This promotional material is intended for UK Healthcare Professionals only.
BOTOX® (botulinum toxin type A) Prescribing Information and adverse event reporting information can be found below.
BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions5-7
BOTOX® is generally well tolerated in NDO5
The frequency of adverse reactions reported in the clinical trials is defined as follows: Very Common (≥1/10); Common (≥1/100 to <1/10)
Cases of iatrogenic botulism have been reported following injection of botulinum toxin products. Patients and caregivers should be advised to seek immediate medical advice if they experience any signs or symptoms consistent with the spread of botulinum toxin effect or if swallowing, speech or respiratory disorders arise (see section 4.9). Most cases have been reported following the use of botulinum toxin containing products when used for unapproved indications and/or administration into unapproved injection sites or following use of higher than recommended doses and the use of unlicensed products.5
Adapted from BOTOX® Summary of Product Characteristics.5
Please refer to the Summary of Product Characteristics for further information.
*Adverse reactions occurring in the Phase 2 and pivotal Phase 3 clinical trials; †Adverse reactions occurring in the post-approval study of BOTOX® 100 U in patients with MS not catheterising at baseline; ‡Elevated PVR not requiring catheterisation; §only in MS; ¶Procedure-related adverse reactions.
Clean intermittent catheterisation (CIC) rates in NDO5
Adapted from BOTOX® Summary of Product Characteristics.5
Study context: Two double-blind, placebo controlled, randomised Phase III clinical studies, in 691 patients with UI due to NDO. To compare the change in baseline for BOTOX® vs placebo. The primary endpoint was the mean change at Week 6 in weekly frequency of UI.5
CIC rates are higher in NDO than OAB5, however QoL was still improved in de novo catheterisers8
BOTOX® in NDO: Urinary retention 17% BOTOX® (n=227) vs 3% placebo (n=241)5
MS – 29% BOTOX® vs 4% placebo5; SCI – 5% BOTOX® vs 1% placebo5
QoL scores improved with BOTOX® regardless of whether patients needed to CIC or not8
Adapted from Allergan Ltd. Data on File 0408
Study context: The pooled results of two multicentre, double-blind, randomised, placebo-controlled, parallel group Phase III clinical studies, in 142 patients with UI due to NDO, to compare the safety and efficacy of BOTOX® vs placebo. The primary endpoint for both studies was the number of weekly episodes of UI.8
Mean baseline scores: BOTOX® 200 U non-CIC 31.33, BOTOX® 200 U CIC 34.85.
CIC: clean intermittent catheterisation; I-QoL: incontinence quality of life; MS: multiple sclerosis; NDO: neurogenic detrusor overactivity; OAB: overactive bladder; PVR: post-void residual volume; QoL: quality of life; SCI: spinal cord injury; UI: urinary incontinence.
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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: May 2026. UK-BUO-260068
