Animal reproduction studies administering nivolumab to cynomolgus monkeys showed increased abortion and premature infant death. There are no controlled data available for the combination product. There are no controlled data in human pregnancy.

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 health care 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.

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: This drug can cause fetal harm when administered during pregnancy.

Comments:
-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.

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects 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.