Fesoterodine Fumarate

Fesoterodine fumarate extended-release tablets are indicated for the treatment of:

• Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (
  1.1 Adult Overactive Bladder

  Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
  )
• Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (
  1.2 Pediatric Neurogenic Detrusor Overactivity

  Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.
  )

• 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 Recommended Dosage for Adult Patients with OAB

  The recommended starting dosage of fesoterodine fumarate extended-release tablets in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of fesoterodine fumarate extended-release tablets 8 mg once daily. For administration instructions,

  see

  Dosage and Administration .
  )
• 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 Fesoterodine Fumarate Extended-Release Tablets Dosage Modifications Due to Strong CYP3A4 Inhibitors

  Adult Patients with OAB

  The maximum recommended dosage is fesoterodine fumarate extended-release tablets 4 mg orally once daily in adult patients taking strong CYP3A4 inhibitors

  [see Drug Interactions

  and

  Clinical Pharmacology ].

  For administration instructions,

  see

  Dosage and Administration .

  Pediatric Patients with NDO

  Pediatric Patients Weighing Greater than 25 kg and up to 35 kg

  The use of fesoterodine fumarate extended-release tablets in pediatric patients weighing greater than 25 kg and up to 35 kg and taking strong CYP3A4 inhibitors is not recommended

  [see Drug Interactions and Clinical Pharmacology ]

  . For administration instructions,

  see Dosage and Administration

  .

  Pediatric Patients Weighing Greater than 35 kg

  The maximum recommended dosage is fesoterodine fumarate extended-release tablets 4 mg orally once daily in pediatric patients weighing greater than 35 kg and taking strong CYP3A4 inhibitors

  [see Drug Interactions and Clinical Pharmacology ]

  . For administration instructions,

  see Dosage and Administration

  .
  )
• Administration:
  Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (
  2.6 Administration Instructions

  Swallow fesoterodine fumarate extended-release tablets whole with liquid. Do not chew, divide, or crush. Take with or without food

  [see Clinical Pharmacology ].
  )

• Fesoterodine fumarate extended-release tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side.
• Fesoterodine fumarate extended-release tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side.

There are no available data with the use of fesoterodine fumarate in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. 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

No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre-and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. No effects were noted on mating and reproduction of the F₁ dams or on the F₂ offspring.

• Angioedema:
  Promptly discontinue fesoterodine fumarate extended-release tablets and provide appropriate therapy. (
  5.1 Angioedema

  Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine fumarate extended-release tablets. In some cases, angioedema occurred after the first dose; however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life-threatening.

  Fesoterodine fumarate extended-release tablets are contraindicated in patients with a known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients

  [see Contraindications ].

  If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine fumarate extended-release tablets should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.
  )
• Urinary Retention:
  Fesoterodine fumarate extended-release tablets are not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (
  5.2 Urinary Retention in Adult Patients with Bladder Outlet Obstruction

  The use of fesoterodine fumarate extended-release tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury. The use of fesoterodine fumarate extended-release tablets is not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention

  [see Contraindications and Adverse Reactions ].
  )
• Decreased Gastrointestinal Motility:
  Fesoterodine fumarate extended-release tablets are not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (
  5.3 Decreased Gastrointestinal Motility

  Fesoterodine fumarate extended-release tablets are associated with decreased gastric motility. Fesoterodine fumarate extended-release tablets are contraindicated in patients with gastric retention

  [see Contraindications ].

  The use of fesoterodine fumarate extended-release tablets are not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation.
  )
• Worsening of Narrow Angle Glaucoma:
  Use fesoterodine fumarate extended-release tablets with caution in patients being treated for narrow-angle glaucoma. (
  5.4 Worsening of Narrow-Angle Glaucoma

  Fesoterodine fumarate extended-release tablets can worsen controlled narrow-angle glaucoma. Fesoterodine fumarate extended-release tablets are contraindicated in patients with uncontrolled narrow-angle glaucoma

  [see Contraindications ].

  Fesoterodine fumarate extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma.
  )
• Central Nervous System Effects:
  Somnolence has been reported with fesoterodine fumarate extended-release tablets. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate extended-release tablets affects them. (
  5.5 Central Nervous System Effects

  Fesoterodine fumarate extended-release tablets are associated with anticholinergic central nervous system (CNS) adverse reactions

  [see Adverse Reactions ].

  A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. If a patient experiences anticholinergic CNS effects, fesoterodine fumarate extended-release tablets dose reduction or discontinuation should be considered.
  )
• Worsening of Myasthenia Gravis Symptoms:
  Use fesoterodine fumarate extended-release tablets with caution in patients with myasthenia gravis. (
  5.6 Worsening of Myasthenia Gravis Symptoms

  Fesoterodine fumarate extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of worsening of symptoms of the disease.
  )