Administering BOTOX^® for your overactive bladder (OAB) patients^*

BOTOX^® provides approximately 6 months of symptom relief⁵

• Instill with enough saline to visualise empty bladder wall for the injections  and avoid backflow of the product,  but over-distension should be avoided⁶
• Reconstituted BOTOX^® is injected via a flexible or rigid cystoscope⁶
• The needle should be inserted approximately 2 mm into the detrusor and 20 injections of 0.5 ml each (total volume of 10 ml) should be spaced approximately 1 cm apart⁶
• The recommended dose for OAB is 100 Units, as 0.5 ml (5 Units) injections across 20 sites in the detrusor muscle⁶
• Patients should be considered for reinjection when the clinical effect of the previous injection has diminished but no sooner than 3 months from the prior bladder injection⁶

Please follow the SmPC for reconstitution protocol (section 6.6). For the patient preparation and post-injection monitoring, please see section 4.4 of the SmPC

BOTOX^® in overactive bladder: Treatment benefit sustained over time⁵

BOTOX^® sustained reductions in daily episodes of UI and urgency from baseline, throughout the entire 3.5 year study period^†5

Adapted from Nitti VW, et al. 2016.⁵

Study context: The final results of the prospective, multicentre, long-term (3.5 year) study of the efficacy/safety of BOTOX^® for overactive bladder syndrome. The co-primary endpoints were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the treatment benefit scale. In the overall population the most common AEs within the first 12 weeks of BOTOX^® treatment were localised to the urinary tract. There was no evidence of increasing occurence of these AEs with repeat treatments, UTI was the most frequently reported AE⁵

^†n values denote the number of patients with data available at week 12 post treatment. Error bars represent 95% confidence intervals.

Overall median duration of effect was 7.6 months⁵

Duration of botulinum toxin type A effect based on time to patient request for re-treatment^‡5

Adapted from Nitti VW, et al. 2016.⁵

Study context: The final results of the prospective, multicenter, long-term (3.5 year) study of the efficacy/safety of BOTOX^® for overactive bladder syndrome.⁵

^‡Median duration in patients (n=428) who received BOTOX^® only throughout study with complete treatment cycles, with 1 month defined as 4 weeks. Total study duration 3.5 years. Patients recieved up to 6 treatment cycles.⁵

AE, adverse event; BL: baseline; SmPC: summary of product characteristics; UI: urinary incontinence; UTI: urinary tract infection.

^*BOTOX^® is indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: overactive bladder with symptoms of urinary incontinence, urgency and frequency.⁶