Can you take nivolumab while breastfeeding?
What LactMed says
The National Library of Medicine’s own summary, quoted in full. We do not write a verdict of our own on this question, and we do not compress theirs into a label.
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. 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.
Quoted from Nivolumab — Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, revised November 15, 2023.
How much nivolumab gets into breastmilk
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.
Infant Levels. Relevant published information was not found as of the revision date.
What has been seen in breastfed infants
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.
Frequently asked questions
Can you take nivolumab while breastfeeding?
What the NIH's Drugs and Lactation Database says about Nivolumab while breastfeeding — quoted in full. The full record is quoted on this page, and the decision is one to make with the person who prescribed it — LactMed itself states it is not a substitute for professional judgement.
Does nivolumab pass into breastmilk?
LactMed's measured drug levels for nivolumab are quoted in full on this page, under "How much gets into breastmilk".
Do I need to pump and dump after taking nivolumab?
LactMed does not frame its records that way — it reports measured drug levels in milk and what has been observed in breastfed infants, which is what this page quotes. "Pump and dump" advice for a specific drug and dose should come from your clinician or a pharmacist, not from a general rule.
More on nivolumab
LactMed states that the information it presents is not a substitute for professional judgement, and that you should consult your healthcare provider for breastfeeding advice related to your particular situation. Nothing on this page is medical advice.