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.

Background

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.

Agent and route

  • Intramuscular injection 
  • Botulinum toxin products are not interchangeable therefore only onabotulinum toxin A (Botox®) should be used

Patient population applicable to

Patients will be known to the Headache service in the Institute of Neurological Sciences.

Authorised and Designated Areas applicable to

Institute Outpatients clinic room.

Indication and place in therapy

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.

Dose, duration and administration

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

Strength of preparation used

200 unit vial where available

2 x 100 unit vials if above not available.

Licensed status:

Licensed Medicine

Authorised prescribers

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

Authorised for administration

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

Authorised for preparation in clinical area:

Yes

Authorised for storage in clinical areas

Yes. Store in a refrigerator

Updated by

Graham Christie, Clinical Services Manager, Institute of Neurological Sciences, NHS GGC

Checked by

Lesley Murray, Lead Pharmacist for Neurosciences, NHS GGC.

Endorsed by

West of Scotland Regional Headache Service, NHS GGC

Last reviewed: 04 September 2020

Next review: 13 July 2022

Author(s): Lesley Murray

Version: 2

Author Email(s): [email protected]

Approved By: Institute of Neurological Sciences Medical Clinical Governance Group

Document Id: 548