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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.

      Understanding and addressing unmet need in Urology: Overactive bladder (OAB)

      OAB is a highly prevalent, chronic condition6

      Overall, on average, 16.6% of the population aged ≥ 40 years in six European countries have symptoms of OAB
      OAB symptoms are seen in both men and women and increase with age

      Adapted from Milsom et al, 20016

      Overall, an average, 16.6% of the population aged ≥ 40 years in six European countries have symptoms of OAB
      OAB symptoms are seen in both men and women and increase with age

      Adapted from Milsom et al, 20015

      What drives a patient to see a doctor?

      Table 2_v2

      OAB  is a complex, multi-symptom syndrome that can be difficult to treat, requiring appropriate effective management - including treatment or referrals to improve patient outcomes7,8

      Definition of OAB

      Understanding the sensation of urgency

      ICS definitions: incontinence9,11

      • Urgency urinary incontinence (UUI) is the complaint of involuntary leakage accompanied by or  immediately preceded by urgency
      • Stress urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion,  or on sneezing or coughing
      • Mixed urinary incontinence (MUI) is the complaint of involuntary leakage associated with urgency  and also with exertion, effort, sneezing or coughing

      OAB can significantly impair patients' quality of life (QoL) when not treated effectively7,8

      Impact of OAB on QoL (SF-36) vs the general population12

      BOTOX Urology GRAPHS

      Adapted from Abrams et al, 200012

      OAB  is a complex, multi-symptom syndrome that can be difficult to treat, requiring appropriate effective management - including treatment or referrals to improve patient outcomes7,8

      ICS: International Continence Society;  MUI: mixed urinary incontinence; OAB: overactive bladder; QoL: quality of life; SUI: stress urinary incontinence; UUI: urgency urinary incontinence.

      DIAGNOSING OAB

       

      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. Milsom I, Abrams P et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766
      7. Starkman J S, Smith C P and Staskin D R. Surgical options for drug-refractory overactive bladder patients. Reviews in Urology. 2010;12(2-3):e97
      8. Stewart W, Van Rooyen J et al. Prevalence and burden of overactive bladder in the United States. World journal of Urology. 2003;20(6):327-336
      9. Abrams P, Cardozo L et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-178
      10. Milsom I. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. Abrams P et al. Incontinence: 6th edition. 2017:50
      11. Haylen B T, De Ridder D et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics: Official Journal of the International Continence Society. 2010;29(1),4-20
      12. Abrams P, Kelleher C J et al. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000;6(11 Suppl):S580-590

       

      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. Milsom I, Abrams P et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766
      7. Starkman J S, Smith C P and Staskin D R. Surgical options for drug-refractory overactive bladder patients. Reviews in Urology. 2010;12(2-3):e97
      8. Stewart W, Van Rooyen J et al. Prevalence and burden of overactive bladder in the United States. World journal of Urology. 2003;20(6):327-336
      9. Abrams P, Cardozo L et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-178
      10. Milsom I. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. Abrams P et al. Incontinence: 6th edition. 2017:50
      11. Haylen B T, De Ridder D et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics: Official Journal of the International Continence Society. 2010;29(1),4-20
      12. Abrams P, Kelleher C J et al. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000;6(11 Suppl):S580-590

      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-240020.

       

       

      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.