If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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.
Can Verzenio® (abemaciclib) be used during pregnancy or lactation and is there an 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
Preclinical Data
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 area under the curve (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
Early Breast Cancer
Clinical Trial Inclusion and Exclusion Criteria in monarchE
monarchE
In the monarchE trial, women of reproductive potential were required to
Advanced or Metastatic Breast Cancer
Clinical Trial Inclusion and Exclusion Criteria in the MONARCH Trials
MONARCH 2
Patients in the MONARCH 2 trial were required to have postmenopausal status, due to either surgical/natural menopause or ovarian suppression (pre/perimenopausal) (initiated at least 28 days prior to day 1 of cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin.2
Postmenopausal status due to surgical/natural menopause required at least one of the following
- prior bilateral oophorectomy
- age ≥60 years
- age <60 years and amenorrheic (nontreatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Estradiol and follicle-stimulating hormone (FSH) must have been in the postmenopausal range.2
If postmenopausal status was due to ovarian suppression with a GnRH agonist, women of reproductive potential must
- have a negative serum pregnancy test at baseline (within 14 days prior to randomization), and
- agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of study drug.2
MONARCH 3
Patients in the MONARCH 3 trial were required to have postmenopausal status, defined as meeting one of the following conditions
- prior bilateral oophorectomy
- age ≥60 years
- age <60 years and amenorrheic (nontreatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Estradiol and FSH must have been in the postmenopausal range.2
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 in the MONARCH and monarchE Trials
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
Paternal Exposure to Abemaciclib in the MONARCH Trials
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.2
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.2
Abemaciclib may impair fertility in males of reproductive potential.1
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. https://doi.org/10.1200/JCO.20.02514
Date of Last Review: September 26, 2023