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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®: prophylaxis treatment for the management of chronic migraine6-26

      +9 YEARS of real-world experience demonstrating reduction in headache days6-26 with evidence from 20 studies in eight countries6-26

      BOTOX® could have a positive impact on the lives and future outlook of your patients with
      chronic migraine4,6,7

      In an international, multicentre, long-term, open-label, single-arm prospective study in patients with chronic migraine:4, 27

      botox-for-cm-2

      In a prospective, real-world study of patients with chronic migraine, patients missed work on average 4x fewer days per month after initiating BOTOX® treatment compared with before (n=58)8
      Pre-treatment median: 4 (IQR: 3-6)
      Post-treatment median: 1 (IQR: 0-4)

      CM: chronic migraine; FDA: Food and Drug Administration; GAD-7: 7-item Generalized Anxiety Disorder Assessment; IQR: interquartile range; PHQ-9: Patient Health Questionnaire-9; SD: standard deviation.

      VIEW REAL-WORLD EFFICACY DATA FOR BOTOX®

       

      References

      1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
      2. Allergan. Data on file. INT/0423/2016
      3. 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
      4. 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
      5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed March 2024
      6. Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36 Suppl 1:33-35
      7. Stark C, Stark R et al. Real-world effectiveness of Onabotulinum toxin A treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019;20(1):81
      8. Khalil M, Zafar H W et al. Prospective analysis of the use of Onabotulinum toxin A (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain. 2014;15:54
      9. Aicua-Rapun I, Martinez-Velasco E et al. Real-life data in 115 chronic migraine patients treated with Onabotulinum toxin A during more than one year. J Headache Pain. 2016;17(1):112
      10. Alina Buture, Ahmed F. Onabotulinum toxin A (Botox) in chronic migraine with and without medication overuse. Curr Neurobio. 2016;7(1):13-15
      11. Aydinlar E I, Dikmen P Y et al. Onabotulinum toxin A effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study. J Headache Pain. 2017;18(1):23
      12. Byun J I, Sim J Y, Kim M. Prolonged effect of Onabotulinum toxin A on chronic migraine in 87 Koreans. J Clin Neurol. 2017;13(1):98-100
      13. Cernuda-Morollon E, Ramon C et al. Onabotulinum toxin A decreases interictal CGRP plasma levels in patients with chronic migraine. Pain. 2015;156(5):820-824
      14. Demiryurek B E, Ertem D H et al. Effects of Onabotulinum toxin A treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci. 2016;37(11):1779-1784
      15. Grazzi L. Onabotulinum toxin A for chronic migraine with medication overuse: clinical results of a long-term treatment. Neurol Sci. 2017;38(Suppl 1):141-143
      16. Guerzoni S, Pellesi L et al. Increased efficacy of regularly repeated cycles with Onabotulinum toxin A in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48
      17. Kollewe K, Escher C M et al. Long-term treatment of chronic migraine with Onabotulinum toxin A: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm. 2016;123(5):533-540
      18. Lee M J, Lee C et al. Factors associated with favorable outcome in botulinum toxin A treatment for chronic migraine: a clinic-based prospective study. J Neurol Sci. 2016;363:51-54
      19. Lia C, Tosi P et al. Onabotulinum toxin A for prophylaxis in chronic migraine: preliminary data from Headache Regional Centre of Aosta Valley. Neurol Sci. 2014;35 Suppl 1:175-176
      20. Negro A, Curto M et al. Onabotulinum toxin A 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826
      21. Negro A, Curto M et al. A two years open-label prospective study of Onabotulinum toxin A 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1
      22. Pedraza M I, de la Cruz C et al. Onabotulinum toxin A treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176
      23. Russo M, Manzoni G C et al. The use of Onabotulinum toxin A (BOTOX®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci. 2016;37(7):1127-1131
      24. Santoro A, Fontana A et al. Quarterly repeat cycles of Onabotulinum toxin A in chronic migraine patients: the benefits of the prolonged treatment on the continuous responders and quality-of-life conversion rate in a real-life setting. Neurol Sci. 2017;38(10):1779-1789
      25. Vikelis M, Argyriou A A et al. Onabotulinum toxin A treatment in Greek patients with chronic migraine. J Headache Pain. 2016;17(1):84
      26. Andreou A P, Trimboli M et al. Prospective real-world analysis of Onabotulinum toxin A in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal. Eur J Neurol. 2018;25(8):1069-e1083
      27. 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

