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Verzenios Summary of Product Characteristics (SmPC)
Visual toxicities were observed with use of abemaciclib in the MONARCH clinical trials.
of Visual Toxicities
most common abemaciclib visual toxicities in MONARCH 2, and MONARCH 3
are presented in Table 1.
1. All Grade Visual Toxicities in the Abemaciclib Arms of the MONARCH
the abemaciclib plus fulvestrant arm of MONARCH 2, photopsia was
experienced in 2 patients (0.5%) and scintillating scotoma was
experienced in 1 patient (0.2%).1
3 unilateral blindness was experienced by 1 patient (0.3%) in the
abemaciclib plus nonsteroidal aromatase inhibitor arm of MONARCH 3.
Aside from the patient who experienced unilateral blindness in
MONARCH 3, all other visual toxicities experienced by patients in
MONARCH 2, and MONARCH 3 were of grade 1 or grade 2 severity.1
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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:August 19, 2020
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