1. Manufacturer: Merck FDA Approval Date: December 15, 2015
Bridion® - Sugammadex
Manufacturer: Merck
FDA Approval Date: December 15, 2015

2. Bridion® - Sugammadex Objectives
At the end of this presentation participants will be able to:
Appropriately recommend Bridion® - Sugammadex
Effectively educate patients on the purpose, proper use and potential adverse effects of Bridion® - Sugammadex

3. 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].

4. 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].

5. 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].

6. 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].

7. 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].

8. 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].

9. Bridion® - Sugammadex Dosing Information
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].

10. Bridion vs. neostigmine reversal agent for NMB induced by rocuronium or vecuronium at reappearance of T2 (Moderate Blockade)
Eur J Anaesthesiol 2001;18:99
-Randomized, single-dose, active-controlled, safety-assessor blinded trial of 198 patients (adults scheduled for surgery under general anesthesia in the supine position)
-Efficacy of sugammadex compared with neostigmine given with glycopyrrolate or atropine in antagonizing block produced by aminosteroidal NMBAs)
-Primary outcome: Time to a train of four ratio (T4/T1) of 0.9

11. 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 μg/kg plus glycopyrrolate 10 μg/kg were administered intravenously in randomized order
-Randomized, single-dose, active-controlled, safety-assessor blinded trial of 198 patients (adults scheduled for surgery under general anesthesia in the supine position)
-Efficacy of sugammadex compared with neostigmine given with glycopyrrolate or atropine in antagonizing block produced by aminosteroidal NMBAs) -
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

12. Primary outcome: Recovery time after reversal agent administration
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
-Randomized, single-dose, active-controlled, safety-assessor blinded trial of 198 patients (adults scheduled for surgery under general anesthesia in the supine position)
-Efficacy of sugammadex compared with neostigmine given with glycopyrrolate or atropine in antagonizing block produced by aminosteroidal NMBAs) -
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

13. Adverse effects were not attributed to the study drug
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
-Randomized, single-dose, active-controlled, safety-assessor blinded trial of 198 patients (adults scheduled for surgery under general anesthesia in the supine position)
-Efficacy of sugammadex compared with neostigmine given with glycopyrrolate or atropine in antagonizing block produced by aminosteroidal NMBAs) -
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

14. Sugammadex achieved significantly faster recovery of T4/T1 ratio to 0
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
-Randomized, single-dose, active-controlled, safety-assessor blinded trial of 198 patients (adults scheduled for surgery under general anesthesia in the supine position)
-Efficacy of sugammadex compared with neostigmine given with glycopyrrolate or atropine in antagonizing block produced by aminosteroidal NMBAs) -
Blobner M, et al. Eur J Anaesthesiol. 2001;18:99.

15. 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

16. 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

17. Bridion® - Sugammadex References
Bridion package insert. Merck. Dec
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 µg/kg). Eur J Anaesthesiol 2001;18:99.

18. 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
5. Neostigmine: DrugDex. (2016). In Micromedex (Columbia Basin College Library ed.)  [Electronic version].Greenwood Village, CO: Truven Health Analytics. Retrieved March 21, 2016 from