       

       

      References

      1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
      2. Allergan. Data on file. INT/0423/2016
      3. 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
      4. 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
      5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed March 2024
      6. Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36 Suppl 1:33-35
      7. Stark C, Stark R et al. Real-world effectiveness of Onabotulinum toxin A treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019;20(1):81
      8. Khalil M, Zafar H W et al. Prospective analysis of the use of Onabotulinum toxin A (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain. 2014;15:54
      9. Aicua-Rapun I, Martinez-Velasco E et al. Real-life data in 115 chronic migraine patients treated with Onabotulinum toxin A during more than one year. J Headache Pain. 2016;17(1):112
      10. Alina Buture, Ahmed F. Onabotulinum toxin A (Botox) in chronic migraine with and without medication overuse. Curr Neurobio. 2016;7(1):13-15
      11. Aydinlar E I, Dikmen P Y et al. Onabotulinum toxin A effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study. J Headache Pain. 2017;18(1):23
      12. Byun J I, Sim J Y, Kim M. Prolonged effect of Onabotulinum toxin A on chronic migraine in 87 Koreans. J Clin Neurol. 2017;13(1):98-100
      13. Cernuda-Morollon E, Ramon C et al. Onabotulinum toxin A decreases interictal CGRP plasma levels in patients with chronic migraine. Pain. 2015;156(5):820-824
      14. Demiryurek B E, Ertem D H et al. Effects of Onabotulinum toxin A treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci. 2016;37(11):1779-1784
      15. Grazzi L. Onabotulinum toxin A for chronic migraine with medication overuse: clinical results of a long-term treatment. Neurol Sci. 2017;38(Suppl 1):141-143
      16. Guerzoni S, Pellesi L et al. Increased efficacy of regularly repeated cycles with Onabotulinum toxin A in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48
      17. Kollewe K, Escher C M et al. Long-term treatment of chronic migraine with Onabotulinum toxin A: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm. 2016;123(5):533-540
      18. Lee M J, Lee C et al. Factors associated with favorable outcome in botulinum toxin A treatment for chronic migraine: a clinic-based prospective study. J Neurol Sci. 2016;363:51-54
      19. Lia C, Tosi P et al. Onabotulinum toxin A for prophylaxis in chronic migraine: preliminary data from Headache Regional Centre of Aosta Valley. Neurol Sci. 2014;35 Suppl 1:175-176
      20. Negro A, Curto M et al. Onabotulinum toxin A 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826
      21. Negro A, Curto M et al. A two years open-label prospective study of Onabotulinum toxin A 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1
      22. Pedraza M I, de la Cruz C et al. Onabotulinum toxin A treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176
      23. Russo M, Manzoni G C et al. The use of Onabotulinum toxin A (BOTOX®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci. 2016;37(7):1127-1131
      24. Santoro A, Fontana A et al. Quarterly repeat cycles of Onabotulinum toxin A in chronic migraine patients: the benefits of the prolonged treatment on the continuous responders and quality-of-life conversion rate in a real-life setting. Neurol Sci. 2017;38(10):1779-1789
      25. Vikelis M, Argyriou A A et al. Onabotulinum toxin A treatment in Greek patients with chronic migraine. J Headache Pain. 2016;17(1):84
      26. Andreou A P, Trimboli M et al. Prospective real-world analysis of Onabotulinum toxin A in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal. Eur J Neurol. 2018;25(8):1069-e1083
      27. 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

       

      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 GBPV@abbvie.com 

       

      Date of preparation: March 2024. UK-BCM-240053.

       

       

      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.