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ALPHANATE
Bleeding disorders
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Drug Name:

ALPHANATE Rx

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.

Company:
Grifols Biologicals, Inc.

Therapeutic Use:

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.

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. 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.

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.

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).

Pharmacological Class:

Coagulation factor complex.

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).

Note:

Report all infections suspected to be transmitted by Alphanate to (888) GRIFOLS.

How Supplied:

Single-dose vial—1 (w. diluent, supplies)

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