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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.

      How to diagnose neurogenic detrusor overactivity (NDO)

      Early diagnosis and treatment of NDO is essential to prevent irreversible changes within the urinary tract.6

      The diagnosis of NDO should include a detailed history, general and neurological physical examination and urinalysis.6–9

      Assessment of the patient’s risk factors and quality of life is also required.6 For initial management, basic diagnostic tests should be used to exclude an underlying disease.8

      For specialised management, more elaborate assessment is generally required, including imaging, endoscopy and urodynamics.8

      Urodynamics assess filling and storage in the urinary tract and can be used for diagnosis and to direct targeted treatments.6

      In patients with spinal cord injury, there is a high correlation between functional level of injury and urodynamic abnormalities. Unmanaged high detrusor pressure is a trigger for upper urinary tract injuries leading to deterioration of the upper urinary tract function and kidney failure.10,11

      In patients with multiple sclerosis, urodynamic assessment should be repeated at regular intervals to optimise clinical management, reduce complications, and better enable patients to manage their condition.12

      Bladder_Data

      NDO: neurogenic detrusor overactivity.

      UNMET NEED 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. 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 April 2024
      7. Abrams P et al. Incontinence: 6th edition 2017;50:520, 526, 530
      8. Thuroff J W, Abrams P et al. EAU guidelines on urinary incontinence. Eur Urol. 2011;59:387–400
      9. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance/cg148. Accessed April 2024
      10. Gerridzen R G, Thijssen A M et al. Risk Factors for Upper Tract Deterioration in Chronic Spinal Cord Injury Patients. J Urol. 1992;147:416–18
      11. Reynard J M, Vass J et al. Sphincterotomy and the treatment of detrusor–sphincter dyssynergia: current status, future prospects. Spinal Cord. 2003;41:1–11
      12. Ciancio S J, Mutchnik S E et al. Urodynamic pattern changes in multiple sclerosis. Urology. 2001;57:239–45

      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. 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 April 2024
      7. Abrams P et al. Incontinence: 6th edition 2017;50:520, 526, 530
      8. Thuroff J W, Abrams P et al. EAU guidelines on urinary incontinence. Eur Urol. 2011;59:387–400
      9. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance /cg148. Accessed April 2024
      10. Gerridzen R G, Thijssen A M et al. Risk Factors for Upper Tract Deterioration in Chronic Spinal Cord Injury Patients. J Urol. 1992;147:416–18
      11. Reynard J M, Vass J et al. Sphincterotomy and the treatment of detrusor–sphincter dyssynergia: current status, future prospects. Spinal Cord. 2003;41:1–11
      12. Ciancio S J, Mutchnik S E et al. Urodynamic pattern changes in multiple sclerosis. Urology. 2001;57:239–45

      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-240032.

       

       

      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.