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
- Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms because these may be signs of a serious allergic reaction: wheezing, trouble breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling of the face, faintness, rash, or hives. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your healthcare provider if you have had an allergic reaction to hamster protein.
- Call your healthcare provider right away if bleeding is not controlled after using XYNTHA; this may be a sign of an inhibitor, an antibody that may stop XYNTHA from working properly. Your healthcare provider may need to take blood tests to monitor for inhibitors.
- The most common adverse reaction in the safety and efficacy study is headache (24% of subjects) and in the surgery study is fever (43% 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 may experience local irritation when infusing XYNTHA after reconstitution in XYNTHA® SOLOFUSE®.
Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.
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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.
RUS462209-01
