Active Ingredient: Botulinum toxin type A
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intramuscular, between 25 international units botulinum toxin type A and 200 international units botulinum toxin type A, once every 10 weeks.
Recommended needle: A 25, 27 or 30 gauge/0.50-0.30 mm needle may be used for superficial muscles, and a 22 gauge needle may be used for deeper musculature.
Administrative guidance: The treatment of cervical dystonia typically may include injection of botulinum toxin type A into the sternocleidomastoid, levator scapulae, scalene, splenius capitis, semispinalis, longissimus and/or the trapezius muscle(s). This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment. The muscle mass and the degree of hypertrophy are factors to be taken into consideration when selecting the appropriate dose. Muscle activation patterns can change spontaneously in cervical dystonia without a change in the clinical presentation of dystonia.
In case of any difficulty in isolating the individual muscles, injections should be made under electromyographic assistance.
Multiple injection sites allow botulinum toxin type A to have more uniform contact with the innervation areas of the dystonic muscle and are especially useful in larger muscles. The optimal number of injection sites is dependent upon the size of the muscle to be chemically denervated.
Recommended dose: Dosing must be tailored to the individual patient based on the patient’s head and neck position, location of pain, muscle hypertrophy, patient’s body weight, and patient response.
Initial dosing in a naïve patient should begin at the lowest effective dose.
To minimise the incidence of dysphagia, the sternomastoid should not be injected bilaterally.
The following doses are recommended:
| Type I Head rotated toward side of shoulder elevation | Sternomastoid | 50-100 Units; at least 2 sites |
| Levator scapulae | 50 Units; 1-2 sites | |
| Scalene | 25-50 Units; 1-2 sites | |
| Splenius capitis | 25-75 Units; 1-3 sites | |
| Trapezius | 25-100 Units; 1-8 sites | |
| Type II Head rotation only | Sternomastoid | 25-100 Units; at least 2 sites if >25 Units given |
| Type III Head tilted toward side of shoulder elevation | Sternomastoid | 25-100 Units at posterior border; at least 2 sites if >25 Units given |
| Levator scapulae | 25-100 Units; at least 2 sites | |
| Scalene | 25-75 Units; at least 2 sites | |
| Trapezius | 25-100 Units; 1-8 sites | |
| Type IV Bilateral posterior cervical muscle spasm with elevation of the face | Splenius capitis and cervicis | 50-200 Units; 2-8 sites, treat bilaterally(This is the total dose and not the dose for each side of the neck) |
Maximum dose:
No more than 50 Units should be given at any one injection site.
No more than 100 Units should be given to the sternomastoid.
No more than 200 Units in total should be injected for the first course of therapy, with adjustments made in subsequent courses dependent on the initial response, up to a maximum total dose of 300 Units.
Additional information: Treatment intervals of less than 10 weeks are not recommended.
No more than 50 Units should be given at any one injection site.
No more than 100 Units should be given to the sternomastoid.
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