Fesoterodine Fumarate
Fesoterodine Fumarate Prescribing Information
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. (
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)
•
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,
•
• 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. (
The recommended dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. If needed, dosage may be increased to fesoterodine fumarate extended-release tablets 8 mg orally once daily. For administration instructions,
The recommended starting dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. After one week, increase to fesoterodine fumarate extended-release tablets 8 mg orally once daily. For administration instructions,
• 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. (
The recommended dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. If needed, dosage may be increased to fesoterodine fumarate extended-release tablets 8 mg orally once daily. For administration instructions,
The recommended starting dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. After one week, increase to fesoterodine fumarate extended-release tablets 8 mg orally once daily. For administration instructions,
•
The recommended dosage of fesoterodine fumarate extended-release tablets in adult patients with renal impairment is described in Table 1
Specific Populations ]
Estimated Creatinine Clearance1 | Recommended Dose |
| CLcr 30 to 89 mL/min | 8 mg |
| CLcr 15 to 29 mL/min | 4 mg |
| CLcr <15 mL/min | 4 mg |
1Calculate CLcr using the Cockcroft-Gault formula
The recommended dosage of fesoterodine fumarate extended-release tablets in pediatric patients with renal impairment weighing greater than 25 kg and up to 35 kg is described in Table 2
Estimated Glomerular Filtration Rate (GFR)1 | Recommended Dose2 |
| eGFR 30 to 89 mL/min/1.73m2 | 4 mg |
| eGFR 15 to 29 mL/min/1.73m2 | Use is Not Recommended |
| eGFR <15 mL/min/1.73m2or requiring dialysis | Use is Not Recommended |
1Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication.
2Dosing was derived assuming similar proportional effects of renal impairment in adults and pediatric patients 6 years and older.
The recommended dosage of fesoterodine fumarate extended-release tablets in pediatric patients with renal impairment weighing greater than 35 kg is described in Table 3
Estimated GFR1 | Recommended Dose3 |
| eGFR 30 to 89 mL/min/1.73m2 | 8 mg2 |
| eGFR15 to 29 mL/min/1.73m2 | 4 mg |
| eGFR <15 mL/min/1.73m2or requiring dialysis | Use is Not Recommended |
1Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication.
2The recommended starting dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. After one week, increase to the recommended dosage of fesoterodine fumarate extended-release tablets 8 mg orally once daily.
3Dosing was derived assuming similar proportional effects of renal impairment in adults and pediatric patients 6 years and older.
•
The maximum recommended dosage is fesoterodine fumarate extended-release tablets 4 mg orally once daily in adult patients taking strong CYP3A4
inhibitors
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
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
•
Swallow fesoterodine fumarate extended-release tablets whole with liquid. Do not chew, divide, or crush. Take with or without food
Extended-release tablets:
· 4 mg are light blue, oval, biconvex, film coated tablets debossed with 'H' on one side and 'F6' on the other side.
· 8 mg are blue, oval, biconvex, film coated tablets debossed with 'H' on one side and 'F7' on the other side.
There are no available data with the use of fesoterodine fumarate extended-release tablets 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 F
1dams or on the F
2offspring.
Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following:
· known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules
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.
Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. 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
· urinary retention
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
· gastric retention
Fesoterodine fumarate extended-release tablets are associated with decreased gastric motility. Fesoterodine fumarate extended-release tablet is contraindicated in patients with gastric retention
· uncontrolled 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
·
Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. 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
·
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
·
Fesoterodine fumarate extended-release tablets are associated with decreased gastric motility. Fesoterodine fumarate extended-release tablet is contraindicated in patients with gastric retention
·
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
·
Fesoterodine fumarate extended-release tablets are associated with anticholinergic central nervous system (CNS) adverse reactions
·
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.