HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TOVIAZ safely and effectively. See full prescribing information for TOVIAZ.
TOVIAZ® (fesoterodine fumarate) extended-release tablets, for oral use
Initial U.S. Approval: 2008
INDICATIONS AND USAGE
Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose of Toviaz is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. (2)
The daily dose of Toviaz should not exceed 4 mg in the following populations:
Toviaz is not recommended for use in patients with severe hepatic impairment (Child-Pugh C). (2)
Toviaz should be taken with liquid and swallowed whole. Toviaz can be administered with or without food, and should not be chewed, divided, or crushed. (2)
DOSAGE FORMS AND STRENGTHS
Toviaz is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Toviaz is also contraindicated in patients with known hypersensitivity to the drug or its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. (4)
WARNINGS AND PRECAUTIONS
The most frequently reported adverse events (≥4%) for Toviaz 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%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.