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TOVIAZ®(fesoterodine fumarate)

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TOVIAZ® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Adult Overactive Bladder

Toviaz is indicated for the treatment of overactive bladder...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients With OAB

The recommended starting dosage...

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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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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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5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

Angioedema of the face, lips, tongue, and/or larynx has been reported...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Angioedema [see

    6.1 Clinical Trials Experience

    ...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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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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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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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).

Angioedema...

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