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Nivolumab Pregnancy and Breastfeeding Warnings

Nivolumab is also known as: Opdivo

Nivolumab Pregnancy Warnings

Human immunoglobulin G4 (IgG4) crosses the placenta and has the potential to be transmitted to the developing fetus. In animal studies, administration of this drug from onset of organogenesis through delivery resulted in increased abortion and premature infant death. Effects of drug therapy are likely greater during the second and third trimester. 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:
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 is not recommended.

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

Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-May cause fetal harm; pregnant women should be advised of the potential risk to the fetus.
-Women of child-bearing potential should use contraception during therapy and for at least 5 months following the last dose.

See references

Nivolumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

References for pregnancy information

  1. "Product Information. Opdivo (nivolumab)." Bristol-Myers Squibb, Princeton, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Opdivo (nivolumab)." Bristol-Myers Squibb, Princeton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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