Generic name: Botulinum Toxin Type A 50[USP'U]
Dosage form: powder, lyophilized, for solution
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Instructions for Safe Use
The potency Units of XEOMIN (incobotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method [see Warnings and Precautions (5.2) and Description (11)]. Reconstituted Xeomin is intended for intramuscular injection only.
The recommended initial total dose of XEOMIN for cervical dystonia is 120 Units. In a placebo-controlled trial utilizing initial XEOMIN doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses [see Clinical Studies (14.1)]. 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 dose.
In the treatment of cervical dystonia, XEOMIN 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 [see Clinical Studies (14.1)]. 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 repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks [see Clinical Studies (14.1)].
The recommended initial total dose of XEOMIN should be the same dose as the patient's previous treatment of onabotulinumtoxinA (Botox), although responses to XEOMIN and onabotulinumtoxinA (Botox) 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 (Botox), the mean dose per eye was about 33 Units (range 10 Units-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 Units-50 Units. In the controlled trial, few patients received a total dose of greater than 75 Units.
If the previous dose of Botox is not known, the initial dose of XEOMIN should be between 1.25 Units-2.5 Units/injection site.
The total initial dose of XEOMIN 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 (Botox) injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 Units per eye [see Clinical Studies 14.2]. XEOMIN dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA (Botox).
The frequency of XEOMIN repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks [see Clinical Studies (14.2)].
The total recommended XEOMIN dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each. The five injection sites are: two injections in each corrugator muscle and one injection in the procerus muscle.
Retreatment with XEOMIN should be administered no more frequently than every three months.
|Figure 1: Injection Sites for Glabellar Lines|
The safety and effectiveness of XEOMIN in the treatment of cervical dystonia, blepharospasm, and glabellar lines in patients below 18 years of age have not been assessed [see Warnings and Precautions (5.1)].
Preparation and Reconstitution Technique
Prior to injection, reconstitute each vial of XEOMIN with sterile, preservative-free 0.9% Sodium Chloride Injection, USP [see Dosage Form and Strengths (3)]. Draw up an appropriate amount of preservative-free 0.9% Sodium Chloride Injection, USP into a syringe (see Table 1 and [Dosage Form and Strengths (3)]). Clean the exposed portion of the rubber stopper of the vial with alcohol (70%) prior to insertion of the needle. Gently inject the saline solution into the vial. If the vacuum does not pull the saline into the vial, then XEOMIN must be discarded. Gently mix XEOMIN with the saline by rotating the vial. Reconstituted XEOMIN is a clear, colorless solution free of particulate matter. XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.
Diluent volumes for reconstitution of XEOMIN are indicated in Table 1.
|Volume of Preservative-free 0.9% Sodium Chloride Injection, USP||50 Unit Vial:
Resulting dose in Units per 0.1 mL
|100 Unit Vial:
Resulting dose in Units per 0.1 mL
|200 Unit Vial:
Resulting dose in Units per 0.1 mL
|0.25 mL||20 Units||-||-|
|0.5 mL||10 Units||20 Units||40 Units|
|1 mL||5 Units||10 Units||20 Units|
|1.25 mL||4 Units||8 Units||16 Units|
|2 mL||2.5 Units||5 Units||10 Units|
|2.5 mL||2 Units||4 Units||8 Units|
|4 mL||1.25 Units||2.5 Units||5 Units|
|5 mL||1 Unit||2 Units||4 Units|
Reconstituted XEOMIN solution should be administered within 24 hours after dilution. During this time period, reconstituted XEOMIN should be stored in a refrigerator 2-8°C (36-46°F) [see How Supplied/Storage and Handling (16.2)].
Reconstituted XEOMIN is intended for intramuscular injection only. After reconstitution, XEOMIN should be used for only one injection session and for only one patient.
If proposed injection sites are marked with a pen, the product must not be injected through the pen marks; otherwise a permanent tattooing effect may occur.
The number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted XEOMIN injected.
XEOMIN should be injected carefully when injected at sites close to sensitive structures, such as the carotid artery, lung apices and esophagus. Before administering XEOMIN, the physician should be familiar with the patient's anatomy and any anatomic alterations, e.g., due to prior surgical procedures.
A suitable sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for injections into deeper muscles) should be used in the administration in the treatment of cervical dystonia.
Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful.
A suitable sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for injections into deeper muscles) should be used in the administration in the treatment of blepharospasm.