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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.

      Neurogenic detrusor overactivity (NDO) can be debilitating and negatively affect patients’ quality of life6

      Spinal lesions caused by trauma, such as spinal cord injury (SCI), or by a progressive neurological condition, such as multiple sclerosis (MS) can lead to NDO7,8

      The consequences of untreated NDO can result in hospitalisation with life-threatening conditions such as:6,9,10

      Urinary dysfunction is very common in patients with MS and SCI

      - Up to 80% of patients with MS report some form of urinary incontinence11

      - 81% of patients with SCI report some degree of bladder dysfunction within 1 year of injury12

      Bladder symptoms are often inadequately managed

       Patients with MS have bladder symptoms that are often not adequately managed13

       Approximately 51% of patients with moderate to severe LUTS are on anticholinergic therapy14

      • <14% of patients started on oxybutynin and tolterodine (two of the most common oral OAB medications) continued treatment
      for 1 year15
      • Median of 31 days until discontinuation15

       Poor oral therapy adherence may be linked to:13

      • UTI, retention and obstruction
      • Systemic complications
      • Increased hospitalisation rates

       Urologists/urogynaecologists should work closely with neurologists in order to optimally manage NDO

      Spectrum of treatments for NDO8,16

      X1470 NDO UK BOTOX Sales Aid - New Branding_6

      Adapted from EAU Guidelines 2020 and NICE Guidelines 20128,16

      NB: not all treatments mentioned here are licensed for NDO in the UK.

      LUTS: lower urinary tract symptoms; MS: multiple sclerosis; NDO, neurogenic detrusor overactivity; OAB: overactive bladder; SCI: spinal cord injury; UTI: urinary tract infection.

      HOW TO DIAGNOSE NDO

       

      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 May 2024
      6. Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004;64(suppl 6A);2–6
      7. Abrams P et al. Incontinence: 6th Edition 2017;50
      8. Blok B, et al. EAU Guidelines on Neuro-Urology 2022. Available from: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-Guidelines-on-Neuro-Urology-2022.pdf. Last accessed May 2024
      9. de Seze M, Ruffion A et al. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Multiple Sclerosis. 2007;13:915–928
      10. Goldmark E, Niver B and Ginsberg D A. Neurogenic bladder: from diagnosis to management. Curr Urol Rep. 2014;15:448
      11. National US MS Society. Available at: https://www.nationalmssociety.org. Accessed May 2024
      12. Ginsberg D. The epidemiology and pathophysiology of neurogenic bladder. Am J Manag Care. 2013;19:S191-S196
      13. Manack A, Motsko S P et al. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011;30:395–401 
      14. Mahajan S T, Patel P B et al. Under treatment of overactive bladder symptoms in patients with multiple sclerosis: an ancillary analysis of the NARCOMS Patient Registry. J Urol. 2010;183:1432–1437
      15. Watanabe J H, Campbell J D et al. Cost analysis of interventions for antimuscarinic refractory patients with overactive bladder. Urology. 2010;76:835–840
      16. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance/cg148. Accessed May 2024

       

      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 May 2024
      6. Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004;64(suppl 6A);2–6
      7. Abrams P et al. Incontinence: 6th Edition 2017;50
      8. Blok B, et al. EAU Guidelines on Neuro-Urology 2022. Available from: https://d56bochluxqnz.cloudfront.net /documents/full-guideline/EAU-Guidelines-on-Neuro-Urology-2022.pdf. Last accessed May 2024
      9. de Seze M, Ruffion A et al. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Multiple Sclerosis. 2007;13:915–928
      10. Goldmark E, Niver B and Ginsberg D A. Neurogenic bladder: from diagnosis to management. Curr Urol Rep. 2014;15:448
      11. National US MS Society. Available at: https://www.nationalmssociety.org. Accessed May 2024
      12. Ginsberg D. The epidemiology and pathophysiology of neurogenic bladder. Am J Manag Care. 2013;19:S191-S196
      13. Manack A, Motsko S P et al. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011;30:395–401 
      14. Mahajan S T, Patel P B et al. Under treatment of overactive bladder symptoms in patients with multiple sclerosis: an ancillary analysis of the NARCOMS Patient Registry. J Urol. 2010;183:1432–1437
      15. Watanabe J H, Campbell J D et al. Cost analysis of interventions for antimuscarinic refractory patients with overactive bladder. Urology. 2010;76:835–840
      16. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance /cg148. Accessed May 2024

      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: May 2024. UK-BUO-240012.

       

       

      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.