When dealing with overactive bladder...
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IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB.
Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.
ADVERSE REACTIONS
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see accompanying Brief Summary on the following page.
References: 1. Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and safety of once-daily vibegron for treatment of overactive bladder in patients aged ≥65 and ≥75 years: subpopulation analysis from the EMPOWUR randomized, international, phase III study.Drugs Aging. 2021;38(2):137-146. doi:10.1007/ s40266-020-00829-z 2. GEMTESA. Prescribing information. Urovant Sciences; 2020. 3. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β3
Yeaw J, et al. High utilization of CYP2D6 substrate prescriptions among long-term care residents with overactive bladder. Ann Long Term Care. 2022;30(October 7). doi:10.25270/altc.2022.10.001 5. Zimmerman S, Sloane PD, Reed D. Dementia prevalence and care in assisted living. Health Aff (Millwood). 2014;33(4):658-666. doi:10.1377/hlthaff.2013.1255 6. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction; 2019. Accessed June 26, 2022.
https://www.auanet.org/guidelines-and-quality/guidelines/overactive-bladder- (oab)-guideline 7. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807
UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.
©2022 Urovant Sciences. All rights reserved. US-VBGN-2200307 12/22 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/
acs.jmedchem.5b01372 4. Stefanacci RG, Horn JR,
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