Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Tovedeso 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 3.5 mg once daily. Based upon individual response, the dose may be increased to 7 mg once daily. The maximum daily dose is 7 mg.
Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to re-evaluate 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 Tovedeso should be 3.5 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 | 3.5→7 mg2 | 3.5 mg | Should be avoided |
| Moderate | 3.5→7 mg2 | 3.5 mg | Contraindicated | |
| Severe | 3.5 mg | Should be avoided | Contraindicated | |
| Hepatic impairment | Mild | 3.5→7 mg2 | 3.5 mg | Should be avoided |
| Moderate | 3.5 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
Tovedeso is contraindicated in subjects with severe hepatic impairment (see section 4.3).
The safety and efficacy of desfesoterodine 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. Tovedeso can be administered with or without food.
Overdose with antimuscarinics, including desfesoterodine 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 desfesoterodine overdose, treat with gastric lavage and give activated charcoal. Treat symptoms as follows:
2 years.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Aluminium-aluminium blisters containing 14, 28, 56, 84, 98, 100 or 112 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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