Bedaquiline Pregnancy and Breastfeeding Warnings

Brand names: Sirturo

Medically reviewed by Drugs.com. Last updated on Jul 24, 2023.

Bedaquiline Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform regarding drug-related risk of birth defects, miscarriage, or adverse maternal/fetal outcomes. Active tuberculosis is associated with adverse maternal and/or neonatal outcomes.

Comment: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have failed to reveal evidence of direct or indirect harm on reproductive toxicity (e.g., embryotoxicity, fetotoxicity), and fetal harm, at doses at least 6 times the recommended human dose (based on AUC) given during organogenesis. Active tuberculosis has been associated with maternal anemia, cesarean section, birth asphyxia, low birth weight, preterm birth, and perinatal infant death. There are no controlled data in human pregnancy.

A small number of male animal models have revealed evidence of failure to produce pups when given high doses. There are no controlled data in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Bedaquiline Breastfeeding Warnings

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

Comments:
-The effects in the nursing infant are unknown.
-Breastfed infants should be monitored for signs/symptoms of adverse reactions (e.g., arthralgia, chest pain, headache, hemoptysis, hepatotoxicity, nausea).
-The effects of this drug on milk production are unknown.

Animal models given 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. Pups in high-dose groups had reduced body weights compared to control groups when this drug was given throughout lactation.

See references

Further information

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