Fesoterodine

Fesoterodine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Fesoterodine is a muscarinic antagonist that is FDA approved for the {{{indicationType}}} of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Common adverse reactions include dry mouth and constipation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Overactive bladder

• 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.

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

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fesoterodine in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fesoterodine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Fesoterodine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fesoterodine in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fesoterodine in pediatric patients.

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.

Warnings

Precautions

• Angioedema

• Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.

• Bladder Outlet Obstruction

• Toviaz should be administered with caution to patients with clinically significant bladder outlet obstruction because of the risk of urinary retention.

• Decreased Gastrointestinal Motility

• Toviaz, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility, such as those with severe constipation.

• Controlled Narrow-Angle Glaucoma

• Toviaz should be used with caution in patients being treated for narrow-angle glaucoma, and only where the potential benefits outweigh the risks.

• Central Nervous System Effects

• Toviaz is associated with anticholinergic central nervous sytem (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

• Hepatic Impairment

• Toviaz has not been studied in patients with severe hepatic impairment and therefore is not recommended for use in this patient population.

• Renal Impairment

• Doses of Toviaz greater than 4 mg are not recommended in patients with severe renal impairment.

• Concomitant Administration with CYP3A4 Inhibitors

• Doses of Toviaz greater than 4 mg are not recommended in patients taking a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin).
• No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice).
• While the effect of weak CYP3A4 inhibitors (e.g. cimetidine) was not examined by clinical study, some pharmacokinetic interaction is expected, albeit less than that observed with moderate CYP3A4 inhibitors.

• Myasthenia Gravis

• Toviaz should be used with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fesoterodine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fesoterodine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fesoterodine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fesoterodine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fesoterodine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fesoterodine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fesoterodine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fesoterodine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fesoterodine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fesoterodine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fesoterodine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fesoterodine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fesoterodine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Fesoterodine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Fesoterodine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Fesoterodine in the drug label.

Pharmacology

There is limited information regarding Fesoterodine Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fesoterodine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fesoterodine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fesoterodine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fesoterodine in the drug label.

How Supplied

Storage

There is limited information regarding Fesoterodine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fesoterodine in the drug label.

Precautions with Alcohol

• Alcohol-Fesoterodine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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