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HELIXATE FS
Bleeding disorders
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Drug Name:

HELIXATE FS Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU; per bottle; dried concentrate for IV infusion after reconstitution; contains sucrose; preservative-free.

Company:
CSL Behring, LLC

Therapeutic Use:

Indications for HELIXATE FS:

Prevention and control of hemorrhagic episodes or in order to perform emergency or elective surgery in Hemophilia A patients.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse over 5–10minutes if tolerated. Minor hemorrhage: 10–20 IU/kg; may repeat dose if needed. Moderate/major hemorrhage or minor surgery: 15–30 IU/kg; may repeat 1 dose at 12–24hrs if needed. Major/life-threatening hemorrhage, fractures or head trauma: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: pre-op dose: 50 IU/kg (verify ~100% activity prior to surgery); may repeat after 6–12hrs initially, and for 10–14 days until completely healed.

Contraindications:

Mouse or hamster protein sensitivity.

Warnings/Precautions:

Not for treating von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Inj site reactions, dizziness, rash, dysgeusia, increased BP, pruritus, depersonalization, GI upset, rhinitis; antibody formation, hypersensitivity reactions.

How Supplied:

Single-use bottle—1 (w. diluent)

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