UK-BCM-220070. DOP: April 2022.
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
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
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.
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.
*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
†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
References
- Allergan. Data on file. INT/0423/2016
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- Allergan Ltd. Data on file 014
- BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022
- Blumenfeld A, Silberstein S D et al. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache 2010;50(9):1406-1418
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
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: April 2022. UK-BCM-220067.
