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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: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.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: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.5

      UK-BUO-240005. DOP: April 2024.

      BOTOX®: For treating neurogenic detrusor overactivity (NDO)5

      BOTOX®: significant improvements for NDO patients5,6,7

      X1470 NDO UK BOTOX Sales Aid - New Branding_7 1

      Reduce the impact of NDO symptoms on your patients’ lives.

      Study context: Pooled analysis of two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. Mean baseline weekly frequency of UI: 32.4 BOTOX® and 31.5 Placebo.5

      3 reasons to trust BOTOX®

      Over 4 years of continued BOTOX® treatment, durable improvements were seen in NDO symptoms and quality of life8

      BOTOX® provides sustained reduction in daily episodes of UI and urgency for up to 6 cycles5

      BOTOX® is generally well tolerated in NDO5

      Safety and tolerability experience from +30 years of use in a range of conditions2, 3, 5, 9, 10

      I-QoL: Incontinence-quality of life; NDO: neurogenic detrusor overactivity; 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. Ginsberg D, et al. J Urol. 2012;187:2131-2139.
      7. Cruz F, et al. Eur Urol. 2011;60:742-750.
      8. Rovner E, Kohan A et al. Long-term efficacy and safety of Onabotulinum toxin A in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol. 2016;196(3):801-808
      9. Rothrock J F, Adams JF et al. A Multicenter, Prospective, Randomized, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of Onabotulinum toxin A and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study. European Headache Federation (EHF) 2017; 3rd December presentation
      10. Whitcup SM. Handb Experimental Pharmacol 2019;263:3-10.

       

      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. Ginsberg D, et al. J Urol. 2012;187:2131-2139.
      7. Cruz F, et al. Eur Urol. 2011;60:742-750.
      8. Rovner E, Kohan A et al. Long-term efficacy and safety of Onabotulinum toxin A in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol. 2016;196(3):801-808
      9. Rothrock J F, Adams JF et al. A Multicenter, Prospective, Randomized, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of Onabotulinum toxin A and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study. European Headache Federation (EHF) 2017; 3rd December presentation
      10. Whitcup SM. Handb Experimental Pharmacol 2019;263:3-10.

      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-240007.

       

       

      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.