BRIDION®

(sugammadex) injection, for intravenous use

Efficacy

Reversal in specific populations

BRIDION (sugammadex) demonstrated efficacy in selected patient populations with no dose adjustments 

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.

Median time from start of 2 mg/kg of BRIDION to a TOF ratio of 0.9
Patients 18 to 64 years (n=48) Patients 65 to 74 years (n=62) Patients ≥75 years (n=40)
2.2 minutes 2.5 minutes 3.6 minutes

Study design

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 end point was the time from start of BRIDION administration to a TOF ratio (T4/T1) of 0.9.10

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 posttetanic counts [PTCs])11 to recovery of the TOF ratio to 0.9 in geriatric patients.

Median time from start of 4 mg/kg of BRIDION to a TOF ratio of 0.9
Patients 18 to 64 years (n=359) Patients ≥65 years (n=63)
2.0 minutes 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.

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.  

Median time from start of BRIDION to a TOF ratio of 0.9
Treated with BRIDION 2 mg/kg Treated with BRIDION 4 mg/kg
1.7 minutes 1.3 minutes

Study design

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 (eg, patients with ischemic disease, chronic heart failure, or arrhythmia), primarily New York Heart Association (NYHA) Class II. The primary end point 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 end point.12

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.

Median time from start of BRIDION to a TOF ratio of 0.9
Treated with BRIDION 2 mg/kg Treated with BRIDION 4 mg/kg
2.1 minutes 1.9 minutes

Study design

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.13

Indication

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

Selected Safety Information

  • 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.
  • 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.

References

10. 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.

11. Fuchs-Buder T, Claudius C, Skovgaard LT, et al. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007;51(7):789–808.

12. 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.

13. 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.

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