Alphanine SD

Coagulation factor IX (human), solvent detergent-treated, w/ nanofiltration

Prevention & control of bleeding in patients w/ factor IX deficiency due to hemophilia B.

Individualized dose. IV Adult Major hemorrhage eg, joint & muscle hemorrhages (especially in large muscles), major trauma, hematuria, intracranial & IP bleeding 30-50 IU FIX/kg bid. Following this treatment period, maintain FIX levels at 20 IU FIX/kg bid until healing has been achieved. May require treatment up to 10 days. Moderate hemorrhage eg, nose, mouth & gum bleeds, dental extraction, hematuria 25-50 IU FIX/kg bid until healing has been achieved (ave 2-7 days). Minor hemorrhage eg, bruise, cut or scrape, uncomplicated joint hemorrhage 20-30 IU FIX/kg bid until hemorrhage stops & healing has been achieved (1-2 days). Surgery 50-100 IU FIX/kg bid. Maintain dose for the next 7-10 days, or until healing has been achieved.

Discontinue use if symptoms of hypersensitivity occur. Not to be administered at >10 mL/min rate. Not for treatment of factor II, VII or X deficiencies & hemophilia A patients w/ factor VIII inhibitors; for reversal of coumarin anticoagulant-induced hemorrhage. Risk of transmitting infectious agents eg, viruses & Creutzfeldt-Jakob disease agent. Nephrotic syndrome in hemophilia B patients w/ factor IX inhibitors & history of severe allergic reactions to factor IX. Attempted immune tolerance induction. Consider hepatitis A & B vaccination in patients w/ hemophilia at birth or diagnosis. Closely observe surgery patients & individuals w/ known liver disease for signs or symptoms of potential disseminated intravascular coagulation (DIC); patients known to have major deletion mutations of factor IX gene for signs & symptoms of acute hypersensitivity reactions. Closely monitor previously untreated patients between 10th & 20th exposure day. Pregnancy. Ped <16 yr.

Allergic reactions, mild chills, nausea, stinging at infusion site. Thrombosis or DIC.

Haemostatics

B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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