Summary of Use during Lactation

Minimal information is available on the clinical use of bedaquiline during breastfeeding. Because bedaquiline is more than 99.9% bound to plasma proteins, exposure of the breastfed infant is likely to be low. However, the half-lives of the drug and its main metabolite are over 5 months. If bedaquiline is required by the mother, it is not a reason to discontinue breastfeeding. Monitor breastfed infants for adverse reactions, such as liver toxicity, nausea, arthralgia, headache, haemoptysis, and chest pain.[1]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A woman who was co-infected with HIV and rifampin-resistant tuberculosis took bedaquiline (dosage not stated) as part of her antituberculosis regimen, which consisted of pyrazinamide and other unnamed drugs. At the 1-month follow-up, the infant was small and not gaining weight well, but the mother was nauseated from her medication regimen and had also lost weight. Six months later after completion of the mother’s therapy, her infant’s weight was increasing, following the normal trajectory of the growth chart, and reaching her developmental milestones.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Loveday M, Hlangu S, Furin J. Breastfeeding in women living with tuberculosis. Int J Tuberc Lung Dis. 2020;24:880–91. [PubMed: 33156754]

Substance Name

Bedaquiline

CAS Registry Number

843663-66-1

Drug Class

Breast Feeding

Lactation

Anti-infective Agents

Antitubercular Agents