Yudu - European Urological Disease Volume 3 Issue1

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s¬ Toviaz is effective in relieving the most bothersome symptoms of OAB
at both 4mg and 8mg doses
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s¬ Toviaz 4mg and 8mg delivers early efficacy, with an initial treatment effect
antimuscarinic
observed by week 2 and enhanced and sustained at week 12
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Starting dose 4mg titrated up to 8mg for more efficacy
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TOVIAZ
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Abbreviated Prescribing Information. risk factors for QT-prolongation including: congenital or documented acquired QT
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prolongation; electrolyte disturbances, bradycardia and concomitant administration
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(See Toviaz Summary of Product characteristics for full Prescribing Information)
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Presentation: Prolonged-release tablets containing fesoterodine fumarate. The of drugs known to prolong QT-interval, relevant pre-existing cardiac diseases
4mg is light blue, oval, engraved FS containing 3.1mg of fesoterodine. The 8mg is especially when taking potent CYP3A4 inhibitors. Concomitant treatment with
blue, oval, engraved FT containing 6.2mg of fesoterodine. Indications: potent CYP2D6 inhibitors may increase exposure, and the dose should be increased The ability to drive and use machines may be affected by blurred vision, dizziness
Symptomatic treatment of urge incontinence and/or urinary frequency and/or with caution especially in patients with hepatic or renal impairment. Patients with a and somnolence, see side effects. Overdose: Treat with gastric lavage and give
urgency that may occur in patients with overactive bladder syndrome. Dosage: combination of hepatic or renal impairment or concomitant administration of potent activated charcoal. Treat symptomatically. Legal Category: POM. Marketing
Adults (including Elderly): 4mg once daily. The tablet should be taken whole with or moderate CYP3A4 inhibitors or potent CYP2D6 inhibitors are expected to have authorisation holder: Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ,
some liquid. The dose may be increased to max daily dose of 8mg once daily. The additional exposure increases and dose dependant side effects – dose increase to UK. Package quantities, Marketing Authorisation numbers and basic
max dose in patients with severe renal impairment or moderate hepatic impairment 8mg where possible should be preceded by an evaluation of response and NHS price: TOVIAZ 4mg, 28 prolonged-release tablets, EU/1/07/386/003
is 4mg. Treatment should be re-valuated after 8 weeks. Children: Not recommended. tolerability. Organic reasons for urge, frequency or overactive bladder should be £29.03; TOVIAZ 8mg, 28 prolonged-release tablets, EU/1/07/386/008
Cautious dose increase recommended in patients with mild or moderate renal considered before treatment. Drug Interactions: Concomitant use of other £29.03. Further information is available on request from: Medical
impairment or mild hepatic impairment. Max dose with patients using moderate antimuscarinic agents and medicinal products with anticholinergic properties or Information at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey,
CYP3A4 inhibitors with mild or moderate renal impairment or mild hepatic with strong inhibitors of CYP3A4, may lead to more pronounced therapeutic and KT20 7NS, UK. Tel: +44 (0) 1304 616161
impairment is 4mg. Use should be avoided in patients with mild renal or hepatic side-effects. Moderate CYP3A4 inhibitors are expected to cause a lesser increase Date of Preparation: June 2008.
impairment using potent CYP3A4 inhibitors, or patients with severe renal impairment of exposure to the active metabolite. Induction of CYP3A4 may lead to Company reference: TV1_5
or moderate hepatic impairment using moderate CYP3A4 inhibitors. In patients subtherapeutic plasma levels. Concomitant use with CYP3A4 inducers is not
receiving concomitant potent CYP3A4 inhibitors the max. daily dose is 4mg. recommended. Fesoterodine may reduce the effect of products that stimulate the
Adverse events should be reported.
Contraindications: Hypersensitivity to fesoterodine, soya, peanut or excipients, motility of the gastro-intestinal tract. Co-administration of Toviaz with potent CYP2D6
urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, inhibitors may lead to increased exposure and adverse events. A dose reduction to
Reporting forms and information can be found at
myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative 4mg may be required. Pregnancy & Lactation: Not recommended. See Full
www.yellowcard.gov.uk
colitis, toxic megacolon. Concomitant use of potent CYP3A4 inhibitors in patients Prescribing Information. Side Effects: In clinical trials, the most commonly reported Adverse events should also be reported to
with moderate or severe renal impairment, or patients with moderate hepatic adverse reaction was dry mouth. Common reported events include dizziness, Pfizer Medical Information on 01304 616161
impairment. Warnings and Precautions: Use with caution in patients with headache, dry eye, dry throat, abdominal pain, diarrhoea, dyspepsia, constipation,
significant bladder outlet obstruction at risk of urinary retention, gastrointestinal nausea, dysuria, insomnia; uncommon (5 or more cases) tachycardia, dysgeusia, References: 1. Chapple C, et al. Clinical efficacy, safety, and tolerability of
obstructive disorders, e.g. pyloric stenosis, gastro-oesophageal reflux, concurrent somnolence, vertigo, pharyngolaryngeal pain, cough, nasal dryness, abdominal once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007.
medicinal products that may cause or exacerbate gastro-oesophageal reflux, discomfort, flatulence, urinary retention (including feeling of residual urine, Oct; 52(4):1204-12. 2. Chapple C, et al. Comparison of fesoterodine and
autonomic neuropathy, controlled narrow-angle glaucoma, decreased micturation disorder), urinary hesitation, rash, dry skin, urinary tract infection, tolterodine in subjects with overactive bladder. Br J Urol Int.
gastrointestinal motility. Toviaz should not be used in patients with hereditary fatigue, ALT increased, GGT increased. The heart rate corrected QT interval in Article in press.
problems of fructose intolerance, glucose-galactose malabsorption or sucrase- fesoterodine treated patients did not differ from that seen in placebo treated Date of preparation: June 2008
isomaltase insufficiency. Fesoterodine should be used with caution in patients with patients. See Full Prescribing Information. Driving and operating machinery: TOV157a