• {%buzbrandMenuItems%}
    • {%bitemName%} {%barrowSpan%}
        {%bsubBrandMenuItems%}
    • {%sbitemName%} {%sbarrowSpan%}
        {%sbproductMenuItems%}
    • {%pselfProduct%}
      • {%cSlanguages%}
    • This website is for UK Healthcare Professionals only

      This promotional material is intended for UK Healthcare Professionals only. BOTOX® (botulinum toxin type A) Prescribing Information and adverse event reporting information can be found below.

      Treatment options

      Treatment options for the management of migraine may include:5-9

      • Analgesics, especially NSAIDS
      • Anti-emetics
      • Specific anti-migraine drugs: serotonin 5-HT1 receptor agonists or triptans
      • Rimegepant

      • Natural remedies (including riboflavin)
      • Pharmacological treatments such as anti-convulsants or beta‑blockers
      • BOTOX® (botulinum toxin type A)5
      • CGRP receptor antagonists (AQUIPTA®▼ (atogepant)* and rimegepant)6,7
      • Monoclonal antibodies (eptinezumab, fremanezumab, erenumab and galcanezumab)


      (according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2025)10

      • Offer combination therapy with an oral triptan and an NSAID, or an oral triptan and paracetamol, for the acute treatment of migraine, taking into account the person's preference, comorbidities and risk of adverse events. For young people aged 12-17 years consider a nasal triptan in preference to an oral triptan.

      - In June 2025, this was an off-label use of triptans (except nasal sumatriptan) in under 18s.

      • For people who prefer to take only one drug, consider monotherapy with an oral triptan, NSAID, aspirin (900 mg) or paracetamol for the acute treatment of migraine, taking into account the person's preference, comorbidities and risk of adverse events. For young people aged 12 to 17 years consider a nasal triptan in preference to an oral triptan.

      - In June 2025, this was an off-label use of triptans (except nasal sumatriptan) in under 18s. Because of the association with Reye's syndrome, preparations containing aspirin should not be offered to under 16s.

      • When prescribing a triptan start with the one that has the lowest acquisition cost; if this is consistently ineffective, try one or more alternative triptans.

      - In June 2025, this was an off-label use of triptans (except nasal sumatriptan) in under 18s.

      • Consider an anti-emetic in addition to other acute treatment for migraine even in the absence of nausea and vomiting
      • For people in whom oral preparations (or nasal preparations in young people aged 12-17 years) for the acute treatment of migraine are ineffective or not tolerated:

      - offer a non-oral preparation of metoclopramide or prochlorperazine and
      - if non-oral metoclopramide or prochlorperazine is used, consider adding a non-oral NSAID or triptan if they have not been tried.
      - Note the special warnings and precautions for use in the SmPC for metoclopramide and prochlorperazine, and discuss the benefits and risks with the person (or their parents or carers, as appropriate).
      - In June 2025, only a buccal preparation of prochlorperazine was licensed for this indication (other preparations of prochlorperazine and metoclopramide were licensed for the relief of nausea and vomiting); nasal sumatriptan was the only triptan licensed for this indication in under 18s. This was an off-label use of metoclopramide in children and young people.

      • Rimegepant (an oral CGRP inhibitor placed on or under the tongue) is recommended as an option in NICE technology appraisal guidance for the acute treatment of migraine with or without aura in adults, only if for previous migraines: 

      - at least 2 triptans were tried and they did not work well enough or
      - triptans were contraindicated or not tolerated, and NSAIDs and paracetamol were tried but did not work well enough. 

      • Do not offer ergots or opioids for the acute treatment of migraine

      (according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2025)10

      • Discuss the benefits and risks of prophylactic treatment for migraine with the person, taking into account the person's preference, comorbidities, risk of adverse events and the impact of the headache on their quality of life
      • Consider propranolol, topiramate or amitriptyline for migraine prevention after a full discussion of the benefits, risks and suitability of each option, including the potential benefit in reducing migraine recurrence and severity. Take into account  the following factors and include them in the discussion if relevant: 

      - People with depression and migraine could be at an increased risk of using propranolol for self-harm. Use caution when prescribing propranolol, to minimise the risk of harm from toxicity and rapid deterioration in overdose.
      - Topiramate should not be used for migraine prophylaxis in pregnancy, or in women able to have children unless the conditions of the Pregnancy Prevention Programme are fulfilled.
      - For amitriptyline, take into account the advice on safe prescribing of antidepressants and managing withdrawal in NICE's guideline on medicines associated with dependence or withdrawal symptoms.
      - In June 2025, this was an off-label use of topiramate and amitriptyline in children and young people.

      • If the first treatment tried does not work or is not tolerated, discuss trying a second option and then the remaining option, unless unsuitable because of safety concerns
      • Do not offer gabapentin for the prophylactic treatment of migraine
      • If propranolol, topiramate and amitriptyline have not worked or are not tolerated or are unsuitable because of safety concerns, consider a course of up to 10 sessions of acupuncture over 5 to 8 weeks according to the person's preference, comorbidities and risk of adverse events
      • For people who are already having treatment with another form of prophylaxis and whose migraine is well controlled, continue the current treatment as required
      • Advise people with migraine that the food supplement riboflavin (400 mg once a day) may be effective in reducing migraine frequency and intensity for some people
      • For CGRP inhibitors recommended as options in NICE technology appraisal guidance for preventing episodic or chronic migraine in adults who have at least 4 migraine days a month, only if at least 3 preventive medicines have not worked or are not tolerated or are unsuitable because of safety concerns, see the guidance on: 

      - atogepant (TA973, 2024)
      - eptinezumab (TA871, 2023)
      - fremanezumab (TA764, 2022)
      - erenumab (TA682, 2021)
      - galcanezumab (TA659, 2020)

      • Rimegepant is recommended as an option in NICE technology appraisal guidance for preventing episodic migraine in adults who have at least 4 and fewer than 15 migraine attacks per month, only if at least 3 preventive medicines have not worked or are not tolerated or are unsuitable because of safety concerns
      • Intramuscular injection of botulinum toxin type A is recommended as an option in NICE technology appraisal guidance for preventing chronic migraine in adults, only if at least 3 preventive medicines have not worked or are not tolerated or are unsuitable because of safety concerns, and when the condition is appropriately managed for medication overuse.

