What is the typical dosing regimen for Abemaciclib (Verzenio)?

From the Guidelines

Abemaciclib (Verzenio) is typically dosed at 150 mg taken orally twice daily when used as monotherapy for advanced or metastatic breast cancer, and the same dose is used when combined with endocrine therapy, such as an aromatase inhibitor or fulvestrant, with a recommended duration of 2 years for adjuvant treatment of high-risk early breast cancer 1.

Key Considerations for Dosing

• The dosing regimen for abemaciclib is consistent across different indications, including advanced or metastatic breast cancer and adjuvant treatment of high-risk early breast cancer.
• The medication should be taken at approximately the same times each day with or without food.
• Dose modifications may be necessary based on individual tolerability, with common reductions to 100 mg twice daily or 50 mg twice daily if side effects occur.

Mechanism of Action and Side Effects

• Abemaciclib works as a CDK4/6 inhibitor, blocking cell cycle progression and preventing cancer cell proliferation.
• Common side effects requiring monitoring include diarrhea (which often occurs early in treatment), neutropenia, fatigue, and liver enzyme elevations.
• Proactive management of diarrhea with antidiarrheal medications like loperamide is recommended at the first sign of loose stools.

Recent Guideline Updates

• The most recent guideline update from 2024 recommends 2 years of abemaciclib (150 mg twice daily) plus endocrine therapy for patients with node-positive, hormone receptor-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer at high risk of recurrence 1.
• The St Gallen International Consensus Conference for the primary therapy of individuals with early breast cancer 2023 also endorses the use of abemaciclib for a duration of 2 years in high-risk patients 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION VERZENIO tablets are taken orally with or without food. (2.1) Recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily. (2.1) Recommended starting dose as monotherapy: 200 mg twice daily. (2.1) Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. (2.2)

The typical dosing regimen for Abemaciclib (Verzenio) is:

• 150 mg twice daily when used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor.
• 200 mg twice daily when used as monotherapy. Dosing may be adjusted based on individual safety and tolerability 2.

From the Research

Abemaciclib Dosing Regimen

• The typical dosing regimen for Abemaciclib (Verzenio) is 150 mg or 200 mg every 12 hours, administered orally on a continuous schedule or on a 28-day cycle 3, 4, 5, 6.
• In the MONARCH 2 trial, abemaciclib was administered at a dose of 150 mg twice daily on a continuous schedule 4.
• In the Phase 1b study, abemaciclib was administered at a dose of 200 mg every 12 hours in combination with endocrine therapy for metastatic breast cancer 5.
• In the randomized Phase I study in Chinese patients, abemaciclib was administered at doses of 150 mg or 200 mg every 12 hours on a 28-day cycle 6.

Administration and Schedule

• Abemaciclib can be administered in combination with fulvestrant, an aromatase inhibitor, or tamoxifen 4, 5.
• The medication should be taken orally, with or without food, at the same time every day 3.
• The dosing schedule may vary depending on the specific treatment regimen and patient population 5, 6.

Dose Adjustments and Management

• Dose adjustments may be necessary to manage adverse events, such as diarrhea, neutropenia, and fatigue 7, 4, 5.
• In the MONARCH 2 trial, dose reductions were allowed for patients experiencing adverse events, with 16.7% of patients requiring a dose reduction 4.
• Supportive medications, such as antidiarrheal medication, may be used to manage adverse events 7.