an-ti-hem-oh-fill-ik fak-tor ree-kom-bi-nant por-seen
clotting factor replacements
Treatment of bleeding episodes associated with acquired Hemophilia A.
Temporarily replaces deficient levels of factor VIII.
Hemostasis in patients with acquired Hemophilia A.
Vary from patient to patient
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Used up in the hemostatic process.
TIME/ACTION PROFILE (effect on factor VIII levels)
|IV||rapid||30 min||4–12 hr|
Use Cautiously in:
Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS, development of inhibitory antibodies to porcine factor VIII
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Bleeding may be ↑ by aspirin, NSAIDs, antiplatelet agents, anticoagulants and SSRIs.
IV: (Adults) Initial dose– 200 units/kg; further doses every 4–12 hr are titrated and based on clinical response and factor VIII recovery levels.
Lyophilized powder for IV solution (requires reconstitution): 500 units/single-use vial
Lab Test Considerations:
Perform one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and maintained. Monitor factor VIII activity 30 minutes and 3 hours after initial dose. Monitor factor VIII activity 30 minutes after subsequent doses. For superficial muscle bleeding with no neurovascular compromise, and joint bleeding, Factor VIII of 50–100 units/dL or % of normal are required. For moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, or intracranial bleeding, use 100–200 units/dL or % normal to treat an acute bleed. Administer 50–100 units/dL or % of normal after acute bleed if more is required.
Hemostasis in patients with acquired Hemophilia A. If the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled after OBIZUR administration, suspect the presence of an anti-porcine factor VIII antibody. If such inhibitory antibodies to anti-porcine factor VIII are suspected and there is a lack of clinical response, consider other therapeutic options.
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