Important Safety Information and Indication
Important Safety Information and Indication
- Do not use in patients who have manifested life-threatening 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.
- Across all studies, the most common adverse reactions (≥10%) with XYNTHA in previously treated adult and pediatric patients were headache (26% of subjects), arthralgia (25%), fever (21%), and cough (11%). Other adverse reactions reported in ≥5% of subjects were diarrhea, vomiting, weakness, and nausea.
- XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Patients should be advised that local irritation may occur when infusing XYNTHA after reconstitution in XYNTHA® SOLOFUSE®.
Indication
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.
Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.
Reference
1. XYNTHA SOLOFUSE [prescribing information]. New York, NY: Pfizer Inc; 2014.
References
1. XYNTHA SOLOFUSE [prescribing information]. New York, NY: Pfizer Inc; 2014.
2. Recht M, Nemes L, Matysiak M, et al. Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII. Haemophilia. 2009;15(4):869-880.
3. Windyga J, Rusen L, Gruppo R, et al. BDDrFVIII (moroctocog alfa [AF-CC]) for surgical haemostasis in patients with haemophilia A: results of a pivotal study. Haemophilia. 2010;16(5):731-739.
4. Data on file. Pfizer Inc, New York, NY.
References
1. XYNTHA SOLOFUSE [prescribing information]. New York, NY: Pfizer Inc; 2014.
2. XYNTHA [prescribing information]. New York, NY: Pfizer Inc; 2014.
References
1. XYNTHA SOLOFUSE [prescribing information]. New York, NY: Pfizer Inc; 2014.
2. Kelley B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2010;16(5):717-725.
Reference
1. Xyntha® Solofuse® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
