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ERAXIS® (anidulafungin) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

17.1 Hepatic Effects

Inform patients about the risk of developing abnormal liver function tests and/or hepatic dysfunction. Advise the patient that liver function tests may be monitored during treatment.

17.2 Hypersensitivity

Inform the patient that anaphylactic reactions, including shock were reported with ERAXIS. Inform the patient if these reactions occur, ERAXIS may be discontinued and appropriate treatment administered.

Inform the patient that ERAXIS is also known to cause infusion-related adverse reactions, possibly histamine-mediated. Inform the patient to report symptoms including rash, urticaria, flushing, pruritus, dyspnea, and hypotension to their healthcare provider.

17.3 Pregnant Women and Breastfeeding Mothers

Inform patients that ERAXIS has not been studied in pregnant women or breastfeeding mothers so the effects of ERAXIS on pregnant women or breastfed infants are not known. Instruct patients to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant. Instruct patients to tell their healthcare provider if they plan to breastfeed their infant.

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