Bridion - Sugammadex

Manufacturer: Merck

FDA Approval Date: December 15, 2015

Bridion - Sugammadex

Objectives

At the end of this presentation

participants will be able to:

1. Appropriately recommend Bridion -

Sugammadex
2. Effectively educate patients on the
purpose, proper use and potential
adverse effects of Bridion Sugammadex

Bridion - Sugammadex

Clinical Application
Indications:
Used for adults undergoing surgery for the

reversal of neuromuscular blockade (NMB)

induced by rocuronium or vecuronium
Not indicated to reverse blockade of

nonsteroidal neuromuscular blocking

agents (eg, succinylcholine)
Not indicated for use in ICU setting
Bridion [package insert].

Bridion - Sugammadex

Clinical Application
Contraindications:
Hypersensitivity to sugammadex or any

component of the product

Precautions:
Use not recommended with severe renal

impairment or dialysis-dependent patients

Caution with mild-to-moderate renal
impairment (no dosage adjustment)
Bridion [package insert].

Bridion - Sugammadex

Clinical Application
Pregnancy:
No available human data
In animal studies, fetal birthweight was

reduced when 8x human dose was

administered

Lactation:
Unknown excretion in human breast milk
Present in animal milk
Bridion [package insert].

Bridion - Sugammadex

Drug Facts

Mechanism of Action
Cyclodextrin that forms a 1:1 complex

with rocuronium and vecuronium

This reduces the amount of free NMB
agent in plasma
In turn, the concentration gradient favors
movement of NMB agent away from the
neuromuscular junction
Bridion [package insert].

Bridion - Sugammadex

Drug Facts

Drug Interactions:
Hormonal contraceptives: must

recommend additional, non-hormonal

method of contraception for next 7 days
Toremifene: recovery can be delayed

Bridion [package insert].

Bridion - Sugammadex

Adverse Effects
Side effects are dose-dependent
Common (2-4 mg/kg) {16 mg/kg} [placebo]:
Nausea (23%) {26%} [23%]
Vomiting (11%) {15%} [10%]

Serious (2-4 mg/kg) {16 mg/kg} [placebo]:

Prolonged QT interval (1%) {6%} [1%]
Bradycardia (1%) {5%} [1%]
Hypotension (4%) {13%} [4%]
Anaphylaxis (0%) {1%} [0%]

Bridion [package insert].

Bridion - Sugammadex

Dosing Information
Dosing:
2-4 mg/kg IV bolus based on actual body

weight depending on blockade status

Immediate Reversal: 16 mg/kg IV bolus
based on actual body weight
This dose has only been studied for
rocuronium reversal

Bridion [package insert].

Bridion vs. neostigmine reversal agent for NMB

induced by rocuronium or vecuronium at
reappearance of T2 (Moderate Blockade)
Eur J Anaesthesiol 2001;18:99

 Purpose: Comparing the efficacy of

sugammadex with neostigmine given with
glycopyrrolate or atropine in antagonizing block
produced by aminosteroidal NMBAs
Design:
Randomized, single-dose, active-controlled,
safety-assessor blinded trial of 98 patients
Sugammadex 2.0mg/kg or neostigmine 50
g/kg plus glycopyrrolate 10 g/kg were
administered intravenously in randomized
order
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

 Included: Adult patients scheduled for

surgery under general anesthesia in the
supine position
> 18 years old
ASA class 1 to 3
Primary outcome: Recovery time after
reversal agent administration
measured as train of four ratio (T4/T1)
of 0.9
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

 Serious adverse effects were

reported for 2 subjects in the
sugammadex group and 3 in the
neostigmine group
Adverse effects were not attributed
to the study drug

Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

 Sugammadex achieved significantly

faster recovery of T4/T1 ratio to 0.9
compared with neostigmine after
neuromuscular block with rocuronium
Outliers and variability of recovery times
were significantly lower following
reversal with sugammadex

Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

Bridion - Sugammadex

Cost Comparison
Neuromuscular Blocking and Reversal Agents

AWP
Pricing

Sugammadex 200 mg/2 ml SDV

$1140

Sugammadex 500 mg/5 ml SDV

$2088

Neostigmine (Bloxiverz) 1 mg/ml 10 ml MDV

$1185

Pyridostigmine (Regonol) 5 mg/ml 2ml Vial

$384

Glycopyrrolate (Robinul) 0.2 mg/ml SDV

$390

AWP pricing as of 2/26/2016

Bridion - Sugammadex

Summary

Bridion , sugammadex, is first-in-class cyclodextrin

that directly reverses neuromuscular blockade

It is indicated for the reversal of neuromuscular

blockade for rocuronium and vecuronium for patients

undergoing surgical procedures only
Dosed: 2-4 mg/kg IV bolus based on total body weight

OR 16 mg/kg IV bolus reserved for emergent reversal

Offers faster reversal times compared to neostigmine
All women of child bearing age should be counseled

on using backup contraception for 7 days post-op

It is not cost prohibitive, but is more expensive than

neostigmine

Bridion - Sugammadex

References

1.

www.bridion.com

2.

Bridion package insert. Merck. Dec. 2015.

3.

Blobner M, Eriksson L, Scholz J, Hillebrand H, Pompei

L. Sugammadex (2.0 mg/kg) significantly faster
reverses shallow rocuronium-induced neuromuscular
blockade compared with neostigmine (50 g/kg). Eur J
Anaesthesiol 2001;18:99.

Bridion - Sugammadex

References

4.

Sugammadex: DrugDex. (2016). In Micromedex

(Columbia Basin College Library ed.) [Electronic
version].Greenwood Village, CO: Truven Health
Analytics. Retrieved March 21, 2016 from
http://www.micromedexsolutions.com/
5.
Neostigmine: DrugDex. (2016). In Micromedex
(Columbia Basin College Library ed.) [Electronic
version].Greenwood Village, CO: Truven Health
Analytics. Retrieved March 21, 2016 from
http://www.micromedexsolutions.com/