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TOVIAZ®(fesoterodine fumarate)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TOVIAZ® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Adult Overactive Bladder
Toviaz is indicated for the treatment of overactive bladder...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Adult Patients With OAB
The recommended starting dosage...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Extended-release tablets:
- 4 mg, light blue, oval, biconvex, film-coated, and engraved with "FS" on one side.
- 8 mg, blue, oval, biconvex, film-coated, and engraved...
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Contraindications
4 CONTRAINDICATIONS
Toviaz is contraindicated in patients with any of the following:
- known or suspected hypersensitivity to Toviaz or any of its...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Angioedema
Angioedema of the face, lips, tongue, and/or larynx has been reported...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Angioedema [see Warnings and Precautions (5.1)...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Antimuscarinic Drugs
Coadministration of Toviaz with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available...
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Overdosage
10 OVERDOSAGE
Overdosage with Toviaz can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.
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Description
11 DESCRIPTION
Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adult Overactive Bladder
The efficacy of Toviaz extended-release tablets was evaluated in two, Phase 3, randomized, double-blind, placebo-...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Toviaz (fesoterodine fumarate) extended-release tablets 4 mg are light blue, oval, biconvex, film-coated, and engraved with "FS" on one side. They are supplied as follows:
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).
Angioedema...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.