Summary of Use during Lactation

Delamanid is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. No information is available on the clinical use of delamanid during breastfeeding. Preliminary evidence indicates that delamanid and its active metabolite are present in milk at low levels. Delamanid is usually given with several other drugs for resistant tuberculosis, so the clinical importance of these small amounts is unclear.

Drug Levels

Maternal Levels. The breastmilk of two patients receiving delamanid in unspecified doses had peak delamanid milk levels 4 hours after a dose. One had a peak delamanid milk level of about 200 mcg/L and a level of the active metabolite DM-6705 that was undetectable (<10 mcg/L) at all time points. The second woman had a peak delamanid level of about 700 mcg/L and a peak milk level of the active metabolite DM-6705 of about 40 mcg/L at 4 hours after the dose. Because the serum level of the first patient was also low, it was thought that her adherence to the regimen was poor.[1]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

References

1.

Mkhize B, Court R, Castel S, et al. Validation and application of an online extraction and liquid chromatography tandem mass spectrometry assay for the analysis of delamanid and its DM-6705 metabolite in human breast milk. J Pharm Biomed Anal 2024;246:116225. [PubMed: 38761519]

Substance Name

Delamanid

CAS Registry Number

681492-22-8

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-infective Agents

Antitubercular Agents