Medication Monitor

Generic Name (Trade Name—Company)
September 20, 2019

Rimabotulinumtoxin B

(Myobloc—US WorldMeds)
FDA approves botulinum toxin injection for chronic drooling

FDA approved rimabotulinumtoxinB, an acetylcholine release inhibitor, to treat chronic sialorrhea (drooling) in adults, which is a common and often problematic symptom of many neurological disorders (e.g., Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy, stroke, and other condition).

It is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as 1 week, stated the manufacturer in a news release, and one treatment significantly decreases symptoms of sialorrhea for up to 3 months.

The recommended dosage is 1,500 units to 3,500 units; 500 units to 1,500 units per parotid gland and 250 units per submandibular gland, no more frequently than every 12 weeks. The botulinum toxin injection must be administered by a licensed health care provider and requires no reconstitution.

Common adverse effects include dry mouth and dysphagia.

The drug is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, or in those with infection at the proposed injection site(s).

A boxed warning cites the risk of spreading from the injection area to produce symptoms consistent with botulinum toxin effects hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk is greatest in children treated for spasticity, but symptoms can also occur in adults, particularly in patients with a predisposing underlying condition.