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Pregnancy: There are no or limited amount of data from the use of delamanid in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Deltyba is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether delamanid/metabolites are excreted in human milk. Available pharmacokinetic/toxicological data in animals have shown excretion of delamanid and/or its metabolites in milk (for details see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the newborns/infant cannot be excluded. It is recommended that women should not breastfeed during treatment with Deltyba.
Fertility: Deltyba had no effect on male or female fertility in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no clinical data on the effects of delamanid on fertility in humans.
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