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+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

+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

Administering BOTOX® for your patients with neurogenic detrusor overactivity (NDO)

BOTOX® provides approximately 9 months of symptom relief†5

Image adapted from BOTOX® Summary of Product Characteristics5

As demonstrated by patients who continued into the open label extension study.


BOTOX® in NDO: Treatment benefit sustained over time6

Reductions in mean UI episodes per day at Week 6 after BOTOX® 200U compared with baseline were consistent during the 4 years of treatment (n=122; primary endpoint)6

Adapted from Rovner, 2016.6

Study context: Post-hoc analysis of 227 patients with urinary incontinence due to NDO, who completed 4 years of treatment following an initial 52-week phase 3 trial and then a 3-year open label extension study. Primary efficacy endpoint was change from baseline in UI episodes per day at Week 6.6


BOTOX® duration of effect6

Adapted from Rovner, 2016.6

Study context: Post-hoc analysis of 227 patients with urinary incontinence due to NDO, who completed 4 years of treatment following an initial 52-week phase 3 trial and then a 3-year open label extension study. Primary efficacy mendpoint was change from baseline in UI episodes per day at Week 6. Overall median duration of effect by time in 112 patients on 200U based on 4-week months. Time to request for re-treatment was calculated from date of patient request for re-treatment in relation to previous treatment date.6


I-QoL: Incontinence-quality of life; NDO: neurogenic detrusor overactivity; SmPC: summary of product characteristics; UI: urinary incontinence.

 

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. Rovner E, Kohan A et al. Long-term efficacy and safety of Onabotulinum toxin A in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol. 2016;196(3)801-808

 

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. Rovner E, Kohan A et al. Long-term efficacy and safety of Onabotulinum toxin A in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol. 2016;196(3)801-808

Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.

 

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-240017.