Summary of Use during Lactation

The amount of rifapentine and its metabolite in milk is insufficient to treat tuberculosis in the breastfed infant. The Centers for Disease Control and Prevention and other professional organizations state that breastfeeding should not be discouraged in women taking rifapentine.[1-3] Monitor the infant for signs of liver toxicity. Breastmilk may be stained a red-orange color.

Drug Levels

Rifapentine is metabolized to 25-O-desacetylrifapentine, which has about half the in vitro activity of rifapentine against M. tuberculosis. 25-O-desacetylrifapentine has a longer half-life and accumulates over time, increasing its antimycobacterial impact.

Maternal Levels. In a study of pregnant and postpartum women with latent tuberculosis infection, participants received 12 directly observed once-weekly doses of rifapentine 900 mg, isoniazid 900 mg, and pyridoxine 25 to 100 mg. In 22 women who donated milk samples, the average rifapentine milk concentrations were about 280 mcg/L at 3 hours after the first dose, 533 mcg/L at 6 hours after the second dose and 293 mcg/L at 24 hours after the last dose. The average 25-O-desacetylrifapentine milk concentrations were about 67 mcg/L at 3 hours after the first dose, 180 mcg/L at 6 hours after the second dose and 360 mcg/L at 24 hours after the last dose.[4]

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.

Alternate Drugs to Consider

Rifampin

References

1.

Blumberg HM, Burman WJ, Chaisson RE, et al. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of tuberculosis. Am J Respir Crit Care Med. 2003;167:603–62. [PubMed: 12588714]

2.

Anon. Treatment of tuberculosis. MMWR Recomm Rep. 2003;52:1–77. [PubMed: 12836625]

3.

Bartlett JG. Guidelines section. Infect Dis Clin Pract. 2002;11:467–71. [CrossRef]

4.

Mkhize B, Kellermann T, Norman J, et al. Validation and application of a quantitative liquid chromatography tandem mass spectrometry assay for the analysis of rifapentine and 25-O-desacetyl rifapentine in human milk. J Pharm Biomed Anal. 2022;215:114774. [PMC free article: PMC9871952] [PubMed: 35462285]

Substance Name

Rifapentine

CAS Registry Number

61379-65-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-infective Agents

Antitubercular Agents

Leprostatic Agents

Rifamycins