Country: Israel
Language: English
Source: Ministry of Health
ABEMACICLIB
ELI LILLY ISRAEL LTD, ISRAEL
L01EF03
FILM COATED TABLETS
ABEMACICLIB 100 MG
PER OS
Required
ELI LILLY AND COMPANY, USA
ABEMACICLIB
VERZENIO™ (abemaciclib) is indicated:•In combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women 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 women 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 in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.Verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor.• Verzenio 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.In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
2023-11-30
I VERZTB I 05 Page 1 of 8 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only VERZENIO 100 MG Film-coated tablets ACTIVE INGREDIENT AND ITS QUANTITY: Each film-coated tablet contains: abemaciclib 100 mg VERZENIO 50 MG Film-coated tablets ACTIVE INGREDIENT AND ITS QUANTITY: Each film-coated tablet contains: abemaciclib 50 mg VERZENIO 150 MG Film-coated tablets ACTIVE INGREDIENT AND ITS QUANTITY: Each film-coated tablet contains: abemaciclib 150 mg INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION: see section 2 “Important information about some of the ingredients of this medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE . This leaflet contains concise information about this medicine. If you have any further questions, contact your doctor or pharmacist . This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? EARLY BREAST CANCER • Verzenio 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. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. ADVANCED OR METASTATIC BREAST CANCER • Verzenio, in combination with a non-steroidal aromatase inhibitor, is indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. • Verzenio, in combination with fulvestrant, is indicated for the treatment of women with hormone receptor (HR)-positive, human epiderm Read the complete document
X VERZTB I 08 Page 1 of 28 VERZENIO (ABEMACICLIB) TABLETS, FOR ORAL USE FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Verzenio 50 mg, (Abemaciclib 50 mg) film-coated tablets for oral use. Verzenio 100 mg, (Abemaciclib 100 mg) film-coated tablets for oral use. Verzenio 150 mg, (Abemaciclib 150 mg) film-coated tablets for oral use. 2. THERAPEUTIC INDICATIONS 2.1 EARLY BREAST CANCER Verzenio 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 Clinical Studies (14.1)]._ In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. 2.2 ADVANCED OR METASTATIC BREAST CANCER VERZENIO (abemaciclib) is indicated: in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women 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 women 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 in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting. Verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor. 3. DOSAGE AND ADMINISTRATION 3.1 RECOMMENDED DOSE AND SCHEDULE When used in combination with fulvestrant, tamoxifen, or a non-steroidal aromatase inhibitor, the recommended Read the complete document