BENEFIX® Patient Counseling Information

(Coagulation Factor IX (Recombinant))

17 PATIENT COUNSELING INFORMATION

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Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
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Allergic-type hypersensitivity reactions are possible. Inform patients of 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 and contact their physicians if these symptoms occur.
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Advise patients to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

•
Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
•
Allergic-type hypersensitivity reactions are possible. Inform patients of 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 and contact their physicians if these symptoms occur.
•
Advise patients to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor.
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