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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.

      The Patient Experience: Neurogenic detrusor overactivity (NDO) can impact on patients' quality of life in many ways

      Definition of NDO: NDO is characterised by overactivity of the bladder due to a relevant neurological condition5,6

      Consequences of untreated NDO: impact on quality of life 7

      Adapted from Tubaro, 2004.7

      Adapted from Tubaro, 2004.7

      Consequences of untreated NDO7-9

      Adapted from Tubaro, 2004.7

      Adapted from Tubaro, 2004.7

      Spinal lesions caused by a trauma, such as spinal cord injury, or by a progressive neurological condition, such as multiple sclerosis can lead to NDO10,11

      Expanded Disability Status Scale12,13

      Adapted from Fowler et al, 200912

      Approximately 80% of patients with MS report some form of UI14
      Frequency, urgency and UI are all commonly reported

      62% of patients with MS have NDO without bladder outlet obstruction15

      Voiding LUTS are prevalent; in approximately 5–10% of patients, bladder symptoms are present at the onset of MS16

      BoNT/A: botulinum toxin type A; CIC: clean intermittent catheterisation; DDAVP: desmopressin; IDC: indwelling catheter; LUTS: lower urinary tract symptoms; MS: multiple sclerosis; NDO: neurogenic detrusor overactivity; QoL: quality of life; UI: urinary incontinence.

      LEARN ABOUT THE MANAGEMENT OF 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 April 2024
      6. Salvatore S et al. Pathophysiology of Urinary Incontinence, Faecal Incontinence and Pelvic Organ Prolapse. Abrams et al. Incontinence: 6th edition. 2017;50:1026 
      7. Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004;64(suppl 6A);2–6
      8. 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
      9. Goldmark E, Niver B and Ginsberg D A. Neurogenic bladder: from diagnosis to management. Curr Urol Rep. 2014;15:448
      10. Abrams P et al. Incontinence: 6th Edition 2017;50
      11. 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. Accessed April 2024. 
      12. Fowler C J, Panicker JN et al. A UK consensus on the management of the bladder in multiple sclerosis. Postgrad Mrd J. 2009;85:552-559
      13. Multiple Sclerosis Trust. Expanded Disability Status Scale (EDSS). Available at: https://mstrust.org.uk/a-z/expanded-disability-status-scale-edss. Accessed April 2024
      14. National US MS Society. Symptoms: bladder dysfunction. Autoimmune disease. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Bladder-Dysfunction. Accessed April 2024
      15. Kalsi V and Fowler C J. Therapy insight: bladder dysfunction associated with multiple sclerosis. Nature Clinical Practice Urology. 2005;2:492–501
      16. McCombe P A, Gordan T P and Jackson M W. Bladder dysfunction in multiple sclerosis. Expert Rev Neurotherap. 2009;9:331–340

       

      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. Salvatore S et al. Pathophysiology of Urinary Incontinence, Faecal Incontinence and Pelvic Organ Prolapse. Abrams et al. Incontinence: 6th edition. 2017;50:1026
      7. Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004;64(suppl 6A);2–6
      8. 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
      9. Goldmark E, Niver B and Ginsberg D A. Neurogenic bladder: from diagnosis to management. Curr Urol Rep. 2014;15:448
      10. Abrams P et al. Incontinence: 6th Edition 2017;50
      11. 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. Accessed April 2024. 
      12. Fowler C J, Panicker JN et al. A UK consensus on the management of the bladder in multiple sclerosis. Postgrad Mrd J. 2009;85:552-559
      13. Multiple Sclerosis Trust. Expanded Disability Status Scale (EDSS). Available at: https://mstrust.org.uk/a-z/expanded-disability-status-scale-edss. Accessed April 2024
      14. National US MS Society. Symptoms: bladder dysfunction. Autoimmune disease. Available at: https://www.nationalmssociety.org /Symptoms-Diagnosis/MS-Symptoms/Bladder-Dysfunction. Accessed April 2024
      15. Kalsi V and Fowler C J. Therapy insight: bladder dysfunction associated with multiple sclerosis. Nature Clinical Practice Urology. 2005;2:492–501
      16. McCombe P A, Gordan T P and Jackson M W. Bladder dysfunction in multiple sclerosis. Expert Rev Neurotherap. 2009;9:331–340

      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-240008.

       

       

      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.