| 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)
| CLINICAL PHARMACOLOGY
Mechanism of Action
Muscarinic receptors play a role in contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.
| INDICATIONS AND USAGE
Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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
| WARNINGS AND PRECAUTIONS
–Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine
–Toviaz should be administered with caution to patients with clinically significant bladder outlet obstruction because of the risk of urinary retention.
–Toviaz, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility, such as those with severe constipation.
–Toviaz should be used with caution in patients being treated for narrow-angle glaucoma, and only where the potential benefits outweigh the risks
–Doses of Toviaz greater than 4 mg are not recommended in patients taking a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin). In patients taking weak or moderate CYP3A4 inhibitors (e.g., erythromycin), careful assessment of tolerability at the 4 mg daily dose is advised prior to increasing the daily dose to 8 mg.
–Toviaz should be used with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
USE IN SPECIFIC POPULATIONS
| ADVERSE REACTIONS
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%).
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.
| 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.
The daily dose of Toviaz should not exceed 4 mg in the following populations:
–Patients with severe renal impairment (CLCR <30 mL/min)
Toviaz is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
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.
| HOW SUPPLIED/STORAGE AND HANDLING
Toviaz (fesoterodine fumarate) extended-release tablets 4 mg are light blue, oval, biconvex, film-coated, and engraved with “FS” on one side. They are supplied as follows:
Toviaz (fesoterodine fumarate) extended-release tablets 8 mg are blue, oval, biconvex, film-coated, and engraved with “FT” on one side. They are supplied as follows:
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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