TOVIAZ

Contraindications

TOVIAZ® (fesoterodine fumarate) is contraindicated in patients with known or suspected hypersensitivity to TOVIAZ or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended release capsules. Reactions have included angioedema. 

​​​​​​​TOVIAZ is also contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.

Warnings and Precautions

Angioedema of the face, lips, tongue, and/or larynx has been reported with TOVIAZ in some cases after the first dose however, cases have been reported to occur hours after the first dose or after multiple doses. Patients and/or their caregivers should be advised to promptly discontinue TOVIAZ and seek immediate medical attention if they experience edema of the lips, tongue, laryngopharynx, or difficulty breathing.

TOVIAZ is not recommended in patients with clinically significant bladder outlet obstruction, decreased gastrointestinal motility, or severe hepatic impairment (Child-Pugh C).

TOVIAZ should be used with caution in patients being treated for controlled narrow-angle glaucoma or in patients with myasthenia gravis.

TOVIAZ is associated with anticholinergic central nervous system (CNS) adverse reactions including headache, dizziness and somnolence. Advise patients not to drive or operate heavy machinery until they know how TOVIAZ affects them. Consider TOVIAZ dose reduction or discontinuation if a patient experiences anticholinergic CNS effects.

Adverse Events

The most frequently reported adverse events (≥4%) for TOVIAZ in adults with OAB were: dry mouth (placebo, 7%; TOVIAZ 4 mg, 19%; TOVIAZ 8 mg, 35%) and constipation (placebo, 2%; TOVIAZ 4 mg, 4%; TOVIAZ 8 mg, 6%).

Dosage

The recommended starting dosage of TOVIAZ in adults is 4 mg orally once daily swallowed whole. Based upon individual response and tolerability, increase to the maximum dosage of TOVIAZ 8 mg once daily. The maximum recommended dosage is 4 mg orally once daily in adult patients with severe renal insufficiency (CL_CR <30 mL/min), or in adult patients taking a strong CYP3A4 inhibitor, such as ketoconazole, itraconazole, and clarithromycin. 

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Please see full Prescribing Information and Patient Information.

TOVIAZ® (fesoterodine fumarate) is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.