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Bedaquiline Pregnancy and Breastfeeding Warnings

Bedaquiline is also known as: Sirturo

Medically reviewed on October 6, 2017

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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Sirturo (bedaquiline)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. "Product Information. Sirturo (bedaquiline)." Janssen Pharmaceuticals, Titusville, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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