Bridion (sugammadex)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2015

Specific Treatments:

reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery

Therapeutic Areas

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General Information

Bridion (sugammadex) is a modified gamma cyclodextrin.

Bridion is specifically indicated for the reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery.

Bridion is supplied as an injection for intravenous administration. Monitor for twitch responses to determine the timing and dose for Bridion administration. The recommended dose is as follows:

For rocuronium and vecuronium:

  • 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation.
  • 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation.

For rocuronium only:

  • 16 mg/kg is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. 

Clinical Results

FDA Approval

The FDA approval of Bridion was based on the following studies:

Comparative Study of Bridion versus Neostigmine as a Reversal Agent for Neuromuscular Blockade Induced by Rocuronium or Vecuronium at Reappearance of T2 (Moderate Blockade):

A multicenter, randomized, parallel-group, active-controlled, safety-assessor blinded study comparing Bridion and neostigmine enrolled 189 subjects. The subjects were randomly assigned to the rocuronium or vecuronium group and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. At the reappearance of T2, after the last dose of rocuronium or vecuronium, 2 mg/kg Bridion or 50 mcg/kg neostigmine was administered in a randomized order as a single bolus injection. The time from start of administration of Bridion or neostigmine to recovery of the TOF (T4/T1) ratio to 0.9 was assessed. Generally, a T4/T1 ratio ≥0.9 correlates with recovery from neuromuscular blockade. Return of the T4/T1 ratio to 0.9 after the reappearance of T2 was overall faster with Bridion 2 mg/kg as compared to neostigmine 50 mcg/kg in the setting of rocuronium or vecuronium-induced neuromuscular blockade.

Comparative Study of Bridion versus Neostigmine as a Reversal Agent for Neuromuscular Blockade Induced by Rocuronium or Vecuronium at 1 to 2 PTCs (Deep Blockade)

One hundred fifty-seven patients were evaluated in a phase 3, multicenter, randomized, parallel-group, active-controlled safety assessor-blinded clinical study. In the study, patients received either rocuronium or vecuronium and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. At 1-2 PTCs (deep block), after the last dose of rocuronium or vecuronium, 4 mg/kg Bridion or 70 mcg/kg neostigmine was administered. The time from the start of administration of Bridion  or neostigmine to recovery of the train-of-four (T4/T1) ratio of 0.9 was assessed. Generally, a T4/T1 ratio ≥0.9 correlates with recovery from neuromuscular blockade. Neostigmine was not expected to reverse neuromuscular blockade at a depth of 1-2 PTCs. The subjects treated with Bridion achieved rapid recovery of neuromuscular function from rocuronium-induced (n=37) deep block (1-2 PTCs) in a median time of 2.7 minutes with a 25th and 75th percentiles of 2.1 and 4.3 minutes respectively, and from vecuronium-induced (n=47) deep block in a median time of 3.3 minutes with a 25th and 75th percentiles of 2.3 and 6.6 minutes, respectively. There were 7 and 6 censored observations in the rocuronium and vecuronium groups, respectively.

Side Effects

Adverse effects associated with the use of Bridion may include, but are not limited to, the following:

  • vomiting
  • pain
  • nausea
  • hypotension
  • headache

Mechanism of Action

Bridion (sugammadex) is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

Additional Information

For additional information regarding Bridion or the reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery, please visit http://www.merck.com/