Kogenate Fs

  • Bleeding disorders

Kogenate Fs Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

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


Kogenate Fs Indications


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.

Kogenate Fs Dosage and Administration

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.

Kogenate Fs Contraindications


Mouse or hamster protein sensitivity.

Kogenate Fs Boxed Warnings

Not Applicable

Kogenate Fs 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.

Kogenate Fs Pharmacokinetics

See Literature

Kogenate Fs Interactions

Not Applicable

Kogenate Fs Adverse Reactions

Adverse Reactions

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

Kogenate Fs Clinical Trials

See Literature

Kogenate Fs Note

Not Applicable

Kogenate Fs Patient Counseling

See Literature