Monograph Details
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Hematology
> Bleeding disorders
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ADVATE |
| 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, 1500 IU, 2000 IU, 3000 IU; per vial; pwd for IV inj after reconstitution; albumin- and preservative-free. |
| Indications |
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Prevention and control of hemorrhagic episodes and for perioperative management in patients with Hemophilia A. |
| Adults and Children |
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See prescribing note for dosing equation. Infuse over ≤5 minutes (max infusion rate 10mL/min); monitor pulse; 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 60–100% FVIII increase; give single bolus infusion within 1 hour of surgery, then every 12–24hrs as needed to control bleeding; Major: pre- and post-op: obtain 80–120% FVIII increase; repeat every 8–24hrs based on healing. |
| 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. Pregnancy (Cat.C). |
| Adverse Reactions |
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Headache, arthralgia, pyrexia, cough, nasopharyngitis, pharyngolaryngeal pain; antibody formation, hypersensitivity reactions. |
| How Supplied |
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Single-dose vial—1 (w. diluent, Baxject II needleless transfer device) |
| Additional Resources |
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• Related Prescribing Note |
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