Generic Name and Formulations:
Antihemophilic Factor VIII/von Willebrand Factor Complex (human) 250 IU, 500 IU, 1000 IU, 1500 IU; per vial; lyophilized pwd for IV inj after reconstitution; contains albumin.
Grifols Biologicals, Inc.
Indications for ALPHANATE:
Prevention and control of bleeding in Hemophilia A or acquired Factor VIII deficiency. Surgical and/or invasive procedures in von Willebrand disease (VWD) when desmopressin is ineffective or contraindicated.
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Give by IV inj; max infusion rate ≤10mL/min. Hemorrhage: Minor: 15 FVIII IU/kg twice daily for 1–2 days. Moderate: 25 FVIII IU/kg twice daily for 2–7 days. Severe: 40–50 FVIII IU/kg twice daily for at least 3–5 days, then 25 FVIII IU/kg twice daily until healed (up to 10 days). Surgery: 40–50 FVIII IU/kg prior to surgery then 25–50 FVIII IU/kg twice daily for 7–10 days or until healed. Von Willebrand: pre-op dose: 60 VWF:RCof IU/kg, then 40–60 VWF:RCof IU/kg every 8–12hrs if needed; may reduce dose after 3rd post-op day; treat until healed. Others: see literature.
Give by IV inj; max infusion rate ≤10mL/min. Von Willebrand: initially 75 VWF:RCof IU/kg, then 50–75 VWF:RCof IU/kg every 8–12hrs if needed; may reduce dose after 3rd post-op day; treat until healed.
Not for those with severe VWD undergoing major surgery. Contains human plasma; monitor for possible infection transmission. Blood groups A, B or AB; large and/or frequent dosing may result in hemolytic anemia. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C).
Coagulation factor complex.
Urticaria, fever, chills, GI upset, headache, somnolence, lethargy, inj site reactions, pruritus, pharyngitis, paresthesia, facial edema, rash; antibody formation, infection, thromboembolic events (in VWD patients), hemolytic anemia (rare).
Report all infections suspected to be transmitted by Alphanate to (888) GRIFOLS.
Single-dose vial—1 (w. diluent, supplies)