For women with HR +, HER2- MBC * who have visceral disease † or primary ET resistance ‡
Survival doesn ’ t have to be at higher risk 1 §
Visceral disease † and primary ET resistance ‡ are associated with higher risk . 1-4
* With disease progression following ET . † Visceral disease was defi ned as at least 1 lesion on an internal organ or in the third space and could have included lung , liver , pleural , or peritoneal metastatic involvement . 5 ‡ Primary resistance was defi ned as relapse within the fi rst 2 years of adjuvant ET or progressive disease within the fi rst 6 months of fi rst-line ET for MBC . 6 , 7
§
Patients with higher-risk disease , defi ned as the presence of visceral disease or primary ET resistance , were included in the MONARCH 2 clinical trial . 8 ET = endocrine therapy ; HER2- = human epidermal growth factor receptor 2 – negative ; HR += hormone receptor – positive ; MBC = metastatic breast cancer .
Indication
Verzenio ® ( abemaciclib ) is indicated for the treatment of hormone receptor – positive ( HR +), human epidermal growth factor receptor 2 – negative ( HER2− ) advanced or metastatic breast cancer ( MBC ) 6 :
• In combination with fulvestrant for women with disease progression following endocrine therapy Important Safety Information
Diarrhea occurred in 81 % of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3 , 86 % of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90 % of patients receiving Verzenio alone in MONARCH 1 . Grade 3 diarrhea occurred in 9 % of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3 , 13 % of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 20 % of patients receiving Verzenio alone in MONARCH 1 . Episodes of diarrhea have been associated with dehydration and infection .
Diarrhea incidence was greatest during the fi rst month of Verzenio dosing . In MONARCH 3 , the median time to onset of the fi rst diarrhea event was 8 days , and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days , respectively . In MONARCH 2 , the median time to onset of the fi rst diarrhea event was 6 days , and the median duration of diarrhea for Grades 2 and 3 were 9 days and 6 days , respectively . In MONARCH 3 , 19 % of patients with diarrhea required a dose omission and 13 % required a dose reduction . In MONARCH 2 , 22 % of patients with diarrhea required a dose omission and 22 % required a dose reduction . The time to onset and resolution for diarrhea were similar across MONARCH 3 , MONARCH 2 , and MONARCH 1 .
Instruct patients that at the fi rst sign of loose stools , they should start antidiarrheal therapy such as loperamide , increase oral fl uids , and notify their healthcare provider for further instructions and appropriate follow-up . For Grade 3 or 4 diarrhea , or diarrhea that requires hospitalization , discontinue Verzenio until toxicity resolves to ≤Grade 1 , and then resume Verzenio at the next lower dose .
Please see Important Safety Information throughout and Brief Summary of full Prescribing Information for Verzenio on the following pages .