Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
TOVIAZ is indicated in adults for treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur with overactive bladder syndrome.
The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg.
Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to reevaluate the efficacy for the individual patient after 8 weeks of treatment.
In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section 4.5).
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2).
| Moderate3 or potent4 CYP3A4 inhibitors | ||||
|---|---|---|---|---|
| None | Moderate | Potent | ||
| Renal impairment1 | Mild | 4→8 mg2 | 4 mg | Should be avoided |
| Moderate | 4→8 mg2 | 4 mg | Contraindicated | |
| Severe | 4 mg | Should be avoided | Contraindicated | |
| Hepatic impairment | Mild | 4→8 mg2 | 4 mg | Should be avoided |
| Moderate | 4 mg | Should be avoided | Contraindicated | |
1 Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = <30 ml/min
2 Cautious dose increase. See sections 4.4, 4.5 and 5.2
3 Moderate CYP3A4 inhibitors. See section 4.5
4 Potent CYP3A4 inhibitors. See sections 4.3, 4.4 and 4.5
TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
The safety and efficacy of TOVIAZ in children below 18 years of age have not yet been established. No data are available.
Tablets are to be taken once daily with liquid and swallowed whole. TOVIAZ can be administered with or without food.
Overdose with antimuscarinics, including fesoterodine can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdose, ECG monitoring is recommended; standard supportive measures for managing QT prolongation should be adopted. Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/day.
In the event of fesoterodine overdose, treat with gastric lavage and give activated charcoal. Treat symptoms as follows:
2 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 30, 56, 84, 98 or 100 tablets. In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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