XYNTHA^® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe 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).
• 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.