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+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

Treatment options

Treatment options for the management of migraine may include:5-7

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

• Natural remedies (including riboflavin)
• Pharmacological treatments such as anti-convulsants or
beta-blockers
• BOTOX® (botulinum toxin type A)5


(according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2021)8

  • 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
  • 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
  • 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
  • Consider an anti-emetic in addition to other acute treatment for migraine even in the absence of nausea and vomiting
  • Do not offer ergots or opioids for the acute treatment of migraine
  • 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
- consider adding a non-oral NSAID or triptan if these have not been tried

(according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2021)8

  • 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
  • Offer topiramate or propranolol for the prophylactic treatment of migraine according to the person's preference, comorbidities and risk of adverse events. Advise women and girls of childbearing potential that topiramate is associated with a risk of foetal malformations and can impair the effectiveness of hormonal contraceptives. Ensure they are offered suitable contraception if needed
  • Consider amitriptyline for the prophylactic treatment of migraine according to the person's preference, comorbidities and risk of adverse events
  • Do not offer gabapentin for the prophylactic treatment of migraine
  • If both topiramate and propranolol are unsuitable or ineffective, consider a course of up to 10 sessions of acupuncture over 5-8 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
  • Review the need for continuing migraine prophylaxis 6 months after the start of prophylactic treatment
  • Advise people with migraine that riboflavin (400 mg once a day) may be effective in reducing migraine frequency and intensity for some people

(according to NICE Headaches in over 12s: diagnosis and management (CG150), 2012, updated 2021)8

  • 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

1.1 NICE recommends BOTOX® as an option and the SMC accepts its use 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):7-9

  • that has not responded to at least 3 prior pharmacological/ oral prophylactic treatments
  • when condition is appropriately managed for medication overuse

1.2 NICE states that treatment with botulinum toxin type A that is recommended according to 1.1 should be stopped in people whose condition:7

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

1.3 People currently receiving botulinum toxin type A that is not recommended according to 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.7

No stopping rules for BOTOX® are outlined by the SMC.9

Chronic migraine is a complex neurological disease requiring appropriate effective management - including treatment or referrals to improve patient outcomes2,10,11

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

© 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. 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. Migraine Trust. Treatments. Available at: migrainetrust.org. Accessed March 2024
  7. 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: nice.org.uk. Accessed March 2024
  8. National Institute for Health and Care Excellence (NICE). CG150: Headaches in over 12s: diagnosis and management. Available at: nice.org.uk. Accessed March 2024
  9. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: scottishmedicines.org.uk. Accessed March 2024
  10. International Headache Society (IHS). International classification of headache disorders (3rd edition) guidelines. Available at: ihs-headache.org. Accessed March 2024
  11. 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. 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. Migraine Trust. Treatments. Available at: migrainetrust.org. Accessed March 2024
  7. 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: nice.org.uk. Accessed March 2024
  8. National Institute for Health and Care Excellence (NICE). CG150: Headaches in over 12s: diagnosis and management. Available at: nice.org.uk. Accessed March 2024
  9. Scottish Medicines Consortium (SMC) Medicines advice: botulinum toxin A (Botox). SMC 692/11. Available at: scottishmedicines.org.uk. Accessed March 2024
  10. International Headache Society (IHS). International classification of headache disorders (3rd edition) guidelines. Available at: ihs-headache.org. Accessed March 2024
  11. 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.

 

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-240038.