Dosing and uses of Toviaz (fesoterodine)
Adult dosage forms and strengths
tablet, extended-release
- 4mg
- 8mg
Overactive Bladder
Indicated for overactive bladder with urge incontinence, urgency, and frequency
4 mg/day PO; may increase to 8 mg/day
Renal Impairment, severe (CrCl <30 mL/min): do not exceed dose >4 mg/day
Dosage modifications
Coadministration with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not to exceed 4 mg/day
Renal Impairment
CrCl <30 mL/min: Not to exceed dose 4 mg/day
CrCl≥30 mL/min: Dose adjustment not necessary
Hepatic Impairment
Mild to mederate: Dose adjustment not necessary
Severe hepatic impairment (Child-Pugh C): Not recommended
Pediatric dosage forms and strengths
Safety and efficacy not established
Toviaz (fesoterodine) adverse (side) effects
>10%
Dry mouth (18-34%)
1-10%
Abdominal pain (1%)
Constipation (4-6%)
Dyspepsia (2%)
Insomnia (1%)
Nausea (1-2%)
Urinary retention (1%)
UTI (3-4%)
Xerophthalmia (1-4%)
Upper respiratory tract infection (2-3%)
Dry throat (1-2%)
Postmarketing Reports
General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema
Central nervous system disorders: Dizziness, headache, somnolence
Skin and subcutaneous tissue disorders: Urticaria, pruritus
Warnings
Contraindications
Hypersensitivity to drug or ingredients
Urinary or gastric retention
Uncontrolled narrow-angle glaucoma
Cautions
Concomitant strong CYP3A4 inhibitors: Not to exceed 4 mg/day recommended; if coadministered with weak/moderate inhibitors, may increase to 8 mg/day carefully
Controlled narrow-angle glaucoma, bladder outflow obstruction, GI obstruction, reduced hepatic/renal function, and autonomic neuropathy
Angioedema of the face, lips, tongue, and/or larynx reported; in some cases angioedema occurred after the first dose
Anticholinergic CNS effects (eg, headache, dizziness, somnolence) reported; advise patients not to drive or operate heavy machinery until they adjust to therapy
Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction, bladder flow obstruction
Heat prostration may occur in the presence of increased environmental temperature
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known wehther excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Toviaz (fesoterodine)
Mechanism of action
Competitive muscarinic receptor antagonist; inhibition of receptors in the bladder prevent symptoms of urgency and frequency
Absorption
Bioavailability: 52%
Protein Bound: 50%
Vd: 169 L (5-HMT active metabolite)
Metabolism
Rapidly hydrolyzed to active metabolite, and THEN by liver CYP3A4 and CYP2D6 to inactive metabolites
Elimination
Half-Life: 7 hr
Excretion: Urine (70%); feces (7%)
