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XYNTHA® Lyophilized Powder Patient Counseling Information (antihemophilic factor [Recombinant])

17 PATIENT COUNSELING INFORMATION

  • Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Advise patients to report any adverse reactions or problems that concern them when taking XYNTHA to their healthcare provider.
  • Allergic-type hypersensitivity reactions are possible. Discuss the early signs of hypersensitivity reactions (including hives [rash with itching]), generalized urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis. Advise patients to discontinue use of the product, call their healthcare provider, and go to the emergency department if these symptoms occur.
  • Advise patients to 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.
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy, or if they are breastfeeding.
  • Advise patients to consult their healthcare provider prior to travel and to bring an adequate supply of XYNTHA, based on their current regimen, for anticipated treatment when traveling.
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