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Pembrolizumab Pregnancy and Breastfeeding Warnings

Pembrolizumab is also known as: Keytruda

Medically reviewed on Sep 25, 2018

Pembrolizumab Pregnancy Warnings

Based on its mechanism of action, this drug may increase the risk of immune-mediated disorders or altered normal immune response in the fetus. Additionally, an assessment of the reproduction effects suggested the drug may increase rates of abortion or stillbirth through its blockade of PD-L1 signaling. Animal reproduction studies have not been conducted, and 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 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

Comment: Females of reproductive potential should be advised to use highly effective contraception during treatment and for 4 months after the last dose.

See references

Pembrolizumab 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: Yes

Comments:
-The effects in the nursing infant are unknown.
-Mothers should discontinue nursing during treatment with this drug and for 4 months after the final dose.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Keytruda (pembrolizumab)." Merck & Company Inc, Whitehouse Station, NJ.

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Keytruda (pembrolizumab)." Merck & Company Inc, Whitehouse Station, NJ.
  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. "UK Summary of Product Characteristics." O 0

Further information

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

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