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      • This website is for UK Healthcare Professionals only
      Prescribing Information
      BOTOX® SMPC
      RESOURCES

      +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
      Prescribing Information
      BOTOX® SMPC
      RESOURCES

      +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

      UK-BUO-240019. DOP: April 2024.

      BOTOX®: For treating OAB5

      BOTOX® demonstrates significant and sustained improvements for OAB patients5-7

      Week 12 co-primary endpoint results:

      BOTOX® demonstrated significant reductions from baseline in daily UI episodes compared with placebo (-2.74 vs -0.95; p<0.001 vs placebo).5

      Significantly greater proportion of BOTOX® patients achieved a positive response on the TBS compared to placebo (61.8% vs 28.0%; p<0.001 vs placebo).7

      X1470 OAB UK BOTOX Sales Aid - New Branding_9 1
      X1470 OAB UK BOTOX Sales Aid - New Branding_9 2
      X1470 OAB UK BOTOX Sales Aid - New Branding_9 3

      Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. To evaluate the impact of efficacy, safety and health-related quality of life of BOTOX® in patients with OAB with UI. Patients were randomised to receive either 100U of BOTOX® (n=557) or placebo (n=548). Mean baseline for daily UI episodes: BOTOX® 100U 5.49/day, placebo 5.39/day. Mean baseline for daily urgency episodes: BOTOX® 100U 8.82/day, placebo 8.31/day.5

      3 reasons to trust BOTOX® in your OAB patients

      Over 3.5 years of continued BOTOX® treatment, durable improvements were seen in OAB symptoms and quality of life6

      BOTOX® provides sustained reduction in daily episodes of UI and urgency for up to 6 cycles of treatment from baseline*6

      BOTOX® is generally well tolerated in OAB with CIC rates that are low and generally transient5,7

       

      Safety and tolerability experience from +30 years of use in a range of conditions2-4,8,9

      *By comparison to placebo (p<0.001).5

      CIC: clean intermittent catheterisation; OAB: overactive bladder; TBS: treatment benefit scale; UI: urinary incontinence.

      VIEW EFFICACY DATA FOR BOTOX®

       

      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
      7. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Practice. 2014;68:1246-1256
      8. Whitcup SM. The History of Botulinum Toxins in Medicine: A Thousand Year Journey. Handb Experimental Pharmacol. 2019;263:3-10.
      9. Rothrock JF, et al. European Headache Federation (EHF) 2017; 3rd December presentation.

       

      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
      7. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Practice. 2014;68:1246-1256
      8. Whitcup SM. The History of Botulinum Toxins in Medicine: A Thousand Year Journey. Handb Experimental Pharmacol. 2019;263:3-10.
      9. Rothrock JF, et al. European Headache Federation (EHF) 2017; 3rd December presentation.

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

      BOTOX® PRESCRIBING INFORMATION

       

      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-240021.

       

       

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.