Cervical Dystonia

The recommended initial total dose of XEOMIN® (incobotulinumtoxinA) for cervical dystonia is 120 Units. In a placebo-controlled trial utilizing initial XEOMIN® (incobotulinumtoxinA) doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses. In previously treated patients, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the XEOMIN® (incobotulinumtoxinA) dose.

In the treatment of cervical dystonia, XEOMIN® (incobotulinumtoxinA) is usually injected into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s). This list is not exhaustive, as any of the muscles responsible for controlling head position may require treatment. The dose and number of injection sites in each treated muscle should be individualized based on the number and location of the muscle(s) to be treated, the degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections.

The frequency of XEOMIN® (incobotulinumtoxinA) repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Lyophilized powder in single-use vials for dosing precision

• 50-unit vial may allow for more precise billing
• 50-unit vial may help reduce waste

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Blepharospasm

When initiating XEOMIN® (incobotulinumtoxinA) therapy, the dose, number, and location of injections should be based on the previous dosing of onabotulinumtoxinA. If the previous dose of onabotulinumtoxinA is not known, the recommended starting dose is 1.25-2.5 units per injection site.

In the XEOMIN® (incobotulinumtoxinA) clinical trials, the mean dose per injection site was 5.6 Units, the mean number of injections per eye was 6, and the mean dose per eye was 33.5 Units.

Available in 50-unit and 100-unit single-use vials

• 50-unit vial may allow for more precise billing
• 50-unit vial may help reduce wastage

Dosing recommendations for adults with blepharospasm
The recommended initial total dose of XEOMIN® (incobotulinumtoxinA) should be the same dose as the patient’s previous treatment of onabotulinumtoxinA, although responses to XEOMIN® (incobotulinumtoxinA) and onabotulinumtoxinA may differ in individual patients.

In a placebo-controlled trial in which patients were dosed with the same number of Units as they had received previously with onabotulinumtoxinA, the mean dose per eye was about 33 Units (range 10-50 Units), and the mean number of injections per eye was 6. The maximum dose per eye in the controlled trials was 50 Units, with a range of 10-50 Units. In the controlled trial, few patients received a total dose of greater than 75 Units. If the previous dose of onabotulinumtoxinA is not known, the initial dose of XEOMIN® (incobotulinumtoxinA) should be between 1.25-2.5 Units/injection site. The total initial dose of XEOMIN® (incobotulinumtoxinA) in both eyes should not exceed 70 Units (35 Units/eye). The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response to onabotulinumtoxinA injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 Units per eye. XEOMIN® (incobotulinumtoxinA) dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA. The frequency of XEOMIN® (incobotulinumtoxinA) repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

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