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Through the CMS Extra Help program, eligible low-income Medicare patients may qualify to pay less than $10 for branded medications^1*

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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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

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.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

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 GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

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.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

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