fesoterodine (Rx)

Brand and Other Names:Toviaz
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, extended-release

  • 4mg
  • 8mg
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Overactive Bladder

Indicated for overactive bladder with urge incontinence, urgency, and frequency

4 mg PO qDay; may increase 8 mg PO qDay based upon individual response and tolerability

Dosage Modifications

Concomitant use with CYP3A4 inhibitors

  • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not to exceed 4 mg PO qDay
  • Moderate CYP3A4 inhibitors (eg, erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice): No dosage adjustment necessary
  • Weak CYP3A4 inhibitors (eg, cimetidine): Safety and efficacy has not been established

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Not to exceed 4 mg PO qDay

Hepatic impairment

  • Mild-to-moderate (Child Pugh A to B): No dosage adjustment necessary
  • Severe (Child Pugh C): Not recommended

Safety and efficacy not established

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Interactions

Interaction Checker

and fesoterodine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dry mouth (18.8-34.6%)

            1-10%

            Constipation (4.2-6%)

            Dyspepsia (1.6-2.3%)

            Urinary tract infection (3.2-4.2%)

            Xerophthalmia (1.4-3.7%)

            Upper respiratory tract infection (1.8-2.5%)

            Dysuria (1.3-1.6%)

            Urinary retention (1.1-1.4%)

            Dry throat (0.9-2.3%)

            Insomnia (0.4-1.3%)

            Back pain (0.9-2%)

            Nausea (0.7-1.9%)

            ncreased ALT (0.5-1.2%)

            Increased GGT (0.4-1.2%)

            Peripheral edema (0.7-1.2%)

            Upper abdominal pain (0.5-1.1%)

            Rash (0.7-1.1%)

            Postmarketing Reports

            General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema

            Central nervous system disorders: Dizziness, headache, somnolence

            Skin and subcutaneous tissue disorders: Urticaria, pruritus

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            Warnings

            Contraindications

            Hypersensitivity to drug or ingredients

            Urinary or gastric retention

            Uncontrolled narrow-angle glaucoma

            Cautions

            Controlled narrow-angle glaucoma, bladder outflow obstruction, GI obstruction, reduced hepatic/renal function, and autonomic neuropathy

            Angioedema of the face, lips, tongue, and/or larynx reported; in some cases angioedema occurred after the first dose

            Anticholinergic CNS effects (eg, headache, dizziness, somnolence) reported; advise patients not to drive or operate heavy machinery until they adjust to therapy

            Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction, bladder flow obstruction

            Heat prostration may occur in the presence of increased environmental temperature

            Drug interactions overview

            • Anticholinergic agents may potentially alter absorption of fesoterodine owing to decreased decreased GI motility
            • Coadministration of potent CYP3A4 inhibitors ketoconazole with fesoterodine led to approximately a doubling of peak plasma concentration and area under the concentration versus time curve of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine (see Dosage Modifications)
            • Coadministration of moderate CYP3A4 inhibitors had no clinically relevant effect on the pharmacokinetics of fesoterodine
            • Coadministration of rifampin 600 mg/day, a CYP3A4 inducer, Cmax and AUC of active metabolite of fesoterodine decreased by ~70% and 75% after fesoterodine 8 mg dose
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            Pregnancy & Lactation

            Pregnancy

            There are no data with fesoterodine use in pregnant women to inform a drug associated risk for birth defects or miscarriage

            In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (MRHD) of 8 mg/day based on AUC

            Lactation

            There is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive muscarinic receptor antagonist; inhibition of receptors in the bladder prevent symptoms of urgency and frequency

            Absorption

            Bioavailability: 52%

            Protein Bound: 50%

            Vd: 169 L (5-HMT active metabolite)

            Metabolism

            Rapidly hydrolyzed to active metabolite, and THEN by liver CYP3A4 and CYP2D6 to inactive metabolites

            Elimination

            Half-Life: 7 hr

            Excretion: Urine (70%); feces (7%)

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            Administration

            Oral administration

            Take with liquid and swallowed whole

            Administer with or without food Should not be chewed, divided, or crushed

            Missed dose: Resume taking fesoterodine the next day; do not take 2 doses of fesoterodine in the same day

            Storage

            Extended-release tablets: Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

            Protect from moisture

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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