Medication Guide App

Incobotulinumtoxina Dosage

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Cervical Dystonia

Initial total dose: 120 Units

In a placebo-controlled trial utilizing initial 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 incobotulinumtoxinA dose.

In the treatment of cervical dystonia, 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 incobotulinumtoxinA repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Usual Adult Dose for Blepharospasm

The recommended initial total dose of incobotulinumtoxinA should be the same dose as the patient's previous treatment of onabotulinumtoxinA (Botox), although responses to incobotulinumtoxinA 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 to 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 to 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 incobotulinumtoxinA should be between 1.25 to 2.5 Units/injection site.

The total initial dose of 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 (Botox) injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 Units per eye.
IncobotulinumtoxinA dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA (Botox).

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

Usual Adult Dose for Glabellar Lines

The total recommended incobotulinumtoxinA dose is 20 units per treatment session divided into five equal intramuscular injections of 4 units each. The five injection sites are: 2 injections in each corrugator muscle and 1 injection in the procerus muscle.

Retreatment with incobotulinumtoxinA should be administered no more frequently than every 3 months.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

Reconstituted incobotulinumtoxinA is intended for intramuscular injection only. After reconstitution, incobotulinumtoxinA should be used for only one injection session and for only one patient. 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 for administration.

Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful.

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 incobotulinumtoxinA injected.

IncobotulinumtoxinA should be injected carefully when injected at sites close to sensitive structures, such as the carotid artery, lung apices and esophagus. Before administering incobotulinumtoxinA, the physician should be familiar with the patient's anatomy and any anatomic alterations (e.g., due to prior surgical procedures).

Safety and effectiveness have not been established in pediatric patients (less than 18 years old).

Dialysis

Data not available

Other Comments

Reconstituted incobotulinumtoxinA solution should be administered within 24 hours after dilution. During this time period, reconstituted incobotulinumtoxinA should be stored in a refrigerator at 2 to 8 degrees C (36 to 46 degrees F).

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

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