INDICATION FOR XYNTHA
Xyntha® Antihemophilic Factor (Recombinant) is
indicated in adults and children with hemophilia A
(congenital factor VIII deficiency or classic hemophilia)
for control and prevention of bleeding episodes and for
perioperative management.
XYNTHA does not contain von Willebrand factor and,
therefore, is not indicated in von Willebrand’s disease.
IMPORTANT SAFETY INFORMATION FOR XYNTHA
• Do not use in patients who have manifested lifethreatening immediate hypersensitivity reactions,
including anaphylaxis, to the product or its components,
including hamster proteins.
• Allergic-type hypersensitivity reactions, including
anaphylaxis, are possible with XYNTHA. Inform patients of
the early signs or symptoms of hypersensitivity reactions
(including hives, generalized urticaria, chest tightness,
wheezing, and hypotension) and anaphylaxis. Discontinue
XYNTHA if hypersensitivity symptoms occur and
administer appropriate emergency treatment. XYNTHA
contains trace amounts of hamster proteins. Patients may
develop hypersensitivity to these proteins.
• Inhibitors have been reported following administration of
XYNTHA. Monitor patients for the development of factor
VIII inhibitors by appropriate clinical observations and
laboratory tests.
• Clinical response to XYNTHA may vary. If bleeding is
not controlled with the recommended dose of factor,
determine the plasma level and administer a dose of
XYNTHA sufficient to achieve clinical response. If the
factor level does not increase or there is no response,
suspect an inhibitor and perform appropriate testing.