This website is for UK Healthcare Professionals only

 

BOTOX® has a safety and tolerability profile from
+30 years of global use in a range of conditions2,3,13

Explore the licensed indications timeline1

First approved by the US FDA in 198914 and 25 years of experience in the UK1

*BOTOX® is indicated for prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).10

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; neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.10

BOTOX® is indicated for the symptomatic treatment of wrist and hand disability due to upper limb spasticity and ankle and foot disability due to lower limb spasticity, associated with stroke in adults.10

References

  1. Allergan Ltd. Data on file 014
  2. Allergan. Data on file. INT/0423/2016
  3. 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
  4. 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
  5. Natoli J L, Manack A et al. Global prevalence of chronic migraine: a systematic review. Cephalalgia 2010;30(5):599-609
  6. Steiner T J, Stovner L J et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain 2018;19(1):17
  7. Dodick D W, Turkel C C et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache 2010;50(6):921-936
  8. Khalil M, Zafar H W et al. Prospective analysis of the use of onabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain 2014;15:54
  9. Stewart W F, Van Rooyen J B et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20(6):327-336
  10. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022
  11. Royal College of Physicians. Spasticity in adults: management using botulinum toxin. National guidelines, 20 March 2018. Available at: www.rcplondon.ac.uk. Accessed April 2022
  12. Glaess-Leistner S, Ri S J et al. Early clinical predictors of post-stroke spasticity. Top Stroke Rehabil 2020:1-11
  13. Blumenfeld A M, Stark R et al. Efficacy and safety of onabotulinumtoxinA in an open-label study for the prophylactic treatment of chronic migraine in adult patients: COMPEL. Presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) 2016 in Glasgow, UK, 15-18 September (abstract 030)
  14. Chen S. Clinical uses of botulinum neurotoxins: current indications, limitations and future developments. Toxins (Basel) 2012;4(10):913-939

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 2022. UK-BTX-220039.