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Incobotulinumtoxina Dosage

Medically reviewed on September 10, 2018.

Applies to the following strengths: 50 units; 100 units; 200 units

Usual Adult Dose for Sialorrhea

Total dose per treatment session: 100 Units via intra-salivary gland injection as follows:
--Parotid gland: 30 Units per side
--Submandibular gland 20 Units per side

Comments:
-Injection should be into the parotid and submandibular glands on both sides. Product labeling provides an illustration and directions for locating salivary glands using anatomic landmarks.
-A cumulative dose for any indication should not exceed 400 Units in a treatment session.
-Repeat treatment should be individualized, but no sooner than every 16 weeks.

Use: For the treatment of chronic sialorrhea.

Usual Adult Dose for Upper Limb Spasticity

Individualize dose based on size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness and patient's response to prior treatment.

-For botulinum toxin-naive patients: Initial dosing should begin at the low end of the dosing range and titrated as necessary

Suggested Dosing Ranges:
CLENCHED FIST:
-Flexor digitorum superficialis: 25 to 100 Units; (2 injection sites per muscle)
-Flexor digitorum profundus: 25 to 100 Units; (2 injection sites per muscle)
FLEXED WRIST:
-Flexor carpi radialis: 25 to 100 Units; (1 to 2 injection sites per muscle)
-Flexor carpi ulnaris: 20 to 100 Units; (1 to 2 injection sites per muscle)
FLEXED ELBOW:
-Brachioradialis: 25 to 100 Units; (1 to 3 injection sites per muscle)
-Biceps: 50 to 200 Units; (1 to 4 injection sites per muscle)
-Brachialis: 25 to 100 Units; (1 to 2 injection sites per muscle)
PRONATED FOREARM:
-Pronator quadratus: 10 to 50 Units; (1 injection site per muscle)
-Pronator teres: 25 to 75 Units; (1 to 2 injection sites per muscle)
THUMB-IN-PALM:
-Flexor pollicis longus: 10 to 50 Units; (1 injection site per muscle)
-Adductor pollicis: 5 to 30 Units; (1 injection site per muscle)
-Flexor pollicis brevis/Opponens pollicis: 5 to 30 Units; (1 injection site per muscle)

Comments:
-Maximum total recommended dose: Up to 400 Units per treatment session
-Repeat treatment should be no more frequent than every 12 weeks; most patients in clinical trials were retreated between 12 and 14 weeks.

Use: For the treatment of upper limb spasticity

Usual Adult Dose for Cervical Dystonia

Individualize dose based on number and location of muscles to be treated, degree of spasticity/dystonia, muscle mass, body weight, and response to any previous treatment

Initial total dose: 120 Units
-Injections are 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

Comments:
-In a study of initial doses of 120 or 240 Units, no meaningful difference in effectiveness was demonstrated between the doses.
-Frequency of repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Use: For the treatment of adults with cervical dystonia in both botulinum toxin-naive and previously treated patients.

Usual Adult Dose for Blepharospasm

Initial dose: Same as previous dose of onabotulinumtoxinA
-If previous dose is unknown, initial dose should be between 1.25 and 2.5 Units per injection site
Total initial dose should not exceed 70 Units (35 Units/eye)
-Frequency of repeat treatments should be determined by clinical response, but generally no more frequent than every 12 weeks
Subsequent doses should be based on response, up to a maximum of 35 Units/eye

Comments:
-Dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA.
-In clinical trials, patients received the same number of incobotulinumtoxinA Units as they had received with onabotulinumtoxinA; mean dose per eye was about 33 Units (range 10 to 50 Units) and mean number of injections/eye was 6. Maximum dose per eye was 50 Units, with a range of 10 to 50 Units; few patients received a total dose of greater than 75 Units.
-Response to incobotulinumtoxinA and onabotulinumtoxinA may differ in individual patients.

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

Usual Adult Dose for Glabellar Lines

20 Units per treatment session divided into 5 equal IM injections of 4 Units each:
-Two injections in each corrugator muscle
-One injection in the procerus muscle

Retreatment should be 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: DISTANT SPREAD OF TOXIN EFFECT
-Postmarketing reports indicate the effects of this drug and all botulinum toxin effects may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These 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, and there have been reports of death. The risk is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, particularly those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

CONTRAINDICATIONS:
-Hypersensitivity to any botulinum neurotoxin or any product excipients
-Infection at the proposed injection sites

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:
-For intramuscular or intra-salivary gland injection only
-Maximum cumulative dose for any indication should not exceed 400 Units in a treatment session.
-Safe and effective use depends upon selection of the correct dose, dilution, and proper administration techniques; see product labeling for indication specific administration recommendations.
-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.

Storage requirements:
-Unopened vials: May be stored at room temperature, refrigerated, or in freezer; do not use after expiration date on label
-Once reconstituted, store in refrigerator at 2 to 8 degrees C (36 to 46 degrees F) and use within 24 hours; discard unused portion
-Vials should be used for 1 injection session and 1 patient only

General:
-Potency Units of incobotulinumtoxinA are specific to preparation and assay method utilized; botulinum toxins are not interchangeable.
-When initiating treatment, the lowest recommended dose should be used.
-Standard electromyographic techniques are required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia.
-Median onset of effect occurs within 7 days of injection; typical duration is up to 3 months, although the effect may last significantly longer, or shorter in individual patients.

Monitoring:
-Monitor for distant spread of toxin

Patient advice:
-Read the US FDA-approved patient labeling (Medication Guide).
-Patients and caregivers should be instructed to inform their healthcare provider if they develop any unusual symptoms or if any existing symptoms worsen; they should be instructed to seek immediate medical attention if they have trouble swallowing, speaking, or breathing.
-Patients experiencing loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids should avoid engaging in potentially hazardous activities including driving.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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