3 Key Considerations for Sugammadex Administration

MARCH 16, 2016
The reversal agent for rocuronium (Zemuron)—and to a lesser extent vecuronium (Norcuron) and pancuronium (Pavulon)—is creating big buzz among emergency departments and anesthesia suites.
 
Although the only FDA-approved indication for sugammadex (Bridion) is the reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults undergoing surgery, the drug will almost certainly be used in different settings.1 These off-label target areas are emergency departments, operating suites, and potentially pre-hospital environments.
 
Preparing for discussions with key stakeholders in any hospital will be key to ensure the appropriate and specific use of sugammadex and to understand its limitations. A number of considerations have been raised during discussions on how and when this medication will be incorporated into pharmacy practice.
 
The following are key considerations to include in any discussions on sugammadex.
 
1. Rapid Reversal of Paralysis
The most novel use for sugammadex would be immediate rescue reversal (IRR) of paralysis after rapid sequence intubation (RSI) in patients with traumatic brain injuries, intracranial hemorrhage, ongoing seizures, burns, or spinal cord injuries.
 
In many of these clinical scenarios, succinylcholine is avoided or used cautiously because of its short duration of action. This allows for relatively quick recovery and the ability to conduct a neurological assessment or other critical tests.

Based on the limited literature available, however, the turnaround time from the decision to administer sugammadex to the reversal of paralysis is not known in a real-world clinical setting. The study results that best provide an idea of this time were derived from a simulation-based experiment with anesthesiology teams.2
 
These investigators simulated real-world cases of RSI that required IRR with the primary outcome of rocuronium administration to train-of-4 recovery >90%. Although the average time observed was 8.9 minutes, 78% of teams administered the wrong dose of sugammadex.
 
Editorials of this paper suggested that pre-drawn syringes of sugammadex could reduce this average time, as well as administration errors.3,4 This may be laughable to some pharmacy coordinators and administrators, considering that each dose of the drug may be in the neighborhood of $1000 per dose. Still, this simulation gives us a ballpark of a 9-minute turnaround time from the decision to administer to paralysis recovery.
 
In a scenario where sugammadex may be appropriate, the 9-minute turnaround time from decision to administer to reversal of paralysis must be taken into consideration.
 
Say a patient required RSI for status epilepticus and received rocuronium 20 minutes prior to arrival at the emergency department. It may reasonable to administer sugammadex because the time since administration of paralytic and the preparation and onset of sugammadex is less than the duration of action of rocuronium.
 
Alternatively, say a patient experienced a traumatic brain injury, required RSI before arriving at the hospital, and is now arriving at the emergency department 45 minutes after rocuronium administration. In this scenario, sugammadex may not be a good decision because the time from preparation, to administration, to onset of action extends beyond rocuronium’s expected duration of action.

Of course, these examples are general, and extenuating circumstances will arise in clinical practice. However, this is a good place to start when deriving hospital protocols and order sets.
 
2. Kidney Clearance
In patients with reduced kidney clearance (glomerular filtration rate <30 mL/min), the effect of persistent sugammadex may impair the ability of similar paralytics to work if re-paralysis is needed. In such cases, atracurium, cisatracurim, and succinylcholine should still have activity and may be considered.
 
Typical clearance is about 8 hours, but in some patients, it could take as many as 42 hours.
 
3. Cost Is King
While it is not currently known exactly how much a typical IRR dose of sugammadex will cost in the United States, a 200 mg vial costs approximately $170 in Australia,5 meaning a 16 mg/kg dose for a patient who weighs 80 kg costs about $1100.
 
Given the trend of increasing drug pricing in the United States, the cost of sugammadex will most likely be higher here than in Australia.
 
References
  1. Bridion (sugammadex) [prescribing information]. Whitehouse Station, NJ; Merck & Co, Inc: December 2015.
  2. Bischops MM, et al. Can sugammadex save a patient in a simulated ‘cannot intubate, cannot ventilate’ situation? Anaesthesia. 2010;65(9): 936-941.
  3. Mercer SJ, Moneypenny MJ. Can sugammadex save a patient in a simulated 'cannot intubate, cannot ventilate' situation? Anaesthesia. 2011 Mar;66(3): 223-224.
  4. Dada A, Dunsire F. Can sugammadex save a patient in a simulated 'cannot intubate, cannot ventilate' scenario? Anaesthesia. 2011 Feb;66(2): 141-142.
  5. Staals LM, et al. Reduced clearnace of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010;104(1):31-39.


Craig Cocchio, PharmD
Craig Cocchio, PharmD
Craig Cocchio, PharmD, BCPS, is an Emergency Medicine Clinical Pharmacist at Trinity Mother Frances Hospital in Tyler, Texas. Follow on Twitter @iEMPharmD and on his blog at empharmd.blogspot.com
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