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ERAXIS®Patient Counseling Information (anidulafungin)

17 PATIENT COUNSELING INFORMATION

Hepatic Adverse Reactions

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.

Anaphylactic and Hypersensitivity Reactions

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.

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk of ERAXIS to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.

Patients with Hereditary Fructose Intolerance (HFI)

Inform patients and caregivers that ERAXIS contains fructose and can be life-threatening when administered to patients with hereditary fructose intolerance (HFI) [see Warnings and Precautions (5.4)]. Inquire for symptoms of fructose and/or sucrose intolerance.

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