INDICATIONS AND USAGE（适应症）

Early Breast Cancer

VERZENIO® (abemaciclib) is indicated:

in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.

Advanced or Metastatic Breast Cancer

VERZENIO (abemaciclib) is indicated:

in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

DOSAGE（服用剂量）

Patient Selection for Early Breast Cancer

Select patients for treatment of early breast cancer with VERZENIO in combination with endocrine therapy based on a Ki-67 score ≥20% in tumor specimens.

Recommended Dose and Schedule

When used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, the recommended dose of VERZENIO is 150 mg taken orally twice daily. Refer to the Full Prescribing Information for the recommended dose of the fulvestrant, tamoxifen, or aromatase inhibitor being used.

Pre/perimenopausal women and men treated with the combination of VERZENIO plus an aromatase inhibitor should be treated with a gonadotropin-releasing hormone agonist (GnRH) according to current clinical practice standards.

Pre/perimenopausal women treated with the combination of VERZENIO plus fulvestrant should be treated with a GnRH according to current clinical practice standards

When used as monotherapy, the recommended dose of VERZENIO is 200 mg taken orally twice daily.

For early breast cancer, continue VERZENIO until completion of 2 years of treatment or until disease recurrence, or unacceptable toxicity.

For advanced or metastatic breast cancer, continue treatment until disease progression or unacceptable toxicity.

VERZENIO may be taken with or without food.

Instruct patients to take their doses of VERZENIO at approximately the same times every day.

If the patient vomits or misses a dose of VERZENIO, instruct the patient to take the next dose at its scheduled time. Instruct patients to swallow VERZENIO tablets whole and not to chew, crush, or split tablets before swallowing. Instruct patients not to ingest VERZENIO tablets if broken, cracked, or otherwise not intact.

ADVERSE REACTIONS（不良反应）

Diarrhea

Neutropenia

Interstitial Lung Disease (ILD) or Pneumonitis

Hepatotoxicity

Venous Thromboembolism

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/be4bc0de-0fdc-4d46-8d25-be43c79e6a06/spl-doc?hl=Abemaciclib

Ramiveninformation