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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.

      Administering BOTOX® to your patients with chronic migraine5-7

      This treatment paradigm is based on the PREEMPT study protocol, which is the culmination of 10 years’ experience in migraine research2,5-13







      UNITS5-7

       

      UNITS5-7
      Corrugator

      10 Units (2 sites)
      Procerus

      5 Units (1 sites)
      Frontalis

      20 Units (4 sites)
      Temporalis

      40 Units (8 sites)
      Temporalis†

      Up to additional 10 Units (2 sites)







      UNITS5-7

       

      UNITS5-7
      Occipitalis

      30 Units (6 sites)
      Occipitalis†

      Up to additional 10 Units (2 sites)
      Cervical paraspinal

      20 Units (4 sites)
      Trapezius

      30 Units (6 sites)
      Trapezius†

      Up to additional 20 Units (4 sites)

      †Follow the pain.

      0.1 mL (5 Units) of BOTOX® per site. Please refer to the dilution table in your Summary of Product Characteristics (SmPC). The recommended dose for treating chronic migraine is 155 U to 195 U. BOTOX® should be individualised for each patient.5

      Based on a publication by Blumenfeld A M, et al. Headache 2017;57(5):766-777,7 the injection points demonstrated in the images differ from the images shown in the BOTOX® product licence. Importantly, these are not changes to the muscle groups identified in the licence, but simply reflect an amendment in technique to localise these muscles groups more effectively and minimise side effect profile.

      Dr Andrew Blumenfeld, Director of the Headache Center of Southern California, explains the treatment paradigm in further detail

      The nature of chronic migraine and progressive response with BOTOX® makes treatment persistence important14,15

      BOTOX® reduces headache days in patients with chronic migraine progressively for up to 3 treatment cycles.†‡15

      Cumulative proportion of BOTOX® -treated patients responding with a ≥50% reduction in headache days in the PREEMPT trials with the 1st, 2nd and 3rd treatment cycle (N = 688) from baseline.§15

      Adapted from Silberstein S D et al, 201515

      CM: chronic migraine.

      †Response was defined as a ≥50% reduction in monthly headache days from baseline.15
      ‡Primary endpoint was mean change from baseline in frequency of headache days.15
      §Cumulative response of first time responders. First-time responders for a given time point are patients who never responded at any previous time points.15

      Request further information on 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. Blumenfeld A, Silberstein S D et al. Method of injection of Onabotulinum toxin A for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50(9):1406-1418
      7. Blumenfeld A M, Silberstein S D et al. Insights into the functional anatomy behind the PREEMPT injection paradigm: guidance on achieving optimal outcomes. Headache. 2017;57(5):766-777
      8. Binder W J, Brin M F et al. Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study. Otolaryngol Head Neck Surg. 2000;123(6):669-676
      9. Elkind A H, O'Carroll P et al. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7(10):688-696
      10. Saper J R, Mathew N T et al. A double-blind, randomized, placebo-controlled comparison of botulinum toxin type A injection sites and doses in the prevention of episodic migraine. Pain Med. 2007;8(6):478-485
      11. Relja M, Poole A C et al. A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia. 2007;27(6):492-503
      12. Aurora S K, Gawel M et al. Botulinum toxin type A prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study. Headache. 2007;47(4):486-499
      13. Silberstein S D, Stark S R et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005;80(9):1126-1137
      14. Serrano D, Lipton R B et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18(1):101
      15. Silberstein S D, Dodick D W et al. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015;86(9):996-1001

       

       

      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. Blumenfeld A, Silberstein S D et al. Method of injection of Onabotulinum toxin A for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50(9):1406-1418
      7. Blumenfeld A M, Silberstein S D et al. Insights into the functional anatomy behind the PREEMPT injection paradigm: guidance on achieving optimal outcomes. Headache. 2017;57(5):766-777
      8. Binder W J, Brin M F et al. Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study. Otolaryngol Head Neck Surg. 2000;123(6):669-676
      9. Elkind A H, O'Carroll P et al. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7(10):688-696
      10. Saper J R, Mathew N T et al. A double-blind, randomized, placebo-controlled comparison of botulinum toxin type A injection sites and doses in the prevention of episodic migraine. Pain Med. 2007;8(6):478-485
      11. Relja M, Poole A C et al. A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia. 2007;27(6):492-503
      12. Aurora S K, Gawel M et al. Botulinum toxin type A prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study. Headache. 2007;47(4):486-499
      13. Silberstein S D, Stark S R et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005;80(9):1126-1137
      14. Serrano D, Lipton R B et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18(1):101
      15. Silberstein S D, Dodick D W et al. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015;86(9):996-1001

       

      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-240041.

       

       

      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.