United States - English - NLM (National Library of Medicine)

eli lilly and company - abemaciclib (unii: 60uab198hk) (abemaciclib - unii:60uab198hk) - abemaciclib 50 mg - 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 [see clinical studies (14.1)]. verzenio (abemaciclib) is indicated: - in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients 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. none. risk summary based on findings in animals and its mechanism of action, verzenio can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. in animal reproduction studies, administration of abemaciclib during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on auc at the maximum recommended human dose (see data). advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data in an embryo-fetal development study, pregnant rats received oral doses of abemaciclib up to 15 mg/kg/day during the period of organogenesis. doses ≥4 mg/kg/day caused decreased fetal body weights and increased incidence of cardiovascular and skeletal malformations and variations. these findings included absent innominate artery and aortic arch, malpositioned subclavian artery, unossified sternebra, bipartite ossification of thoracic centrum, and rudimentary or nodulated ribs. at 4 mg/kg/day in rats, the maternal systemic exposures were approximately equal to the human exposure (auc) at the recommended dose. risk summary there are no data on the presence of abemaciclib in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed infants from verzenio, advise lactating women not to breastfeed during verzenio treatment and for 3 weeks after the last dose. based on animal studies, verzenio can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with verzenio. contraception females advise females of reproductive potential to use effective contraception during verzenio treatment and for 3 weeks after the last dose. infertility males based on findings in animals, verzenio may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and effectiveness of verzenio have not been established in pediatric patients. of the 2791 verzenio-treated patients in monarche, 15% were 65 years of age or older and 2.7% were 75 years of age or older. of the 900 patients who received verzenio in monarch 1, monarch 2, and monarch 3, 38% were 65 years of age or older and 10% were 75 years of age or older. the most common adverse reactions (≥5%) grade 3 or 4 in patients ≥65 years of age across monarch 1, 2, and 3 were: neutropenia, diarrhea, fatigue, nausea, dehydration, leukopenia, anemia, infections, and alt increased. no overall differences in safety or effectiveness of verzenio were observed between these patients and younger patients. no dosage adjustment is required for patients with mild or moderate renal impairment (clcr ≥30-89 ml/min, estimated by cockcroft-gault [c-g]). the pharmacokinetics of abemaciclib in patients with severe renal impairment (clcr <30 ml/min, c-g), end stage renal disease, or in patients on dialysis is unknown [see clinical pharmacology (12.3)] . no dosage adjustments are necessary in patients with mild or moderate hepatic impairment (child-pugh a or b). reduce the dosing frequency when administering verzenio to patients with severe hepatic impairment (child-pugh c) [see dosage and administration (2.2) and clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 100 mg - 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.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 150 mg - 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.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 200 mg - 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.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 50 mg - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - abemaciclib, quantity: 50 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; macrogol 3350; iron oxide yellow; iron oxide red; polyvinyl alcohol; sodium stearylfumarate; lactose monohydrate; purified talc; microcrystalline cellulose; silicon dioxide; titanium dioxide - early breast cancer verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of 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 peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.,advanced or metastatic breast cancer verzenio is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,in pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Australia - English - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - abemaciclib, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; purified talc; iron oxide yellow; silicon dioxide; polyvinyl alcohol; macrogol 3350; sodium stearylfumarate; titanium dioxide - early breast cancer verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of 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 peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.,advanced or metastatic breast cancer verzenio is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,in pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Australia - English - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - abemaciclib, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; polyvinyl alcohol; microcrystalline cellulose; silicon dioxide; sodium stearylfumarate; titanium dioxide; macrogol 3350; purified talc - early breast cancer verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of 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 peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.,advanced or metastatic breast cancer verzenio is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,in pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - breast neoplasms - antineoplastic agents - early breast cancerverzenios 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 5.1).in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Australia - English - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - abemaciclib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; macrogol 3350; iron oxide yellow; polyvinyl alcohol; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide red; silicon dioxide; lactose monohydrate; croscarmellose sodium - early breast cancer verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of 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 peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.,advanced or metastatic breast cancer verzenio is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,in pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.