Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 19 May 2017

Indication(s)

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A. (1)

Limitations of Use:
• Safety and efficacy of OBIZUR has not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 BU. (1)
• OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease. (1)

Full Prescribing information

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Advisory information

contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components, including hamster protein. (4)

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue OBIZUR and administer appropriate treatment. (5.1)
• Development of inhibitory antibodies to OBIZUR has occurred. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures porcine factor VIII inhibitor concentration. (5.2)

Adverse reactions

Common adverse reaction observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII. (6.1)

Usage information

Dosing and administration

For intravenous use after reconstitution only (2)
• Initial dose of OBIZUR is 200 units per kg. (2.1)
• Titrate dose and frequency of administration based on factor VIII recovery levels and individual clinical response. (2.1)

Use in special populations
• Pregnancy: No human or animal data. Use only if clinically needed. (8.1)

More information

Category Value
Authorisation number BLA125512
Orphan designation No
Product NDC 0944-5001
Date First Approved 23-10-2014
Marketing authorisation holder Baxter Healthcare Corporation