Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

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Verzenios® ▼ (abemaciclib): Synrelaterade biverkningar

Synrelaterade biverkningar observerades vid användning av abemaciclib i kliniska MONARCH-prövningar.

Incidence of Visual Toxicities

The most common abemaciclib visual toxicities in MONARCH 2, and MONARCH 3 are presented in Table 1

Table 1. All Grade Visual Toxicities in the Abemaciclib Arms of the MONARCH Clinical Trials1

Event, n (%)

MONARCH 2

N=441

MONARCH 3

N=327

Diplopia

1 (0.2)

1 (0.3)

Visual Acuity Reduced

1 (0.2)

1 (0.3)

Vision Blurred

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

References

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

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.

Datum fӧr senaste ӧversyn 2020 M08 19


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