TOVIAZ® Highlights

(fesoterodine fumarate)

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 indicated for the treatment of:

•
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
•
Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)

DOSAGE AND ADMINISTRATION

•
OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. (2.1)
•
NDO in Pediatric Patients 6 Years and Older:
•
Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:
The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. (2.2)
•
Pediatric Patients Weighing Greater than 35 kg:
The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. (2.2)
•
Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3, 2.4)
•
Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5)
•
Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (2.6)

DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 4 mg and 8 mg (3)

CONTRAINDICATIONS

•
Known or suspected hypersensitivity to Toviaz or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. (4)
•
Urinary retention (4)
•
Gastric retention (4)
•
Uncontrolled narrow-angle glaucoma. (4)

WARNINGS AND PRECAUTIONS

•
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 being treated for narrow-angle glaucoma. (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)
•
Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis. (5.6)

ADVERSE REACTIONS

•
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%). (6.1)
•
Most frequently reported adverse reactions with Toviaz in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache. (6.1)

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.

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

Revised: 2/2024

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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 indicated for the treatment of:

•
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
•
Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)

DOSAGE AND ADMINISTRATION

•
OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. (2.1)
•
NDO in Pediatric Patients 6 Years and Older:
•
Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:
The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. (2.2)
•
Pediatric Patients Weighing Greater than 35 kg:
The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. (2.2)
•
Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3, 2.4)
•
Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5)
•
Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (2.6)

DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 4 mg and 8 mg (3)

CONTRAINDICATIONS

•
Known or suspected hypersensitivity to Toviaz or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. (4)
•
Urinary retention (4)
•
Gastric retention (4)
•
Uncontrolled narrow-angle glaucoma. (4)

WARNINGS AND PRECAUTIONS

•
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 being treated for narrow-angle glaucoma. (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)
•
Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis. (5.6)

ADVERSE REACTIONS

•
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%). (6.1)
•
Most frequently reported adverse reactions with Toviaz in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache. (6.1)

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.

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

Revised: 2/2024
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