Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of Mycamine in pregnant women. Animal reproduction studies in rabbits showed visceral abnormalities and increased abortion at 4 times the recommended human dose. However, animal studies are not always predictive of human response. Mycamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
When pregnant rabbits were given 4 times the recommended human dose, there were increased abortion and visceral abnormalities including abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter [see Toxicology: Nonclinical Toxicology: Animal Toxicology and/or Pharmacology under Actions].
Nursing Mothers: It is not known whether micafungin is excreted in human milk. Caution should be exercised when Mycamine is administered to a nursing woman.