TOVIAZ

AbsorptionAfter oral administration, fesoterodine is well absorbed. Due to rapid and extensive hydrolysis by nonspecific esterases to its active metabolite 5-hydroxymethyl tolterodine, fesoterodine cannot be detected in plasma. Bioavailability of the active metabolite is 52%. After single or multiple-dose oral administration of fesoterodine in doses from 4 mg to 28 mg, plasma concentrations of the active metabolite are proportional to the dose. Maximum plasma levels are reached after approximat...

14.1 Adult Overactive Bladder The efficacy of Toviaz extended-release tablets was evaluated in two, Phase 3, randomized, double-blind, placebo-controlled, 12-week studies for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Entry criteria required that patients have symptoms of overactive bladder for ≥6-months duration, at least 8 micturitions per day, and at least 6 urinary urgency episodes or 3 urge incontinence episodes per 3-day diary period. Patients were randomized to a fixed dose of Toviaz 4 or 8 mg/day or placebo. In one of...

The following clinically significant adverse reactions are described elsewhere in labeling:

• Angioedema [see Warnings and Precautions (5.1) ]
• Urinary Retention [see Warnings and Precautions (5.2) ]
• Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ]
• Most frequently reported adverse events with Toviaz in adult patients with OAB (≥4%) 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....

Toviaz is contraindicated in patients with any of the following:

• known or suspected hypersensitivity to Toviaz or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1) ] . Reactions have included angioedema [see Warnings and Precautions (5.1) ]
• urinary retention [see Warnings and Precautions (5.2) ]
• gast...

• Angioedema : Promptly discontinue Toviaz and provide appropriate therapy. ( 5.1 )
• Urinary Retention : Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. ( 5.2 )
• Decreased Gastrointestinal Motility : Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. ( 5.3 )
• Worsening of Narrow-Angle Glaucoma : Use Toviaz with caution in patients ...

7 DRUG INTERACTIONS 7.1 Antimuscarinic Drugs Coadministration of Toviaz with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effe...