Product Description

Formula & Concentration

Antihemophilic Factor (Recombinant), Porcine Sequence

Manufacturer

Takeda

Indications

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)

Product Options

Package Size

NDC #

Presentation

1-PACK 500 AU

00944-5001-01

Vial

OBIZUR-RECOMBINANT FACTOR VIII SUBSTRATE, 1 Carton = 1 vial

1505746

Vial

Shelf Life and Storage

Store OBIZUR at refrigeration temperature of 2° to 8°C [36° to 46°F]. Do not freeze. Store vials in the original package to protect from light. Do not use beyond the expiration date printed on the carton or vial. Use OBIZUR within 3 hours after reconstitution. Discard any unused reconstituted product if not used within 3 hours after reconstitution. Do not use OBIZUR if the reconstituted solution is cloudy or has particulate matter.