Monograph Details
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Hematology
> Bleeding disorders
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MONONINE |
| 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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Coagulation Factor IX (human) 500 IU, 1000 IU; per vial; lyophilized pwd for IV infusion after reconstitution. |
| Indications |
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Prevention and control of bleeding in Hemophilia B. |
| Adults and Children |
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See prescribing note for dosing equation. Individualize. Infuse at a rate of 2mL/min. Minor spontaneous hemorrhage, prophylaxis: increase FIX 15–25%; give up to 20–30 IU/kg once; may repeat in 24hrs if needed. Major trauma, surgery: increase FIX 25–50%; give up to 75 IU/kg every 18–30hrs for up to 10 days; adjust based on FIX levels. FIX inhibitors: may use higher doses. |
| Contraindications |
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Mouse protein sensitivity. |
| Precautions |
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Not for Hemophilia A or other factor deficiencies, reversal of coumarin-induced anticoagulation or for bleeding due to low levels of liver-dependant coagulation factors. Fibrinolysis, disseminated intravascular coagulation (DIC), liver disease, neonates, or during post-op period; increased risk of thromboembolic events. Immune tolerance induction. Contains human plasma; monitor for possible infection transmission. Monitor for Factor IX inhibitors and deletion mutations of Factor IX gene; increased risk of hypersensitivity reactions. Pregnancy (Cat.C). |
| Adverse Reactions |
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Headache, fever, chills, flushing, GI upset, tingling, lethargy, inj site reaction, elevated ALT, inhibitor development; hypersensitivity reactions, thrombosis. |
| Extra Text |
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Note: Report all infections suspected to be transmitted by Mononine 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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