BETHESDA, MD 16 Dec 2015—FDA on December 15 announced the approval of sugammadex, or Bridion, for reversal of the neuromuscular blockade induced by rocuronium or vecuronium in adults who received either neuromuscular blocking agent (NMBA) during surgery.
Sugammadex, its labeling (PDF) states, is a cyclodextrin that forms a complex with rocuronium or vecuronium. Formation of this complex reduces the amount of rocuronium or vecuronium that can bind to nicotinic cholinergic receptors in the neuromuscular junction.
The labeling for sugammadex recommends a single 2- or 4-mg/kg bolus injection of the reversal agent, with the timing and dose dependent on the patient's response to train-of-four stimulation.
A 16-mg/kg bolus injection is an option only if the patient received a single 1.2-mg/kg dose of rocuronium and the clinical need for reversal of neuromuscular blockade arises within about three minutes after administration of the NMBA.
All recommended doses of sugammadex are based on actual body weight, the labeling states.
The three controlled clinical studies described in the labeling for sugammadex involved adults, mostly white, who underwent elective surgical procedures under general anesthesia.
There is a statement in the labeling declaring that the drug has not been studied for neuromuscular blockade reversal after administration of rocuronium or vecuronium in the intensive care unit.
There are also statements in the labeling telling healthcare providers not to use sugammadex to reverse the blockade induced by nonsteroidal NMBAs, such as succinylcholine, or by steroidal NMBAs other than rocuronium or vecuronium.
Rocuronium and vecuronium are aminosteroids whose labeling describes them as having an intermediate duration of action.
FDA said the most common adverse reactions to sugammadex in the clinical studies were vomiting, hypotension, pain, headache, and nausea.
Potentially serious hypersensitivity reactions, such as anaphylaxis, have occurred in sugammadex-treated patients, the labeling states. Known hypersensitivity to sugammadex is a contraindication to use of the drug.
Sugammadex can bind to progestogen. The labeling advises healthcare providers to tell female users of hormonal contraceptives who have received a dose of sugammadex to also use a nonhormonal method of contraception for the next seven days.
Merck Sharp & Dohme Corp. will supply Bridion in single-dose vials containing 2 or 5 mL of sugammadex 100 mg/mL, 10 vials to a box.
The vials should be stored at 25 °C and protected from light. Sugammadex injection is colorless to slightly yellow–brown. If not protected from light, the vials should be used within five days.
Bridion, according to a spokeswoman for Merck & Co. Inc., parent company of Merck Sharp & Dohme Corp., is expected to be commercially available in January.