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Published on: October 11, 2019
Tafenoquine lactation pharmacokinetics: a pilot study
Mary Ellen Gilder1,2, Thanaporn Wattanakul3, Joel Tarning4,3
1Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 78/1 Moo 5 Mae Ramat, Tak, 63140, Thailand. Mellie@shoklo-unit.com.
Tafenoquine is excreted in breastmilk at low levels, with estimated infant doses below safety thresholds. Further research is needed to confirm tafenoquine safety for breastfeeding mothers and infants.
Area of Science:
- Pharmacology
- Maternal-fetal medicine
- Infectious diseases
Background:
- Radical cure of Plasmodium vivax malaria requires 8-aminoquinolines.
- Tafenoquine offers advantages over primaquine for single-dose treatment.
- Excretion of tafenoquine in breastmilk and infant safety are unknown.
Purpose of the Study:
- To quantify tafenoquine excretion in human breastmilk.
- To estimate the dose of tafenoquine ingested by breastfed infants.
- To inform recommendations for breastfeeding women on tafenoquine use.
Main Methods:
- Pilot pharmacokinetic study in six healthy lactating volunteers.
- Paired breastmilk and venous blood samples collected serially.
- Analysis of foremilk and hindmilk for tafenoquine concentrations.
Main Results:
- Tafenoquine concentrations in milk were similar to plasma concentrations (milk/plasma ratio 1.09).
- Estimated infant doses were below conventional safety thresholds (RID < 13.52%).
- Tafenoquine was well tolerated by mothers.
Conclusions:
- Tafenoquine is measurable in breastmilk in small amounts.
- Further studies are required to confirm infant safety and establish dosing guidelines.
- Recommendations for breastfeeding women require additional data on infant exposure and outcomes.
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