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KOGENATE FS
Bleeding disorders
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Drug Name:

KOGENATE FS Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; contains sucrose; preservative-free.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for KOGENATE FS:

Prevention and control of hemorrhagic episodes in Hemophilia A. Surgical prophylaxis in Hemophilia A. Routine prophylaxis to reduce frequency of hemorrhagic episodes and joint damage in children with Hemophilia A with no pre-existing joint damage.

Adults and Children:

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

Contraindications:

Mouse or hamster protein sensitivity.

Warnings/Precautions:

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

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Inj site reactions, dizziness, rash, BP increase, pruritus, hypersensitivity reactions, antibody formation, central venous line-associated infections.

How Supplied:

Kit—1 (vial w. diluent and BIO-SET system)

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