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Dysport

BOTULINUM TOXIN TYPE A

Manufacturer: Galderma Laboratories, L.P.

Score: 148.0

Quick Summary

Dysport (abobotulinumtoxinA) is a neurotoxin indicated for the treatment of cervical dystonia in adults, temporary improvement in the appearance of moderate to severe glabellar lines in adults under 65, and spasticity in patients 2 years of age and older. The primary mechanism of action is the inhibition of acetylcholine release from peripheral cholinergic nerve endings, resulting in a decrease in muscle activity. Key clinical findings include efficacy in reducing symptoms of cervical dystonia, glabellar lines, and spasticity. Important safety information includes warnings about distant spread of toxin effect, lack of interchangeability with other botulinum toxin products, and potential for hypersensitivity reactions. Main dosing recommendations vary by indication and include initial doses and titration schedules. Special population considerations include use during pregnancy, nursing, pediatric, and geriatric populations, with specific guidance for each group.

Key Clinical Findings and Indications

  • Treatment of cervical dystonia in adults
  • Temporary improvement in the appearance of moderate to severe glabellar lines in adults under 65
  • Treatment of spasticity in patients 2 years of age and older

Important Safety Information

Warning

Distant spread of toxin effect can occur, causing symptoms such as asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties

Contraindications

  • Known hypersensitivity to any botulinum toxin products or cow's milk protein
  • Infection at the proposed injection site(s)

Adverse Reactions

  • Muscular weakness
  • Dysphagia
  • Dry mouth
  • Injection site discomfort
  • Fatigue
  • Headache
  • Musculoskeletal pain
  • Dysphonia
  • Injection site pain
  • Eye disorders

Dosing Recommendations

General Guidance

Dose adjustment may be necessary based on individual patient response and adverse reaction history

Cervical dystonia

Adult Dose

500 Units given intramuscularly as a divided dose among affected muscles

Pediatric Dose

Not established

Glabellar lines

Adult Dose

50 Units divided in five equal aliquots of 10 Units each

Pediatric Dose

Not recommended

Spasticity

Adult Dose

500-1000 Units for upper limb spasticity, 1000-1500 Units for lower limb spasticity

Pediatric Dose

8-16 Units/kg for upper limb spasticity, 10-15 Units/kg for lower limb spasticity

Special Population Considerations

Pregnancy

  • Use only if potential benefit justifies potential risk to fetus
  • Embryo-fetal toxicity observed in animal studies

Nursing Mothers

  • No data available on presence of Dysport in human or animal milk
  • Caution advised when administering to nursing mothers

Pediatric Use

  • Safety and effectiveness established in patients 2 years of age and older for spasticity
  • Not recommended for use in pediatric patients less than 18 years of age for glabellar lines
  • Not established for cervical dystonia in pediatric patients

Geriatric Use

  • No specific studies conducted in geriatric population
  • Caution advised when administering to geriatric patients