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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.

      How to diagnose post-stroke spasticity (PSS)

      Diagnosis and treatment of PSS during the first 3 months post-stroke may benefit patients in their aim for a full recovery6, 7

      It is possible to identify the functional risk factors that may contribute to the development of chronic spasticity.8

      Dense weakness, sensory loss, light touch8

      Visual impairment, cognitive loss, memory8

      Proprioception, perception, neglect8

      The PSS risk classification tool has been developed by a panel of experts and AbbVie to help spasticity patients get the timely treatment they need

      The PSS Classification System was created with the assistance of a group of International experts in the field of PSS and AbbVie, utilising both published risk factors and their own clinical experience9

      diagnose classification tool

      Figure adapted from Wissel J et al. 20209 and Bavikatte G et al. 202110

      *Mildly increased muscle stiffness = Modified Ashworth Scale (MAS) 1 or +1; moderately = MAS 2; markedly = MAS 3; severe = MAS 4.19 †Measured using the Fugl-Meyer Upper Extremity Scale.12 ‡Muscle contractions should be differentiated from contractures. §Visual inattention includes hemianopsia, scotoma or visual neglect. **Can be measured with the Barthel Index (low score) and EQ-5D (low score).11

      Possible additional risk factors for the development of post-stroke spasticity include:

      • smoking (defined as current and past smokers)11,13
      • left-sided stroke11
      • enhanced manual activities prior to the stroke11

      CT: computerised tomography; EQ-5D: EuroQol-5D; MAS: Modified Ashworth Scale; MDT: multidisciplinary team; MRI: magnetic resonance imaging; PSS: post-stroke spasticity.

      TREATMENT FOR PSS

      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 August 2024
      6. Stinear C et al. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke 2013;44(7):2039–45
      7. Rosales RL, et al. Botulinum toxin as early intervention for spasticity after stroke or non-progressive brain lesion: A meta-analysis. J Neurol Sci. 2016;371:6–14
      8. Ward AB. Long-term modification of spasticity. J Rehabil Med 2003(41 Suppl):60–65
      9. Wissel J et al. Development of an early identification tool in post-stroke spasticity (PSS): The PSS risk classification system. Arch Phys Med Rehabil. 2020-11;101:e35
      10. Bavikatte G et al. Early identification, intervention and management of  post-stroke spasticity: Expert consensus recommendations. J Cent Nerv Syst Dis. 2021;13:11795735211036576
      11. Wissel J et al. Post-stroke spasticity: Predictors of early development and considerations for therapeutic intervention. PM R. 2015;7:60–67
      12. Opheim A et al. Early prediction of long-term upper limb spasticity after stroke. Neurology. 2015;85:873–880
      13. Leathley MJ et al. Predicting spasticity after stroke in those to 12 months. Clin Rehabil. 2004:18:438–443
      14. Wilkinson D et al. Patients with hemispatial neglect are more prone to limb spasticity, but this does not prolong their hospital stay. Arch Phys Med Rehabil. 2012;93:1191–1195
      15. Moura R et al. Predictive factors for spasticity among ischemic stroke patients. Arq Neuropsiquitar. 2009;67:1029–1036
      16. Picelli A et al. Association between severe upper limb spasticity and brain lesion location in stroke patients. BioMed Res Int. 2014;2014:162754
      17. Wissel J et al. European consensus table on the use of botulinum toxin type a in adult spasticity. J Rehabil Med. 2009;41:13–25
      18. NICE Clinical Guideline. Stroke rehabilitation in adults. 2023. Available at: https://www.nice.org.uk/guidance/ng236. Accessed August 2024
      19. Bohannon RW and Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987;67:206–207

      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 August 2024
      6. Stinear C et al. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke 2013;44(7):2039–45
      7. Rosales RL, et al. Botulinum toxin as early intervention for spasticity after stroke or non-progressive brain lesion: A meta-analysis. J Neurol Sci. 2016;371:6–14
      8. Ward AB. Long-term modification of spasticity. J Rehabil Med 2003(41 Suppl):60–65
      9. Wissel J et al. Development of an early identification tool in post-stroke spasticity (PSS): The PSS risk classification system. Arch Phys Med Rehabil. 2020-11;101:e35
      10. Bavikatte G et al. Early identification, intervention and management of  post-stroke spasticity: Expert consensus recommendations. J Cent Nerv Syst Dis. 2021;13:11795735211036576
      11. Wissel J et al. Post-stroke spasticity: Predictors of early development and considerations for therapeutic intervention. PM R. 2015;7:60–67
      12. Opheim A et al. Early prediction of long-term upper limb spasticity after stroke. Neurology. 2015;85:873–880
      13. Leathley MJ et al. Predicting spasticity after stroke in those to 12 months. Clin Rehabil. 2004:18:438–443
      14. Wilkinson D et al. Patients with hemispatial neglect are more prone to limb spasticity, but this does not prolong their hospital stay. Arch Phys Med Rehabil. 2012;93:1191–1195
      15. Moura R et al. Predictive factors for spasticity among ischemic stroke patients. Arq Neuropsiquitar. 2009;67:1029–1036
      16. Picelli A et al. Association between severe upper limb spasticity and brain lesion location in stroke patients. BioMed Res Int. 2014;2014:162754
      17. Wissel J et al. European consensus table on the use of botulinum toxin type a in adult spasticity. J Rehabil Med. 2009;41:13–25
      18. NICE Clinical Guideline. Stroke rehabilitation in adults. 2023. Available at: https://www.nice.org.uk /guidance/ng236. Accessed August 2024
      19. Bohannon RW and Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987;67:206–207

      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: August 2024. UK-BTX-240033.

       

       

      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.