Verzenio® (Abemaciclib)

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Abemaciclib: Visual Toxicity

Visual toxicities were observed with use of abemaciclib in the MONARCH clinical trials.

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Incidence of Visual Toxicities

The most common abemaciclib visual toxicities in MONARCH 1, MONARCH 2, and MONARCH 3 are presented in All Grade Visual Toxicities in the Abemaciclib Arms of the MONARCH Clinical Trials. 

All Grade Visual Toxicities in the Abemaciclib Arms of the MONARCH Clinical Trials1

Event, n (%)

MONARCH 1

N=132

MONARCH 2

N=441

MONARCH 3

N=327

Diplopia

0 (0)

1 (0.2)

1 (0.3)

Visual Acuity Reduced

1 (0.8)

1 (0.2)

1 (0.3)

Vision Blurred

3 (2.3)

12 (2.7)

6 (1.8)

In 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

Grade 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 1, MONARCH 2, and MONARCH 3 were of grade 1 or grade 2 severity.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Fecha de la última revisión: 2020 M08 19


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