Artemether and Lumefantrine and 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 much lower than the dose approved for use in African countries in young infants <5 kg (5 mg artemether plus 60 mg lumefantrine daily). If a mother requires artemether and lumefantrine, it is not a reason to discontinue breastfeeding. Tablets can be crushed and administered in breastmilk to enhance absorption in small infants.[1]

Drug levels in milk and infant serum

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.[2] A physiologically based pharmacokinetic model of the active artemether metabolite, dihydroartemesin, estimated that it has an RID of 0.2%.[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.

Alternative drugs to consider

Atovaquone and Proguanil, Chloroquine, Mefloquine,

References

1. Adjei GO, Goka BQ, Binka F, et al. Artemether-lumefantrine: An oral antimalarial for uncomplicated malaria in children. Expert Rev Anti Infect Ther 2009;7:669–81.19681693 PubMed
2. 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):184–5.25365928 PubMed
3. Almond LM, Abduljalil K, Pansari A, et al. PBPK-led assessment of antimalarial drug concentrations in breastmilk: A strategy for optimal use of prediction methods to guide decision making in an understudied population. CPT Pharmacometrics Syst Pharmacol 2025;14:738–50.39930940 PubMed