Alphanine Sd

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Alphanine Sd Generic Name & Formulations

General Description

Coagulation Factor IX (human) 500 IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains non-therapeutic Factor II, Factor VII, Factor X.

Pharmacological Class

Clotting factor.

How Supplied

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

Alphanine Sd Indications

Indications

Prevention and control of bleeding in Hemophilia B.

Alphanine Sd Dosage and Administration

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 full labeling.

Alphanine Sd Contraindications

Not Applicable

Alphanine Sd Boxed Warnings

Not Applicable

Alphanine Sd Warnings/Precautions

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).

Alphanine Sd Pharmacokinetics

See Literature

Alphanine Sd Interactions

Not Applicable

Alphanine Sd Adverse Reactions

Adverse Reactions

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

Alphanine Sd Clinical Trials

See Literature

Alphanine Sd Note

Notes

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

Alphanine Sd Patient Counseling

See Literature