Important Safety Information and Indication
OFFER TERMS: By using the Pfizer Factor Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare, or other federal or state health care programs (including any state prescription drug assistance programs) and the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). You may receive a total benefit of $12,000 per calendar year, or the amount of your co-pay over one year, whichever is less. This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs. You must deduct the value of this offer from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. The Card is not valid where prohibited by law. The Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. The Card will be accepted only at participating factor suppliers. This Card is not health insurance. Offer good only in the United States and Puerto Rico. The Card is limited to 1 per person during this offering period and is not transferable. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. Offer expires 12/31/18. No membership fees. Go to PfizerFactorSavingsCard.com and download your card today.
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® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
Reference
1. Xyntha® Solofuse® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
References
1. Xyntha® Solofuse® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
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. Data on file. Pfizer Inc, New York, NY.
References
1. Xyntha® Solofuse® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
2. Xyntha® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
References
1. Xyntha® Solofuse® Antihemophilic Factor (Recombinant) Prescribing Information, Pfizer Inc.
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.
