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      • This website is for UK Healthcare Professionals only
      BOTOX® Prescribing information
      BOTOX® Summary of Product Characteristics
      RESOURCES

      +30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

       

      CHRONIC MIGRAINE

      BOTOX® (botulinum toxin type A) is indicated for the 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).5

      UK-BCM-240035. DOP: April 2024.

      BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions, with 10 years in chronic migraine5-7

      Adverse events in the PREEMPT and COMPEL studies

      Discontinuation rates due to adverse events in the PREEMPT and COMPEL studies

      PREEMPT: at Week 24 (N=687)2

      At Week 24, placebo discontinue rate was 1.2%

      COMPEL: at Week 108 (N=716)8

      COMPEL was an open-label prospective study, with no placebo arm

      The rate of treatment-emergent adverse events progressively decreases with subsequent rounds of BOTOX® treatment.9

      DB: double blind; CM: chronic migraine; OL: open label; TRAE: treatment-related adverse event.

      Find out more about using BOTOX® for your patients with chronic migraine⁵

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
      3. Blumenfeld A M, Stark R J 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 March 2024
      6. Allergan. Data on file. INT/0423/2016(1). 2018
      7. Allergan. Data on file. INT/0572/2016(2). 2019
      8. Blumenfeld A M, Tepper S J et al. Effects of Onabotulinum toxin A treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019;90(3):353-360
      9. Aurora S K, Dodick D W et al. Onabotulinum toxin A for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand. 2014;129(1):61-70

       

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
      3. Blumenfeld A M, Stark R J 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 March 2024
      6. Allergan. Data on file. INT/0423/2016(1). 2018
      7. Allergan. Data on file. INT/0572/2016(2). 2019
      8. Blumenfeld A M, Tepper S J et al. Effects of Onabotulinum toxin A treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019;90(3):353-360
      9. Aurora S K, Dodick D W et al. Onabotulinum toxin A for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand. 2014;129(1):61-70

       

      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/.

      Adverse events should also be reported to AbbVie on [email protected] 

       

      Date of preparation: March 2024. UK-BCM-240040.

       

       

      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 [email protected]

       

      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.