BRIDION®

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

Efficacy for BRIDION® (sugammadex)

Recovery in Special Patient Populations

Following rocuronium-induced NMB, choose BRIDION (sugammadex) to achieve rapid recovery.

Clinically relevant recovery is defined as a TOF ratio ≥0.91


Median time from start of BRIDION or neostigmine administration to recovery of a TOF ratio (T 4 /T 1 ) of 0.9
Median time from start of BRIDION or neostigmine administration to recovery of a TOF ratio (T 4 /T 1 ) of 0.9
BRIDION 2 mg/kg showed a 1.4 minute median time to recovery of a TOF ratio of 0.9 for moderate block vs. Neostigmine at 21.5 minutes median time 1.4 MINUTES 21.5 MINUTES MEDIAN TIME MEDIAN TIME 50 µg/kg + glycopyrrolate 10 µg/kg 2 (n=48) 2 mg/kg (n=48) Quartiles (Q1, Q3): 1.2, 1.7 minutes Quartiles (Q1, Q3): 9.8, 42.0 minutes BRIDION Neostigmine Moderate Block (reappearance of T 2 )
BRIDION 4 mg/kg showed a 2.7 minute median time to recovery of a TOF ratio of 0.9 for deep block 2.7 MINUTES MEDIAN TIME 4 mg/kg (n=37) a BRIDION Quartiles (Q1, Q3): 2.1, 4.3 minutes Neostigmine was not expected to reverse NMB at a depth of 1-2 PTCs. Deep Block (1-2 post-tetanic counts [PTCs])

aThere were 7 censored observations in the rocuronium group.

Keep reading for study designs, BRIDION efficacy data in special patient populations, and selected safety information

Moderate block study design2,3

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).1,4 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.

Deep block study design5,6

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).1,7 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.



BRIDION (sugammadex) demonstrated efficacy with no dose adjustments in these special patient populations:

Geriatric patients

Recovery in geriatric patients with moderate block

In a dedicated clinical study of geriatric patients (n=102) that compared the time to recovery from rocuronium-induced moderate neuromuscular blockade (NMB), BRIDION demonstrated time to recovery of the train-of-four (TOF) ratio to 0.9 comparable with other treatment groups.8

Median time from start of 2 mg/kg of BRIDION administration to recovery of a TOF ratio of 0.9 Median time from start of 2 mg/kg BRIDION to recovery of a TOF ratio of 0.9 for different patient populations with moderate block 2.2 MINUTES Patients 18 to 64 years (n=48) Median time from start of 2 mg/kg BRIDION to recovery of a TOF ratio of 0.9 for different patient populations with moderate block 2.5 MINUTES Patients 65 to 74 years (n=62) Patients ≥75 years (n=40) 3.6 MINUTES

Study design8

Multicenter, parallel-group, open-label study compared the efficacy of 2 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 48 adult patients (18–64 years), 62 geriatric patients (65–74 years), and 40 older geriatric patients (≥75 years) (American Society of Anesthesiologists [ASA] class 1–3). The primary endpoint was the time from start of BRIDION administration to a TOF ratio (T4/ T1) of 0.9.


Recovery in geriatric patients with deep block

In an analysis of pooled clinical trial data, BRIDION demonstrated rapid reversal of rocuronium-induced deep NMB (TOF count of 0, 1–2 post-tetanic counts [PTCs]) to recovery of the TOF ratio to 0.9 in geriatric patients.

Median time from start of 4 mg/kg of BRIDION administration to recovery of a TOF ratio of 0.9 Median time from start of 4 mg/kg of BRIDION administration to a recovery of a TOF ratio of 0.9 for geriatric patients with deep block 2.0 MINUTES Patients 18 to 64 years (n=359) Median time from start of 4 mg/kg of BRIDION administration to a recovery of a TOF ratio of 0.9 for geriatric patients with deep block Patients ≥65 years (n=63) 2.5 MINUTES
  • No dose adjustment is necessary in geriatric patients with normal organ function.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.

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Cardiac patients

Recovery in cardiac patients with moderate block

In a clinical study, BRIDION provided reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the TOF ratio to 0.9 in patients diagnosed with or having a history of cardiac disease.9  

Median time from start of BRIDION administration to a recovery TOF of 0.9 for cardiac patients with moderate block 1.3 MINUTES 1.7 MINUTES BRIDION 2 mg/kg BRIDION 4 mg/kg Median time from start of BRIDION administration to recovery of a TOF ratio of 0.9

Study design9

Multicenter, randomized, parallel-group, placebo-controlled, safety-assessor-blinded study compared the safety and efficacy of 2 mg/kg and 4 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 76 patients who were diagnosed with or have a history of cardiac disease (e.g., patients with ischemic disease, chronic heart failure, or arrhythmia), primarily New York Heart Association (NYHA) Class II. The primary endpoint was to evaluate the safety of BRIDION 2 mg/kg and 4 mg/kg, with the time from start of BRIDION administration to a TOF ratio of 0.9 as a secondary endpoint.

