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Pregnancy: There are very limited 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 in pregnant women or in women of childbearing potential unless they are using a reliable form of contraception.
Breast-feeding: It is unknown whether this medicinal product or its metabolites are excreted in human milk. Available pharmacokinetic data in animals have shown excretion of delamanid and/or its metabolites in milk. Because a potential risk to the breast-feeding infant cannot be ruled out, it is recommended that women should not breastfeed during treatment with Deltyba.
Fertility: Deltyba had no effect on male or female in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no clinical data on the effects of delamanid on fertility in humans.
