Is Osimertinib 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 Osimertinib. 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 clinical use of osimertinib during breastfeeding. Because osimertinib is 95% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 48 hours and it might accumulate in the infant. The drug also has 2 active metabolites that have not been studied in breastmilk. The manufacturer recommends that breastfeeding be discontinued during osimertinib therapy and for 2 weeks after the final dose.

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

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

“No published information” means the studies do not exist yet — not that Osimertinib 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 “Osimertinib” (LM1276). 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.