Verzenio® (Abemaciclib)

Para consultar la información para prescribir completa de Verzenio® (Abemaciclib) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Abemaciclib: Cramping

Abemaciclib dose modification recommendations for adverse reactions including abdominal cramping/pain are available.

MX_cFAQ_ABE085_CRAMPING
MX_cFAQ_ABE085_CRAMPING
es-MX

Detailed Information

The information contained in this letter may not completely match the current local labeling for ABEMACICLIB. Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.

The NCI CTCAE does not provide a definition for abdominal cramping.1

The NCI CTCAE definition of abdominal pain is defined as a disorder characterized by a sensation of marked discomfort in the abdominal region.1 The NCI CTCAE grade definition of abdominal pain is presented in NCI CTCAE Grade Definitions.

NCI CTCAE Grade Definitions1

Adverse Event

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Abdominal pain

Mild pain

Moderate pain; limiting instrumental ADL

Severe pain; limiting self care ADL

NA

NA

Abbreviations: ADL = activities of daily living; CTCAE = Common Terminology Criteria for Adverse Events; NA = not applicable; NCI = National Cancer Institute.

Abemaciclib dose modification recommendations for adverse reactions including abdominal cramping and abdominal pain are provided in Abemaciclib Dose Modification for Adverse Reactions and Abemaciclib Dose Modification and Management - Nonhematologic Toxicities Excluding Diarrhea, ALT/AST Increased, ILD/Pneumonitis and VTEs .

Abemaciclib Dose Modification for Adverse Reactions2

Dose Level

Abemaciclib Dose
in Combination With Endocrine Therapy

Abemaciclib Dose
Single Agent

Recommended starting dose

150 mg twice daily

200 mg twice daily

First dose reduction

100 mg twice daily

150 mg twice daily

Second dose reduction

50 mg twice daily

100 mg twice daily

Third dose reduction

NA

50 mg twice daily

Abbreviation: NA = not applicable.

Note: Discontinue if unable to tolerate abemaciclib 50 mg twice daily.

Abemaciclib Dose Modification and Management - Nonhematologic Toxicities Excluding Diarrhea, ALT/AST Increased, ILD/Pneumonitis and VTEs 2

CTCAE Grade

Abemaciclib Dose Modifications

Grade 1 or 2

No dose modification is required.

Persistent or recurrent grade 2 toxicity that does not resolve with maximal supportive measures within 7 days to baseline or grade 1

Suspend dose until toxicity resolves to baseline or grade 1.

Resume at next lower dose.



Grade 3 or 4

Abbreviation: ALT = alanine transaminase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; VTE = venous thromboembolic events.

References

1US 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. Updated June 14, 2010. Accessed March 15, 2021. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

CTCAE = Common Terminology Criteria for Adverse Events

NCI = National Cancer Institute

Fecha de la última revisión: 2021 M03 15


Contáctenos para saber más de la información Médica de Lilly

Contacto vía correo electrónico

Correo electrónico: infomed@lilly.com

Envíe su consulta

Escriba su consulta