About BRIDION® (sugammadex)

About BRIDION® (sugammadex)

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Bridion hero image

BRIDION is for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults1

For the paediatric population, sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years1

Why BRIDION?

BRIDION provides predictable, complete* and rapid reversal from any depth of neuromuscular block2-3

*Reversal was considered complete at Train-of-Four (TOF) ratio of 0.9

Moderate NMB

BRIDION provided complete* reversal from moderate NMB2

% of patients fully recovered from reappearance of T2  to a TOF of 0.9 within 5 minutes following rocuronium-induced NMB2

98% of patients following BRIDION (2 mg/kg) and 11% of patients following neostigmine (50 µg/kg)

*Reversal was considered complete at Train-of-Four (TOF) ratio of 0.9

Percentage of patients achieving complete reversal (TOFR 0.9) after administration of sugammadex or neostigmine given at reappearance of the second twitch for reversal of moderate rocuronium-induced NMB4

A multicentre, randomized, parallel-group, comparative, active-controlled, safety-assessor– blinded study of 98 adult (ASA Class 1–2) surgical patients. At the reappearance of T2 after the last dose of rocuronium, patients were randomly assigned to receive 2 mg/kg of BRIDION vs 50 μg/kg of neostigmine with 10 μg/kg of glycopyrrolate.

Deep NMB 

BRIDION provided complete* reversal from deep NMB3

% of patients fully recovered from 1-2 PTCs to a TOF of 0.9 within 5 minutes following rocuronium-induced NMB3

97% of patients following BRIDION (4 mg/kg) and 0% of patients following neostigmine (70 µg/kg)

*Reversal was considered complete at Train-of-Four (TOF) ratio of 0.9

Percentage of patients achieving complete reversal (TOFR 0.9) after administration of sugammadex or neostigmine given at reappearance post tetanic count (PTC) of 1-2 for reversal from deep rocuronium-induced NMB3

A multicentre, randomized, parallel-group, comparative, active-controlled, safety-assessor–blinded study of 74 adult (ASA Class 1–2) surgical patients. At the reappearance of 1–2 PTCs after the last dose of rocuronium, patients were randomly assigned to receive 4 mg/kg of BRIDION vs 70 µg/kg of neostigmine with 14 µg/kg of glycopyrrolate.

Impact on enhanced patient outcomes

Residual NMB can be detected in up to 40 % of patients up to 2 hours after administration of neuromuscular blocking agents5

Residual NMB increases the risk of serious clinical complications including post-operative pulmonary complications (PPC’s) 6-8

PPCs are among the most common post-surgical complications9

An important patient safety issue9,10

Patients are 10 times more likely to die within 30 days of major surgery if they suffer a PPC10

30-day mortality rates in patients with and without pulmonary complications

22% with PPCs (n=1255/5704) and 2% without PPCs (n=2005/100247)

An important health service cost issue11,13

‘PPCs consume huge resources within hospital, particularly in critical care’ 12

Extra costs that may be incurred11,13

  • Reintubation
  • Unplanned ICU/HDU admission
  • Increased hospital length of stay
  • Discharge to a nursing home
  • Hospital readmission

The importance of complete and rapid reversal in your high-risk patients

Cardiac

Hypertension increases risk of intra-operative CV events almost 2-fold14 and is a risk factor for developing post-operative pulmonary complications15

Compared to neostigmine:

  • BRIDION was faster at reversing NMB (p>0.001) and presented a lower risk of post-operative residual curarization after extubation (p=0.0068) 16
  • BRIDION use was associated with significantly lower risk of CV adverse events (p=0.0036) 16

Obese

Obese (BMI >30 kg/m2  ) patients are almost 4 times more likely to experience an intra-operative and post-operative respiratory AE14

BRIDION use in morbidly obese (BMI >40 kg/m2  ) patients compared to neostigmine:

  • Reversed NMB faster17
  • Provided shorter anaesthesia and recovery times18
  • Provided quicker mobility for patients postoperatively18

Respiratory

Careful consideration needs to be given when administering anaesthetic agents to these patients as they may exacerbate their underlying respiratory issues19

Compared to neostigmine:

  • BRIDION was faster at reversing moderate NMB (p>0.0001) and presented a lower risk of postoperative residual curarisation after extubation (p=0.0068)16
  • BRIDION was associated with significantly lower risk of respiratory AEs (p=0.0386)16

Elderly

Incidence of residual NMB (TOF ratio <0.9) is nearly twice as high in elderly patients compared to younger patients 20

57.7% elderly (70-90 years) vs. 30% younger (18-50 years
  • BRIDION rapidly reverse NMB in adults of all ages, including the elderly21
  • Median time to complete recovery (TOF > 0.9) from moderate block following sugammadex 2 mg/kg:21
  • BRIDION was well tolerated by all age groups with an AE profile that was consistent with other studies21

Important safety information

BRIDION safety information

Please refer to BRIDION SPC for full prescribing information.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Adverse events

Summary of the safety profile 

BRIDION® (sugammadex) is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients. The causality of adverse events is therefore difficult to assess. 
The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).

