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Ipilimumab Pregnancy and Breastfeeding Warnings

Ipilimumab is also known as: Yervoy

Medically reviewed on April 23, 2018

Ipilimumab Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: In animal studies, this drug caused higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birth weight), and infant mortality in a dose-related manner. The effects are likely to be greater during the second and third trimesters of pregnancy.

Comments:
-Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
-Human IgG1 is known to cross the placental barrier and may be transmitted from the mother to the developing fetus.
-Females reproductive potential should use effective contraception during therapy and for 3 months following the last dose.
-Advise pregnant women of the potential risk to a fetus.

Animal reproduction studies have shown reproductive toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

See references

Ipilimumab Breastfeeding Warnings

The amount of this drug present in breastmilk appears to be very low, but it appears to increase with subsequent doses during a treatment cycle. Absorption from the infant GI tract is unknown. Because this drug is a large protein molecule absorption is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant GI tract.

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

Excreted into human milk: Data not available; however, human IgG is known to be secreted in human breast milk.
Excreted into animal milk: Yes

Comments:
-Secretion of IgG in human milk is generally limited and IgG has a low oral bioavailability.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Yervoy (ipilimumab)." 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. 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 -]):
  2. "Product Information. Yervoy (ipilimumab)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  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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