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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.

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

       

      BOTOX® has proven long-term evidence and experience in PSS in the upper and lower limb6, 7

      • Localisation of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended5
      • Multiple injection sites may allow BOTOX® to have more uniform contact with the innervation areas of the muscle and are especially useful in larger muscles5
      • The recommended dose for treating adult upper limb spasticity is up to 400 Units divided among the affected muscles5
      • The exact dosage and number of injection sites may be tailored to the individual based on the size, number and location of muscles involved, the severity of spasticity, the presence of local muscle weakness, and the patient response to previous treatment5
      • Localisation of the involved muscles with techniques such as electromyographic guidance, nerve stimulation or ultrasound is recommended5

      Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.5

      †When injecting the shoulder muscles in combination, the recommended maximum dose is 250 U.5

      ‡When injecting both lumbricals and/or interossei, the recommended maximum dose is 50 U per hand.5

      • The recommended dose for treating adult lower limb spasticity is 300 Units to 400 Units divided among up to six muscles5
      • Localisation of the involved muscles with techniques such as electromyographic guidance, nerve stimulation or ultrasound is recommended5
      BOTOX SmPC _P7_image v3
      BOTOX SmPC _P7_table

      Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.5

      MAS: Modified Ashworth Scale; PSS: post-stroke spasticity; SmPC: summary of product characteristics.

      Request further information on 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(6):395–400
      7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicentre, double-blind, placebo-controlled trial. J Neurol 2010;257:1330–37
      8. Wein T, et al. Onabotulinum toxin A for the Treatment of Post-stroke Distal Lower Limb Spasticity: A Randomized Trial. PM R 2018;10(7):693–03

       

      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(6):395–400
      7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicentre, double-blind, placebo-controlled trial. J Neurol 2010;257:1330–37
      8. Wein T, et al. Onabotulinum toxin A for the Treatment of Post-stroke Distal Lower Limb Spasticity: A Randomized Trial. PM R 2018;10(7):693–03

      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-240030.

       

       

      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.