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Dysport Generic Name & Formulations
Legal Class
Rx
General Description
AbobotulinumtoxinA 300 Units, 500 Units; per vial; lyophilized pwd for IM inj after reconstitution; contains human albumin, lactose. May contain cow's milk proteins (trace amounts).
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial (300 Units)—1; (500 Units)—1, 2
Manufacturer
Generic Availability
NO
Dysport Indications
Indications
Temporary improvement in the appearance of moderate-to-severe glabellar lines associated with procerus and corrugator muscle activity in adults <65yrs.
Dysport Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Give by IM inj a total of 50 Units divided in 5 equal aliquots of 10 Units each to affected muscles to achieve clinical effect. May repeat treatment no more than every 3 months.
Children
<18yrs: not recommended.
Dysport Contraindications
Contraindications
Cow's milk protein allergy. Infection at proposed inj site.
Dysport Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Dysport Warnings/Precautions
Warnings/Precautions
Risk of distant spread of toxin effect esp. in children. Not interchangeable with other botulinum toxin products. Pre-existing dysphagia or breathing difficulties. Compromised respiratory status. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Consider referral to ophthalmologist if dry eye symptoms persist. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Dysport Pharmacokinetics
See Literature
Dysport Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Dysport Adverse Reactions
Adverse Reactions
Muscular weakness, dysphagia, dry mouth, inj site pain/discomfort, fatigue, headache, musculoskeletal pain, dysphonia, eye disorders, nasopharyngitis, upper RTI, sinusitis, nausea, hematuria, falls, pain in extremity; severe hypersensitivity reactions (discontinue if occur). In children: also pharyngitis, cough, pyrexia.
Dysport Clinical Trials
See Literature
Dysport Note
Not Applicable
Dysport Patient Counseling
See Literature
Dysport Generic Name & Formulations
Legal Class
Rx
General Description
AbobotulinumtoxinA 300 Units, 500 Units; per vial; lyophilized pwd for IM inj after reconstitution; contains human albumin, lactose. May contain cow's milk proteins (trace amounts).
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial (300 Units)—1; (500 Units)—1, 2
Manufacturer
Generic Availability
NO
Dysport Indications
Indications
Cervical dystonia in adults. Spasticity in patients ≥2yrs.
Dysport Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Individualize; see full labeling. Spasticity: usual range: 500–1000 Units (upper limb) or 1000–1500 Units (lower limb) divided among selected muscles per treatment session; max 1mL/site. Total max 1500 Units for upper and lower limb combined. May repeat treatment after effect of the previous injection diminishes, but no sooner than 12 weeks. Cervical dystonia: initially 500 Units divided among affected muscles. May adjust dose in 250 Unit steps based on response; max 1000 Units/dose. May repeat treatment no sooner than 12 weeks.
Children
Should be administered and managed by experienced physicians. Cervical dystonia: <18yrs: not established. Spasticity: <2yrs: not established. Max total dose per treatment session (combined): 30 Units/kg or 1000 Units in a 3-month interval. Individualize; see full labeling. ≥2yrs: Upper limb: usually 8–16 Units/kg divided among selected muscles per treatment session; max 0.5mL/site. Total dose per treatment session: max 16 Units/kg or 640 Units, whichever is lower. May repeat treatment after effect of the previous injection diminishes, but no sooner than 16 weeks. Lower limb: usually 10–15 Units/kg total for unilateral inj or 20–30 Units/kg total for bilateral inj divided among selected muscles per treatment session; max 0.5mL/site. Total dose per treatment session (3-month interval): max 15 Units/kg for unilateral inj, 30 Units/kg for bilateral inj, or 1000 Units, whichever is lower. May repeat treatment after effect of the previous injection diminishes, but no sooner than 12 weeks.
Dysport Contraindications
Contraindications
Cow's milk protein allergy. Infection at proposed inj site.
Dysport Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Dysport Warnings/Precautions
Warnings/Precautions
Risk of distant spread of toxin effect esp. in children. Not interchangeable with other botulinum toxin products. Pre-existing dysphagia or breathing difficulties. Compromised respiratory status. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Consider referral to ophthalmologist if dry eye symptoms persist. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Dysport Pharmacokinetics
See Literature
Dysport Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Dysport Adverse Reactions
Adverse Reactions
Muscular weakness, dysphagia, dry mouth, inj site pain/discomfort, fatigue, headache, musculoskeletal pain, dysphonia, eye disorders, nasopharyngitis, upper RTI, sinusitis, nausea, hematuria, falls, pain in extremity; severe hypersensitivity reactions (discontinue if occur). In children: also pharyngitis, cough, pyrexia.
Dysport Clinical Trials
See Literature
Dysport Note
Not Applicable
Dysport Patient Counseling
See Literature
