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Prescribing InformationIndicationRelated: See information on our hemophilia B product
Efficacy & Safety DataXYNTHA—Proven efficacy and an established safety profile1-4Bleed Control and PreventionProphylaxisInhibitor DataAdverse ReactionsProphylactic bleed protection for PTPsIn adolescents and adults

of patients reported no bleeding (N=94)

  • 1.9 median annualized bleeding rate (ABR) (interquartile range [IQR], 0.00-5.56)
  • Zero median ABR for patients who experienced spontaneous (IQR, 0.00-2.14) or traumatic (IQR, 0.00-2.14) bleeds
In children

of patients reported no bleeding (N=8)

  • 0.6 median ABR (IQR, 0.00-2.17)
  • Zero median ABR for patients who experienced spontaneous (IQR, 0.00-0.56) or traumatic (IQR, 0.00-1.79) bleeds

Study design
Two completed open-label studies compared the ABRs of 102 subjects (94 subjects ≥12 years of age and 8 subjects <12 years of age) who received XYNTHA for routine prophylaxis with those who used on-demand treatment alone. XYNTHA was administered for routine prophylaxis at a dose of 25 ± 5 IU/kg every other day (in subjects <12 years of age) or 30 ± 5 IU/kg administered 3 times weekly (in subjects 12 years of age or older), with provisions for dose escalation based on pre-specified criteria (over a 4-week period, 2 spontaneous bleeds into a major joint and/or target joint, or 3 or more spontaneous bleeding episodes in any location). Among these 102 subjects, 7 dose escalations were prescribed for 6 subjects.

References:XYNTHA SOLOFUSE. Prescribing information. Pfizer Inc.; 2020.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. doi:10.1111/j.1365-2516.2009.02027.xWindyga 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. doi:10.1111/j.1365-2516.2010.02239.xData on file. Pfizer Inc., New York, NY.

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PP-MCL-USA-0367
INDICATION XYNTHA® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.  XYNTHA is not indicated in patients with von Willebrand’s disease. 

Please see full  Prescribing Information  for XYNTHA and  XYNTHA SOLOFUSE.

Important Safety Information
  • 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 (24% of subjects), arthralgia (23%), fever (23%), and cough (12%). Other adverse reactions reported in ≥5% of subjects were diarrhea, vomiting, and weakness.
  • 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 for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. 

XYNTHA is not indicated in patients with von Willebrand’s disease.

Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.