FRCA Notes


Sugammadex


  • Sugammadex is a modified ɣ-cyclodextrin 'selective relaxant binding agent'
  • Cyclodextrins are a family of compounds with a wide range of clinical uses
  • They are ring structures made up of sugars, and can be classified by the number of sugars:
    • ɑ-cyclodextrins have 6 sugars
    • β-cyclodextrins have 7 sugars
    • ɣ-cyclodextrins have 8 sugars

  • The inside of the ring is hydrophobic, while the outside is hydrophilic, enabling the cyclodextrin to form complexes with hydrophobic drugs
  • This increases hydrophobic drug solubility, which may be used for better drug delivery, drug elimination or to eliminate odors (i.e. how Febreeze works)

Uses

  • Reversal of rocuronium (and vecuronium) induced neuromuscular blockade
  • Despite some affinity for pancuronium, not used for its reversal
  • Putative role in rocuronium anaphylaxis

Presentation

  • Presents as a colourless solution stored in glass vials at room temperature with a 3yr shelf life
  • Concentration 100mg/ml

Dose

  • Dosing is based on actual body weight
  • For routine reversal:
    • 2mg/kg for moderate block as identified by 2 twitches on ToF (effect in 1 - 1.5mins)
    • 4mg/kg for deep block e.g. 1-2 post-tetanic count (effect in 2 - 3mins)
  • Immediate reversal of RSI dose rocuronium: 16mg/kg (effect in 3.5 - 5mins)

  • Selectively encapsulates the aminosteroid NMBAs
  • The active site of these drugs is thus bound to carboxyl groups within the cyclodextrin, so cannot interact with nAChR at the NMJ

  • Binding the agent effectively removes it from the plasma and the NMJ
  • Encapsulation in the plasma generates a concentration gradient and causes diffusion of the agent away from the NMJ to plasma

Adverse reactions

  • Can cause hypersensitivity reactions
  • Bradycardia ± asystolic arrest reported (rare)
  • Does not appear to affect blood sugar despite dextrin component

Drug interactions

  • Aminosteroid NMBA should not be used for 24hrs following sugammadex administration as may take a very long time for onset of paralysis e.g. 4mins with rocuronium

  • There is the potential for sugammadex to release the encapsulated aminosteroid NMBA in the presence of:
    • Toremifene (a selective oestrogen receptor modulator)
    • Fusidic acid via IV infusion

  • Sugammadex reduces the progesterone available from contraceptives
    • For the OCP a bolus dose equates to missing one day
    • For non-oral hormonal contraception, a bolus equates to 7 days missed

Effect on clotting

  • Seems to cause dose-dependent, temporary (≤30min) increases in APTT and PT of up to 22% (Cureus, 2021)
  • Also manifests as a prolonged K time on a TEG (Int J Med Sci, 2021)
  • The effect is not clinically relevant with respect to the incidence of peri-operative bleeding complications, including interaction with prophylactic dose anticoagulants (European Medicines Agency)

  • Non-biologically active, non-protein bound molecule
  • Volume of distribution 11-14L
  • Demonstrates linear kinetics at therapeutic doses
  • T1/2 2hrs
  • It is not metabolised and excreted solely via the kidneys
    • Caution advised once CrCl ≤30ml/min