Monograph Details
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Hematology
> Bleeding disorders
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KOATE-DVI |
| Manufacturer |
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Talecris Biotherapeutics, Inc. |
| 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 (human) 250 IU, 500 IU, 1000 IU; per bottle; dried concentrate for IV infusion after reconstitution; contains albumin. |
| Indications |
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Prevention and control of hemorrhagic episodes or in order to perform emergency or elective surgery in Hemophilia A patients. |
| Children |
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Not recommended. |
| Adults |
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See prescribing note for dosing equation. Individualize. Infuse over 5–10 minutes if tolerated. Use filter needle. Hemorrhage: Mild: 10 IU/kg as single dose. Moderate: 15–25 IU/kg, then 10–15 IU/kg every 8–12hrs if needed. Severe: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: pre-op dose: 50 IU/kg, then verify Factor VIII level achieved prior to surgery; may repeat every 6–12hrs initially and for 10–14 days until healing complete. |
| Precautions |
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Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Contains human plasma; monitor for possible infection transmission. Large or frequent doses: monitor hematocrit for signs of progressive anemia. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). |
| Adverse Reactions |
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Allergic reactions, tingling sensations, blurred vision, headache, GI upset, jittery feeling, antibody formation. |
| How Supplied |
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Single-dose bottle—1 (w. diluent) |
| Additional Resources |
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• Related Prescribing Note |
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