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+30 YEARS' GLOBAL EXPERIENCE
ACROSS MULTIPLE INDICATIONS1-4

 

UROLOGY

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.5

+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

UROLOGY

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.5

Administering BOTOX® for your overactive bladder (OAB) patients

BOTOX® provides approximately 6 months of symptom relief6

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 time6

BOTOX® sustained reductions in daily episodes of UI and urgency from baseline, throughout the entire 3.5 year study period6

Approximately 52% of patients completed the entire 3.5 year study6

The most common reasons for discontinuation were related to study burden and trial duration6

Only 5.7% discontinued due to lack of efficacy and 5.1% due to adverse events6

Adapted from Nitti VW, et al. 2016.6

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 AE6

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 months6

Duration of botulinum toxin type A effect based on time to patient request for re-treatment6

Adapted from Nitti VW, et al. 2016.6

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. Median duration in patients (n=438) who received 100U BOTOX® only throughout study with complete treatment cycles, with 1 month defined as 4 weeks. Total study duration 3.5 years. Patients received up to 6 treatment cycles.6


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

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed April 2024.
  6. Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinum toxin A treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology. 2016;196(3),791-800

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed April 2024.
  6. Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinum toxin A treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology. 2016;196(3),791-800

Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.

 

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to AbbVie on GBPV@abbvie.com 

 

Date of preparation: April 2024. UK-BUO-240029.