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Palbociclib Pregnancy and Breastfeeding Warnings

Palbociclib is also known as: Ibrance

Medically reviewed on April 13, 2017

Palbociclib Pregnancy Warnings

This drug can cause fetal harm based on findings in animals and its mechanism of action.

US FDA pregnancy category: Not assigned

Comments:
-Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during therapy and for at least 2 weeks after the last dose.
-Advise females to contact their healthcare provider if they become pregnant or if pregnancy is suspected during treatment.
-Animal studies suggest this drug may compromise male fertility.

Animal studies have revealed that this drug is teratogenic and fetotoxic at maternal exposures 4 times or more the human clinical exposure (based on AUC at the recommended human dose). Embryofetal toxicities included reduced fetal body weights and increased incidence of skeletal variations. In repeat-dose toxicity studies in animals, testicular degeneration was observed at doses ranging from 0.1 to 11 times the human clinical exposure. There are no controlled data in humans.

See references

Palbociclib Breastfeeding Warnings

Discontinue breastfeeding during treatment.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects on the breastfed child are unknown; however, this drug has potential to cause serious adverse reactions in nursing infants.

See references

References for pregnancy information

  1. "Product Information. Ibrance (palbociclib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. "Product Information. Ibrance (palbociclib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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