What is XYNTHA?
Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
is indicated for the control and prevention of bleeding episodes in patients with
hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical
prophylaxis in patients with hemophilia A.
XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in
von Willebrand's disease.
Important Safety Information for XYNTHA
- Allergic reactions are possible with XYNTHA. Signs of an allergic reaction may include
hives, rash with itching, chest tightness, difficulty breathing, faintness, or fast
heartbeat. XYNTHA contains trace amounts of hamster protein. You may develop an
allergic reaction to these proteins. Tell your doctor if you have had an allergic
reaction to hamster protein.
- Call your doctor right away if bleeding is not controlled after using your factor
VIII replacement therapy; this may be a sign of an inhibitor. Inhibitors have been
observed in patients receiving factor VIII products, including XYNTHA.
- The most common adverse reaction in study 1 (safety and efficacy study) is headache
(24% of subjects) and in study 2 (surgery study) is fever (41% of subjects). Other
common side effects of XYNTHA include nausea, vomiting, diarrhea, or weakness.
- XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Local
irritation may occur when infusing XYNTHA after reconstitution in XYNTHA Solofuse.
Please see full Prescribing Information
for XYNTHA and XYNTHA Solofuse.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
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Marketed by Pfizer Inc.
September 2011
The health information contained herein is provided for educational purposes only
and is not intended to replace discussions with a health care provider. All decisions
about patient care must be made with a health care provider, considering the unique
characteristics of the patient.
The product information provided in this site is intended for residents of the United
States. The products discussed herein may have different product labeling in different
countries.
RUS292940-01