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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)
For oral administration
Initial U.S. Approval: October 31, 2008
Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.
Mechanism of Action
Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine and is also one of the active moieties of tolterodine tartrate tablets and tolterodine tartrate extended-release capsules.
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.
In a urodynamic study involving patients with involuntary detrusor contractions, the effects after the administration of fesoterodine on the volume at first detrusor contraction and bladder capacity were assessed. Administration of fesoterodine increased the volume at first detrusor contraction and bladder capacity in a dose-dependent manner. These findings are consistent with an antimuscarinic effect on the bladder.
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.
--Doses of Toviaz greater than 4 mg are not recommended in patients taking potent CYP3A4 inhibitors. The effects of weak or moderate CYP3A4 inhibitors were not examined.
--No dosing adjustments are recommended in the presence of CYP3A4 inducers or CYP2D6 inhibitors.
--There were no changes in the plasma concentrations of combined oral contraceptives containing ethinyl estradiol and levonorgestrel.
USE IN SPECIFIC POPULATIONS
--Pregnancy and Nursing Mothers: Toviaz should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. (8.1) Toviaz should not be administered during nursing unless the potential benefit outweighs the potential risk to the neonate.
--Pediatric Use: The safety and effectiveness of Toviaz in pediatric patients have not been established.
--Geriatric Use: No dose adjustment is recommended for the elderly.
--Renal Impairment: Doses of Toviaz greater than 4 mg are not recommended in patients with severe renal impairment.
--Hepatic Impairment: Subjects with severe hepatic impairment (Child-Pugh C) have not been studied; therefore Toviaz is not recommended for use in these patients.
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)
--Patients taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin.
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:
Bottles of 30 NDC 0069-0242-30
Bottles of 90 NDC 0069-0242-68
Unit Dose Package of 100 NDC 0069-0242-41
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:
Bottles of 30 NDC 0069-0244-30
Bottles of 90 NDC 0069-0244-68
Unit Dose Package of 100 NDC 0069-0244-41
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.
Package Insert data:
PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label
extended release tablets
Division of Pfizer Inc, NY, NY 10017