Is Nivolumab 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 Nivolumab. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Nivolumab milk levels in one mother were unexpectedly high and appeared to accumulate with repeated doses, possibly because it is an IgG4 antibody rather than the more typical IgG1 for other monoclonal antibodies It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] However, until more data become available, nivolumab should probably be avoided during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during nivolumab therapy and for 5 months after the last dose of the drug.
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. A mother with melanoma was started on intravenous nivolumab 480 mg every four weeks at 6 weeks post-partum. Seventy-two breast milk samples were collected over a 34-day period during the first and second cycles of therapy. A peak concentration of 157 mcg/L occurred on day 3 after the first dose, then after a decline in concentrations another increase in concentrations started at day 7 reaching a peak concentration of 503 mcg/L on day 13. The milk concentration at the time of the second dose on day 27 was about 175 mcg/L and the peak milk concentration of nivolumab at 7 days after the second dose was higher after the second dose. The authors speculated that nivolumab accumulation in milk could continue because of its long half-life.[2]
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 Nivolumab 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 “Nivolumab” (LM1164). 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.