Bridion

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

Bridion was more effective than neostigmine in reducing the time it took for the muscles to recover, after both moderate and deep muscle relaxation using rocuronium or vecuronium.

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

When used for rapid recovery, patients receiving 16 mg/kg Bridion recovered after 4.2 minutes. In contrast, muscle relaxation recovered spontaneously after 7.1 minutes.

The effect of Bridion seen in adults was similar in adolescents and children aged over two years. There were too few children aged below two years to determine the safety and effectiveness of Bridion in this age group.

The CHMP decided that Bridion’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The most common side effects with Bridion (seen in between 1 and 10 patients in 100) are cough, airway problems due to the anaesthesia wearing off, reduced blood pressure and other complications such as changes in heart rate. For the full list of all side effects reported with Bridion, see the package leaflet.

Bridion must not be used in people who are hypersensitive (allergic) to sugammadex or any of the other ingredients.

Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Bridion is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.

Bridion can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium.

The medicine can only be obtained with a prescription.

Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants.

Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the muscles due to rocuronium or vecuronium. Bridion was compared with neostigmine (another medicine used to stop the effect of muscle relaxants) given 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 Bridion with that of neostigmine after deep relaxation of the muscles using rocuronium or vecuronium in 182 patients.

The fourth study, involving 115 patients, looked at the effectiveness of 16 mg/kg Bridion in producing rapid reversal of the muscle relaxation using rocuronium. This was compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant).

An additional study looked at the effectiveness of Bridion given after rocuronium in 90 children and adolescents.

In all of the studies, the main measure of effectiveness was how long it took for the muscles to recover.

The medicine can only be obtained with a prescription and must be given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). It is given as a single injection into a vein. The dose depends on the patient’s age, weight and how much the muscle relaxant is affecting the muscles.

For more information about using Bridion, see the package leaflet or contact your doctor or pharmacist.

The active substance in Bridion, sugammadex, is a selective relaxant binding agent. This means that it attaches to the muscle relaxants rocuronium and vecuronium to form a complex that inactivates the muscle relaxants, blocking their effect. As a result, the muscle-relaxing effect of rocuronium and vecuronium is reversed and the muscles begin to work normally again, including the muscles that help the patient breathe.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bridion have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Bridion are continuously monitored. Suspected side effects reported with Bridion are carefully evaluated and any necessary action taken to protect patients.

Bridion received a marketing authorisation valid throughout the EU on 25 July 2008.

Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants. In all the studies, the main measure of effectiveness was how long it took for the muscles to recover.

The studies found that Bridion was more effective than neostigmine (another medicine used to stop the effect of muscle relaxants) at reducing the time it took for the muscles to recover after both moderate and deep muscle relaxation using rocuronium or vecuronium.

Two of the studies, involving a total of 282 patients, compared the effect of Bridion with that of neostigmine given either after rocuronium or vecuronium or after cis-atracurium (another muscle relaxant). After moderate muscle relaxation, the average time until recovery was between 1.4 and 2.1 minutes with Bridion, compared with 17.6 to 18.9 minutes with neostigmine.

A third study involving 182 patients compared the effectiveness of Bridion with that of neostigmine after deep muscle relaxation using rocuronium or vecuronium. Recovery from deep muscle relaxation took an average of around 3 minutes with Bridion, compared with around 49.5 minutes for neostigmine.

A fourth study, involving 115 patients, looked at the effectiveness of Bridion at rapidly reversing muscle relaxation using rocuronium compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant). Patients who received Bridion recovered after 4.2 minutes compared with 7.1 minutes for patients with spontaneous recovery from muscle relaxation.

Two further studies looked at the effectiveness of Bridion given after rocuronium or vecuronium in children and adolescents. One study, which involved 288 children and adolescents (aged 2 to less than 17 years), found that the average time for recovery from moderate muscle relaxation was 1.6 minutes for those who received Bridion compared with 7.5 minutes for those who received neostigmine. The effect was consistent across the entire age range. For recovery from deep muscle relaxation, the average time was 2 minutes in children and adolescents who received Bridion, which is similar to the effect seen in adults.

A second study involved 145 children from birth up to 2 years old and compared the effect of Bridion with that of neostigmine in reversing muscle relaxation caused by rocuronium or vecuronium. Children given Bridion recovered from moderate muscle relaxation after an average of 1.4 minutes compared with 4.4 minutes for those given neostigmine. Recovery from deep muscle relaxation happened after an average of 1.1 minute in children given Bridion, which is similar to the effect seen in children aged 2 to 17 years and in adults.

For the full list of side effects and restrictions with Bridion, see the package leaflet.

The most common side effects with Bridion (which may affect up to 1 in 10 people) include cough, airway problems due to the anaesthesia wearing off, other complications due to anaesthesia, reduced blood pressure and other complications due to the surgical procedure such as a change in heart rate.

Bridion has been found to be effective at reversing the effect of the muscle relaxants rocuronium and vecuronium in adults; in children it has been shown to be effective at reversing the effect of rocuronium. The safety of Bridion is considered acceptable. The European Medicines Agency therefore decided that Bridion’s benefits are greater than its risks and that it can be authorised for use in the EU.