Select therapeutic use:

Aesthetic medicine:

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 Dosage:

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 Dosage:

<18yrs: not recommended.

DYSPORT Contraindications:

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

Boxed Warning:

Distant spread of toxin effect.

DYSPORT 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 Classification:

Neuromuscular blocker.

DYSPORT 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.

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.

Generic Drug Availability:

NO

How Supplied:

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

Muscle spasms:

Indications for: DYSPORT

Cervical dystonia in adults. Spasticity in patients ≥2yrs.

Adult Dosage:

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 Dosage:

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:

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

Boxed Warning:

Distant spread of toxin effect.

DYSPORT 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 Classification:

Neuromuscular blocker.

DYSPORT 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.

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.

Generic Drug Availability:

NO

How Supplied:

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