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Pulmonary patients

Recovery in pulmonary patients with moderate block

In a clinical study, BRIDION achieved rapid reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the TOF ratio to 0.9 in patients diagnosed with or having a history of pulmonary complications.10

Median time from start of BRIDION administration to a recovery TOF of 0.9 for pulmonary patients with moderate block MINUTES 2.1 MINUTES BRIDION 2 mg/kg BRIDION 4 mg/kg 1.9 Median time from start of BRIDION administration to recovery of a TOF ratio of 0.9

Study design10

Multicenter, randomized, parallel-group, comparative, safety-assessor–blinded study compared the safety and efficacy of 2 mg/kg and 4 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 77 patients who were diagnosed with or have a history of pulmonary complications (ASA class 2 and 3). The primary objective was to evaluate the safety of BRIDION 2 mg/kg and 4 mg/kg, with the time from start of BRIDION administration to a TOF ratio of 0.9 as a primary efficacy objective.

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Obese patients

Recovery in Obese* patients

In a study of obese patients (n=188), BRIDION demonstrated statistically significantly faster recovery in patients dosed by ABW compared to IBW pooled across NMB (moderate or deep) and neuromuscular blocking agent (rocuronium or vecuronium).11

*Obese is defined as a BMI ≥40 kg/m2

Median time from start of BRIDION administration to a recovery TOF of 0.9 for obese patients with moderate block MINUTES 1.8 MINUTES Actual body weight (ABW) Ideal body weight (IBW) 3.3 Median time from start of 2 mg/kg or 4 mg/kg of BRIDION administration to recovery of a TOF ratio of ≥0.9

Study design11

Randomized, double-blind trial in 188 obese patients investigated the time to recovery from moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Patients received 2 mg/kg or 4 mg/kg BRIDION, as appropriate for level of block, dosed according to either ABW or IBW. The primary efficacy endpoint, time to recovery of TOF ratio ≥0.9, was compared for ABW vs IBW dosing, pooled across depth of block and NMBA.

Exploratory endpoint: BRIDION and neostigmine in obese patients

BRIDION and neostigmine in obese patients 1.7 MINUTES 95% CI: 1.5, 2.1 minutes 3.4 MINUTES BRIDION IBW 2 mg/kg (n=38) 95% CI: 2.2, 4.4 minutes 34.5 MINUTES 95% CI: 27.0, 67.4 minutes BRIDION ABW 2 mg/kg (n=38) NEOSTIGMINE 5 mg + GLYCOPYRROLATE 1 mg (n=38) Exploratory median times to recovery (TOF ratio of ≥0.9) from moderate block pooled across NMBA 11

The study was not designed for a comparative analysis on this exploratory endpoint and the exploratory results must be interpreted with caution.

Study design11

Randomized, double-blind trial in 188 obese patients investigated the time to recovery from moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Patients received 2 mg/kg or 4 mg/kg BRIDION, as appropriate for level of block, dosed according to either ABW or IBW. Pooled across depth of block and neuromuscular agent, the primary endpoint, i.e. the median time to recover to a TOF ratio ≥0.9 in patients dosed by ABW (1.8 minutes), was statistically significantly faster compared to the patients dosed by IBW (3.3 minutes). An exploratory endpoint of the study was to understand the distributions of recovery times for BRIDION and neostigmine in moderate depth of block pooled across NMBA.

Explore other special patient populations

Definitions

  • NMB = neuromuscular blockade
  • TOF = train-of-four
  • T2 = second twitch
  • PTC = post-tetanic count
  • ASA = American Society of Anesthesiologists
  • NYHA = New York Heart Association
  • ABW = actual body weight
  • IBW = ideal body weight
  • BMI = body mass index
  • NMBA = neuromuscular blocking agent
  • CI = confidence interval

References

  1. Claudius C et al. Neuromuscular monitoring. In: Gropper MA, ed. Miller's Anesthesia. 9th ed. Philadelphia, PA: Elsevier; 2020: 1354-1372.
  2. 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.
  3. 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.
  4. 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.
  5. Jones RK, Caldwell JE, Brull SJ, et al. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigimine. Anesthesiology. 2009:109(5):816-824.
  6. 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.
  7. 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.
  8. McDonagh DL, Benedict PE, Kovac AL, et al. Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients. Anesthesiology. 2011;114(2):318-329.
  9. Dahl V, Pendeville PE, Hollmann MW, et al. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009;26(10):874-884.
  10. Amao R, Zornow MH, Cowan RM, et al. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012;24(4):289-297.
  11. Horrow, J.C., Li, W., Blobner, M. et al. Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial. BMC Anesthesiol 21, 62 (2021).


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Mechanism of Action for BRIDION® (sugammadex)

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-0147310/22