Bridion

About Bridion

• The active substance in Bridion is Sugammadex (100 mg/ml).
• Rocuronium bromide and vecuronium bromide are neuromuscular blocking medications that induce temporary paralysis and are especially being used for general anesthesia, ventilation, or tracheal intubation for surgical procedures.
• Sugammadex binds to the muscle relaxants rocuronium and vecuronium and forms a complex. This complex formation inactivates the muscle relaxants. As a result, the effect of the blockade of muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work, including the muscles that help the patient to breathe. Bridion also speeds up the recovery process.
• Bridion can be administered to adults who have received rocuronium and vecuronium, and to children and adolescents who have received rocuronium.

Strength:

• 200 mg/2 mL (100 mg/mL) in a vial for bolus injection (single dose)
• 500 mg/5 mL (100 mg/mL) in a vial for bolus injection (single dose)

Recommended Dosage:

For rocuronium and vecuronium:

• Dosing of Sugammadex at 4 mg/kg: If spontaneous recovery of the twitch response has occurred up to 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade.
• Sugammadex dosing at 2 mg/kg: If spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade.

For rocuronium only:

• Bridion dose at 16 mg/kg: If the therapeutic need is to reverse neuromuscular blockade soon (approx 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. Bridion dosing should be based on body weight.
• The efficacy of the 16 mg/kg dose of Bridion following administration of vecuronium has not been studied.

Important: Bridion (Sugammadex) should be administered i.v. by healthcare providers who are well-trained in the actions and complications of neuromuscular blocking agents and neuromuscular block reversal agents.

• Monitoring for twitch response and the extent of recovery should be considered while administering Bridion.
• Bridion is administered intravenously as a single bolus injection even in the clinical trial setting. The bolus injection can be given over 10 seconds into an existing intravenous line.
• Monitoring of patients for their adequate ventilation and airway is required during the Bridion administration process until complete recovery.
• Recovery should be assessed through the functioning of skeletal muscle tone, respiratory measurements, and response to peripheral nerve stimulation.
• The dose of Bridion does not depend on the anesthetic regimen.

Warnings & Precautions

• Anaphylaxis: Patients should be monitored for the entire duration of Bridion administration until the time of recovery.
• Marked Bradycardia: Monitoring for hemodynamic changes and administration of anticholinergic agents such as atropine should be done if significant bradycardia is observed.
• Respiratory Function Monitoring: Ventilatory support and maintenance of airway should be taken care for patients until spontaneous respiration is restored. If neuromuscular blockade persists after administration following extubation, appropriate measures should be taken to provide appropriate ventilation.
• Waiting Times for Re-Administration of Neuromuscular Blocking Agent: If re-administration is required after reversal with Bridion, waiting times should depend on Bridion dose and the renal function of the patient. Nonsteroidal neuromuscular blocking agent should be used in such incidences.

Common Bridion Side Effects

• Vomiting
• Pain
• Nausea
• Hypotension
• Headache

Use in Specific Population

Pediatric population: Safety and effectiveness of Bridion have not been established in patients ≤17 years of age.

Severe Renal Impairment: Not recommended.

Storage and Handling

• The packaging of this product is not made with natural rubber latex.
• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

It should be protected from light. If left unprotected, the vial should be used within 5 days