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ALPHANINE SD
Bleeding disorders
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Drug Name:

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.

Company:
Grifols Biologicals, Inc.

Therapeutic Use:

Indications for ALPHANINE SD:

Prevention and control of bleeding in Hemophilia B.

Adult:

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.

Children:

See literature.

Warnings/Precautions:

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).

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Chills, nausea, inj site reactions; hypersensitivity reactions, thrombosis, disseminated intravascular coagulation.

Note:

Report all infections suspected to be transmitted by AlphaNine SD to (888) 675-2762.

How Supplied:

Single-use vials—1 (w. diluent, supplies)

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