Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free | Safety Info

Important Safety Information

Call your health care 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, difficulty breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling of the face, faintness, rash, low blood pressure, or hives. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your health care provider if you have had an allergic reaction to hamster protein.
Call your health care 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 health care provider may need to take blood tests to monitor for inhibitors.
Across all clinical studies, the most common side effects (10% or more) with XYNTHA in adult and pediatric previously treated patients were headache (24% of subjects), joint pain (23%), fever (23%), and cough (12%). Other side effects reported in 5% or more of patients were diarrhea, vomiting, and weakness.
XYNTHA is an injectable medicine administered by intravenous (IV) infusion. You may experience local irritation when infusing XYNTHA after reconstitution in XYNTHA ^® SOLOFUSE ^®.

XYNTHA ^® Antihemophilic Factor (Recombinant) is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia. Your doctor might also give you XYNTHA before surgical procedures.

XYNTHA is not used to treat von Willebrand’s disease.

Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.

Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a health care provider.

PP-XYN-USA-0507

July 2023

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Important Safety Information

What Is XYNTHA?