Abemaciclib Pregnancy and Breastfeeding Warnings

Brand names: Verzenio

Abemaciclib 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.

Comments:
-Advise female patients of reproductive potential to use effective contraception during therapy and for 3 weeks after the last dose.
-Verify pregnancy status in females of reproductive potential prior to initiating therapy.
-Based on findings from animal studies, male fertility may be compromised by this drug.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. In pregnant rats administered this drug during organogenesis, developmental toxicity occurred at maternal systemic exposure approximately equal to the human exposure at the recommended dose. There are no controlled data in human pregnancy.

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

Abemaciclib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 3 weeks after the last dose.

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

Comments:
-There are no data on the presence of this drug, its effects on the breastfed infant, or the effects on milk production.
-The amount of this drug in breast milk is likely low since it is over 90% bound to plasma proteins.
-According to some authorities, there is potential for serious adverse reactions in nursing infants.

See references

Further information

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

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