Skip to Content
Not all colorectal cancer treatments are the same. Find out more >

Nivolumab Pregnancy and Breastfeeding Warnings

Nivolumab is also known as: Opdivo

Nivolumab Pregnancy Warnings

As human immunoglobulin G4 (IgG4) is known to cross the placenta, this drug, an IgG4 monoclonal antibody, 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: This drug can cause fetal harm when administered to a pregnant woman based on its mechanism of action. In animal studies, administration of from the onset of organogenesis through delivery resulted in increased abortion and premature infant death. 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 clinical use of this drug during breastfeeding. Because it is a large protein molecule with a molecular weight of 146,000, 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. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

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

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide