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SafetyEfficacy & Safety DataPublicationsDosingDosingDosing With All-in-One ReconstitutionManufacturing and PurificationResourcesResourcesMaterialsVideosResources for Patients and CaregiversAdditional Resources
Prescribing InformationIndicationRelated: See information on our hemophilia B product
Dosing With All-in-One ReconstitutionXYNTHA comes in a travel-ready kit for your active patients1,2XYNTHA SOLOFUSE

Prefilled with XYNTHA and diluent, XYNTHA SOLOFUSE eliminates the transfer step and the vials for all-in-one reconstitution.

 XYNTHA SOLOFUSE is available in a range of dosing options Prophylactic dosing for XYNTHA
  • The recommended starting regimen for adults and adolescents (≥12 years) is 30 IU/kg administered 3 times weekly
  • The recommended starting regimen for children (<12 years) is 25 IU/kg administered every other day
    • More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group
  • Dosing amount and frequency should be adjusted based on individual clinical response
Travel-ready kit

XYNTHA SOLOFUSE is available in a travel-ready kit and a wide range of doses with everything your patients need to infuse on the go.

Additional convenience of the Rapid Reconstitution (R2) Kit

The R2 Kit comes with a low, 4-mL diluent volume, prefilled syringe; needleless transfer system; and distinct vial adapter. Available in 4 vial sizes: 250 IU, 500 IU, 1000 IU, and 2000 IU.

References:XYNTHA SOLOFUSE. Prescribing information. Pfizer Inc.; 2020.XYNTHA. Prescribing information. Pfizer Inc.; 2020. Manufacturing and Purification See the processLoading

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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.