DAXIBOTULINUMTOXINA-LANM INJ,LYPHL

Clinical Criteria Summary

125 to 250 Units intramuscularly (IM) among affected muscles
Administered no more frequently than every 3 months
Available as sterile lyophilized powder in single-dose vials (50 Units or 100 Units)

Known hypersensitivity to botulinum toxins or any other component in the formulation
Infection at the injection site
Boxed Warning: Distant spread of toxin may occur; symptoms can range from difficulty swallowing or breathing to death, with risk increased by certain underlying conditions
Cardiovascular system adverse events (e.g., arrhythmia, myocardial infarction); use caution in patients with pre-existing cardiovascular disease
Neuromuscular compromise: Increased risk of muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis)

Most common adverse events: Headache, dysphagia, injection site erythema or bruising, injection site pain, and muscular weakness
Additive neuromuscular blocking effect may occur with concurrent use of aminoglycosides, anticholinergic drugs, muscle relaxants, or other agents interfering with neuromuscular transmission

First-line option for the treatment of CD per American Academy of Neurology (AAN) 2016 practice guideline
Insufficient evidence to support that any one botulinum toxin is more efficacious than another for CD
No established unit-to-unit conversion from daxibotulinumtoxinA to other botulinum toxins
Treatment effect may last longer than 12 weeks, though 20–36% of patients requested retreatment prior to the defined "loss of effect" point