Pediatric Use
The safety and effectiveness of VERZENIO have not been established in pediatric patients .
Geriatric Use
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 .
Renal Impairment
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 .
Hepatic Impairment
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 ).
OVERDOSAGE
There is no known antidote for VERZENIO . The treatment of overdose of VERZENIO should consist of general supportive measures .
Rx only .
Additional information can be found at www . verzenio . com . Eli Lilly and Company , Indianapolis , IN 46285 , USA Copyright © 2019 , Eli Lilly and Company . All rights reserved .
AL HCP BS _ M2 28JAN2020
B : 11.25 "