Geriatric Use: Of 526 patients who received GEMTESA in the clinical studies for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency, 242 (46%) were 65 years of age or older, and 75 (14%) were 75 years of age or older. No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients.
Renal Impairment: No dosage adjustment for GEMTESA is recommended for patients with mild, moderate, or severe renal impairment t (eGFR 15 to <90 mL/min/1.73 m2 <15 mL/min/1.73 m2 in these patients.
). GEMTESA has not been studied in patients with eGFR (with or without hemodialysis) and is not recommended
Hepatic Impairment: No dosage adjustment for GEMTESA is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). GEMTESA has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in this patient population.
NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity was observed in long-term studies conducted in mice and rats treated with daily oral doses of vibegron for approximately 2 years. In the mouse carcinogenicity study, CD-1 mice were treated with daily oral doses of vibegron up to 90 mg/kg/day in males and up to 150 mg/kg/day in females, corresponding to estimated systemic exposures (AUC) 21- and 55-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA. In the rat carcinogenicity study, Sprague Dawley rats were treated with daily oral doses of vibegron up to 30 mg/kg/day in males and up to 180 mg/kg/day in females, corresponding to systemic exposures (AUC) 18- and 117-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA.
Vibegron was not mutagenic in in vitro microbial reverse mutation assays, showed no evidence of genotoxic activity in an in vitro human peripheral blood lymphocyte chromosomal aberration assay, and did not increase the frequency of micronucleated polychromatic erythrocytes in an in vivo rat bone marrow micronucleus assay.
In fertility/general reproductive toxicity studies conducted in rats, females were treated with daily oral doses of 0, 30, 100, 300, or 1000 mg/kg/day vibegron and males were treated with daily oral doses of 0, 10, 30, or 300 mg/kg/day vibegron. No effects on fertility were observed in female or male rats at doses up to 300 mg/kg/day, associated with systemic exposure (AUC) at least 274-fold higher than in humans treated with the recommended daily dose of GEMTESA. General toxicity, decreased fecundity, and decreased fertility were observed in female rats at 1000 mg/kg/day, associated with estimated systemic exposure 1867-fold higher than in humans treated with the recommended daily dose of GEMTESA.
PATIENT COUNSELING INFORMATION Advise the patient to read the FDA- approved patient labeling (Patient Information).
Urinary Retention: Inform patients that GEMTESA has been associated with urinary retention. Inform patients that the risk of urinary retention may be increased in patients taking muscarinic antagonist medications for the treatment of OAB. Instruct patients to contact their healthcare provider if they experience symptoms consistent with urinary retention while taking GEMTESA.
Administration Instructions: Advise patients that GEMTESA tablets can be swallowed whole with a glass of water or may be crushed, mixed with a tablespoon of applesauce and taken immediately with a glass of water.
RX only
Manufactured for and Distributed by: Urovant Sciences, Inc. Irvine, CA 92617 GEMTESA®
is a trademark of Urovant Sciences GmbH, registered in the
U.S. and other countries. All other trademarks are the property of their respective owners.
Patented: see
https://www.urovant.com/about/product-patents ©2021 Urovant Sciences. All rights reserved. For more information, go to
www.GEMTESA.com or call 1-833-876-8268.
This Patient Information has been approved by the U.S. Food and Drug Administration.
US-VBGN-2100230 (V2.0) Based on 12/2020 PI.
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