Treatment to help control bleeding in acquired hemophilia A
Fast and effective hemostasis in a clinical trial 1 *
• 100 % ( 28 / 28 ) ( 95 % CI : 88.1 – 100 ) positive response at 24 hours , 95 % ( 19 / 20 ) at 8 hours , and 100 % ( 18 / 18 ) at 16 hours 1 Measurable to assess response by standard assay , which along with individual clinical response , enables treatment evaluation and tailored dosing 1
CI = confidence interval .
Learn more at OBIZUR . com / results
* The efficacy and safety of OBIZUR for the treatment of serious bleeding episodes in adult subjects with acquired hemophilia A that required hospitalization was investigated in a prospective , open-label trial ( N = 28 ). Subjects with a prior history of bleeding disorders other than AHA , anti-porcine factor VIII antibody titer > 20 Bethesda Units ( BU ), or in whom the bleeding episode was judged likely to resolve on its own were excluded . All subjects received immunosuppressive therapy to treat their underlying autoimmune disease during the study . An initial dose of 200 units per kg OBIZUR was administered to subjects for the treatment of life- or limb-threatening initial bleeding episodes . Hemostatic response was assessed using a pre-specified rating scale that was based on subjective clinical assessments combined with objective factor VIII activity levels achieved . An assessment of effective or partially effective was considered as a positive response .
OBIZUR [ Antihemophilic Factor ( Recombinant ), Porcine Sequence ] Important Information
Indication
OBIZUR , Antihemophilic Factor ( Recombinant ), Porcine Sequence , is a recombinant DNA derived , antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A .
Limitations of Use :
• Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU
• OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease
Detailed Important Risk Information CONTRAINDICATIONS
OBIZUR is contraindicated in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components ( including traces of hamster proteins ).
WARNINGS AND PRECAUTIONS Hypersensitivity Reactions
Hypersensitivity reactions can occur with OBIZUR . OBIZUR contains trace amounts of hamster proteins . Early signs of allergic reactions , which can progress to anaphylaxis , include angioedema , chesttightness , dyspnea , hypotension , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if allergic or anaphylactic-type reactions occur .
Inhibitory Antibodies
Inhibitory antibodies to OBIZUR , including anamnestic reactions with rise in human FVIII inhibitors and / or porcine FVIII inhibitors , have occurred . Monitor patients for the development of antibodies to OBIZUR by appropriate assays . 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 are suspected and there is a lack of clinical response , consider management options such as discontinuing OBIZUR and initiating other therapeutics such as a factor VIII bypassing agent .
Monitoring Laboratory Tests
• 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
• Monitor the development of inhibitory antibodies to OBIZUR . Perform a Nijmegen Bethesda inhibitor assay if expected plasma factor VIII activity levels are not attained or if bleeding is not controlled with the expected dose of OBIZUR . Use Bethesda Units ( BU ) to report inhibitor levels
ADVERSE REACTIONS
Common adverse reactions observed in greater than 5 % of subjects in the clinical trial were development of inhibitors to porcine factor VIII .
Please see OBIZUR brief summary on following page . For full Prescribing Information , visit www . obizur . com .
REFERENCE : 1 . OBIZUR ( Prescribing Information ).
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