SAFETY DATA

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Safety profile

Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII (FVIII).1 The safety and efficacy of OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence has not been established in patients with baseline anti-porcine FVIII inhibitor titer greater than 20 BU.1

  • The majority of patients received immunosuppressants concomitantly3

Safe and effective in the adult population1

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Safe and effective in the adult population1

  • 10/28 subjects had detectable anti-porcine FVIII at baseline3
  • 28/28 patients showed a positive response at 24 hours1

Minimize the risk of overdosing by measuring FVIII activity levels1,3

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Minimize the risk of overdosing by measuring FVIII activity levels1,3

  • None of the subjects in the OBIZUR clinical trial experienced any related thrombotic events3