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Pembrolizumab Pregnancy and Breastfeeding Warnings

Pembrolizumab is also known as: Keytruda

Medically reviewed by Drugs.com. Last updated on Jun 18, 2020.

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 Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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: Not assigned.
US FDA pregnancy category: Not assigned.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.

See references

Pembrolizumab Breastfeeding Warnings

No information is available on the clinical 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.

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 therapy 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.