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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  ReactionsInhibitor rate in clinical trialsAcross clinical trials of PTPs, XYNTHA has demonstrated a low rate of inhibitor
formation

Immunogenicity

  • Evaluated in multiple clinical trials of 167 adult and pediatric PTPs with ≥50 exposure days
  • Across all studies, 2 adult PTPs and 2 pediatric PTPs (2.4%) developed FVIII inhibitors
  • In the surgical study of 30 patients, 1 low-titer, persistent and 1 transient, false-positive inhibitor were reported

Additional inhibitor data

  • A Bayesian statistical analysis was used to calculate the posterior probability that the population (true) inhibitor rate was below a predefined acceptable value (4.4%, 95% CI)
  • Bayesian analysis indicates that the estimate of 95% upper limit of the population (true) inhibitor rate for XYNTHA was 4.17%
  • This analysis included data from 3 studies in PTPs

Monitor patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.

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.Efficacy & Safety

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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.