DAR DRUG ASSESSMENT REPORT 04 / 2020

www.dtb.navarra.es @DTB_Navarre TOVEDESO® DESFESOTERODINE IN SYNDROME OVERACTIVE BLADDER Making the profitable

IMPORTANT MODEST SOME ADDED NO THERAPEUTIC INSUFFICIENT + THERAPEUTIC THERAPEUTIC VALUE IN SPECIFIC INNOVATION EVIDENCE DATA INNOVATION INNOVATION SITUATIONS SHEET

WHAT IS IT? Decreased gastrointestinal motility. Autonomic neuropathy. Urinary . Risk of long QT syndrome and relevant heart diseases (myo- cardial ischemia, arrhythmia, heart failure). INDICATION Symptoms of overactive bladder syndrome. PLACE IN THERAPEUTICS Due to the absence of comparative studies and assimilate POSOLOGY AND METHOD OF ADMINISTRATION data of its prodrug fesoterodine, it is considered desfesotero- Recommended initial dose in adults, including the elderly, dine does not imply an improvement over other urinary an- is 3.5 mg daily. Maximum daily dose 7 mg. Recommended tispasmodics for treatment of overactive bladder syndrome. reevaluating the response after 8 weeks of treatment. Ad- ministration with or without food. PRESENTATIONS Tovedeso® 3.5 mg prolonged-release tablets, EFFECTIVENESS 28 tablets (TEVA PHARMA S.L.U.) € 41.93 Versus placebo. It uses the fesoterodine data, which shows Tovedeso® 7 mg prolonged-release tablets, limited efficacy. Reduction does not reach one over an ave- 28 tablets (TEVA PHARMA S.L.U.) € 67.08 rage of 12 micturitions per 24 hours vs placebo.

RISKS Adverse reactions: Antimuscarinic effects: dry mouth, dry Daily cost treatment (€) eye, dyspepsia, constipation, urinary retention. Contraindi- (15 mg) 0.21 cated: Urinary retention. Gastric retention. Narrow angle glaucoma. Myasthenia gravis. Severe hepatic impairment. TROSPIUM (40 mg) 0.36 Concomitant use with potent CYP3A4 inhibitors. Severe ul- cerative colitis. Toxic megacolon. Gastroesophageal reflux. (5 mg) 0.72

TOLTERODINE (4 mg) 1.02 Active metabolite (30 mg) 1.10 of fesoterodine.

It has not been studied FESOTERODINE (4 mg) 1.20 specifically. DESFESOTERODINE (3,5 mg) 1.50

MIRABEGRON (50 mg) 1.50

REPORT [IN SPANISH] 0.00 0.50 1.00 1.50

This information is subject to modifications depending on the evolution of scientific knowledge. Notify the suspicions of adverse reactions in www.notificaram.es