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Pregnancy: There are no data from the use of micafungin in pregnant women. In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Micafungin NIKP for Injection should not be used during pregnancy unless clearly necessary.
Breast-feeding: It is not known whether micafungin is excreted in human breast milk. Animal studies have shown excretion of micafungin in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Micafungin NIKP for Injection should be made taking into account the benefit of breast-feeding to the child and the benefit of Micafungin NIKP for Injection therapy to the mother.
Fertility: Testicular toxicity was observed in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). Micafungin may have the potential to affect male fertility in humans.
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