Monograph Details
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Hematology
> Bleeding disorders
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KOGENATE FS |
| Manufacturer |
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Bayer Corp, Pharmaceutical Div. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Clotting factor. |
| Generic Name |
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Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; contains sucrose; preservative-free. |
| Indications |
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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 |
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See prescribing note for dosing equation. 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 |
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Mouse or hamster protein sensitivity. |
| Precautions |
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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. |
| Adverse Reactions |
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Inj site reactions, dizziness, rash, BP increase, pruritus, hypersensitivity reactions, antibody formation, central venous line-associated infections. |
| How Supplied |
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Kit—1 (vial w. diluent and BIO-SET system) |
| Additional Resources |
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• Related Prescribing Note |
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