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TOVIAZ® (fesoterodine fumarate) Highlights

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) extended-release tablets, for oral use
Initial U.S. Approval: 2008

INDICATIONS AND USAGE

Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)

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. (2)

The daily dose of Toviaz should not exceed 4 mg in the following populations:

  • Patients with severe renal impairment (CLCR <30 mL/min) (2)
  • Patients taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin. (2)

Toviaz is not recommended for use in patients with severe hepatic impairment (Child-Pugh C). (2)

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. (2)

DOSAGE FORMS AND STRENGTHS

Toviaz 4 mg extended-release tablets are light blue, oval, biconvex, film-coated, and engraved with "FS" on one side. (3)

Toviaz 8 mg extended-release tablets are blue, oval, biconvex, film-coated, and engraved with "FT" on one side. (3)

CONTRAINDICATIONS

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. (4)

WARNINGS AND PRECAUTIONS

  • Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. (5.1)
  • Toviaz should be administered with caution to patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2)
  • Toviaz, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3)
  • Toviaz should be used with caution in patients being treated for narrow-angle glaucoma, and only where the potential benefits outweigh the risks (5.4)
  • Central Nervous System Effects: Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them (5.5)
  • Toviaz should be used with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. (5.9)

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%). (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.

USE IN SPECIFIC POPULATIONS

  • Pediatric Use: The safety and effectiveness of Toviaz in pediatric patients have not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2017

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