Vesicare (solifenacin succinate) tablets Information for Healthcare Professionals
Information for Consumers
 
 
 
WHAT IS OAB? TREATING OAB ABOUT VESIcare PATIENTS ON VESIcare PROFESSIONAL RESOURCES
Efficacy Dosing Pharmacology Contraindications Precautions Adverse Reactions
About VESIcare
Efficacy
VESIcare is effective in reducing what many OAB patients consider their most distressful symptom: incontinence.6,16

Drier at 12 weeks
51% of subjects who took VESIcare once-daily 5 mg reported no incontinence episodes in their consecutive three-day diary prior to the end of the study, compared to 38% of subjects who were administered placebo.6

Results from a post hoc responder analysis

Drier at 1 year
60% of patients treated with VESIcare reported no incontinence episodes at the end of a 40-week, open-label extension safety study in a post hoc responder analysis.17

Patients incontinence chart

For first 4 weeks of extension, patients took 5 mg and for remaining 36 weeks were allowed flexible dosing of VESIcare 5 mg or 10 mg.
Primary objective was to assess safety and tolerability of long-term treatment.
Post hoc responder analysis in patients who reported incontinence at baseline and no incontinence episodes for 3 consecutive days prior to study visits.

Drier than tolterodine
59% of patients receiving VESIcare 5 mg or 10 mg reported no incontinence episodes at 12 weeks, versus 49% of receiving tolterodine 4 mg extended release in a head-to-head study (P=0.006).18 In terms of the study’s primary endpoint, mean change from baseline in micturitions per 24 hours, demonstrated VESIcare to be noninferior to tolterodine (P = 0.004).18

Chart Showing Incontinent Patients Reporting Relief of Incontinence at 12 weeks

Results from a double-blind, double-dummy, 12-week study comparing efficacy and safety of VESIcare in a flexible-dosing regimen of 5 mg or 10 mg and tolterodine 4 mg extended release.
The primary endpoint, mean change from baseline in micturitions/24 h, demonstrated VESIcare to be noninferior to tolterodine (P=0.004).
The most common drug-related, treatment-emergent adverse events reported by patients were dry mouth (30.0%, 24.1%), constipation (6.4%, 2.5%), headache (2.7%, 3.6%), and dyspepsia (2.2%, 0.8%) with VESIcare (n=593) and tolterodine (n=607), respectively.

 Warning Time
 Warning Time is defined in one study as the duration from the first sensation of urgency to voiding.19 Because the difference between making it to the restroom and having an incontinence episode may be a matter of seconds, an increase in  Warning Time may help to improve some of your patients’ chances of staying drier.

VESIcare is the first once-daily OAB treatment that has demonstrated the ability to significantly increase Warning Time compared to placebo at the approved dose. The effects of VESIcare 5 and 10 mg on Warning Time were assessed in a 12-week, double-blind, placebo-controlled trial. The primary endpoint of the trial was mean change in urgency episodes per twenty-four hours. The median change in Warning Time from baseline for patients on VESIcare was 31.5 seconds, compared to 12 seconds for those on placebo.19

Warning Time Bar Chart

Results from a 12-week, placebo controlled study of the efficacy and safety of VESIcare 5 mg and 10 mg in a flexible-dosing regimen.
The primary endpoint, mean change in urgency episodes/24 h: VESIcare provided significantly greater reductions compared with placebo (P<0.0001).
Other secondary endpoints: VESIcare provided significantly greater reductions in micturitions/24 h and incontinence episodes/24 h compared to placebo (P<0.05); no difference was observed for nocturia-related endpoints compared to placebo.
The most common drug-related, treatment-emergent adverse events reported by patients were dry mouth (25.3%, 9.0%), constipation (14.8%, 9.3%), blurred vision (3.8%, 1.1%), dizziness (3.2%, 1.9%), and fatigue (2.7%, 1.1%) with VESIcare 5 mg or 10 mg and placebo, respectively.

vesicarerx.com
Learn more about VESIcare with an interactive online experience. Click here.
Patient Resources
The VESIcare.com website for consumers contains a bladder checklist, a bladder dairy and other important information to help patients gain a better understanding of overactive bladder.

The Vantage ProgramSM provides valuable information and exclusive savings for your patients. Click here to learn more.

Important Safety Information

VESIcare tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once daily.

As with other anticholinergic agents, VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

As with other anticholinergic agents, VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function. Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.

In placebo-controlled studies, the most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%), and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5 mg, 10 mg, and placebo, respectively.

The overall rate of serious adverse events was 2%. For the 10-mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction, and one intestinal obstruction). For the 5-mg dose, one case of angioneurotic edema was reported.

Complete Prescribing Information for VESIcare

Astellas
VESIcare is a registered trademark of Astellas Pharma Inc.

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