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Obizur Generic Name & Formulations
Legal Class
Rx
General Description
Antihemophilic Factor VIII (recombinant), porcine sequence 500 Units; per vial; lyophilized pwd for IV inj after reconstitution.
Pharmacological Class
Clotting factor.
How Supplied
Single-use vials—1, 5, 10 (w. diluent + vial adapter)
Manufacturer
Obizur Indications
Indications
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.
Obizur Dosage and Administration
Adult
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.
Children
Not established.
Obizur Contraindications
Contraindications
Hamster protein sensitivity.
Obizur Boxed Warnings
Not Applicable
Obizur Warnings/Precautions
Warnings/Precautions
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.
Obizur Pharmacokinetics
See Literature
Obizur Interactions
Not Applicable
Obizur Adverse Reactions
Adverse Reactions
Porcine factor VIII inhibitor development; hypersensitivity reactions (discontinue if occur).
Obizur Clinical Trials
See Literature
Obizur Note
Not Applicable
Obizur Patient Counseling
See Literature
