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4 O V I A Z � D U E � T O � D R Y � M O U T H � O R � C O N S T I P A T I O N � P O O L E D � A N A L Y S I S
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*Bothersome symptoms of OAB including increased micturition frequency, urgency, UUI, and MVV
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** Pooled analysis of data from two 12-week, randomised, placebo-controlled, phase 3 trials with fesoterodine 4mg, 8mg and tolterodine ER 4mg.
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Discontinuation due to all adverse events was: 3.4% in the placebo group; 4.9% in the Toviaz 4mg group; and 7.2% in the Toviaz 8mg group
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TOVIAZ
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Abbreviated Prescribing Information: including: congenital or documented acquired QT prolongation; electrolyte disturbances,
(See Toviaz Summary of Product characteristics for full Prescribing Information) bradycardia and concomitant administration of drugs known to prolong QT-interval,
Presentation: Prolonged-release tablets containing fesoterodine fumarate. The 4mg is relevant pre-existing cardiac diseases especially when taking potent CYP3A4 inhibitors. The ability to drive and use machines may be affected by blurred vision, dizziness and
light blue, oval, engraved FS containing 3.1mg of fesoterodine. The 8mg is blue, oval, Concomitant treatment with potent CYP2D6 inhibitors may increase exposure, and the somnolence, see side effects. Overdose: Treat with gastric lavage and give activated
engraved FT containing 6.2mg of fesoterodine. Indications: Symptomatic treatment of dose should be increased with caution especially in patients with hepatic or renal charcoal. Treat symptomatically. Legal Category: POM. Marketing authorisation
urge incontinence and/or urinary frequency and/or urgency that may occur in patients impairment. Patients with a combination of hepatic or renal impairment or concomitant holder: Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Package
with overactive bladder syndrome. Dosage: Adults (including Elderly): 4mg once daily. administration of potent or moderate CYP3A4 inhibitors or potent CYP2D6 inhibitors are quantities, Marketing Authorisation numbers and basic NHS price: TOVIAZ
The tablet should be taken whole with some liquid. The dose may be increased to max expected to have additional exposure increases and dose dependant side effects – dose 4mg, 28 prolonged-release tablets, EU/1/07/386/003 £25.78; TOVIAZ 8mg, 28
daily dose of 8mg once daily. The max dose in patients with severe renal impairment or increase to 8mg where possible should be preceded by an evaluation of response and prolonged-release tablets, EU/1/07/386/008 £25.78. Further information is
moderate hepatic impairment is 4mg. Treatment should be re-valuated after 8 weeks. tolerability. Organic reasons for urge, frequency or overactive bladder should be available on request from: Medical Information at Pfizer Limited, Walton Oaks,
Children: Not recommended. Cautious dose increase recommended in patients with mild considered before treatment. Drug Interactions: Concomitant use of other Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Tel: +44 (0) 1304 616161
or moderate renal impairment or mild hepatic impairment. Max dose with patients using antimuscarinic agents and medicinal products with anticholinergic properties or with Date of Preparation: December 2008.
moderate CYP3A4 inhibitors with mild or moderate renal impairment or mild hepatic strong inhibitors of CYP3A4, may lead to more pronounced therapeutic and side-effects. Company reference: TV2_0
impairment is 4mg. Use should be avoided in patients with mild renal or hepatic Moderate CYP3A4 inhibitors are expected to cause a lesser increase of exposure to the
impairment using potent CYP3A4 inhibitors, or patients with severe renal impairment or active metabolite. Induction of CYP3A4 may lead to subtherapeutic plasma levels.
moderate hepatic impairment using moderate CYP3A4 inhibitors. In patients receiving Concomitant use with CYP3A4 inducers is not recommended. Fesoterodine may
Adverse events should be reported. Reporting forms and
concomitant potent CYP3A4 inhibitors the max. daily dose is 4mg. Contraindications: reduce the effect of products that stimulate the motility of the gastro-intestinal tract. information can be found at www.yellowcard.gov.uk
Hypersensitivity to fesoterodine, soya, peanut or excipients, urinary retention, gastric Co-administration of Toviaz with potent CYP2D6 inhibitors may lead to increased
Adverse events should also be reported to
retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic exposure and adverse events. A dose reduction to 4mg may be required. Pregnancy &
impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon. Concomitant use of Lactation:
Pfizer Medical Information on 01304 616161
Not recommended. See Full Prescribing Information. Side Effects: In clinical
potent CYP3A4 inhibitors in patients with moderate or severe renal impairment, or trials, the most commonly reported adverse reaction was dry mouth. Common reported
patients with moderate hepatic impairment. Warnings and Precautions: Use with events include dizziness, headache, dry eye, dry throat, abdominal pain, diarrhoea, References: 1. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical Efficacy,
caution in patients with significant bladder outlet obstruction at risk of urinary retention, dyspepsia, constipation, nausea, dysuria, insomnia; uncommon (5 or more cases) Safety, and Tolerability of Once-Daily Fesoterodine in Subjects With Overactive
gastrointestinal obstructive disorders, e.g. pyloric stenosis, gastro-oesophageal reflux, tachycardia, dysgeusia, somnolence, vertigo, pharyngolaryngeal pain, cough, nasal Bladder. Eur Urol. 2007 Oct; 52(4):1204-1212. 2. Khullar V, Rovner E, Dmochowski
concurrent medicinal products that may cause or exacerbate gastro-oesophageal reflux, dryness, abdominal discomfort, flatulence, urinary retention (including feeling of residual R et al. Fesoterodine dose response in subjects with overactive bladder syndrome.
autonomic neuropathy, controlled narrow-angle glaucoma, decreased gastrointestinal urine, micturation disorder), urinary hesitation, rash, dry skin, urinary tract infection, Urology 2008 May; 71(5): 839-843.
motility. Toviaz should not be used in patients with hereditary problems of fructose fatigue, ALT increased, GGT increased. The heart rate corrected QT interval in
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. fesoterodine treated patients did not differ from that seen in placebo treated Date of preparation: May 2009
Fesoterodine should be used with caution in patients with risk factors for QT-prolongation patients. See Full Prescribing Information. Driving and operating machinery: TOV289
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