Monograph Details
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Hematology
> Bleeding disorders
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RECOMBINATE |
| Manufacturer |
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Baxter |
| 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; per bottle; lyophilized pwd for IV infusion after reconstitution; contains albumin; preservative-free. |
| Indications |
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Prevention and control of hemorrhagic episodes and perioperative management in Hemophilia A. |
| Adults and Children |
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See prescribing note for dosing equation. Infuse at rate of up to 10mL/min. Monitor pulse rate; if increased significantly, reduce infusion rate or hold. Hemorrhage: Mild: obtain 20–40% FVIII increase; give every 12–24hrs for 1–3 days until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3 days or until pain or disability resolved. Life-threatening: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Surgery: Minor: obtain 60–80% FVIII increase; give single infusion plus oral antifibrinolytic therapy within 1 hour; Major: pre- and post-op: obtain 80–100% FVIII increase; repeat every 8–24hrs based on healing. |
| Contraindications |
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Mouse, hamster, or bovine 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. Latex allergy. Pregnancy (Cat.C). |
| Adverse Reactions |
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Allergic reactions, nausea, fever, chills, urticaria, 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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