding (Minor): obtain 20–40% FVIII increase every 12–24hrs for ≥1 day depending on severity; (Moderate): obtain 30–60% FVIII increase every 12–24hrs for 3–4 days or until hemostasis achieved; (Major): obtain 60–100% FVIII increase every 8–24hrs until resolved. Peri-op (Minor): obtain 30–60% FVIII increase every 12–24hrs for 3–4 days or until hemostasis achieved (for tooth extraction: a single dose plus oral antifibrinolytic therapy within 1hr may be sufficient); (Major): obtain 60–100% FVIII increase every 8–24hrs until resolved or adequate healing achieved. Routine prophylaxis (<12yrs): initially 25 IU/kg every other day (more frequent or higher doses may be required); (≥12yrs): initially 30 IU/kg 3 times weekly. Adjust dose based on response.
XYNTHA SOLOFUSE Contraindications:
Hypersensitivity to hamster proteins.
XYNTHA SOLOFUSE Warnings/Precautions:
Discontinue if hypersensitivity reactions occur. Monitor for development of Factor VIII inhibitors; may need dose adjustment. Pregnancy. Labor & delivery. Nursing mothers.
XYNTHA SOLOFUSE Classification:
Headache, arthralgia, pyrexia, cough, diarrhea, vomiting, asthenia; anaphylaxis.
Generic Drug Availability:
Kit—1 (w. diluent, supplies)