البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
Abemaciclib
DKSH SINGAPORE PTE. LTD.
L01EF03
TABLET, FILM COATED
Abemaciclib 150.0mg
ORAL
Prescription Only
Lilly del Caribe, Inc.
ACTIVE
2019-08-26
Page 1 of 42 NAME OF THE MEDICINAL PRODUCT VERZENIO FILM-COATED TABLET 50MG VERZENIO FILM-COATED TABLET 100MG VERZENIO FILM-COATED TABLET 150MG QUALITATIVE AND QUANTITATIVE COMPOSITION VERZENIO FILM-COATED TABLET 50MG Each film-coated tablet contains 50 mg abemaciclib. VERZENIO FILM-COATED TABLET 100MG Each film-coated tablet contains 100 mg abemaciclib. VERZENIO FILM-COATED TABLET 150MG Each film-coated tablet contains 150 mg abemaciclib. 1 INDICATIONS AND USAGE 1.1 EARLY BREAST CANCER Verzenio (abemaciclib) in combination with endocrine therapy is indicated 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 (see section 14.1). 1.2 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. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSE AND SCHEDULE Page 2 of 42 • When used in combination with fulvestrant, tamoxifen or an aromatase inhibitor, the recommended dose of Verzenio is 150mg taken orally twice daily. Refer to the Full Prescribing Information for the recommended dose of fulvestrant, or tamoxifen or aromatase inhibitor being used. • Pre/perimenopausal women treated with the combination of Verzenio plus endocrine therapy should be treated with a gonadotropin-releasing hormone agonist according to current clinical practice standards. • For early breast cancer, Verzenio should be taken continuously for two years or until disea اقرأ الوثيقة كاملة