      (according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2025)10

      • Explain to people with medication overuse headache that it is treated by withdrawing overused medication
      • Advise people to stop taking all overused acute headache medications for at least 1 month and to stop abruptly rather than gradually
      • Advise people that headache symptoms are likely to get worse in the short term before they improve and that there may be associated withdrawal symptoms, and provide them with close follow-up and support according to their needs
      • Consider prophylactic treatment for the underlying primary headache disorder in addition to withdrawal of overused medication for people with medication overuse headache
      • Do not routinely offer inpatient withdrawal for medication overuse headache
      • Consider specialist referral and/or inpatient withdrawal of overused medication for people who are using strong opioids, or have relevant comorbidities, or in whom previous repeated attempts at withdrawal of overused medication have been unsuccessful
      • Review the diagnosis of medication overuse headache and further management 4-8 weeks after the start of withdrawal of overused medication

      BOTOX® is recommended as an option for the prophylaxis of headaches in adults with chronic migraine5

      NICE recommendation9

      1.1 Botulinum toxin type A is recommended as an option for the prophylaxis of headaches in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine), only if:

      • at least 3 preventive medicines have not worked, or are not tolerated or are unsuitable because of safety concerns, and 
      • the condition is appropriately managed for medication overuse. 

      1.2 Treatment with botulinum toxin type A that is recommended according to section 1.1 should be stopped in people whose condition:

      • is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after 2 treatment cycles) or 
      • has changed to episodic migraine (defined as fewer than 15 headache days per month) for 3 consecutive months.

      1.3 People currently receiving botulinum toxin type A that is not recommended according to sections 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.

      SMC recommendation:11

      Botulinum toxin A (BOTOX®) is accepted for restricted use within NHS Scotland.

      Indication under review: 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).

      SMC restriction: use in adults with chronic migraine whose condition has failed to respond to ≥3 prior oral prophylactic treatments, where medication overuse has been appropriately managed.

      No stopping rules for BOTOX® are outlined by the SMC.

      Chronic migraine is a complex neurological disease requiring appropriate effective management - including treatment or referrals to improve patient outcomes2,12,13

      CGRP: calcitonin gene-related peptide; CM: chronic migraine; NICE: National Institute for Health and Care Excellence; NSAID: non-steroidal anti-inflammatory drug; SMC: Scottish Medicine Consortium

       

      *AQUIPTA® is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.6

      © NICE [2012] Headaches in over 12s: diagnosis and management. Available from nice.org.uk. All rights reserved. Subject to Notice of rights

      © NICE [2012] Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available from nice.org.uk. All rights reserved. Subject to Notice of rights.

      NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

       

      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. REF-112127.
      5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
      6. AQUIPTA® Summary of Product Characteristics. Available at: www.medicines.org.uk
      7. Rimegepant Summary of Product Characteristics. Available at: www.medicines.org.uk
      8. Migraine Trust. Treatments. Available at: migrainetrust.org. Accessed July 2025
      9. National Institute for Health and Care Excellence (NICE). TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available at: https://www.nice.org.uk/guidance/TA260. Accessed July 2025
      10. National Institute for Health and Care Excellence (NICE). CG150: Headaches in over 12s: diagnosis and management. Available at: https://www.nice.org.uk/Guidance/CG150. Accessed July 2025
      11. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: https://scottishmedicines.org.uk/medicines-advice/botulinum-toxin-a-botox-resubmission-69211/. Accessed July 2025
      12. International Headache Society (IHS). International classification of headache disorders (3rd edition) guidelines. Available at: ihs-headache.org. Accessed July 2025
      13. Weatherall M W. The diagnosis and treatment of chronic migraine. Ther Adv Chronic Dis. 2015;6(3):115-12

       

      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. REF-112127.
      5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
      6. AQUIPTA® Summary of Product Characteristics. Available at: www.medicines.org.uk
      7. Rimegepant Summary of Product Characteristics. Available at: www.medicines.org.uk
      8. Migraine Trust. Treatments. Available at: migrainetrust.org. Accessed July 2025
      9. National Institute for Health and Care Excellence (NICE). TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Available at: https://www.nice.org.uk/guidance/TA260. Accessed July 2025
      10. National Institute for Health and Care Excellence (NICE). CG150: Headaches in over 12s: diagnosis and management. Available at: https://www.nice.org.uk/Guidance/CG150. Accessed July 2025
      11. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: https://scottishmedicines.org.uk/medicines-advice/botulinum-toxin-a-botox-resubmission-69211/. Accessed July 2025
      12. International Headache Society (IHS). International classification of headache disorders (3rd edition) guidelines. Available at: ihs-headache.org. Accessed July 2025
      13. Weatherall M W. The diagnosis and treatment of chronic migraine. Ther Adv Chronic Dis. 2015;6(3):115-12

      Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use. The BOTOX® Summary of Product Characteristics can be found here

      By clicking the links above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      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: July 2025. UK-BCM-250054.