Verzenio® (Abemaciclib)

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Abemaciclib: Alopecia

The majority of alopecia events with abemaciclib were grade 1, defined as <50% hair loss that is not obvious and does not require a wig or hair piece.

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NCI CTCAE Grade Definition

This medical response may not completely match the information in the current local labeling for ABEMACICLIB. Please see local labeling for approved label information.

In the abemaciclib clinical trials, toxicities were graded according to the NCI CTCAE Version 4.03.1

The grade definition for alopecia is shown in NCI CTCAE Grade Definition.

NCI CTCAE Grade Definition2

Adverse Event

Grade 1

Grade 2

Grade 3

Grade 4

Alopecia

A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location

Hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection;

a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage.

Hair loss of ≥50% normal for that individual that is readily apparent to others;

a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.

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Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events Version 4.03; NCI = National Cancer Institute.

Incidence of Alopecia in Clinical Trials

The incidence of alopecia is presented in Alopecia in the Abemaciclib Arms of the MONARCH Clinical Trials.

Alopecia in the Abemaciclib Arms of the MONARCH Clinical Trials1

Study

Alopecia, %

All Grades

Grade 1

Grade 2

Grade 3

Grade 4

MONARCH 1
(N=132)

12

10

2

NA

NA

MONARCH 2
(N=441)

16

14

2

NA

NA

MONARCH 3
(N=327)

28

25

2

NA

NA

Abbreviation: NA = not applicable per CTCAE definition.

References

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

2US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Version 4.03. May 28, 2009. Accessed March 15, 2021. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf

Glossary

CTCAE = Common Terminology Criteria for Adverse Events

NCI = National Cancer Institute

Fecha de la última revisión: 2021 M06 15


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