Dysport

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine
  • Muscle spasms
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Ipsen Biopharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    AbobotulinumtoxinA inhibits the release of the neurotransmitter, acetylcholine, from peripheral cholinergic nerve endings.

    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. Pre-existing conditions at the inj site (eg, excessive weakness, atrophy). In glabellar lines treatment: surgical alterations to the facial anatomy, marked facial asymmetry, inflammation at the inj site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart. Do not exceed the recommended dosage and frequency. 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

    Ipsen Biopharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    AbobotulinumtoxinA inhibits the release of the neurotransmitter, acetylcholine, from peripheral cholinergic nerve endings.

    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. Pre-existing conditions at the inj site (eg, excessive weakness, atrophy). In glabellar lines treatment: surgical alterations to the facial anatomy, marked facial asymmetry, inflammation at the inj site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart. Do not exceed the recommended dosage and frequency. 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

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