TOVIAZ Safety Information
TOVIAZ® (fesoterodine fumarate) is indicated for the treatment of overactive bladder with symptoms of urge
urinary incontinence, urgency, and frequency.
IMPORTANT SAFETY INFORMATION
TOVIAZ is contraindicated in patients with urinary retention, gastric retention,
or uncontrolled narrow-angle glaucoma, and in patients with known hypersensitivity
to the drug or its ingredients.
TOVIAZ tablets should be used with caution in patients with clinically significant
bladder outlet obstruction, decreased gastrointestinal motility, controlled narrow-angle
glaucoma, or myasthenia gravis. TOVIAZ is not recommended for use in patients with
severe hepatic impairment.
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. Doses greater
than 4 mg are not recommended in patients with severe renal insufficiency or in
patients taking a potent CYP3A4 inhibitor; in patients taking a weak or moderate
CYP3A4 inhibitor, careful assessment at 4 mg is advised prior to increasing to 8
mg.
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%).
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