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Palbociclib Pregnancy and Breastfeeding Warnings

Palbociclib is also known as: Ibrance

Palbociclib Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.
-Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.

Animal studies have revealed that this drug is teratogenic and fetotoxic at maternal exposures 4 times or more the human exposure. 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 exposure. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

See references

Palbociclib Breastfeeding Warnings

Because this drug is 85% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 29 hours and it might accumulate in the infant.

Use is not recommended.

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

-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 3 weeks after.

See references

References for pregnancy information

  1. "Product Information. Ibrance (palbociclib)." Pfizer U.S. Pharmaceuticals Group (2015):

References for breastfeeding information

  1. "Product Information. Ibrance (palbociclib)." Pfizer U.S. Pharmaceuticals Group (2015):

Further information

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