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Alphanate Generic Name & Formulations
Legal Class
Rx
General Description
Antihemophilic Factor VIII/von Willebrand Factor Complex (human) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU; per vial; lyophilized pwd for IV inj after reconstitution; contains albumin.
Pharmacological Class
Coagulation factor complex.
How Supplied
Single-dose vial—1 (w. diluent, supplies)
Manufacturer
Alphanate Indications
Indications
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.
Alphanate Dosage and Administration
Adult
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. Major: 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 30–50 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 full labeling.
Children
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.
Alphanate Contraindications
Not Applicable
Alphanate Boxed Warnings
Not Applicable
Alphanate Warnings/Precautions
Warnings/Precautions
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).
Alphanate Pharmacokinetics
See Literature
Alphanate Interactions
Not Applicable
Alphanate Adverse Reactions
Adverse Reactions
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).
Alphanate Clinical Trials
See Literature
Alphanate Note
Notes
Report all infections suspected to be transmitted by Alphanate to (888) GRIFOLS.
Alphanate Patient Counseling
See Literature
