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Bedaquiline Pregnancy and Breastfeeding Warnings

Bedaquiline is also known as: Sirturo

Bedaquiline Pregnancy Warnings

Avoid use during pregnancy unless the benefit outweighs the risks. US FDA pregnancy category: B

Animal studies have not revealed any evidence of harm to the fetus or any effects on fertility in females; some males treated with high doses failed to produce offspring. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Bedaquiline Breastfeeding Warnings

In rats treated with doses 1 to 2 times the human clinical dose (based on AUC comparisons), drug concentrations in milk were 6- to 12-fold higher than the maximum concentrations observed in maternal plasma. Offspring showed reduced body weights in high dose groups compared to control animals throughout the lactation period.

A decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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