How is Abemaciclib (Verzenio) administered?

Abemaciclib Administration Guidelines

Abemaciclib is administered orally at a dose of 150 mg twice daily with or without food for patients with hormone receptor-positive, HER2-negative breast cancer. 1

Standard Dosing

• Early Breast Cancer (Adjuvant Setting):

  • 150 mg twice daily for 2 years 2, 3
  • Administered in combination with endocrine therapy 2
  • Tablets can be taken with or without food 1

• Metastatic Breast Cancer:

  • In combination with endocrine therapy: 150 mg twice daily 1
  • As monotherapy: 200 mg twice daily 1, 2

Administration Details

• Abemaciclib tablets should be swallowed whole
• Doses should be taken approximately 12 hours apart 1
• A high-fat, high-calorie meal may increase drug exposure (AUC) by 9% and maximum concentration by 26%, but this is not clinically significant 1
• Continue treatment until disease progression or unacceptable toxicity 2

Dose Modifications

Dose interruptions and/or reductions may be required based on individual safety and tolerability 1:

• Common reasons for dose adjustments include:
  • Diarrhea (occurs in 83.5% of patients) 2
  • Neutropenia (occurs in 45.8% of patients) 2
  • Fatigue (occurs in 40.6% of patients) 2

Special Populations

• Hepatic Impairment:

  • Mild to moderate impairment (Child-Pugh A or B): No dose adjustment needed
  • Severe impairment (Child-Pugh C): Reduce dosing frequency 1

• Renal Impairment:

  • Mild to moderate impairment (CLcr ≥30-89 mL/min): No dose adjustment needed
  • Severe impairment (CLcr <30 mL/min): Insufficient data 1

• Geriatric Patients:

  • No specific dose adjustments required based on age alone 1

Monitoring During Treatment

• Regular assessment for adverse events, particularly:
  • Diarrhea (most common adverse effect)
  • Neutropenia
  • Thromboembolic events (occur in 3% of patients) 2
  • Interstitial lung disease (occur in 3% of patients) 2

Important Considerations

• Fatal adverse events occurred in 0.8% of patients taking abemaciclib plus endocrine therapy in clinical trials 2, 3
• Verify pregnancy status in females of reproductive potential before initiating treatment 1
• Advise patients to use effective contraception during treatment and for 3 weeks after the last dose 1

Abemaciclib has shown significant improvement in invasive disease-free survival when added to endocrine therapy in high-risk early breast cancer patients, with a hazard ratio of 0.70 (95% CI, 0.59 to 0.82) 2, making proper administration crucial for optimal outcomes.