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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.

      What is post-stroke spasticity (PSS)?

       

      What is spasticity?

      • Spasticity is a common consequence of neurological disorders, such as stroke,6 and presents as intermittent or sustained involuntary activation of muscles7
      • Spasticity primarily affects the shoulder, elbow, forearm, wrist, fingers/hand, thumb, ankle and foot.5
      • If left untreated, spasticity can cause shortening of muscles and tendons, and a vicious cycle can develop8

      Adapted from Royal College of Physicians. Spasticity in adults: management using botulinum toxin, 20188

      Features of spasticity8

      Prevalence of PSS increases with post-stroke survival time9

      TIME POST-STROKE:

      Adapted from Wissel J et al, 2013.9

      In a prospective cohort study of patients after a first ischaemic stroke, when 211 patients were assessed after 6 months, 43% had developed spasticity and 15.6% had developed a more severe degree of spasticity (MAS ≥3).10

      A timely diagnosis may avoid worsening of untreated spasticity8

      Post-stroke timeline

      Neural changes may drive the onset of post-stroke spasticity9,11

      X1451 Spasticity Sales Aid 2023 6_23

      If patients are not treated in a timely manner their spasticity may become more disabling over time, causing pain, deformity and contracture.15,16

      A switch to intrinsic muscle remodelling between 3 and 18 months may lead to chronic severe spasticity, preventing a full recovery.9, 11, 15, 16

      47% of patients do not receive botulinum toxin within a year of developing spasticity (N=132).17

      Rehabilitation therapies applied within the first 3 months post-stroke are likely to deliver the most benefit.18

      MAS, Modified Ashworth Scale; PSS: post-stroke spasticity.

      IDENTIFY AND MANAGE YOUR PSS PATIENTS

       

      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 June 2024
      6. Kheder A and Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol 2012;12(5):289–98
      7. Pandyan AD, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005;27(1−2):2−6
      8. 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 June 2024
      9. Wissel J, Manack A and Brainin M. Toward an epidemiology of post-stroke spasticity. Neurology 2013;80(3 Suppl 2):S13–19
      10. Urban PP, et al. Occurrence and clinical predictors of spasticity after ischemic stroke. Stroke 2010;41(9):2016–20
      11. Welmer AK, Widen Holmqvist L, Sommerfeld DK. Location and severity of spasticity in the first 1-2 weeks and at 3 and 18 months after stroke. Eur J Neurol 2010;17(5):720–25
      12. Opheim A, et al. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology 2015;85(10):873–80
      13. Sommerfeld DK et al. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke 2004;35(1):134–39
      14. Fellows SJ, Ross HF, Thilmann AF. The limitations of the tendon jerk as a marker of pathological stretch reflex activity in human spasticity. J Neurol Neurosurg Psychiatry 1993;56(5):531–37
      15. O’Dwyer NJ, et al. Brain. 1996;119:1737–49
      16. Shaw L, et al. Health Technol Assess. 2010;14(26):1–113
      17. Barnes M, et al. Disabil rehabil. 2017;39(14):1428–34
      18. Stinear C, Ackerley S, Byblow W. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke 2013;44(7):2039–45

       

      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 June 2024
      6. Kheder A and Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol 2012;12(5):289–98
      7. Pandyan AD, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005;27(1−2):2−6
      8. 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 June 2024
      9. Wissel J, Manack A and Brainin M. Toward an epidemiology of post-stroke spasticity. Neurology 2013;80(3 Suppl 2):S13–19
      10. Urban PP, et al. Occurrence and clinical predictors of spasticity after ischemic stroke. Stroke 2010;41(9):2016–20
      11. Welmer AK, Widen Holmqvist L, Sommerfeld DK. Location and severity of spasticity in the first 1-2 weeks and at 3 and 18 months after stroke. Eur J Neurol 2010;17(5):720–25
      12. Opheim A, et al. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology 2015;85(10):873–80
      13. Sommerfeld DK et al. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke 2004;35(1):134–39
      14. Fellows SJ, Ross HF, Thilmann AF. The limitations of the tendon jerk as a marker of pathological stretch reflex activity in human spasticity. J Neurol Neurosurg Psychiatry 1993;56(5):531–37
      15. O’Dwyer NJ, et al. Brain. 1996;119:1737–49
      16. Shaw L, et al. Health Technol Assess. 2010;14(26):1–113
      17. Barnes M, et al. Disabil rehabil. 2017;39(14):1428–34
      18. Stinear C, Ackerley S, Byblow W. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke 2013;44(7):2039–45

      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: June 2024. UK-BTX-240031.

       

       

      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.