Tabulated list of adverse reactions

The safety of sugammadex has been evaluated in 3,519 unique subjects across a pooled phase I-III safety database. The following adverse reactions were reported in placebo controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1,078 subject exposures to sugammadex versus 544 to placebo): 
[Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)]

System organ classFrequenciesAdverse reactions (preferred terms)
Immune system disordersUncommonDrug hypersensitivity reactions
Respiratory, thoracic and mediastinal disordersCommonCough
Injury, poisoning and procedural complicationsCommonAirway complication of anaesthesia 
Anaesthetic complication 
Procedural hypotension 
Procedural complication

ESMERON® (rocuronium bromide) safety information

Please refer to ESMERON SPC for full prescribing information.

Contraindications and drug interactions

Contraindications

Hypersensitivity to rocuronium or to the bromide ion or to any of the excipients.

Drug interactions

The following drugs have been shown to influence the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents. 
Anaesthetics, other neuromuscular blocking agents (NMBAs), antibiotics, suxamethonium, corticosteroids, diuretics, quinidine, quinine, lithium, magnesium and certain other salts, calcium channel blocking agents, phenytoin, beta-blocking agents, carbamazepine, protease inhibitors, calcium chloride and potassium chloride. ESMERON combined with lidocaine may result in a quicker onset of action of lidocaine. These interactions should be taken into account for paediatric patients.

Adverse events

The most commonly occurring adverse drug reactions include injection site pain/reaction, changes in vital signs and prolonged neuromuscular block. The most frequently reported serious adverse drug reactions during post-marketing surveillance is ‘anaphylactic and anaphylactoid reactions’ and associated symptoms.

MedDRA SOCPreferred term*
Uncommon/rare† (<1/100, >1/10 000)Very rare (<1/10 000)Not known
Immune system disorders Hypersensitivity 
Anaphylactic reaction 
Anaphylactoid reaction 
Anaphylactic shock 
Anaphylactoid shock
Nervous system disorders Flaccid paralysis
Cardiac disordersTachycardia Kounis syndrome
Vascular disordersHypotensionCirculatory collapse and shock 
Flushing
Respiratory, thoracic and mediastinal disorders Bronchospasm
Skin and subcutaneous tissue disordersAngioneurotic oedema 
Urticaria 
Rash 
Erythematous rash 
Musculoskeletal and connective tissue disordersMuscular weakness‡ 
Steroid myopathy‡
General disorders and administration site conditionsDrug ineffective 
Drug effect/ therapeutic response decreased 
Drug effect/ therapeutic response increased 
Injection site pain 
Injection site reaction		Face oedema
Injury, poisoning and procedural complicationsProlonged neuromuscular block 
Delayed recovery from anaesthesia		Airway complication of anaesthesia

* Frequencies are estimates derived from post-marketing surveillance reports and data from the general literature. 
† Post-marketing surveillance data cannot give precise incidence figures. For that reason, the reporting frequency was divided over two rather than five categories. 
‡ After long-term use in the ICU

References

  1. BRIDION Summary of Product Characteristics.
  2. Blobner M, Eriksson LI, Scholz J et al. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared to neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. European Journal Anaesthesiology. 2010;27:874-881.
  3. 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.
  4. Blobner M, Eriksson LI, Scholz J et al. Reversal of rocuronium-induced blockade with sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017;8:CD012763.
  5. Association of Anaesthetists of Great Britain and Ireland. Recommendations for standards of monitoring during anaesthesia and recovery 2015. Anaesthesia. 2016;71:85-93.
  6. Dubois PE and Mulier JP A review of the interest of sugammadex for deep muscular block management in Belgium. Acta Anaesth Belg. 2013;64(2):49–60.
  7. Murphy GS, Szokol JW, Marymont JH et al. Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit. Anesthesiol. 2008;109:389-98.
  8. Murphy GS, Szokol JW, Marymont JH et al. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008;107:130–137.
  9. Odor PM, Bampoe S, Gilhooly D et al. Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis. BMJ 2020; 368: m540.
  10. Khuri SF, Henderson WG, DePalma RG et al. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005; 242(3): 326-341.
  11. Ruscic KJ, Grabitz SD, Rudolph M et al. Prevention of respiratory complications of the surgical patient: actionable plan for continued process improvement. Curr Opin Anaesthesiol. 2017; 30(3): 399-408.
  12. Mills GH. Respiratory complications of anaesthesia. Anaesthesia 2018; 73(Suppl. 1): 25-33.
  13. Eikermann M, Santer P, Ramachandran S-K et al. Recent advances in understanding and managing postoperative respiratory problems. F1000Res 2019; doi: 10.12688/f1000research.16687.1.
  14. Chung F, Mezei G, Tong D. Pre-existing medical conditions as predictors of adverse events in day-case surgery. Br J Anaesth. 1999;83:262-270.
  15. Miskovic A and Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017; 118:317-334.
  16. Carron M, Zarantonello C, Tellaroli P et al. Efficacy and safety compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomised controlled trials. J Clin Anesth. 2016; 35:1-12.
  17. De Robertis E, Zito Marinosci GZ, Romano GM et al. The use of sugammadex for batriatric surgery: analysis of recovery time from neuromuscular blockade and possible economic impact. Clinicoecon Outcomes Res.2016;8:317-322.
  18. Carron M, Veronese S, Foletto, M et al. Sugammadex allows fast-track bariatric surgery. Obse Surg. 2013;23:1558-1563.
  19. Murphy GS and Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg.2010;111(1):120-128.
  20. Murphy GS, Szokol JW, Avram MJ et al. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015;123:1322-1336.
  21. 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;114:318-329

Supporting documentation

BRIDION
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)

ESMERON
Prescribing Information

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GB-XBR-00459 | Date of preparation: March 2023