HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XYNTHA® safely and effectively. See full prescribing information for XYNTHA®.
XYNTHA® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection
Initial U.S. Approval: 2008
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only (2)
DOSAGE FORMS AND STRENGTHS
XYNTHA is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, or 2000 IU. (3)
Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. (4)
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.