Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant), porcine sequence 500 Units; per vial; lyophilized pwd for IV inj after reconstitution.
Shire US, Inc.
Indications for OBIZUR:
Treatment of bleeding episodes in acquired Hemophilia A.
Limitations Of use:
Not established in baseline anti-porcine Factor VIII inhibitor titer >20 Bethesda Units (BU). Not for treatment of congenital Hemophilia A or von Willebrand disease.
Individualize. Give by IV inj at rate of 1–2mL/min. Minor and moderate bleed: initially 200 Units/kg every 4–12hrs; titrate subsequent doses to maintain 50–100 Units/dL. Major bleed: initially 200 Units/kg every 4–12hrs; titrate subsequent doses to maintain 100–200 Units/dL (to treat acute bleed) or 50–100 Units/dL (after acute bleed is controlled, if required). Adjust based on FVIII recovery levels and clinical response.
Hamster protein sensitivity.
Monitor for development of inhibitory antibodies; consider other therapies if suspected. Perform a Nijmegen Bethesda inhibitor assay if expected plasma FVIII levels not attained or if bleeding uncontrolled with expected dose. Monitor FVIII activity 30 mins and 3hrs after initial dose, then 30 mins after subsequent doses using one-stage clotting assay. Monitor replacement therapy in major surgery or life-threatening bleeding episodes. Pregnancy (Cat.C). Nursing mothers.
Porcine factor VIII inhibitor development; hypersensitivity reactions (discontinue if occur).
Single-use vials—1, 5, 10 (w. diluent + vial adapter)