Version May 2024
Overactive bladder: Oral: 4 mg once daily; may be increased to a maximum dose of 8 mg once daily based on individual response and tolerability
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Maximum dose: 4 mg once daily
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Use is not recommended; has not been studied.
Refer to adult dosing.
(For additional information see "Fesoterodine: Pediatric drug information")
Note: Toviaz is an extended-release dosage form; patients must be able to swallow tablets whole.
Neurogenic detrusor overactivity (NDO):
Children ≥6 years and Adolescents:
>25 kg to ≤35 kg: Oral: 4 mg once daily; may be increased to 8 mg once daily based on individual response and tolerability; in patients >35 kg, doses were titrated after ≥1 week of therapy; maximum daily dose: 8 mg/day.
>35 kg: Oral: Initial: 4 mg once daily; after 1 week of therapy, increase dose to 8 mg once daily; maximum daily dose: 8 mg/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Pediatric dosing recommendations are based on extrapolation of adult data and assumption of similar proportional renal elimination.
Children ≥6 years and Adolescents: Oral:
eGFR 30 to 89 mL/minute/1.73 m2:
>25 kg to ≤35 kg: Maximum daily dose: 4 mg/day.
>35 kg: Initial dose: No dosage adjustment needed; maximum daily dose: 8 mg/day.
eGFR 15 to 29 mL/minute/1.73 m2:
>25 kg to ≤35 kg: Use is not recommended.
>35 kg: Maximum daily dose: 4 mg/day.
eGFR <15 mL/minute/1.73 m2: All pediatric patients: Use is not recommended.
Hemodialysis: All pediatric patients: Use is not recommended.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Use is not recommended; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences are reported for overactive bladder (OAB) unless otherwise noted as neurogenic detrusor overactivity (NDO).
>10%: Gastrointestinal: Diarrhea (NDO: 7% to 12%), xerostomia (NDO: 7% to 10%; OAB: 19% to 35%)
1% to 10%:
Cardiovascular: Peripheral edema (1%)
Dermatological: Skin rash (1%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (1%), weight gain (NDO: 5%)
Gastrointestinal: Abdominal pain (NDO: 5% to 7%; OAB: 1%), constipation (NDO: 7%; OAB: 4% to 6%), dyspepsia (2%), nausea (NDO: 2% to 5%; OAB: 2%)
Genitourinary: Dysuria (1% to 2%), urinary retention (1%), urinary tract infection (NDO: 2% to 10%; OAB: 4%)
Hepatic: Increased serum alanine aminotransferase (1%)
Nervous system: Headache (NDO: 5% to 7%), insomnia (1%)
Neuromuscular & skeletal: Back pain (2%)
Ophthalmic: Accommodation disturbance (NDO: ≤6%), blurred vision (NDO: ≤6%), dry eye syndrome (1% to 4%), myopia (NDO: ≤6%)
Respiratory: Cough (2%), dry throat (2%), upper respiratory tract infection (3%)
<1%:
Cardiovascular: Angina pectoris, chest pain, prolonged QT interval on ECG
Gastrointestinal: Decreased gastrointestinal motility, diverticulitis of the gastrointestinal tract, gastroenteritis, irritable bowel syndrome
Frequency not defined (any indication): Cardiovascular: Increased heart rate
Postmarketing (any indication):
Cardiovascular: Facial edema, palpitations
Dermatologic: Pruritus, urticaria
Hypersensitivity: Angioedema, hypersensitivity reaction
Nervous system: Dizziness, drowsiness
Hypersensitivity (eg, angioedema) to fesoterodine, tolterodine, or any component of the formulation; urinary retention; gastric retention; uncontrolled narrow-angle glaucoma.
Concerns related to adverse effects:
• Angioedema: Cases of angioedema involving the face, lips, tongue, and/or larynx have been reported; may be life-threatening. Cases may occur after the initial dose or after multiple doses. Discontinue immediately if tongue, hypopharynx, or larynx are involved.
• CNS effects: Anticholinergics may cause drowsiness, dizziness, headache, and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Dose reduction or discontinuation should be considered if CNS effects occur.
• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.
Disease-related concerns:
• Bladder flow obstruction: Use is not recommended in patients with significant bladder outlet obstruction; may increase the risk of urinary retention.
• GI obstructive disorders: Use is not recommended in patients with decreased GI motility (eg, severe constipation).
• Glaucoma: Use with caution in patients with controlled (treated) narrow-angle glaucoma.
• Hepatic impairment: Use is not recommended in patients with severe hepatic impairment; has not been studied.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis.
• Renal impairment: Use with caution in patients with renal impairment. Dose adjustment recommended in patients with severe renal impairment (CrCl <30 mL/minute).
