ALPHANINE SD Rx
Generic Name and Formulations:
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.
Grifols Biologicals, Inc.
Indications for ALPHANINE SD:
Prevention and control of bleeding in Hemophilia B.
Dosage Required (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. 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.
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).
Chills, nausea, inj site reactions; hypersensitivity reactions, thrombosis, disseminated intravascular coagulation.
Report all infections suspected to be transmitted by AlphaNine SD to (888) 675-2762.
Single-use vials—1 (w. diluent, supplies)
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