These Highlights Do Not Include All The Information Needed To Use Toviaz Safely And Effectively. See Full Prescribing Information For Toviaz.

Toviaz is indicated for the treatment of:

• •
  Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
• •
  Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)

• •
  OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. (2.1)
• •
  NDO in Pediatric Patients 6 Years and Older:
  • •
    Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:
    
    The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. (2.2)
  • •
    Pediatric Patients Weighing Greater than 35 kg:
    
    The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. (2.2)
• •
  Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3, 2.4)
• •
  Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5)
• •
  Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (2.6)

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:

Toviaz (fesoterodine fumarate) extended-release tablets 8 mg are blue, oval, biconvex, film-coated, and engraved with "FT" on one side. They are supplied as follows:

Toviaz is contraindicated in patients with any of the following:

• •
  known or suspected hypersensitivity to Toviaz or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1)]. Reactions have included angioedema [see Warnings and Precautions (5.1)]
• •
  urinary retention [see Warnings and Precautions (5.2)]
• •
  gastric retention [see Warnings and Precautions (5.3)]
• •
  uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.4)]

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-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.

Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C₃₀H₄₁NO₇ and its molecular weight is 527.66. The structural formula is:

The asterisk (*) indicates the chiral carbon.

Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

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

The safety and effectiveness of Toviaz have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. The information on this use is discussed throughout labeling. Use of Toviaz for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (Study 3) [see Adverse Reactions (6.1) and Clinical Studies (14.2)]. Study results demonstrated that treatment with Toviaz 4 mg and 8 mg daily resulted in improvements from baseline to Week 12 in maximum cystometric bladder capacity (MCBC) for patients weighing greater than 25 kg [see Clinical Studies (14.2) and Clinical Pharmacology (12.3)]. The most commonly reported adverse reactions in patients who received Toviaz 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see Adverse Reactions (6.1)]. Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of Toviaz, with larger mean increases reported in pediatric patients who received the 8 mg daily dose [see Adverse Reactions (6.1)].

The safety and effectiveness of Toviaz have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less.

No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age.

Of the 1,567 patients who received Toviaz 4 mg or 8 mg orally once daily in Phase 2 and 3, placebo-controlled, efficacy and safety studies for OAB, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. No overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. However, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see Clinical Studies (14.1) and Adverse Reactions (6)].

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

• •
  Angioedema [see Warnings and Precautions (5.1)]
• •
  Urinary Retention [see Warnings and Precautions (5.2)]
• •
  Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)]

Overdosage with Toviaz can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.

Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

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 with "FT" on one side.

Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine.

Muscarinic receptors play a role in contractions of urinary bladder smooth muscle. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

In a urodynamic study involving patients with involuntary detrusor contractions, the effects after the administration of fesoterodine on the volume at first detrusor contraction and bladder capacity were assessed. Administration of fesoterodine increased the volume at first detrusor contraction and bladder capacity in a dose-dependent manner. These findings are consistent with an antimuscarinic effect on the bladder.

• •
  Angioedema: Promptly discontinue Toviaz and provide appropriate therapy. (5.1)
• •
  Urinary Retention: Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2)
• •
  Decreased Gastrointestinal Motility: Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3)
• •
  Worsening of Narrow-Angle Glaucoma: Use Toviaz with caution in patients being treated for narrow-angle glaucoma. (5.4)
• •
  Central Nervous System Effects: Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them. (5.5)
• •
  Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis. (5.6)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

NDC 63539-242-77

Rx only

Toviaz^®

(fesoterodine fumarate)

extended release tablets

4 mg 1 card x 7 tablets

Look inside for more information about

your TOVIAZ prescription.

PROFESSIONAL SAMPLE — NOT FOR SALE

In adult patients with severe renal impairment (CL_CR <30 mL/min), C_max and AUC are increased 2.0- and 2.3-fold, respectively. Doses of Toviaz greater than 4 mg are not recommended in adult patients with severe renal impairment. In patients with mild or moderate renal impairment (CL_CR ranging from 30–80 mL/min), C_max and AUC of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3) and Dosage and Administration (2.2, 2.3 )].

The recommended dosage of Toviaz in pediatric patients weighing greater than 25 kg and up to 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m²) is 4 mg once daily and Toviaz is not recommend in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m²). In pediatric patients weighing greater than 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m²), the recommended starting dosage of Toviaz is 4 mg orally once daily, with increase to the recommended dosage of Toviaz 8 mg orally once daily, and in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m²) the recommended dose is 4 mg once daily [see Dosage and Administration (2.2, 2.4)].

Patients with severe hepatic impairment (Child-Pugh C) have not been studied; therefore Toviaz is not recommended for use in these patients. In patients with moderate (Child-Pugh B) hepatic impairment, C_max and AUC of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)].

