Applies to the following strengths: 500 units; 300 units
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Cervical Dystonia
500 units IM given as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin
Below is a description of the average dose, as well as the minimum and maximum dose injected into specific muscles in the pivotal clinical trials:
MUSCLE: MEDIAN DOSE (MINIMUM & MAXIMUM DOSE):
-Sternocleidomastoid: 125 Units (50, 350)
-Splenius capitis: 200 Units (75, 450)
-Trapezius: 102.6 Units (50, 300)
-Levator scapulae: 105.3 Units (50, 200)
-Semispinalis capitis: 131.6 Units (50, 250)
-Longissimus: 150 Units (100, 200)
-Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
-Studies with this drug in cervical dystonia suggest that the peak effect occurs between 2 and 4 weeks after injection.
-Simultaneous EMG-guided application of this drug may be helpful in locating active muscles not identified by physical examination alone.
-Where dose modification is necessary for the treatment of cervical dystonia, studies suggest that dose adjustment can be made in 250 unit steps according to the individual patient's response, with retreatment every 12 weeks or longer, based on return of clinical symptoms. Studies also suggest that the total dose administered in a single treatment should be between 250 units and 1000 units.
-Retreatment, if needed, should not occur in intervals of less than 12 weeks.
-Doses above 1000 Units have not been evaluated.
-The starting dose of 500 units recommended for cervical dystonia is applicable to adults of all ages.
Use: For the treatment of adults with cervical dystonia
Usual Adult Dose for Glabellar Lines
50 units divided into 5 equal aliquots of 10 units each, should be administered to affected muscles to achieve clinical effect
-The clinical effect of this drug may last up to 4 months.
-Repeat dose studies demonstrated continued efficacy with up to 4 repeated administrations.
-This drug should be administered no more frequently than every 3 months. -When used for re-treatment, this drug should be reconstituted and injected using the same techniques as the initial treatment.
Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age
Usual Adult Dose for Upper Limb Spasticity
Dosing in initial and subsequent treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient response to previous treatment, and/or adverse event history with this drug.
IN A CLINICAL TRIAL, DOSES OF 500 UNITS AND 1000 UNITS WERE DIVIDED AMONG SELECTED MUSCLES, AS SHOWN BELOW:
MUSCLES INJECTED/RECOMMENDED DOSE/RECOMMENDED NUMBER OF INJECTIONS PER MUSCLE:
-Flexor carpi radialis (FCR)/ 100 to 200 Units/1 to 2 injections
-Flexor carpi ulnaris (FCU)/ 100 to 200 Units/1 to 2 injections
-Flexor digitorum profundus (FDP)/100 to 200 Units/1 to 2 injections
-Flexor digitorum superficialis (FDS)/100 to 200 Units/1 to 2 injections
-Brachialis/200 to 400 Units/1 to 2 injections
-Brachioradialis/100 to 200 Units/1 to 2 injections
-Biceps Brachii (BB)/200 to 400 Units/1 to 2 injections
-Pronator Teres/100 to 200 Units/1 injection
-No more than 1 mL should generally be administered at any single injection site.
-Repeat treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.
-A majority of patients in clinical studies were retreated between 12 and 16 weeks; however some patients had a longer duration of response (i.e., 20 weeks). -The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose and muscles to be injected.
-Improvement may be expected one week after administration.
Use: For the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
US BOXED WARNING:
Distant Spread of Toxin Effect:
-Postmarketing reports indicate that the effects of this drug and all botulinum toxin products 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 of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in 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 or lower than the maximum recommended total dose.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age) for any indication.
Consult WARNINGS section for additional precautions.
Data not available
-During treatment of strabismus, the dosage of this drug should be administered with electromyographic guidance.
-During treatment of blepharospasm, avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues and can be prevented by applying pressure at the injection site immediately after the injection.
-This drug is contraindicated in the presence of infection at the proposed injection site. Caution is advised if it is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscles.
-Dysphagia is a commonly reported adverse event following treatment of cervical dystonia with all botulinum toxins. Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech or respiratory difficulties occur
Once reconstituted, this drug should be stored in the original container in the refrigerator (2 to 8 degrees C), protected from light, and used within 4 hours.
This drug has reconstitution instructions specific for the 300 Unit and 500 Unit vials.
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- Drug class: skeletal muscle relaxants
Other brands: Dysport