Special populations:
• Older adult: Risk of adverse effects may be increased in older adult patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Extended Release 24 Hour, Oral, as fumarate:
Toviaz: 4 mg, 8 mg [contains fd&c blue #2 (indigo carm) aluminum lake, soybean lecithin]
Generic: 4 mg, 8 mg
Yes
Tablet, 24-hour (Fesoterodine Fumarate ER Oral)
4 mg (per each): $13.41 - $13.55
8 mg (per each): $13.41 - $13.55
Tablet, 24-hour (Toviaz Oral)
4 mg (per each): $11.60
8 mg (per each): $11.60
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Extended Release 24 Hour, Oral, as fumarate:
Toviaz: 4 mg, 8 mg [contains fd&c blue #2 (indigo carm) aluminum lake, soybean lecithin]
Generic: 4 mg, 8 mg
Oral: May be administered with or without food. Swallow whole; do not chew, crush, or divide.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. No IR formulation is available. Consider switching to tolterodine immediate release, since both fesoterodine and tolterodine are metabolized to the same active drug.
Oral: May be administered with or without food. Swallow whole; do not chew, crush, or divide.
Neurogenic detrusor overactivity: Treatment of neurogenic detrusor overactivity in pediatric patients ≥6 years of age and weighing >25 kg.
Overactive bladder: Treatment of overactive bladder in adults with symptoms of urinary frequency, urgency, or urge incontinence.
Fesoterodine may be confused with fexofenadine, tolterodine
Beers Criteria: Fesoterodine is identified in the Beers Criteria as a potentially inappropriate medication in patients 65 years and older due to its strong anticholinergic properties (Beers Criteria [AGS 2023]).
Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Alcohol (Ethyl): May enhance the CNS depressant effect of Fesoterodine. Risk C: Monitor therapy
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification
CYP2D6 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Fesoterodine. Management: Limit fesoterodine doses to 4 mg daily in patients who are also receiving strong CYP3A4 inhibitors. This combination is not recommended in pediatric patients weighing 25 kg up to 35 kg. Risk D: Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Itraconazole: May increase serum concentrations of the active metabolite(s) of Fesoterodine. Management: Limit fesoterodine doses to 4 mg daily when combined with itraconazole. Use of fesoterodine with itraconazole, or for 2 weeks after itraconazole discontinuation, in patients with moderate to severe hepatic or renal impairment is contraindicated. Risk D: Consider therapy modification
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: May enhance the adverse/toxic effect of Fesoterodine. Mirabegron may increase serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Adverse effects have been observed in some animal reproduction studies.
It is not known if fesoterodine is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Anticholinergic effects (ie, dry mouth, constipation, dizziness); renal function; hepatic function; postvoid residual urine volume at baseline and as clinically indicated thereafter (AUA [Lerner 2021]); urinary tract infection prior to initiation of therapy (ACOG 2015).
Fesoterodine acts as a prodrug and is converted to an active metabolite, 5-hydroxymethyl tolterodine (5-HMT); 5-HMT is responsible for fesoterodine’s antimuscarinic activity and acts as a competitive antagonist of muscarinic receptors.
Urinary bladder contractions are mediated by muscarinic receptors; fesoterodine inhibits the receptors in the bladder preventing symptoms of urgency and frequency.
Absorption: Well absorbed.
Distribution: 5-HMT:
Children ≥6 years and Adolescents ≤17 years (weighing ≥35 kg): Oral: 68 L.
Adults: IV: Vd: 169 L.
Protein binding: 5-HMT: ~50% (primarily to albumin and alpha1-acid glycoprotein).
Metabolism: Fesoterodine is rapidly and extensively metabolized to its active metabolite (5-hydroxymethyl tolterodine; 5-HMT) by nonspecific esterases; 5-HMT is further metabolized via CYP2D6 and CYP3A4 to inactive metabolites.
Bioavailability: 5-HMT: 52%.
Half-life elimination:
Children ≥6 years and Adolescents ≤17 years (weighing ≥35 kg): 7.73 hours.
Adults: ~7 hours.
Time to peak, plasma: 5-HMT: Cmax ~2-fold higher in poor CYP2D6 metabolizers.
Children ≥6 years and Adolescents ≤17 years (weighing ≥35 kg): 2.55 hours.
Adults: Median: ~5 hours.
Excretion: Urine (~70%; 16% as 5-HMT, ~53% as inactive metabolites); feces (7%).
Altered kidney function: Plasma concentrations of the active metabolite are increased in patients with renal impairment.
Hepatic function impairment: Plasma concentrations of the active metabolite are increased in patients with hepatic impairment.
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