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XYNTHA® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe (antihemophilic factor [Recombinant]) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise patients to:

  • read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • report any adverse reactions or problems that concern them when taking XYNTHA to their healthcare provider.
  • discontinue use of the product, call their healthcare provider, and go to the emergency department if any allergic-type hypersensitivity reactions occur. Inform patients of the early signs of hypersensitivity reactions (including hives [rash with itching], generalized urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
  • contact their healthcare provider if they experience a lack of a clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
  • notify their healthcare provider if they become pregnant or intend to become pregnant during therapy, or if they are breastfeeding.
  • Local irritation may occur when infusing XYNTHA SOLOFUSE.

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