Generic Name and Formulations:
Antihemophilic Factor (recombinant): nominally 250 IU, 500 IU, 1000 IU, or 2000 IU; per vial; lyophilized pwd for IV inj after reconstitution; plasma/ albumin-free; preservative-free; contains polysorbate 80.
Indications for XYNTHA:
In Hemophilia A: to control and prevent bleeding episodes, and for perioperative management.
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. Bleeding (Minor): factor VIII level required is 20–40 IU/dL or % of normal, repeat infusion every 12–24 hours as needed for at least 1 day, until resolution; (Moderate): 30–60 IU/dL or % of normal; repeat infusion every 12–24 hours for 3–4 days or until hemostasis; (Major): 60–100 IU/dL or % of normal, repeat infusion every 8–24 hours until resolution. Perioperative (Minor): 30–60 IU/dL or % of normal, repeat infusion every 12–24 hours for 3–4 days or until hemostasis; (Major): 60–100 IU/dL or % of normal; repeat infusion every 8–24 hours until hemostasis and wound healing occurs.
Hypersensitivity to hamster proteins.
Discontinue if hypersensitivity reactions occur. Monitor for development of Factor VIII inhibitors; may need dose adjustment. Pregnancy (Cat.C). Labor & delivery. Nursing mothers.
Headache, arthralgia, pyrexia, cough, diarrhea, vomiting, nausea, asthenia; anaphylaxis.
Kit—1 (w. diluent, supplies)