+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4
UROLOGY
UK-BUO-220047. DOP: April 2022.
Administering BOTOX® for your patients with neurogenic detrusor overactivity (NDO)*
BOTOX® provides approximately 9 months of symptom relief†5
- Instil with enough saline to visualise empty bladder wall for the injections and avoid backflow of the product, but over-distension should be avoided
- Reconstituted BOTOX® is injected via a flexible or rigid cystoscope
- The needle should be inserted approximately 2 mm into the detrusor and 30 injections of 1 ml each (total volume of 30 ml) should be spaced approximately 1 cm apart
- The recommended dose for NDO is 200 Units, as 1 ml (~6.7 Units) injections across 30 sites in the detrusor muscle. Patients should be considered for reinjection when the clinical effect of the previous injection has diminished but no sooner than 3 months from the prior bladder injection
Botulinum toxins are not interchangeable with
each other5
Please follow the SmPC for reconstitution protocol (section 6.6). For the patient preparation and post-injection monitoring, please see section 4.4 of the SmPC. Autonomic dysreflexia associated with the procedure can occur and greater vigilance is required in patients known to be at risk.
†As demonstrated by patients who continued into the open label extension study.
BOTOX® in NDO: Treatment benefit sustained over time6
BOTOX® demonstrated sustained reductions in daily episodes of UI from baseline, at week 6, in the 200 U only dose group (n=122)7
I-Qol improvements from baseline sustained with up to 6 cycles6
Adapted from Rovner, 2016.7
Study context: 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.7
BOTOX® duration of effect7
Adapted from Rovner, 2016.7
Study context: 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.7
Efficacy assessments included the change from study baseline in UI episodes per day as the primary efficacy endpoint and I-QOL total summary scores at week 6 after each treatment.7
Overall median duration of effect by time in 112 patients on 200 U based on 4-week months.
I-QoL: Incontinence-quality of life; NDO: neurogenic detrusor overactivity; SmPC: summary of product characteristics; UI: urinary incontinence.
*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
References
- Allergan. Data on file. INT/0423/2016
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- Allergan Ltd. Data on file 014
- BOTOX® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/. Accessed April 2022
- Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinumtoxinA treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. J Urol 2016;196:791–800
- Rovner E, Kohan A et al. Long-term efficacy and safety of onabotulinumtoxinA in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol 2016;196(3)801-808
- Kennelly M, Dmochowski R et al. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: final results of a long‐term extension study. Neurourology and Urodynamics 2015;1-8
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 [email protected]
Date of preparation: April 2022. UK-BUO-220025.
