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Abemaciclib Pregnancy and Breastfeeding Warnings

Abemaciclib is also known as: Verzenio

Abemaciclib Pregnancy Warnings

Safety has not been established during pregnancy. US FDA pregnancy category: Not Assigned Comments: -Based on animal studies and its mechanism of action, this drug may cause fetal harm and impair fertility in males of reproductive potential. -Counsel pregnant women of the potential risk to a fetus. -Perform pregnancy testing on females of reproductive potential prior to treatment initiation. -Advise females of reproductive potential to use effective contraception during treatment with this drug and for at least 3 weeks after the last dose.

Animal studies have revealed evidence of teratogenicity, increased incidence of cardiovascular and skeletal malformations and variations, and decreased fetal body weights at maternal exposures that were similar to human clinical exposure based on AUC at the maximum recommended human dose (MRHD). Findings in animals also showed adverse effects in the testis, epididymis, prostate, and seminal vesicle at doses 0.02 to 2 times the AUC in humans at the MRHD. There are no controlled data in human pregnancy. 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

Due to the potential for serious adverse reactions, breastfeeding is not recommended during treatment and for at least 3 weeks after the last dose. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the breastfed infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Verzenio (abemaciclib)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. "Product Information. Verzenio (abemaciclib)." Lilly, Eli and Company, Indianapolis, IN.

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