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.
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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