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WE'RE COMMITTED TO PROVIDING ACCESS AND SUPPORT TO LTC RESIDENTS AND PROVIDERS

There are options for patients to access GEMTESA

Explore programs and resources designed to help improve access to GEMTESA

Through the CMS Extra Help program, eligible low-income Medicare patients may qualify to pay less than $10 for branded medications1*

Get LIS information

Medicare beneficiaries who need prescription medications but are unable to afford them may be eligible for the Medicare Part D LIS Program. This Social Security Administration program, also known as Extra Help, subsidizes premiums, deductibles, and copays that are paid to the prescription drug provider or Medicare Advantage prescription drug plan for people with limited income/resources.2,3

*Centers for Medicare & Medicaid Services. 2021 Resource and cost-sharing limits for low-income subsidy. Published October 30, 2020. Accessed October 27, 2023. https://www.cms.gov/files/document/2021-lis-resource-limits-memo.pdf.

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The Sumitomo Pharma America Patient Connect Support Program provides personalized support with tools and resources to help patients and providers with access to GEMTESA

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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.

 

INDICATIONS AND USAGE

GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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 full Prescribing Information.

References: 1. Centers for Medicare & Medicaid Services. 2021 Resource and cost-sharing limits for low-income subsidy. Published October 30, 2020. Accessed July 6, 2021. https://www.cms.gov/files/document/2021-lis-resource-limits-memo.pdf 2. Extra Help with Medicare prescriptions drug plan costs. Social Security Administration website. Accessed August 18, 2021. https.//www.ssa.gov/benefits/medicare/prescriptionhelp.html. 3. Program Operations Manual System (POMS): H1 03001.005 Medicare Part D Extra Help (low-income subsidy or LIS). Social Security Administration website. Revised March 25, 2019. Accessed August 18, 2021. https://secure.ssa.gov/poms.nsf/lnx/0603001005

You are encouraged to report side effects and product complaints associated with GEMTESA by calling 1-833-876-8268.

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is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

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