Bloxiverz® is a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Approved in 2013, Bloxiverz® was the first FDA-approved version of neostigmine methylsulfate. Today, neostigmine is the most frequently used product for the reversal of the effects of other agents used for neuromuscular blocks.
Important Safety Information
INDICATIONS AND USAGE
BLOXIVERZ® (Neostigmine Methylsulfate Injection), a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.
DOSAGE AND ADMINISTRATION
- Should be administered by trained healthcare providers
Peripheral nerve stimulator and monitoring for twitch responses should
be used to determine when BLOXIVERZ® should be initiated and if additional doses are needed
- For reversal of NMBAs with shorter half-lives, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present: 0.03 mg/kg by intravenous route
- For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline: 0.07 mg/kg by intravenous route
- Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever is less)
- An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with BLOXIVERZ®
- Hypersensitivity to neostigmine
- Peritonitis or mechanical obstruction of the intestinal or urinary tract
WARNINGS AND PRECAUTIONS
- Bradycardia: Atropine or glycopyrrolate should be administered prior to BLOXIVERZ® to lessen risk of bradycardia.
- Serious Reactions with Coexisting Conditions: Use with caution in patients with, coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis.
- Neuromuscular Dysfunction: Can occur if large doses of BLOXIVERZ® are administered when neuromuscular blockade is minimal; reduce dose if recovery from neuromuscular blockade is nearly complete.
Most common adverse reactions during treatment: bradycardia, nausea and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel Legacy Pharmaceuticals, LLC at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.1216-A BLX HCP ISI