BRIDION®

(sugammadex) injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium), for intravenous use

Efficacy for BRIDION® (sugammadex)

Recovery from moderate and deep block

Following rocuronium-induced moderate NMB, BRIDION demonstrated rapid recovery to a TOF Ratio of 0.9

5 minutes after administration of BRIDION 96% of patients achieved a TOF ratio of 0.9 vs 10% with neostigmine 96% of BRIDION patients achieved a TOF ratio of 0.9 vs 10% with neostigmine. 1 Generally, a TOF ratio ≥0.9 correlates with recovery from NMB. 2 5 minutes after administration Time from administration of BRIDION or neostigmine after rocuronium to a recovery TOF ratio of 0.9 Neostigmine 50 µg/kg + glycopyrrolate 10 µg/kg 3 (n=48) BRIDION 2 mg/kg (n=48) Time to recovery (min) Cumulative recovery rate Censored observations + 0. 9 0. 8 0. 7 0. 6 0. 5 0. 4 0. 3 0. 2 0. 1 0. 0 0 1 1 0 1 0 0 1 2 0 9 0 8 0 7 0 6 0 5 0 4 0 3 0 2 0 1 0 + + 1.0 Time (minutes) from administration of BRIDION or neostigmine at the reappearance of T 2 after rocuronium to recovery of a TOF ratio (T 4 /T 1 ) of 0.9. Adapted with permission of Wolters Kluwer Health, Inc. Blobner M, et al., Eur J Anaesthesiol 2010;27:874-881. © 2010 Copyright European Society of Anaesthesiology. 3

Moderate block study design3,4

Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 2 mg/kg of BRIDION vs 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced moderate NMB (reappearance of T2) in 189 patients (87 women and 102 men, ASA majority class 1,2). Patients underwent elective procedures that were mainly endocrine; ocular; ear, nose, and throat; abdominal (gynecological, colorectal, urological); orthopedic; vascular; or dermatological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF stimulation (TOF count or twitches), and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,5 The primary endpoint was the time from start of BRIDION or neostigmine administration to a TOF ratio of 0.9, which generally correlates with recovery from NMB.

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Recovery from moderate block

BRIDION (sugammadex) achieved rapid recovery from moderate block following rocuronium- and vecuronium-induced neuromuscular blockade (NMB).


In a clinical study, BRIDION demonstrated significantly faster reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the train-of-four (TOF) ratio to 0.9 vs neostigmine.3

Primary endpoint: Time from start of BRIDION or neostigmine administration to recovery of a TOF ratio of 0.9 glycopyrrolate 10 µg/kg 3 (n=48) 1.4 MINUTES MEDIAN TIME 21.5 MINUTES MEDIAN TIME Quartiles (Q1, Q3): 9.8, 42.0 minutes Quartiles (Q1, Q3): 1.2, 1.7 minutes BRIDION 2 mg/kg (n=48) Neostigmine 50 µg/kg + Primary endpoint: Time from start of BRIDION or neostigmine administration to recovery of a TOF ratio (T 4 /T 1 ) of 0.9 3

Vecuronium: Median time from vecuronium-induced moderate NMB to a TOF ratio of 0.9 was 2.1 minutes following administration of 2 mg/kg of BRIDION (Quartiles [Q1, Q3]: 1.8, 3.4 minutes; n=48) vs a median time of 29.0 minutes (Quartiles [Q1, Q3]: 12.2, 76.2 minutes; n=45) following administration of 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate.4

 

Moderate block study design3,4

Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 2 mg/kg of BRIDION vs 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced moderate NMB (reappearance of T2) in 189 patients (87 women and 102 men, ASA majority class 1,2). Patients underwent elective procedures that were mainly endocrine; ocular; ear, nose, and throat; abdominal (gynecological, colorectal, urological); orthopedic; vascular; or dermatological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF stimulation (TOF count or twitches), and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,5 The primary endpoint was the time from start of BRIDION or neostigmine administration to a TOF ratio of 0.9, which generally correlates with recovery from NMB.

Recovery from deep block

BRIDION (sugammadex) provided rapid recovery from deep block.


In a clinical study, BRIDION demonstrated rapid recovery from rocuronium-induced deep NMB (1-2 post-tetanic counts [PTCs]) to recovery of the train-of-four (TOF) ratio to 0.9.6

BRIDION 4mg//kg had a 2.7 minute median time to recovery of a TOF ratio of 0.9 2.7 MINUTES MEDIAN TIME Quartiles (Q1, Q3): 2.1, 4.3 minutes BRIDION 4 mg/kg (n=37) Primary endpoint: Time from start of BRIDION or neostigmine administration to recovery of a TOF ratio (T 4 /T 1 ) of 0.9 6
  • The median time to recovery from deep block was similar to the moderate block study, although a wider range was observed.
  • Neostigmine was not expected to reverse NMB at a depth of 1–2 PTCs.
  • There were 7 censored observations in the rocuronium group.

Most patients who received BRIDION recovered to a TOF ratio (T4/T1) of 0.9 within 5 minutes from the start of administration.6 Generally, a TOF ratio ≥0.9 correlates with recovery from NMB.

