Monograph Details
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Hematology
> Bleeding disorders
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HELIXATE FS |
| Manufacturer |
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CSL Behring, LLC |
| 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; dried concentrate for IV infusion after reconstitution; contains sucrose; preservative-free. |
| Indications |
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Prevention and control of hemorrhagic episodes or in order to perform emergency or elective surgery in Hemophilia A patients. |
| Adults and Children |
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See prescribing note for dosing equation. Individualize. Infuse over 5–10minutes if tolerated. Minor hemorrhage: 10–20 IU/kg; may repeat dose if needed. Moderate/major hemorrhage or minor surgery: 15–30 IU/kg; may repeat 1 dose at 12–24hrs if needed. Major/life-threatening hemorrhage, fractures or head trauma: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: pre-op dose: 50 IU/kg (verify ~100% activity prior to surgery); may repeat after 6–12hrs initially, and for 10–14 days until completely healed. |
| Contraindications |
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Mouse or hamster protein sensitivity. |
| Precautions |
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Not for treating von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). Nursing mothers. |
| Adverse Reactions |
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Inj site reactions, dizziness, rash, dysgeusia, increased BP, pruritus, depersonalization, GI upset, rhinitis; antibody formation, hypersensitivity reactions. |
| How Supplied |
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Single-use bottle—1 (w. diluent) |
| Additional Resources |
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• Related Prescribing Note |
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