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.
Children ≥6 years and Adolescents:
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: Use is not recommended; has not been studied.
(For additional information see "Fesoterodine: Drug information")
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences are reported for overactive bladder (OAB) in adults unless otherwise noted as neurogenic detrusor overactivity (NDO) in children and adolescents.
>10%: Gastrointestinal: Diarrhea (NDO: 7% to 12%), xerostomia (NDO: 7% to 10%; OAB: 19% to 35%)
1% to 10%:
Cardiovascular: Peripheral edema (1%)
Dermatologic: Skin rash (1%)
Endocrine & metabolic: 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 gamma-glutamyl transferase (1%), 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: Palpitations
Dermatologic: Pruritus, urticaria
Gastrointestinal: Oral hypoesthesia
Hypersensitivity: Angioedema, facial edema, hypersensitivity reaction
Nervous system: Confusion, 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.
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.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture.
Treatment of neurogenic detrusor overactivity (NDO) (FDA approved in pediatric patients ≥6 years of age weighing >25 kg); treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence (FDA approved in adults).
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 with inhibitors), CYP3A4 (Minor with inducers); 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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
Acetylcholinesterase Inhibitors: May decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Aclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Acrivastine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Agents with Clinically Relevant Anticholinergic Effects: May increase anticholinergic effects of Fesoterodine. Risk C: Monitor
Alcohol (Ethyl): May increase CNS depressant effects of Fesoterodine. Risk C: Monitor
Amantadine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Benperidol: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Benperidol. Risk C: Monitor
Benztropine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Benztropine. Risk C: Monitor
Biperiden: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Biperiden. Risk C: Monitor
Bornaprine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Botulinum Toxin-Containing Products: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Bromperidol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bromperidol. Risk C: Monitor
Buclizine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Buclizine. Risk C: Monitor
Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of Cannabinoid-Containing Products. Risk C: Monitor
Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Chlorprothixene. Risk C: Monitor
Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Cimetropium. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects 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
Cyclizine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
CYP2D6 Inhibitors (Strong): May increase active metabolite exposure of Fesoterodine. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease active metabolite exposure of Fesoterodine. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase active metabolite exposure 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
Darifenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Darifenacin. Risk C: Monitor
Dicyclomine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dicyclomine. Risk C: Monitor
Dimethindene (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dimethindene (Systemic). Risk C: Monitor
DroNABinol: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of DroNABinol. Risk X: Avoid
Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Eluxadoline. Risk X: Avoid
FluPHENAZine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor
Gepotidacin: May decrease anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Glucagon: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor
Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
Glycopyrrolate (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Systemic). Risk C: Monitor
Glycopyrronium (Topical): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Ipratropium (Nasal): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ipratropium (Oral Inhalation): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Itopride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Itopride. Risk C: Monitor
Itraconazole: May increase active metabolite exposure 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: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Levosulpiride. Risk X: Avoid
Maprotiline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Maprotiline. Risk C: Monitor
Melperone: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Methotrimeprazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Methotrimeprazine. Risk C: Monitor
Methscopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Methscopolamine. Risk C: Monitor
Mirabegron: May increase adverse/toxic effects of Fesoterodine. Mirabegron may increase active metabolite exposure of Fesoterodine. Risk C: Monitor
Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor
OLANZapine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of OLANZapine. Risk C: Monitor
Opioid Agonists: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor
Opipramol: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Oxatomide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
OxyBUTYnin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of OxyBUTYnin. Risk C: Monitor
Perazine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Perphenazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Perphenazine. Risk C: Monitor
Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects 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
Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects 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
Pramlintide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid
Promethazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Promethazine. Risk C: Monitor
Propantheline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Propantheline. Risk C: Monitor
Propiverine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
QuiNIDine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Ramosetron. Risk C: Monitor
Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Revefenacin. Risk X: Avoid
Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Rivastigmine. Rivastigmine may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. 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
Scopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Scopolamine. Risk C: Monitor
Secretin: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects 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
Sofpironium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Sofpironium. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Thiothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Thiothixene. Risk C: Monitor
Tiapride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Tiapride. Risk C: Monitor
Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tiotropium. Risk X: Avoid
Tolterodine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tolterodine. Risk C: Monitor
Topiramate: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Topiramate. Risk C: Monitor
Trimethobenzamide: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trimethobenzamide. Risk C: Monitor
Trospium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trospium. Risk C: Monitor
Umeclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Zuclopenthixol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Zuclopenthixol. Risk C: Monitor
Adverse effects have been observed in some animal reproduction studies.
Anticholinergic effects (ie, dry mouth, constipation, dizziness, blurred vision, urinary retention); renal function; hepatic function; signs/symptoms angioedema or heat intolerance.
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.