Onabotulinum toxin A (Botox®) is the only botulinum toxin which is licensed for chronic migraine in the UK. Botox® been accepted for use by the Scottish Medicines Consortium in patients who have failed to respond to ≥3 prophylactic treatments. In NHS GGC, it is proposed that Botox® should not be considered until patients have received an adequate trial of ≥4 prophylactic treatments.
Botulinum Toxin A (Botox) use in chronic migraine protocol (548)
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A guideline is intended to assist healthcare professionals in the choice of disease-specific treatments.
Clinical judgement should be exercised on the applicability of any guideline, influenced by individual patient characteristics. Clinicians should be mindful of the potential for harmful polypharmacy and increased susceptibility to adverse drug reactions in patients with multiple morbidities or frailty.
If, after discussion with the patient or carer, there are good reasons for not following a guideline, it is good practice to record these and communicate them to others involved in the care of the patient.
- Intramuscular injection
- Botulinum toxin products are not interchangeable therefore only onabotulinum toxin A (Botox®) should be used
Patients will be known to the Headache service in the Institute of Neurological Sciences.
Institute Outpatients clinic room.
Botox® for chronic migraine will only be recommended by the Headache Team (Consultant Neurologists and General Practitioners with Specialist Interest in Headache (GPSIs) where medication overuse has been appropriately managed.
Botox® should only be considered unless patient has received an adequate trial (i.e. at least 6 weeks at therapeutic dose) of the following 4 medicines/classes of medicine (unless contraindicated or side effects):
- Beta blockers (e.g. propranolol)
- Topiramate
- Tricyclic antidepressant drug (e.g. amitriptyline, dosulepin)
- Candesartan
- If the above therapies have failed due to lack of efficacy, tolerability or contra-indicated due to co-morbid condition then headache clinic clinician discretion to try Flunarazine (unlicensed and dispensed via hospital pharmacy)
Botox will be stopped after 2 courses if
- Treatment has failed to reduce the number of headache days by at least 30% or
- If chronic migraine becomes episodic (i.e. <15 days/month with headache for 3 consecutive months).
- Or there must be a 50% reduction in headache severity.
Upon initiation of treatment patients should be advised they are being trialled on the treatment and MUST bring their headache diaries to their appointments in order to assess effects, otherwise treatment will be withheld.
Patients who fail to bring their diary following this can still be administered the treatment on one occasion, however if they fail to present their diary on a second presentation. Treatment will be withheld until diaries are submitted.
155 Units to 195 Units administered intramuscularly as 0.1 ml (5 Units) injections to 31 and up to 39 sites (see below). The recommended re-treatment schedule is every 12 weeks.
1IM injection site = 0.1ml = 5 units Botox
2Dose distributed bilaterally
|
|
Recommended Dose |
|
Head/Neck area |
Total Dosage (number of sites1) |
|
Corrugator2 |
10 Units (2 sites) |
|
Procerus |
5 Units (1 site) |
|
Frontalis2 |
20 Units (4 sites) |
|
Temporalis2 |
40 Units (8 sites) up to 50 Units (up to 10 sites) |
|
Occipitalis2 |
30 Units (6 sites) up to 40 units (up to 8 sites) |
|
Cervical Paraspinal Muscle Group2 |
20 Units (4 sites) |
|
Trapezius2 |
30 Units (6 sites) up to 50 Units (up to 10 sites) |
|
Total Dose Range
|
155 Units to 195 Units 31 to 39 sites |
200 unit vial where available
2 x 100 unit vials if above not available.
Licensed Medicine
Dr Alok Tyagi, Consultant Neurologist, NHS GGC
Dr Johann Selvarajah, Consultant Neurologist, NHS GGC
Dr George Gorrie, Consultant Neurologist, NHS GGC
Dr Michael McKenzie, GPSI
Dr Sandeep Sharma, GPSI
Laura McCorkell Headache CNS
Anissa Benchiheub, Clinical Nurse Specialist – Headache, NHS GGC (pending prescribing results)
Dr Janice Heath, GPSI
Dr Krishna Dani, Consultant Neurologist, NHS GGC
Dr Alok Tyagi, Consultant Neurologist, NHS GGC
Dr Johann Selvarajah, Consultant Neurologist, NHS GGC
Dr George Gorrie, Consultant Neurologist, NHS GGC
Dr Sandeep Sharma, GPSI
Laura McCorkell Headache CNS
Christine Rankin, Headache CNS
Anissa Benchiheub, Clinical Nurse Specialist – Headache, NHS GGC
Dr Janice Heath, GPSI
Dr Krishna Dani, Consultant Neurologist, NHS GGC
Yes
Yes. Store in a refrigerator
Scottish Medicines Consortium
https://www.scottishmedicines.org.uk/medicines-advice/botulinum-toxin-a-botox-resubmission-69211/
Botox® Summary of Product Characteristics
Graham Christie, Clinical Services Manager, Institute of Neurological Sciences, NHS GGC
Lesley Murray, Lead Pharmacist for Neurosciences, NHS GGC.
West of Scotland Regional Headache Service, NHS GGC