Frequently Asked Questions About BRIDION® (sugammadex)
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BRIDION®
(sugammadex) injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium), for intravenous use
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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.
Dosing based on actual body weight and depth of block
Treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.
If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.
BRIDION works differently than neostigmine by directly encapsulating, binding, and thus inactivating rocuronium or vecuronium.1-3
After intravenous injection, BRIDION distributes through the plasma and binds to the neuromuscular blocking agents rocuronium or vecuronium to form a complex.3 BRIDION does not affect the release or breakdown of acetylcholine.2
Yes.
Following rocuronium-induced NMB, choose BRIDION (sugammadex) to achieve rapid recovery.
aThere were 7 censored observations in the rocuronium group.
Moderate block reversal study design
Deep block reversal study design
Recovery from moderate block
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.4
Most patients who received BRIDION recovered to a TOF ratio (T4/T1) of 0.9 within 5 mins from the start of administration.4,5 Generally, a TOF ratio ≥0.9 correlates with recovery from NMB.
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.6
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).1,7 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.
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 0.9.8
Most patients who received BRIDION recovered to a TOF ratio (T4/T1) of 0.9 within 5 minutes from the start of administration.8 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.
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).1,10 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.
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.11
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.
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.
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.12
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.
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.13
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.
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).14
*Obese is defined as a BMI ≥40 kg/m2
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.
The study was not designed for a comparative analysis on this exploratory endpoint and the exploratory results must be interpreted with caution.
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 blocking 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 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.
In a study of randomized pediatric patients 2 to <17 years of age (n=288), BRIDION (vs neostigmine) demonstrated statistically faster recovery to a TOF ratio of ≥0.9 from moderate NMB.15
These effects were consistent across age cohorts studied (2 to <6; 6 to <12; 12 to <17 years of age) and NMBA (rocuronium and vecuronium).15
Primary efficacy objective: time from start of BRIDION or neostigmine administration to recovery of a TOF ratio ≥0.9
Time to recovery from neuromuscular blockade induced by rocuronium or vecuronium followed by administration of BRIDION or neostigmine was assessed in a randomized, double-blind, active comparator-controlled study. The study was conducted in 288 randomized pediatric patients 2 to <17 years of age, of which 276 patients received treatment (153 boys and 123 girls; ASA class 1, 2, and 3; 89.5% were Caucasian; median weight was 25 kg; median age was 7 years). The primary efficacy objective was to evaluate the effect of BRIDION compared to neostigmine for reversal of moderate neuromuscular blockade as measured by time to recovery to a TOF ratio of ≥0.9.
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.