DAXIBOTULINUMTOXINA-LANM INJ,LYPHL

Clinical Criteria Summary

Hypersensitivity to botulinum toxins or any components in the formulation (e.g., human serum albumin, lactose, sucrose, disodium succinate)
Co-administration with neuromuscular blockade
Neurologic condition where botulinum toxins pose risk for additive neuromuscular compromise (e.g., myasthenia gravis, amyotrophic lateral sclerosis), unless risks/benefits have been discussed with the patient and documented in the medical record
Use for cosmetic purposes

Cervical dystonia or focal dystonia
Blepharospasm or hemifacial spasm
Severe focal hyperhidrosis with inadequate response or unmanageable intolerance to prescription topical therapy (e.g., aluminum chloride hexahydrate 20% topical solution)
Upper or lower limb spasticity
Overactive bladder or neurogenic bladder dysfunction with contraindication, intolerance, or inefficacy to behavioral therapy and at least one pharmacotherapy (e.g., antimuscarinic agent, beta-3 adrenergic agonist)
Chronic migraine prevention with contraindication, intolerance, or lack of therapeutic response after at least 12 weeks each of a therapeutic dose of at least 2 of the following: beta blocker, topiramate, divalproex, and ACE inhibitor or ARB
Pharyngoesophageal segment spasm (PES)
Sialorrhea with contraindication, intolerance, or lack of therapeutic response to anticholinergics and/or speech therapy
Chronic anal fissure refractory to conservative treatment including supportive measures (e.g., dietary fiber, sitz bath) and topical vasodilator (e.g., topical nitrates)
Esophageal achalasia if patient is not a candidate for surgery
Idiopathic (primary or genetic) or symptomatic (acquired) torsion dystonia

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