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® SOLOFUSE® (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection
Initial U.S. Approval: 2008
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only (2)
Routine prophylaxis (2.1)
DOSAGE FORMS AND STRENGTHS
XYNTHA SOLOFUSE is available as lyophilized powder in single-use prefilled dual-chamber syringes containing nominally 250, 500, 1000, 2000, or 3000 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 LLC. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
Pediatrics: Half-lives are shorter, volumes of distribution are larger, and recovery is lower after XYNTHA administration in children. Higher or more frequent dosing may be needed. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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