Summary of Use during Lactation

Limited information indicates that a maternal dose of 200 mg orally produced low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Withholding breastfeeding for 6 hours after a dose should markedly reduce the dose the infant receives.

In general, very small amounts of antimalarial drugs are excreted in the breast milk of lactating women. Because the quantity of antimalarial drugs transferred in breast milk is insufficient to provide adequate protection against malaria, infants who require chemoprophylaxis must receive the recommended dosages of antimalarial drugs.[1]

Drug Levels

Maternal Levels. After a single oral dose of 200 mg of artesunate to nursing mothers (number not stated), artesunate was undetectable in breastmilk (<5 mcg/L) at any time. The active metabolite, dihydroartemisinin, reached a peak concentration in breastmilk of about 35 mcg/L at 90 minutes after the dose, and was undetectable (<2.5 mcg/L) 6 hours after the dose.[2]

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

Effects in Breastfed Infants

Breastfed infants who were given dihydroartemisinin and piperaquine as a treatment for malaria had a higher frequency of vomiting than non-breastfed infants given the drugs. Whether this finding applies to infants who receive dihydroartemisinin via breastmilk has not been studied.[3]

Effects on Lactation and Breastmilk

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

References

1.

Malaria In: Prevention CfDCa, ed. CDC Yellow Book 2024: Health Information for International Travel. New York: Oxford University Press; 2024 https://wwwnc​.cdc.gov​/travel/yellowbook/2024​/infections-diseases​/malaria#treatment

2.

Jansen FH, Jansen-Luts A, Ameye C, et al. Is artesunate or its active metabolite dihydroartemisinin being excreted in the milk of lactating mothers? [Abstract 543]. Am J Trop Med Hyg 2006;75 (5 Suppl):158. doi:10.4269/ajtmh.2006.75.151 [CrossRef]

3.

Creek D, Bigira V, Arinaitwe E, et al. Increased risk of early vomiting among infants and young children treated with dihydroartemisinin-piperaquine compared with artemether-lumefantrine for uncomplicated malaria. Am J Trop Med Hyg 2010;83:873-5. [PMC free article: PMC2946759] [PubMed: 20889882]

Substance Name

Artesunate

CAS Registry Number

88495-63-0

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-infective Agents

Antiparasitic Agents

Antimalarials

Antiprotozoal Agents