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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.

      Overactive bladder (OAB) can be debilitating and negatively affect quality of life6

      OAB symptoms can be very distressing and embarrassing for patients, as well as disrupting normal daily functioning and reducing independence.6

      A large proportion of OAB patients may remain untreated7

      Of 1,916 men and women aged 40-74 years with bothersome OAB symptoms, 60% had spoken to a doctor, but only 27% of these (16% of the total cohort) were currently on medication.7

      Typical management pattern for overactive bladder (OAB)8

      X1470 OAB UK BOTOX Sales Aid - New Branding4

      Adapted from Chancellor M B et al, 20148

      Typical management pattern for overactive bladder (OAB)7

      X1470 OAB UK BOTOX Sales Aid - New Branding4

      Adapted from Chancellor M B et al, 20148

      Are oral therapies always the right answer for OAB patients?

      The majority of overactive bladder patients DISCONTINUED oral therapies10-12

      Study context: An epidemiological, cross-sectional, non-interventional study of 2,038 evaluable OAB patients who had their treatment modified during the previous 3–4 months. The objective of this study was to identify the reasons why some patients do not respond and to look for reasons for changes in treatment and patient satisfaction with the new treatment.9

      Anticholinergic cycling can be associated with high rates of treatment discontinuation13

      620 patients initiated ACH therapy - 70% of patients DISCONTINUED by 3rd cycle13

      ach therapy image 2

      Study context: Retrospective claims analysis from a California-based managed care organisation linked to a one-time patient survey of OAB patients with UI. The purpose was to describe treatment patterns and outcomes in wet-OAB patients with anticholinergics. A total of 620 patients were enrolled into the study – having met the following criteria: received ACH therapy between January 2008 and May 2012, had a diagnosis of OAB and reported having ≥1 UI episode per day at the time of the survey.13

      Adapted from Chancellor M et al, 201613

      • Of a cohort of 620 patients initiating ACH therapy, 71% had discontinued by the end of the study period (3 years).13
      • ACHs are commonly used after, or combined with, behavioural therapy as first-line medication for OAB management.8 However, there is emerging evidence about the risks associated with long-term ACH use, particularly in older patients.15
      Cognitive impairmentDementia

      The central nervous systems of older patients (>65 years) may be sensitive to ACH-related adverse effects.15,16

      Use of medications with medium or high ACH activity was associated with deficits of memory, executive function, cognitive performance and increased risk of clinical cognitive impairment.17,18 

      		Higher cumulative ACH use in older patients was associated with an increased risk of dementia.8 Concurrent use of multiple ACH medications in older adults was associated with greater risk of hospitalisation for confusion.19

      ACH, anticholinergic; OAB: overactive bladder, PTNS: percutaneous tibial nerve stimulation; SNM: sacral nerve modulation; UI: urinary incontinence.

      HOW TO DIAGNOSE 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. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014;68(10):1246-1256
      7. 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
      8. 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
      9. Castro D, Miranda P et al. Assessment of reasons for overactive bladder treatment change. Actas Urol Esp. 2011;35(2):73-79
      10. D'Souza A O, Smith M J et al. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008;14(3):291-301
      11. Wagg A, Compion G et al. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int. 2012;110(11):1767-1774
      12. Pindoria N, Malde S et al. Persistence with mirabegron therapy for overactive bladder: A real life experience. Neurourol Urodyn. 2015;36(2):404-408
      13. Chancellor M B, Yehoshua A et al. Limitations of anticholinergic cycling in patients with overactive bladder (OAB) with urinary incontinence (UI): results from the consequences of Treatment Refractory Overactive bLadder (CONTROL) study. Int Urol Nephrol. 2016;48(7):1029-1036
      14. EAU Guidelines on Urinary Incontinence in Adults. Available from: https://uroweb.org/education-events/eau-guidelines-on-urinary-incontinence. Accessed April 2024
      15. Gray S L, Anderson M L et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015;175(3):401-407
      16. Campbell N, Boustani M et al. The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009;4:225-233
      17. Lechevallier-Michel N, Molimard M et al. Drugs with anticholinergic properties and cognitive performance in the elderly: results from the PAQUID Study. Br J Clin Pharmacol. 2005;59(2):143-151
      18. Risacher S L, McDonald B C et al. Association between anticholinergic medication use and cognition, brain metabolism, and brain atrophy in cognitively normal older adults. JAMA Neurol. 2016;73(6):721-732
      19. Kalisch Ellett L M, Pratt N L et al. Multiple anticholinergic medication use and risk of hospital admission for confusion or dementia. J Am Geriatr Soc. 2014;62(10):1916-1922

       

      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. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014;68(10):1246-1256
      7. 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
      8. 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
      9. Castro D, Miranda P et al. Assessment of reasons for overactive bladder treatment change. Actas Urol Esp. 2011;35(2):73-79
      10. D'Souza A O, Smith M J et al. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008;14(3):291-301
      11. Wagg A, Compion G et al. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int. 2012;110(11):1767-1774
      12. Pindoria N, Malde S et al. Persistence with mirabegron therapy for overactive bladder: A real life experience. Neurourol Urodyn. 2015;36(2):404-408
      13. Chancellor M B, Yehoshua A et al. Limitations of anticholinergic cycling in patients with overactive bladder (OAB) with urinary incontinence (UI): results from the consequences of Treatment Refractory Overactive bLadder (CONTROL) study. Int Urol Nephrol. 2016;48(7):1029-1036
      14. EAU Guidelines on Urinary Incontinence in Adults. Available from: https://uroweb.org/education-events/eau-guidelines-on-urinary-incontinence. Accessed April 2024
      15. Gray S L, Anderson M L et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015;175(3):401-407
      16. Campbell N, Boustani M et al. The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009;4:225-233
      17. Lechevallier-Michel N, Molimard M et al. Drugs with anticholinergic properties and cognitive performance in the elderly: results from the PAQUID Study. Br J Clin Pharmacol. 2005;59(2):143-151
      18. Risacher S L, McDonald B C et al. Association between anticholinergic medication use and cognition, brain metabolism, and brain atrophy in cognitively normal older adults. JAMA Neurol. 2016;73(6):721-732
      19. Kalisch Ellett L M, Pratt N L et al. Multiple anticholinergic medication use and risk of hospital admission for confusion or dementia. J Am Geriatr Soc. 2014;62(10):1916-1922

      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-240023.

       

       

      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.