Monograph Details
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Hematology
> Bleeding disorders
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ALPHANINE SD |
| Manufacturer |
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Grifols Biologicals, Inc. |
| 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) 250 IU, 500 IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains non-therapeutic Factor II, Factor VII, Factor X. |
| Indications |
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Prevention and control of bleeding in Hemophilia B. |
| Children |
See literature.
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| Adults |
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See prescribing note for dosing equation. Individualize. Max infusion rate: 10mL/min. Mild hemorrhage: increase FIX 20–30% (20–30 IU/kg twice daily) for 1–2 days or until resolved. Moderate hemorrhage: increase FIX 25–50% (25–50 IU/kg twice daily) for 2–7 days. Major hemorrhage: increase FIX 50% (30–50 IU/kg twice daily) for 3–5 days then maintain at 20% (20 IU/kg twice daily) for up to 10 days. Surgery: pre-op: increase FIX 50–100% (50–100 IU/kg twice daily), then maintain at 50–100% for 7–10 days or until healed. |
| Precautions |
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Not for treating Factor II, VII, or X deficiencies; Hemophilia A with Factor VIII inhibitors, or reversal of coumarin-induced hemorrhage. Contains human plasma; monitor for transmission of infectious diseases. Previously untreated patients: closely monitor for signs of anaphylaxis between days 10 and 20 of exposure. Immune tolerance induction. Major deletion mutations in Factor IX gene. Liver disease. Surgery. Pregnancy (Cat.C). |
| Adverse Reactions |
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Chills, nausea, inj site reactions; hypersensitivity reactions, thrombosis, disseminated intravascular coagulation. |
| Extra Text |
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Note: Report all infections suspected to be transmitted by AlphaNine SD to (888) 675-2762. |
| How Supplied |
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Single-use vials—1 (w. diluent, supplies) |
| Additional Resources |
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• Related Prescribing Note |
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