Medication Monitor



Generic Name (Trade Name—Company)
Notes
December 16, 2015

Sugammadex

(Bridion—Merck Sharp and Dohme)
Agent reverses effects of neuromuscular-blocking drugs used during surgery

FDA approved sugammadex injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator. 

Safety and efficacy of sugammadex injection were evaluated in three Phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared with the comparator groups, with most participants recovering within 5 minutes of routine use of sugammadex.

Because of concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, sugammadex injection was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex injection, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate.

Cases of marked bradycardia (abnormally slow heart action), some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex injection. Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

The most common adverse reactions reported in clinical trials included vomiting, low blood pressure, pain, headache and nausea. Doctors should also advise women using hormonal contraceptives that sugammadex injection may temporarily reduce the contraceptive effect, so they must use an alternate method of birth control for a period of time.