Monograph Details
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Hematology
> Bleeding disorders
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MONOCLATE-P |
| 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:C (human) 250 IU, 500IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains albumin. |
| Indications |
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Treatment and surgical prophylaxis for Hemophilia A. |
| Adults and Children |
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See prescribing note for dosing equation. Individualize. Infusion rate: 2mL/min if tolerated. Mild hemorrhages: single infusion to attain 30% FVIII increase. Moderate hemorrhage or minor surgery: initially 15–25 IU/kg, then 10–15 IU/kg every 8–12hrs if needed. Severe hemorrhage: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: give first dose 1 hour pre-op to attain 80–100% FVIII increase, then give a ½ dose 5 hours after first dose; maintain daily at ≥30% FVIII increase for 10–14 days post-op. |
| Contraindications |
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Mouse protein sensitivity. |
| 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 dosing: 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, chills, GI upset, inj site reactions, antibody formation. |
| Extra Text |
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Note: Report any infections suspected to be transmitted by Monoclate-P to (800) 504-5434. |
| How Supplied |
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Single-dose vial—1 (w. diluent, supplies) |
| Additional Resources |
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• Related Prescribing Note |
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