Bridion - sugammadex

What is Bridion?

Bridion is a solution for injection that contains the active substance sugammadex (100 mg / ml).

What is Bridion used for?

Bridion is used to reverse the effect of rocuronium and vecuronium, two muscle relaxants (substances that cause muscle relaxation). Muscle relaxants are drugs used during certain types of surgery to obtain relaxation of the muscles, including those dedicated to breathing. Muscle relaxants help the surgeon during the operation. Bridion is used, usually at the end of the operation, to accelerate recovery by canceling the effect of the muscle relaxant.

Bridion can be used in adults given rocuronium and vecuronium and in children and adolescents given rocuronium.

The medicine can only be obtained with a prescription.

How is Bridion used?

Bridion can only be administered by the anesthesiologist or under his control. Administration is by single injection of an intravenous bolus (ie a single administration into a vein). The standard dose of Bridion is between 2 and 4 mg per kilogram of body weight, depending on the effect produced by the muscle relaxant on the muscles.

A dose of 16 mg / kg can be used to obtain a rapid recovery. This eventuality may be necessary if the patient must be able to resume breathing independently during the operation. The use of this dose is expected only in a limited number of cases (less than 1%).

In children and adolescents the recommended dose is 2 mg / kg body weight. Bridion is not recommended in children and adolescents for recovery after using vecuronium or for rapid recovery after use of any muscle relaxant, as its use has not been studied in such situations. The use of Bridion is not recommended in children under two years of age due to insufficient data on safety and efficacy for this age group.

The use of Bridion is not recommended in patients with severe kidney problems. It should also be used with extreme caution in patients with severe liver problems.

How does Bridion work?

The active ingredient in Bridion, sugammadex, is a "selective antagonist of muscle relaxants". This means that the drug binds to the muscle relaxants rocuronium and vecuronium forming a "complex" that inactivates them and interrupts their effect. Consequently the muscle block induced by rocuronium and vecuronium is reversed and the muscles regain normal function, and among these also the muscles responsible for breathing.

How has Bridion been studied?

The effects of Bridion were first tested in experimental models before being studied in humans.

Bridion has been the subject of four main studies involving a total of 579 adults undergoing surgery in which muscle relaxants were used.

Two studies involving a total of 282 patients examined the efficacy of 2 mg / kg of Bridion in reversing moderate muscle relaxation induced by rocuronium or vecuronium. Bridion was compared to neostigmine (another drug used to block the effect of muscle relaxants) administered after rocuronium or vecuronium in the first study, and after cis-atracurium (another muscle relaxant), in the second. The third study compared the effectiveness of 4 mg / kg of Bridion on 182 patients compared to neostigmine after a deep muscle relaxation obtained with rocuronium or vecuronium.

The fourth study, which involved 115 patients, examined the effectiveness of 16 mg / kg of Bridion in producing a rapid reversal of muscle relaxation achieved with rocuronium. This effect was compared to spontaneous recovery after succinylcholine-induced muscle relaxation (another muscle relaxant).

A further study examined the efficacy of Bridion administered after rocuronium in 90 children and adolescents.

In all the studies the main parameter of effectiveness was the time needed to achieve muscle recovery.

What benefit has Bridion shown during the studies?

Bridion was more effective than neostigmine in reducing the time needed for recovery after moderate to deep muscle relaxation obtained with rocuronium or vecuronium.

After moderate muscle relaxation, the average time needed for recovery was between 1.4 and 2.1 minutes with 2 mg / kg of Bridion compared to 17.6-18.9 minutes needed with neostigmine. After a deep muscle relaxation, recovery required an average of about 3.0 minutes with 4 mg / kg of Bridion compared to about 49.5 with neostigmine.

If used for rapid recovery, recovery after 4.2 minutes was achieved in patients treated with 16 mg / kg of Bridion. In comparison, spontaneous recovery occurred after 7.1 minutes.

The effect of Bridion in adults was similar to the effect in adolescents and children over two years. The number of children under the age of two was too limited to establish the safety and efficacy of Bridion in this age group.

What is the risk associated with Bridion?

The most common side effect associated with Bridion (seen in over 1 in 10 patients) is dysgeusia (bitter taste in the mouth or other abnormal taste perception). For the full list of all side effects reported with Bridion, see the Package Leaflet.

Bridion should not be used in patients who may be hypersensitive (allergic) to sugammadex or any of the other ingredients.

Why has Bridion been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Bridion's benefits are greater than its risks for the reversal of neuromuscular blockade induced by rocuronium or vecuronium and recommended the granting of a marketing authorization for Bridion.