Hyaluronidase / nivolumab Pregnancy and Breastfeeding Warnings

Brand names: Opdivo Qvantig

Medically reviewed by Drugs.com. Last updated on Feb 24, 2025.

Hyaluronidase / nivolumab Pregnancy Warnings

Safety has not been established during pregnancy; use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to evaluate a drug-associated risk. Based on findings from animal studies and its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Verify the pregnancy status of females of reproductive potential before starting treatment.
-Counsel women of childbearing potential to use effective contraception during therapy and for 5 months after the last dose.
-The effects of this drug are likely to be greater during the second and third trimesters of pregnancy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Nivolumab is an immunoglobulin G4 (IgG4) and human IgG4 is known to cross the placental barrier; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

Nivolumab: Animal studies have revealed evidence of abortion and premature infant death. Administration of this drug to pregnant monkeys from the onset of organogenesis through delivery at doses ranging from 4 to 15 times higher than clinical doses resulted in non-dose-related increases in spontaneous abortion and increased neonatal death. Based on its mechanism of action and studies in mice, fetal exposure to nivolumab may increase the risk of developing immune-mediated disorders or altering the normal immune response, and immune-mediated disorders. However, surviving infants of primates treated with nivolumab did not sustain apparent malformations or adverse effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period.

Hyaluronidase: Animal studies have failed to reveal evidence of teratogenicity. Administration of hyaluronidase to pregnant animals during the period of organogenesis at doses up to 6600 times higher than the human dose demonstrated reduced fetal weights and increased fetal resorptions; however, teratogenic effects were not reported.

There are no controlled data using any of the drugs, alone or in combination, 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

See references

Hyaluronidase / nivolumab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 5 months after the last dose.

Excreted into human milk: Yes (nivolumab); Unknown (hyaluronidase)
Excreted into animal milk: Data not available (hyaluronidase, nivolumab)

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-Limited data indicate the potential for high levels of nivolumab in human milk, which may accumulate with repeated dosing.
-This drug is a large protein molecule and likely to be partially destroyed in the infant's gastrointestinal tract, leading to minimal absorption; however, data is lacking.

See references

Further information

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