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.