TOVIAZ - fesoterodine

What is TOVIAZ?

TOVIAZ is a medicine containing the active substance fesoterodine. It is available as oval prolonged-release tablets of 4 mg (blue) and 8 mg (blue). Prolonged release means that fesoterodine is released slowly from the tablet within a few hours.

What is TOVIAZ used for?

TOVIAZ is used in patients with overactive bladder syndrome to treat the related symptoms: increased urinary frequency (need to urinate frequently), urgency (urgent need to urinate) and urgency incontinence (sudden lack of control over urination).

The medicine can only be obtained with a prescription.

How is TOVIAZ used?

The recommended starting dose of TOVIAZ is 4 mg once a day. The tablets should be swallowed whole with water, should not be chewed and may be taken with or without food. The patient feels the full effect of the treatment after a period of between two and eight weeks. Depending on the individual response, the dose may be increased up to 8 mg once a day.

The dose of TOVIAZ must be adequate, or the drug should not be taken in patients who have problems with their kidneys or liver, particularly when they are also taking other medicines that can interfere with the way TOVIAZ is metabolized in the body. For more details, please refer to the summary of product characteristics, included in the EPAR.

How does TOVIAZ work?

The active substance in TOVIAZ, fesoterodine, is an anticholinergic drug. It blocks some receptors in the body, the muscarinic receptors, and this causes the muscles in the urine bladder to relax in the urinary bladder. In this way there is an increase in the capacity of the bladder and changes in the way the bladder muscles contract as the bladder fills up. This allows TOVIAZ to prevent involuntary urination.

How has TOVIAZ been studied?

The effects of TOVIAZ were first tested in experimental models before being studied in humans. The two main studies involved 1 964 patients (average age: 58 years) and compared the efficacy of TOVIAZ (4 or 8 mg a day) with that of placebo (a dummy treatment). One of the studies also compared TOVIAZ with tolterodine (another medicine used in overactive bladder syndrome). The main measure of effectiveness was the change, over a 24-hour period, in the number of times patients felt the need to urinate, before and after 12 weeks of treatment.

What benefit has TOVIAZ shown during the studies?

TOVIAZ was more effective than placebo and as effective as tolterodine in reducing the number of times patients urinated within 24 hours. Before treatment, patients used to urinate 12 times in 24 hours. This number decreased by 1.74 or 1.86 (4 mg dose) and 1.94 (8 mg dose) after 12 weeks of taking TOVIAZ and 1.02 in placebo-treated patients. The decrease recorded in patients treated with tolterodine was 1.69.

What is the risk associated with TOVIAZ?

The most common side effect of TOVIAZ (occurring in more than 1 patient in 10) was dry mouth. For the full list of all side effects reported with TIOVAZ, see the Package Leaflet.

TIOVAZ should not be used in people who are hypersensitive (allergic) to fesoterodine, peanuts, soya or any of the other ingredients. TOVIAZ should not be used in patients with:

urinary retention (difficulty in expelling urine);
gastric retention (when the stomach does not empty properly);
uncontrolled glaucoma at an acute angle (increased ocular pressure despite treatment);
myasthenia gravis (disease that affects the nerves causing muscle weakness);
severe hepatic failure (severe liver disease);
ulcerative colitis (severe inflammation of the large intestine which causes ulceration and bleeding;
toxic megacolon (very serious complication of colitis).

TOVIAZ should not be used in patients with moderate liver disease or moderate to severe kidney disease concomitantly with other medicines that have a significant blocking effect on one of the liver enzymes (CYP3A4). These are medicines such as ketoconazole and itraconazole (used to treat fungal infections), atanazavir, indinavir, nelfinavir, ritonavir and sachinavir (medicines used in HIV positive patients), clarithromycin and telithromycin as well as nefazodone (used to treat depression).

Why has TOVIAZ been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of TOVIAZ outweigh the risks in treating symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive bladder. The committee recommended the granting of the marketing authorization for TOVIAZ.