Nivolumab / relatlimab Pregnancy and Breastfeeding Warnings

Brand names: Opdualag

Medically reviewed by Drugs.com. Last updated on Sep 26, 2022.

Nivolumab / relatlimab Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-The pregnancy status of females of reproductive potential should be verified before initiating treatment with this drug.
-Females of reproductive potential should use effective contraception during treatment and for at least 5 months following treatment discontinuation.

Animal studies have revealed evidence of a non-dose-related increase in spontaneous abortion and neonatal death when administering nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery. Nivolumab was administered twice weekly at exposure levels between 9 and 42 times higher than the observed clinical dose of 3 mg/kg. There are no controlled data available for the combination product. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused, or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Nivolumab / relatlimab Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown (nivolumab, relatlimab)
Excreted into animal milk: Unknown (nivolumab, relatlimab)

Comments:
-There is no information regarding this drug's presence in human milk, its effects on a breastfed infant, or on milk production.
-As this drug could be excreted in human milk and cause potential adverse effects, the manufacturer advises not to breastfeed during treatment and for at least 5 months after the last dose.

A high level of nivolumab was detected in the breastmilk of one mother after multiple doses, possibly because it is an IgG4 antibody rather than the typical IgG1 found with other monoclonal antibodies. The excretion of nivolumab into breast milk was evaluated over 34 days in a mother who received 480 mg intravenously every 4 weeks. Drug milk levels peaked at about 157 mcg/L on day 3, declined immediately, and then peaked again at about 503 mcg/mL on day 13. The manufacturer recommends that until more data becomes available, nivolumab should be avoided during breastfeeding.

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Further information

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