Following rocuronium- and vecuronium-induced neuromuscular blockade (NMB),

BRIDION (sugammadex) PROVIDED RAPID REVERSAL FROM DEEP BLOCK7

In a clinical study, BRIDION demonstrated rapid reversal of rocuronium-induced deep NMB (1–2 posttetanic counts [PTCs]) to recovery of the train-of-four (TOF) ratio to 0.9

The median time to recovery from deep neuromuscular blockade with BRIDION® (sugammadex) was 2.7 minutes. Neostigmine was not expected to reverse NMB at a depth of 1-2 posttetanic counts. The median time to recovery from deep neuromuscular blockade with BRIDION® (sugammadex) was 2.7 minutes. Neostigmine was not expected to reverse NMB at a depth of 1-2 posttetanic counts.

Most patients who received BRIDION recovered to a TOF ratio (T4/T1) of 0.9 within 5 minutes from the start of administration.7 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.
Study design

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).7,8 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).6,9 The primary end point 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.

References: 6. Viby-Mogensen J. Neuromuscular monitoring. In: Miller RD, ed. Miller’s Anesthesia. 8th ed. Philadelphia, PA: Elsevier Saunders; 2010:1604–1621.e4. 7. Jones RK, Caldwell JE, Brull SJ, et al. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008;109(5):816–824. 8. Lemmens HJM, El-Orbany MI, Berry J, et al. Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex versus neostigmine. BMC Anesthesiol. 2010. doi:10.1186/1471-2253-10-15. 9. 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 ANES-1143289-0002.

Copyright © 2016 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.

Selected Safety Information About 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 4mg/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.
  • The most common adverse reactions (reported in ≥ 10% of 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%).

Before administering BRIDION, please read the Prescribing Information.

ANES-1189823-0000 10/16

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Indication
  • BRIDION (sugammadex) is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

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Selected Safety Information About 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 4mg/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.
  • The most common adverse reactions (reported in ≥ 10% of 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%).

Before administering BRIDION, please read the Prescribing Information.