Is Tafenoquine safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Tafenoquine. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No information is available on the use of tafenoquine during breastfeeding. The amounts in milk are acceptable if the infant is not glucose-6-phosphate dehydrogenase (G6PD) deficient, but tafenoquine can cause hemolysis in patients with G6PD deficiency. If tafenoquine is needed by the mother, testing the mother and infant for G6PD deficiency is required before the drug is given. Because the half-life of tafenoquine averages 15 days, the manufacturer recommends that breastfeeding should not breastfeed for 3 months after the dose if the infant is G6PD deficient, which implies complete cessation of nursing.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Six healthy lactating women with a median weight of 51 kg and infants at least one year old who were planning to stop breastfeeding were given a single dose of 300 mg (6 mg/kg) of tafenoquine. Women had breastmilk samples collected during 5 sampling windows after the dose: 8 to 15 hours, 16 to 24 hours, 30 to 42 hours, 6 to 8 days, and 12 to 16 days. The median peak concentration in breastmilk occurred at a median of 16 hours (range 12 to 36 hours), with a median peak concentration of 308 mcg/L. The authors estimated the median maximum cumulative exposure over the 75 days after a dose to be 0.51 mg/kg, or 8.5% of the maternal dose. Most of the exposure is expected to be in the first week.[1] The authors compared their result to a physiologically based pharmacokinetic model that was previously published that had two very different scenarios depending on how the milk-to-plasma ratio (M/P) was calculated.[2] Results of the clinical study were more consistent with the log-transformed method of M/P calculation.[1]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
“No published information” means the studies do not exist yet — not that Tafenoquine is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Tafenoquine” (LM1408). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.