Dysport (abobotulinumtoxinA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
AbobotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release at peripheral cholinergic and ganglionic autonomic nerve terminals.
AbobotulinumtoxinA is a purified type A botulinum neurotoxin complex produced by fermentation of Clostridium botulinum, a gram-positive bacillus found naturally in soil. AbobotulinumtoxinA is produced from fermentation of Clostridium botulinum type A (Hall strain) using specific methods of purification, stabilization, and formulation. Commercially available botulinum toxin type A preparations differ in molecular size, pharmacologic properties, dosing requirements, and adverse effect profile, and therefore are not interchangeable.
AbobotulinumtoxinA disrupts neurotransmission by inhibiting release of acetylcholine at peripheral cholinergic nerve terminals, inducing a chemical denervation and reduction of muscle activity. The neurotoxic effects of abobotulinumtoxinA occur in 3 phases: binding, internalization, and inhibition of acetylcholine from nerve terminals resulting in neuromuscular blockade. Following initial binding of the heavy chain of botulinum toxin A to specific membrane receptors on the neuronal cell surface, the toxin is internalized by receptor-mediated endocytosis.
The light chain of botulinum toxin undergoes pH-dependent translocation into the cytosol where it cleaves the synaptosome-associated protein of 25 kD (SNAP-25), preventing exocytosis of acetylcholine into the neuromuscular junction. Recovery of neuromuscular activity occurs gradually through regeneration of nerve endings and recovery from SNAP-25 cleavage.
Some evidence suggests that botulinum toxin type A also may have a direct analgesic effect through modulation of certain peptide neurotransmitters.
AbobotulinumtoxinA is not detectable in peripheral circulation following IM administration using currently available analytical technology. Weakness or paralysis of adjacent or distant muscles may occur as a result of toxin diffusion.
AbobotulinumtoxinA is used for the treatment of cervical dystonia, for temporary improvement in the appearance of moderate to severe glabellar facial lines associated with corrugator and/or procerus muscle activity, and for the treatment of spasticity. Currently, there are several botulinum toxin type A preparations and one botulinum toxin type B preparation commercially available in the US. The potency units of each botulinum toxin is specific to the individual manufacturer and/or preparation, and thus are not interchangeable with other botulinum toxin preparations.
Generic name: abobotulinumtoxinA
Pronunciation: (BOT-ue-LYE-num)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Dysport
Indications
The following indications are listed for Dysport:
- Cerebral Palsy-Associated Limb Spasticity
- Glabellar Lines
- Lower Limb Spasticity
- Spasmodic Torticollis
- Upper Limb Spasticity
Also known as: Brow Furrow, Cervical Dystonia, Dystonia Of Neck Muscles, Dystonic Torticollis, Lower Limb Muscle Spasticity, Rhytides Of Glabellar Skin, Rotatory Spasm, Rotatory Tic, Upper Limb Muscle Spasticity.
Dosing
Potency of abobotulinumtoxinA is expressed in units of biologic activity; each unit is equivalent to the median intraperitoneal lethal dose (LD50) in mice. Units of biologic activity of abobotulinumtoxinA cannot be compared with or converted to units of other botulinum toxin preparations.
Dosage of abobotulinumtoxinA should be carefully individualized according to patient response and the particular condition being treated. The recommended dosage and frequency of abobotulinumtoxinA should not be exceeded; excessive and/or unintended neuromuscular weakness may occur if higher than recommended dosages are given. Whenever possible, the minimum effective dose should be used to reduce the risk of adverse effects.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies with abobotulinumtoxinA have been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to any botulinum toxin preparation or any ingredient in their formulations.
*Known hypersensitivity to cow milk protein.
*Infection at proposed injection site(s).
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in at least 5% of adult patients receiving 500 units of abobotulinumtoxinA for the treatment of cervical dystonia (and more frequently than with placebo) in clinical trials included muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, and eye disorders (blurred vision, diplopia, reduced visual acuity and accommodation).
Adverse effects reported in at least 2% of adult patients receiving abobotulinumtoxinA for cosmetic improvement of glabellar facial lines in placebo-controlled clinical trials included nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, ptosis, sinusitis, nausea, and hematuria. No evidence of cumulative adverse effects has been observed with repeated administration of abobotulinumtoxinA (with at least 85 days between treatments).
The most common adverse effect reported in at least 4% of adults receiving abobotulinumtoxinA for the treatment of upper limb spasticity was muscular weakness. The most common adverse effects reported in at least 5% of adults receiving abobotulinumtoxinA for the treatment of lower limb spasticity were falls, muscular weakness, and pain in extremity.
The most common adverse effects reported in at least 10% of pediatric patients receiving abobotulinumtoxinA for the treatment of upper limb spasticity were upper respiratory tract infection and pharyngitis.
The most common adverse effects reported in at least 10% of pediatric patients receiving abobotulinumtoxinA for the treatment of lower limb spasticity were nasopharyngitis, cough, and pyrexia.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of abobotulinumtoxinA for the treatment of cervical dystonia have not been established in pediatric patients younger than 18 years of age.
Safety and efficacy of abobotulinumtoxinA for the treatment of upper and lower limb spasticity have been established in pediatric patients 2 years of age and older. Safety and efficacy of abobotulinumtoxinA injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients have not been established.
The manufacturer states that use of abobotulinumtoxinA is not recommended for cosmetic improvement of glabellar facial lines in pediatric patients younger than 18 years of age.
There are no adequate and well-controlled clinical studies of abobotulinumtoxinA in pregnant women. In animal reproductive studies, embryofetal toxic effects (e.g., early embryonic death, stillbirth) in relation to maternal toxicity were observed in rats and rabbits treated with abobotulinumtoxinA at dosages lower than or similar to the maximum recommended human dose. AbobotulinumtoxinA should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Data on the presence of abobotulinumtoxinA in human milk, the effects on the breastfed infant, or the effects of the drug on milk production are lacking. The benefits of breastfeeding should be considered along with the mother's clinical need for abobotulinumtoxinA and any potential adverse effects on the breastfed infant from abobotulinumtoxinA or from the underlying maternal condition.
Clinical studies of abobotulinumtoxinA in patients with cervical dystonia did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In general, dosage should be selected cautiously in geriatric patients, usually initiating therapy at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.
A higher incidence of adverse ocular effects (except ptosis) has been observed in geriatric individuals receiving abobotulinumtoxinA for cosmesis compared with younger adults (11 versus 5%). In clinical studies of abobotulinumtoxinA in individuals with glabellar facial lines, 1% of individuals enrolled were 65 years of age or older; treatment success was not achieved in any of these individuals. AbobotulinumtoxinA is not indicated for use in individuals 65 years of age or older for cosmetic improvement of glabellar lines.
In clinical studies evaluating abobotulinumtoxinA for the treatment of upper limb spasticity, 30% of patients were 65 years of age and older, while 8% of patients were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
In clinical studies evaluating abobotulinumtoxinA for the treatment of lower limb spasticity, 18% of patients were 65 years of age and older, while 3% of patients were 75 years of age and older. A higher incidence of adverse effects has been observed in geriatric individuals receiving abobotulinumtoxinA for lower limb spasticity compared with that in younger adults (46 versus 39%). Fall and asthenia occurred more frequently in older patients (65 years of age or older) as compared with younger patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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