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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.

      Considerations and guidance for using BOTOX® as a treatment option for managing overactive bladder (OAB)

      ACH: anticholinergic; MDT, multi disciplinary team; NICE: National Institute for Health and Care Excellence; OAB: overactive bladder; SMC: Scottish Medicines Consortium

      BOTOX® is accepted for restricted use for OAB within NHS Scotland:9

      • BOTOX is accepted for restricted use within NHS Scotland 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:
      • SMC restriction: in patients who have failed appropriate oral treatment options. 

      NICE guidelines refer to the management of urinary incontinence in women only.7

      NICE guidance:7

      • 1.4.44 After a local MDT review, offer bladder wall injection with botulinum toxin type A to women with overactive bladder caused by detrusor overactivity that has not responded to non-surgical management, including pharmacological treatments.
      • 1.4.45 Consider treatment with botulinum toxin type A after a local MDT review for women with symptoms of overactive bladder in whom urodynamic investigation has not demonstrated detrusor overactivity, if the symptoms have not responded to non-surgical management and the woman does not wish to have other invasive treatments.
      • 1.4.46 After a local MDT review, discuss the benefits and risks of treatment with botulinum toxin type A with the woman and explain:

      • the likelihood of complete or partial symptom relief

      • the process of clean intermittent catheterisation, the risks, and how long it might need to be continued

      • the risk of adverse effects, including an increased risk of urinary tract infection

      • that there is not much evidence about how long the injections work for, how well they work in the long term and their long-term risks

      Find out more about patients' experience with OAB

       

      ©NICE [2019] Urinary incontinence and pelvic organ prolapse in women: management; NICE [2013] Mirabegron for treating symptoms of overactive bladder. Available from nice.org.uk. All rights reserved. Subject to Notice of rights (link to: https://www.nice.org.uk/terms-and-conditions#notice-of-rights)

      NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

       

      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. Chancellor M B, Levanovich P et al. Optimum management of overactive bladder: medication vs Botox® vs InterStim® vs Urgent® PC. Urol Pract. 2014;1:7–12
      7. National Institute for Health and Care Excellence (NICE). NG123: Urinary incontinence and pelvic organ prolapse in women: management. Available at: https://www.nice.org.uk/guidance/ng123. Accessed April 2024
      8. National Institute for Health and Care Excellence (NICE). Technology appraisal guidance TA290. Mirabegron for treating symptoms of overactive bladder. Available at: https://www.nice.org.uk/guidance/ta290. Accessed April 2024
      9. Scottish Medicines Consortium (SMC). botulinum toxin type A (BOTOX®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/botulinum-toxin-type-a-botox-fullsubmission-93113/. Accessed April 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 April 2024.
      6. Chancellor M B, Levanovich P et al. Optimum management of overactive bladder: medication vs Botox® vs InterStim® vs Urgent® PC. Urol Pract. 2014;1:7–12
      7. National Institute for Health and Care Excellence (NICE). NG123: Urinary incontinence and pelvic organ prolapse in women: management. Available at: https://www.nice.org.uk /guidance/ng123. Accessed April 2024
      8. National Institute for Health and Care Excellence (NICE). Technology appraisal guidance TA290. Mirabegron for treating symptoms of overactive bladder. Available at: https://www.nice.org.uk /guidance/ta290. Accessed April 2024
      9. Scottish Medicines Consortium (SMC). botulinum toxin type A (BOTOX®). Available at: https://www.scottishmedicines.org.uk /medicines-advice/botulinum-toxin-type-a-botox-fullsubmission-93113/. Accessed April 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: April 2024. UK-BUO-240028.

       

       

      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.