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DYSPORT
Aesthetic medicine
Muscle spasms
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Drug Name:

DYSPORT Rx

Generic Name and Formulations:
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).

Company:
Ipsen Biopharmaceuticals, Inc.

Therapeutic Use:

Indications for DYSPORT:

Temporary improvement in the appearance of moderate-to-severe glabellar lines associated with procerus and corrugator muscle activity in adults <65yrs.

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.

Contraindications:

Cow's milk protein allergy. Infection at proposed inj site.

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. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

Muscular weakness, dysphagia, dry mouth, inj site pain/discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, eye disorders, upper RTI, UTI, nasopharyngitis, dizziness, fall, depression.

Generic Availability:

NO

How Supplied:

Single-use vial (300 Units)—1; (500 Units)—1, 2

Indications for DYSPORT:

Treatment of spasticity in patients ≥18yrs. Cervical dystonia in patients ≥18yrs. Lower limb spasticity in children ≥2yrs.

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. Upper limb spasticity, cervical dystonia: <18yrs: not established. Lower limb spasticity: <2yrs: not established. Individualize; see full labeling. ≥2yrs: usually 10–15 Units/kg total for unilateral inj or 20–30 Units/kg total for bilateral inj divided between the affected muscles per treatment session; max 0.5mL/site. Total dose per treatment session: 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.

Contraindications:

Cow's milk protein allergy. Infection at proposed inj site.

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. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

Muscular weakness, dysphagia, dry mouth, inj site pain/discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, eye disorders, upper RTI, UTI, nasopharyngitis, dizziness, fall, depression.

Generic Availability:

NO

How Supplied:

Single-use vial (300 Units)—1; (500 Units)—1, 2

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