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Verzenio

ABEMACICLIB

Manufacturer: Eli Lilly and Company

Score: 141.0

Quick Summary

Verzenio (Abemaciclib) is a kinase inhibitor used for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. It is indicated for adjuvant treatment of early breast cancer, as well as for advanced or metastatic breast cancer in combination with endocrine therapy. The recommended dose is 150 mg twice daily in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, and 200 mg twice daily as monotherapy. Important safety information includes warnings for diarrhea, neutropenia, and hepatotoxicity, with contraindications for use with strong CYP3A inhibitors. Special population considerations include use in pregnancy, pediatric, and geriatric populations.

Key Clinical Findings and Indications

  • Adjuvant treatment of early breast cancer
  • Advanced or metastatic breast cancer in combination with endocrine therapy
  • Monotherapy for HR-positive, HER2-negative advanced or metastatic breast cancer

Important Safety Information

Warning

Diarrhea, neutropenia, and hepatotoxicity

Contraindications

  • None

Adverse Reactions

  • Diarrhea
  • Neutropenia
  • Nausea
  • Abdominal pain
  • Infections
  • Fatigue
  • Anemia
  • Leukopenia
  • Decreased appetite
  • Vomiting
  • Headache
  • Alopecia
  • Thrombocytopenia

Dosing Recommendations

General Guidance

Dose modifications may be necessary for adverse reactions, with dose reductions to 100 mg twice daily or 50 mg twice daily as needed.

Early breast cancer

Adult Dose

150 mg twice daily in combination with fulvestrant, tamoxifen, or an aromatase inhibitor

Pediatric Dose

Not established

Advanced or metastatic breast cancer

Adult Dose

150 mg twice daily in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, or 200 mg twice daily as monotherapy

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Based on findings in animals and its mechanism of action, Verzenio can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

  • No information available

Pediatric Use

  • The safety and effectiveness of Verzenio have not been established in pediatric patients.

Geriatric Use

  • No overall differences in safety or effectiveness of Verzenio were observed between patients ≥65 years of age and younger patients.

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