Sirturo Use In Pregnancy & Lactation

Pregnancy: There are limited data on the use of SIRTURO in pregnant women. At clinically relevant exposures, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, it is recommended to avoid the use of SIRTURO during pregnancy unless the benefit of therapy is considered to outweigh the risks.
Breastfeeding: It is not known whether bedaquiline or its metabolites are excreted in human milk.
In rats, concentrations of bedaquiline in milk were 6- to 12-fold higher than the maximum concentration observed in maternal plasma. Body weight decreases in pups were noted in high dose groups during the lactation period (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Because of the potential for adverse reactions in breastfed infants, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from SIRTURO therapy taking into account the benefit of breast-feeding for the infant and the benefit of therapy for the mother.
Fertility: No human data on the effect of bedaquiline on fertility are available. In female rats, there was no effect on mating or fertility with bedaquiline treatment, however some effects were observed in male rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).