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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

       

      FOCAL SPASTICITY

      BOTOX® is indicated for the symptomatic treatment of focal spasticity, including: upper limb spasticity in adults and ankle and foot disability due to lower limb spasticity in adults.5
      Prescribing Information
      BOTOX® SMPC
      RESOURCES

      +30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

      FOCAL SPASTICITY

      BOTOX® is indicated for the symptomatic treatment of focal spasticity, including: upper limb spasticity in adults and ankle and foot disability due to lower limb spasticity in adults.5

      UK-BNO-240014. DOP: June 2024.

      Trust BOTOX® for your patients with post-stroke spasticity (PSS)

      UPPER LIMB & LOWER LIMB:

      BOTOX® has proven evidence and experience in post stroke spasticity in both the upper & lower limb in a range of muscles5-7

      PROVEN EFFICACY: 

      For these patients, BOTOX® showed reduced muscle tone, reduced pain and greater functional goal achievement compared to baseline6-8 

      PROVEN TOLERABILITY: 

      BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions1,5,9,10

      Early identification should affect course of intervention in PSS, which will be key for patients' outcomes.11

      Importance of early identification 

      arrows 1

      Spasticity can cause complications such as impaired movement, difficulty maintaining hygiene and self-care, poor self-esteem and body image, pain and pressure ulcers12

      arrows 2

      Early identification and intervention may help reduce complications and improve outcomes for patients with spasticity12–15

      arrows 3

      Potential barriers to early identification include:16

      • Lack of access to rehabilitation centres
      • Lack of knowledge around spasticity and it’s management
      • Lack of highly qualified or experienced staff and specialists in spasticity or injection

      PSS: post-stroke spasticity.

      EFFICACY DATA FOR BOTOX®

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
      3. Blumenfeld AM, 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 July 2024
      6. Brashear A, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002; 347:395–400
      7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol 2010;257(8):1330–37
      8. Gordon MF, et al. Repeated dosing of botulinum toxin type A for upper limb spasticity following stroke. Neurology 2004 ;63(10):1971–73
      9. Allergan. Data on file. INT/0572/2016(2). 2019
      10. Naumann M, et al. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol 2006;13 Suppl 4:35–40
      11. Wissel J, et al. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R 2015;7(1):60–67
      12. Royal College of Physicians. Spasticity in adults: management using botulinum toxin. National guidelines 2018. Available at: https://www.rcplondon.ac.uk/guidelines-policy-adulats-management-using-botulinum-toxin. Accessed July 2024
      13. Graham LA.  Management of spasticity revisited. Age Ageing 2013;42:435–41
      14. Wissel J et al. Toward an epidemiology of post-stoke spasticity. Neurology 2013;80:S13–19
      15. Kuo C-L and Hu G-C. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol. 2018;12:280–84
      16. Bowers D et al. Spastic paresis and rehabilitation – The patient journey. Eur Neurol Rev. 2016;11:87–95

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
      3. Blumenfeld AM, 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 July 2024
      6. Brashear A, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002; 347:395–400
      7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol 2010;257(8):1330–37
      8. Gordon MF, et al. Repeated dosing of botulinum toxin type A for upper limb spasticity following stroke. Neurology 2004 ;63(10):1971–73
      9. Allergan. Data on file. INT/0572/2016(2). 2019
      10. Naumann M, et al. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol 2006;13 Suppl 4:35–40
      11. Wissel J, et al. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R 2015;7(1):60–67
      12. Royal College of Physicians. Spasticity in adults: management using botulinum toxin. National guidelines 2018. Available at: https://www.rcplondon.ac.uk /guidelines-policy-adulats-management-using-botulinum-toxin. Accessed July 2024
      13. Graham LA.  Management of spasticity revisited. Age Ageing 2013;42:435–41
      14. Wissel J et al. Toward an epidemiology of post-stoke spasticity. Neurology 2013;80:S13–19
      15. Kuo C-L and Hu G-C. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol. 2018;12:280–84
      16. Bowers D et al. Spastic paresis and rehabilitation – The patient journey. Eur Neurol Rev. 2016;11:87–95

      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/ 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

       

      Date of preparation: July 2024. UK-BTX-240026.

       

       

      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.