Pregnancy: There are no data from the use of CRESEMBA in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
CRESEMBA must not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh the possible risks to the foetus.
Women of child-bearing potential: CRESEMBA is not recommended for women of childbearing potential who are not using contraception.
Breast-feeding: Available pharmacodynamics/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to newborns and infants cannot be excluded.
Breast-feeding should be discontinued during treatment with CRESEMBA.
Fertility: There are no data on the effect of isavuconazole on human fertility. Studies in animals did not show impairment of fertility in male or female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).