Toviaz

IMPORTANT SAFETY INFORMATION AND INDICATION

Contraindications

TOVIAZ® (fesoterodine fumarate) 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 or to DETROL® (tolterodine tartrate) tablets or DETROL® LA (tolterodine tartrate extended release capsules).

Warnings and Precautions

Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine, in some cases after the first dose. Patients should be advised to promptly discontinue fesoterodine therapy and seek immediate medical attention if they experience edema of the tongue, laryngopharynx, or difficult breathing.

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 associated with anticholinergic central nervous system (CNS) effects including headache, dizziness and somnolence. Advise patients not to drive or operate heavy machinery until they know how TOVIAZ affects them. Consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effects.

The recommended starting dose of TOVIAZ is 4 mg once daily swallowed whole. 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 (CLCR <30 mL/min), or in patients taking a potent CYP3A4 inhibitor, such as ketoconazole, itraconazole, and clarithromycin. TOVIAZ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

Adverse Events

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%).

Indication

TOVIAZ® (fesoterodine fumarate) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Please see full Prescribing Information and Patient Information.

References

1. Chapple C, Van Kerrebroeck PE, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52(4):1204-1212.

2. Data on file. Protocol SP583. Table SCS763 13.2.1.1.1. Pfizer Inc, New York, NY.

3. Data on file. Protocol SP583. Table SCS763 13.2.1.1.1B.w12. Pfizer Inc, New York, NY.

4. Data on file. Protocol SP738. Table SCS324a 10.2. Pfizer Inc, New York, NY.

5. Data on file. Protocol SP738. Clinical trial report. Pfizer Inc, New York, NY.

6. Toviaz [package insert]. New York, NY: Pfizer Inc; January 2014.

7. Data on file. SPM 907. Table 24.4. Pfizer Inc, New York, NY.

8. Data on file. SPM 907. Table 18.5. Pfizer Inc, New York, NY.

9. Data on file. SPM 907. Table 26.2. Pfizer Inc, New York, NY.

10. Data on file. SPM 907. Table 31.1. Pfizer Inc, New York, NY.

11. Data on file. Protocol SP583. Table SCS978a 13.2.1.1.1A.w12.

12. Data on file. Protocol A0221049. Full clinical study report. Pfizer Inc, New York, NY.

13. DuBeau CE, Kraus SR, Griebling TL, et al. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind placebo controlled trial. J Urol. 2014;191(2):395-404.

14. Nitti VW, Dmochowski R, Sand PK, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol. 2007;178(6):2488-2494.

Clinical Information