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Verzenios ® ▼ (abemaciclib)
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Verzenios® ▼ (abemaciclib): Use in Pregnancy and Lactation and Effect on Fertility
In animal studies, Verzenios (abemaciclib) caused fetal harm and impaired fertility in males. Advise women not to breastfeed and to use contraception.
UK_cFAQ_ABE015_PREGNANCY_LACTATION_FERTILITY
en-GB
Pregnancy
Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose.1
Women of childbearing potential should use highly effective contraception methods (e.g. double‑barrier contraception) during treatment and for at least 3 weeks after completing therapy.1
Abemaciclib is not recommended during pregnancy and in women of child-bearing potential not using contraception.1
There are no data from the use of abemaciclib in pregnant women. Studies in animals have shown reproductive toxicity.1
Clinical Trial Inclusion and Exclusion Criteria in monarchE
monarchE
In the monarchE trial, women of reproductive potential were required to
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 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 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.4
Women with reproductive potential should use highly effective contraception during abemaciclib treatment and for 3 weeks after the last dose of abemaciclib.2
Fertility
The effect of abemaciclib on fertility in humans is unknown. In animal studies, no effects on female reproductive organs were observed. 1
Cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males.1
Breast-feeding
It is unknown whether abemaciclib is excreted in human milk. A risk to newborns/infants cannot be excluded. Patients receiving abemaciclib should not breast-feed.1
References
1Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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
4Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 22 April 2021
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