TOVIAZ™ (fesoterodine fumarate) extended-release tablets Description

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Prescribing Information

TOVIAZ^® (fesoterodine fumarate) extended-release tablets
Description


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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.

Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C₃₀H₄₁NO₇ and its molecular weight is 527.66. The structural formula is:

The asterisk (*) indicates the chiral carbon.

Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each TOVIAZ extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

PRINTER-FRIENDLY

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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TOVIAZ^® (fesoterodine fumarate)