Interactions

Active ingredient Anidulafungin interacts in the following cases:

Lactation

It is unknown whether anidulafungin is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.

A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from anidulafungin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Pregnancy

There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity.

Anidulafungin is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.

Rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm, hypotension

Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension. Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min.

Anaphylactic reactions

Anaphylactic reactions, including shock, were reported with the use of anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.

Pregnancy

There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity.

Anidulafungin is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.

Nursing Mothers

It is unknown whether anidulafungin is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.

A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from anidulafungin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Carcinogenesis, Mutagenesis and Fertility

Fertility

For anidulafungin, there were no effects on fertility in studies conducted in male and female rats.

Effects on Ability to Drive and Use Machines

Not relevant.