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Pertuzumab Pregnancy and Breastfeeding Warnings

Pertuzumab is also known as: Perjeta

Pertuzumab Pregnancy Warnings

Use is not recommended. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -This drug can cause fetal harm when administered to a pregnant woman. -If this drug is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing fetus. -Females of reproductive potential should be advised to use effective contraception while receiving this drug and for 6 months following the last dose.

Animal studies revealed evidence of oligohydramnios, delayed fetal kidney development, and embryofetal deaths. There are no controlled data in human pregnancy. Women who may be exposed to this drug during pregnancy or within 7 months after the last dose should be encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Pertuzumab 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 nursing 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: -Human IgG is excreted in human milk. -The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Perjeta (pertuzumab)." Genentech, South San Francisco, CA.

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. Perjeta (pertuzumab)." Genentech, South San Francisco, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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