Toviaz is indicated for the treatment of:

• •
  Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
• •
  Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)

• •
  OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. (2.1)
• •
  NDO in Pediatric Patients 6 Years and Older:
  • •
    Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:
    
    The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. (2.2)
  • •
    Pediatric Patients Weighing Greater than 35 kg:
    
    The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. (2.2)
• •
  Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3, 2.4)
• •
  Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5)
• •
  Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (2.6)

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:

Toviaz (fesoterodine fumarate) extended-release tablets 8 mg are blue, oval, biconvex, film-coated, and engraved with "FT" on one side. They are supplied as follows:

Toviaz is contraindicated in patients with any of the following:

• •
  known or suspected hypersensitivity to Toviaz or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1)]. Reactions have included angioedema [see Warnings and Precautions (5.1)]
• •
  urinary retention [see Warnings and Precautions (5.2)]
• •
  gastric retention [see Warnings and Precautions (5.3)]
• •
  uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.4)]

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

The safety and effectiveness of Toviaz have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. The information on this use is discussed throughout labeling. Use of Toviaz for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (Study 3) [see Adverse Reactions (6.1) and Clinical Studies (14.2)]. Study results demonstrated that treatment with Toviaz 4 mg and 8 mg daily resulted in improvements from baseline to Week 12 in maximum cystometric bladder capacity (MCBC) for patients weighing greater than 25 kg [see Clinical Studies (14.2) and Clinical Pharmacology (12.3)]. The most commonly reported adverse reactions in patients who received Toviaz 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see Adverse Reactions (6.1)]. Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of Toviaz, with larger mean increases reported in pediatric patients who received the 8 mg daily dose [see Adverse Reactions (6.1)].

The safety and effectiveness of Toviaz have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less.

No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age.

Of the 1,567 patients who received Toviaz 4 mg or 8 mg orally once daily in Phase 2 and 3, placebo-controlled, efficacy and safety studies for OAB, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. No overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. However, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see Clinical Studies (14.1) and Adverse Reactions (6)].

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

• •
  Angioedema [see Warnings and Precautions (5.1)]
• •
  Urinary Retention [see Warnings and Precautions (5.2)]
• •
  Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)]

Overdosage with Toviaz can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.

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-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.

Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C₃₀H₄₁NO₇ and its molecular weight is 527.66. The structural formula is:

The asterisk (*) indicates the chiral carbon.

Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

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 with "FT" on one side.

Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine.

Muscarinic receptors play a role in contractions of urinary bladder smooth muscle. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

In a urodynamic study involving patients with involuntary detrusor contractions, the effects after the administration of fesoterodine on the volume at first detrusor contraction and bladder capacity were assessed. Administration of fesoterodine increased the volume at first detrusor contraction and bladder capacity in a dose-dependent manner. These findings are consistent with an antimuscarinic effect on the bladder.

• •
  Angioedema: Promptly discontinue Toviaz and provide appropriate therapy. (5.1)
• •
  Urinary Retention: Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2)
• •
  Decreased Gastrointestinal Motility: Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3)
• •
  Worsening of Narrow-Angle Glaucoma: Use Toviaz with caution in patients being treated for narrow-angle glaucoma. (5.4)
• •
  Central Nervous System Effects: Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them. (5.5)
• •
  Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis. (5.6)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

NDC 63539-242-77

Rx only

Toviaz^®

(fesoterodine fumarate)

extended release tablets

4 mg 1 card x 7 tablets

Look inside for more information about

your TOVIAZ prescription.

PROFESSIONAL SAMPLE — NOT FOR SALE

In adult patients with severe renal impairment (CL_CR <30 mL/min), C_max and AUC are increased 2.0- and 2.3-fold, respectively. Doses of Toviaz greater than 4 mg are not recommended in adult patients with severe renal impairment. In patients with mild or moderate renal impairment (CL_CR ranging from 30–80 mL/min), C_max and AUC of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3) and Dosage and Administration (2.2, 2.3 )].

The recommended dosage of Toviaz in pediatric patients weighing greater than 25 kg and up to 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m²) is 4 mg once daily and Toviaz is not recommend in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m²). In pediatric patients weighing greater than 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m²), the recommended starting dosage of Toviaz is 4 mg orally once daily, with increase to the recommended dosage of Toviaz 8 mg orally once daily, and in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m²) the recommended dose is 4 mg once daily [see Dosage and Administration (2.2, 2.4)].

Patients with severe hepatic impairment (Child-Pugh C) have not been studied; therefore Toviaz is not recommended for use in these patients. In patients with moderate (Child-Pugh B) hepatic impairment, C_max and AUC of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)].