Incobotulinumtoxina Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Cervical Dystonia

Initial dose: 120 units injected (usually) into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s); however, 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.

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

Comments:
-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.
-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 dose.
-In a study of doses of 120 units and 240 units, no meaningful difference in effectiveness was demonstrated between the doses.

Use: For the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients.

Usual Adult Dose for Blepharospasm

-The recommended initial dose should be the same as the patient's previous treatment, although responses may differ in individual patients. If the previous dose is not known, the initial dose should be between 1.25 and 2.5 units per injection site.
-The total initial dose of in both eyes should not exceed 70 units (35 units/eye).

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

Comments:
-In a trial in which patients were dosed with the same number of units as they had received previously, 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.
-The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response the injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 units per eye.
-Dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA.

Use: For the treatment of adults with blepharospasm who were previously treated with this drug.

Usual Adult Dose for Glabellar Lines

The total recommended 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.

Duration of therapy: Retreatment should be administered no more frequently than every 3 months.

Use: For temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

US BOXED WARNINGS:
-Botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening or fatal. The risk is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.
-Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Safety and effectiveness have not been established in pediatric patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Reconstituted drug is intended for IM injection only. After reconstitution, the product should be used for only one injection session and for only one patient. A suitable sterile needle (see manufacturer product information for recommended size and length) should be used.
-Prior to administration the physician should be familiar with the anatomy and any alterations to the anatomy due to prior surgical procedures of the patient.
-If injection sites are marked with a pen, the product should not be injected through the pen marks; otherwise a permanent tattooing effect may occur.
-Care should be exercised when injecting at sites close to sensitive structures, such as the carotid artery, lung apices and esophagus.
-Care should be taken to ensure that the product is not injected into a blood vessel.
-This drug should be used with caution if bleeding disorders occur in patients receiving anticoagulant therapy or taking other substances in anticoagulant doses.
-Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful.
-The number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted solution injected.
-The frequency of incobotulinumtoxinA repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

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

Patient advice:
-This product may cause serious and/or life threatening side effects for up to hours or weeks after you receive your injection. Read your patient medication leaflet each time you receive your injections for side effects that you should report to your healthcare provider.

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