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New Drug Introduction: Bridion/sugammadex Pharmacology Manufacturer Approval Date Indications Contraindications Black Box Warnings Warnings & Precautions Pregnancy/Lactation Pharmacokinetics Drug Interactions – Precipitant/Object Adverse Effects (Treatment%) Monitoring Efficacy Dosing – Usual Dosing - Emergent Renal Adjustment Hepatic Adjustment Cyclodextrin that forms a 1:1 complex with vecuronium and rocuronium Merck December 15, 2015 Used for adults undergoing general surgery for the reversal of neuromuscular blockade induced by vecuronium or rocuronium Hypersensitivity to sugammadex or any component of the product None Use not recommended with severe renal impairment or dialysisdependent patients Pregnancy: no adequate or well-controlled studies in pregnant women Lactation: Unknown if excreted in human breast milk A – T1/2: 2 hours D – Vd: 11-14L, no protein binding M – No metabolites E – Renal: 96% Hormonal contraceptives: must recommend additional, non-hormonal method of contraception for 7 days after administration. Sugammadex binds to progestogen component and decreases serum hormone levels. Nausea (23-26%) Bradycardia (1-5%) Vomiting (11-15%) Prolonged QT interval (up to 6%) Headache (5-10%) Anaphylaxis (0.5%) Reversal of neuromuscular blockade Twitch responses and spontaneous recovery 2-4 mg/kg IV bolus based on total body weight and dosing is guided by blockade status 16 mg/kg IV bolus based on total body weight No adjustment needed; Not recommended in severe renal impairment or dialysis-dependent patients No adjustment needed Cost: Source: Lexicomp 4/5/16 Vial Size Drug Bridion (sugammadex) 200 mg/2ml SDV 500 mg/5ml SDV Bloxiverz (neostigmine) 1 mg/ml 10 ml MDV Robinul (glycopyrrolate) 0.2 mg/ml SDV AWP Pricing $1140 $2088 $1185 $390 Summary Bridion, sugammadex, is first-in-class cyclodextrin that directly reverses neuromuscular blockade and offers signifcantly faster recovery times compared to neostigmine It is indicated for the reversal of neuromuscular blockade for rocuronium and vecuronium for patients undergoing surgical procedures It is administered 2-4 mg/kg IV bolus based on total body weight OR 16 mg/kg IV bolus reserved for emergent reversal Sugammadex has a significant drug-drug interaction that decreases the efficacy of hormonal contraceptives. All women of child-bearing age should be counseled on using a backup method of contraception for 7 days post-op. Common side effects include; nausea, vomiting and headache. Patients should be monitored closely for bradycardia and anaphylaxis during procedure and recovery. 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 µg/kg). Eur J Anaesthesiol 2001;18:99. Date Prepared: April 5, 2016 Editor: Peter G. Koval, Pharm.D., BCPS Author: Michael Rollins, Pharm.D. Candidate, UNC Eshelman School of Pharmacy