INCOBOTULINUMTOXINA INJ,LYPHL
Clinical Criteria Summary
Exclusion Criteria
- 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
Inclusion Criteria (Indications)
- 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