Vecuronium: Median time from vecuronium-induced deep NMB to a TOF ratio of 0.9 was 3.3 minutes following administration of 4 mg/kg of BRIDION (Quartiles [Q1, Q3], 2.3, 6.6 minutes; n=47). The median time from deep block was similar to the moderate block study, although a wider range was observed. Neostigmine was not expected to reverse NMB at a depth of 1–2 PTCs. There were 6 censored observations in the vecuronium group.

 

Deep block study design6,7

Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 4 mg/kg of BRIDION vs 70 μg/kg of neostigmine and 14 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced deep NMB (1–2 PTCs) in 157 patients (86 women and 71 men, American Society of Anesthesiologists class 1–3). Patients underwent elective surgical procedures that were mainly abdominal (gynecological, colorectal, urological), orthopedic, reconstructive, or neurological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF or PTC stimulation, and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,8 The primary endpoint was the time from start of BRIDION or neostigmine administration to recovery of a TOF ratio of 0.9, which generally correlates with recovery from NMB.

Abbreviations

  • NMB = neuromuscular blockade
  • TOF = train-of-four
  • T2 = second twitch
  • ASA = American Society of Anesthesiologists
  • PTC = post-tetanic count

References

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-XBR-01218.
  2. Claudius C et al. Neuromuscular monitoring. In: Gropper MA, ed. Miller’s Anesthesia. 9th ed. Philadelphia, PA: Elsevier; 2020: 1354-1372.
  3. Blobner M, Eriksson LI, Scholz J, et al. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010;27(10):874-881.
  4. Khuenl-Brady KS, Wattwil M, Vanacker BF, et al. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010;110(1):64-73.
  5. Data available on request from Merck & Co., Inc. Professional Services-DAP, WPI-127, PO Box 4, West Point, PA 19486. Please specify information package US-XBR-01216.
  6. Jones RK, Caldwell JE, Brull SJ, et al. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2009:109(5):816-824.
  7. Lemmens HJM, El-Orbany Ml, Berry J, et al. Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex versus neostigmine. BMC Anesthesia. 2010;10:15.
  8. Data available on request from Merck & Co., Inc., Professional Services-OAP, WPl-127, PO Box 4, West Point, PA 19486. Please specify information package US-XBR-01217.

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Dosing for BRIDION®(sugammadex)

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Recovery in Pediatric Patients

Indication

  • BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.

Selected Safety Information for BRIDION® (sugammadex)

  • BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
  • Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION. In a clinical study, anaphylaxis occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The most common hypersensitivity adverse reactions reported were nausea, pruritus and urticaria and showed a dose response relationship, occurring more frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups. Observe patients for an appropriate period of time after administration and take the necessary precautions. Anaphylaxis has also been reported in the post-marketing setting. Clinical features in anaphylaxis reports have included dermatologic symptoms; hypotension often requiring the use of vasopressors; and prolonged hospitalization and/or the use of additional respiratory support until full recovery.
  • Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of BRIDION. Monitor for hemodynamic changes and treat with anticholinergic agents, such as atropine, if clinically significant bradycardia is observed.
  • Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Should neuromuscular blockade persist after BRIDION or recur following extubation, take appropriate steps to provide adequate ventilation.
  • In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. Monitor ventilation until recovery occurs.
  • A minimum waiting time is necessary before re-administration of a steroidal neuromuscular blocking agent after administration of BRIDION.

Re-administration of Rocuronium or Vecuronium after Reversal (up to 4 mg/kg BRIDION)

Minimum Waiting Time NMBA and Dose to be Administered
5 minutes 1.2 mg/kg rocuronium
4 hours 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.

  • Due to the administration of BRIDION, certain drugs, including hormonal contraceptives, could become less effective due to a lowering of the (free) plasma concentrations. Consider re-administration of the other drug, administration of a therapeutic equivalent drug, and/or non-pharmacological interventions as appropriate. If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.
  • Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation may be required. Stop the administration of the drug which caused displacement, if being administered by infusion.
  • The use of lower than recommended doses of BRIDION may lead to an increased risk of recurrence of neuromuscular blockade and is not recommended. Also, when drugs which potentiate neuromuscular blockade are used in the post-operative phase, recurrence of neuromuscular blockade is possible.
  • BRIDION doses of up to 16 mg/kg were associated with increases in activated partial thromboplastin time and prothrombin time/international normalized ratio. Carefully monitor coagulation parameters in patients with known coagulopathies; being treated with therapeutic anticoagulation; receiving thromboprophylaxis drugs other than heparin and low molecular weight heparin; or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg sugammadex.
  • BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis.
  • BRIDION has not been studied for reversal following rocuronium or vecuronium administration in the ICU.
  • Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
  • Safety and effectiveness in patients younger than 2 years of age have not been established.
  • The most common adverse reactions (reported in ≥ 10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%, 12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at 38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%, or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at 8%). The most common adverse reactions (reported in ≥ 10% of pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg) were pain (65% and 61%), vomiting (14% and 13%), and nausea (10% and 11%).
Before administering BRIDION® (sugammadex), please read the Prescribing Information.
US-XBR-0160202/23