Alphanine Sd Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
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