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Bedaquiline Pregnancy and Breastfeeding Warnings

Bedaquiline is also known as: Sirturo

Bedaquiline Pregnancy Warnings

FDA pregnancy category: B Bedaquiline should be used only if clearly needed.

Animal studies have failed to reveal evidence of fetal harm. The corresponding plasma exposure (AUC) was 2-fold higher in rats compared to humans in reproduction studies. There are no controlled data in human pregnancy. 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

Rats treated with doses 1 to 2 times the clinical dose (base on AUC comparisons) had levels in milk 6- to 12-fold higher than the maximum level seen in maternal plasma. The pups from these rats had reduced body weights compared to control animals during lactation.

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

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