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Verzenios ^® (abemaciclib)

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How to manage hepatic toxicities in Verzenios® (abemaciclib) treated patients

Dose interruption, reduction, discontinuation, or delay in starting treatment cycles is recommended for persistent or recurrent grade 2, 3 or 4, hepatic transaminase elevations. Please find detailed information below.

UK_cFAQ_ABE013_Z1_HEPATIC_TOX_MANAGEMENT_MBC

en-GB

Management Recommendations for Hepatic Toxicities

Monitor alanine aminotransferase (ALT) and aspartate aminostransferase (AST)

prior to the start of abemaciclib therapy
every two weeks for the first two months
monthly for the next two months, and
as clinically indicated.1

Please find management recommendations for increased aminotransferases in Management recommendations for increased aminotransferases.

Management recommendations for increased aminotransferases1
Toxicitya	Management recommendations
Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN)	No dose adjustment required.
Persistent or Recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN)	Suspend dose until toxicity resolves to baseline or Grade 1. Resume at next lower dose.
Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis	Discontinue abemaciclib.
Grade 4 (>20.0 x ULN)	Discontinue abemaciclib.

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal

aNCI CTCAE

In the metastatic breast cancer trials, the increases in hepatic transaminases were manageable by dose reduction or suspension and resolved after discontinuing abemaciclib.2

Incidence and Duration of Hepatic Toxicities in Clinical

For ALT

the median time to onset of Grade 3 or 4 ALT elevation was 57 to 61 days, and
following management recommendations the median time to resolution was 14 days.

For AST

the median time to onset of Grade 3 or 4 AST elevation was 71 to 185 days, and
the median time to resolution was 13 to 15 days.1

Please find ALT, AST and blood bilirubin increases in MONARCH 2 and MONARCH 3 in ALT and AST Increases in MONARCH 2 and MONARCH 3, Blood Bilirubin Increased in MONARCH 2 andBlood Bilirubin Increased in MONARCH 3.

ALT and AST Increases in MONARCH 2 and MONARCH 32,3
	Abemaciclib + NSAI N=327	Placebo + NSAI N=161	Abemaciclib + Fulvestrant N=441	Placebo + Fulvestrant N=223
Event	MONARCH 3		MONARCH 2
Grade ≥3 ALT increase	6%	2%	4%	2%
Median time to onset	64 days	---	57 days	---
Median time to resolutiona	14 days	---	14 days	---
Grade ≥3 AST increase	4%	1%	2%	3%
Median time to onset	87 days	---	185 days	---
Median time to resolutiona	15 days	---	13 days	---

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; NSAI = nonsteroidal aromatase inhibitor.

aTo normalization or grade <3.

Blood Bilirubin Increased in MONARCH 22
CTCAE, %	All Grades	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
CTCAE, %	Abemaciclib + Fulvestrant, N=441
Blood bilirubin increased	1.6	0	0.7	0.9	0	0
	Placebo + Fulvestrant, N=223
Blood bilirubin increased	0.9	0.4	0.4	0	0	0

Abbreviation: CTCAE = Common Terminology Criteria for Adverse Events.

Blood Bilirubin Increased in MONARCH 32
CTCAE, %	All Grades	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
	Abemaciclib + NSAI, N=327
Blood bilirubin increased	1.8	0.6	0.3	0.9	0	0
	Placebo + NSAI, N=161
Blood bilirubin increased	0.6	0.6	0	0	0	0

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; NSAI = nonsteroidal aromatase inhibitor.

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.

3Rugo HS, Huober J, Garcia-Saenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist. 2021;26(1):e53-e65. http://dx.doi.org/10.1002/onco.13531

Date of Last Review: 19 January 2022

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Verzenios ® (abemaciclib)