When Treating Acquired Hemophilia A
PROCEED WITH CONFIDENCE
FIRST: Recombinant
porcine sequence FVIII
replacement treatment1
FAST-ACTING: 95% (19/20)
response seen at 8 hours; 100%
(18/18) at 16 hours; 100% (28/28)
at 24 hours after initial dosing1
SAFETY:
No related thrombotic
events reported in
the clinical trial 2
The efficacy (N=28) and safety (N=29) of OBIZUR were studied
in the first interventional, prospective, clinical trial for acquired
hemophilia A (AHA) patients. Patients were treated with OBIZUR
until resolution of bleeding, or dosing was continued at the
physician’s discretion according to the clinical assessment.1
Indication
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is
a recombinant DNA derived, antihemophilic factor indicated for the
treatment 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, chest-tightness, dyspnea, hypotension,
wheezing, urticaria, and pruritus. Immediately discontinue
administration and initiate appropriate treatment if allergic
or anaphylactic-type reactions occur.
Visit www.OBIZUR.com
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.
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 following page for Brief Summary.
References: 1. Obizur [Prescribing Information]. Westlake Village, CA: Baxter
Healthcare Corporation; October 2014. 2. Data on file. Baxter Healthcare Corporation.
Inhibitory Antibodies
Inhibitory antibodies to OBIZUR have occurred. Monitor patients
for the development of antibodies to OBIZUR by appropriate assays.
Baxalta and Obizur are trademarks of
Baxalta Incorporated. USBS/MG114/15-0015c
MEASURABLE:
Knowing factor VIII
levels helps find the
right dosing balance1
A Confident Approach.