Artemether and Lumefantrine use while Breastfeeding

Summary of Use during Lactation

Artemether and lumefantrine have not been studied in nursing mothers. Estimates of its excretion into breastmilk indicate that amounts in milk are very low. The Centers for Disease Control and Prevention consider the drug combination acceptable for use in mothers nursing an infant weighing at least 5 kg (11 pounds) and it can be given directly to infants weighing 5 kg or more.[1] The safety of the combination in breastfed infants under 5 kg is not known. Tablets can be crushed and administered in breastmilk to enhance absorption in small infants.[2]

Drug Levels

Maternal Levels. The excretion of artemether and lumefantrine in breastmilk was estimated from average maximum serum concentrations after a standard 6-dose regimen of artemether 40 mg and lumefantrine 240 mg daily, assuming a M/P ratio of 1.04 for artemether and 1.3 for lumefantrine. The authors estimated that a fully breastfed infant would receive 0.03 mg daily of artemether or less than 0.4% of the recommended dose for a 5 kg infant, and 5 mg daily of lumefantrine or less than 10% of the recommended dose for a 5 kg infant.[3]

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

Atovaquone and Proguanil, Chloroquine, Mefloquine,

References

1.

Centers for Disease Control and Prevention. Malaria. In, 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.

Adjei GO, Goka BQ, Binka F, et al. Artemether-lumefantrine: An oral antimalarial for uncomplicated malaria in children. Expert Rev Anti Infect Ther 2009;7:669-81 [PubMed: 19681693]

3.

Jain JP, Ganesan S, Lefevre G, et al. Estimating of the amount of artemether and lumefantrine excreted through breast milk. Trop Med Int Health 2015;20 (Suppl. S1):184-5

Substance Name

Artemether and Lumefantrine

CAS Registry Number

141204-94-6

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antiparasitic Agents

Antimalarials

Antiprotozoal Agents