Verzenio ® (abemaciclib) tablets

50mg, 100mg, 150mg, 200mg

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

VERZENIO® (abemaciclib): Use in Pregnancy and Lactation and Effect on Fertility

In animal studies, Verzenio (abemaciclib) caused fetal harm and impaired fertility in males. Advise women not to breastfeed and to use contraception.

Pregnancy Risk

Based on findings in animals and its mechanism of action, abemaciclib can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of abemaciclib during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on AUC at the maximum recommended human dose. There are no available human data informing the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus.1

Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with abemaciclib.1

Women with reproductive potential should use highly effective contraception during abemaciclib treatment and for 3 weeks after the last dose of abemaciclib.1

Lactation Risk

There are no data on the presence of abemaciclib in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from abemaciclib, advise lactating women not to breastfeed during abemaciclib treatment.1

Fertility Risk

Studies to assess the effects of abemaciclib on fertility have not been performed. In repeat-dose toxicity studies up to 3-months duration, abemaciclib-related findings in the testis, epididymis, prostate, and seminal vesicle at doses ≥10 mg/kg/day in rats and ≥0.3 mg/kg/day in dogs included

  • decreased organ weights

  • intratubular cellular debris

  • hypospermia

  • tubular dilatation

  • atrophy, and

  • degeneration/necrosis.

These doses in rats and dogs resulted in approximately 2 and 0.02 times, respectively, the exposure (AUC) in humans at the maximum recommended human dose.1

Abemaciclib may impair fertility in males of reproductive potential.1

Enclosed Prescribing Information

VERZENIO® (abemaciclib) tablets, for oral use, Lilly

References

1. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

AUC = area under the curve

Date of Last Review: January 27, 2020

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