Sugammadex

Marked bradycardia and bradycardia with cardiac arrest have been reported, usually within minutes after administration. Monitor closely for hemodynamic changes during and after reversal of neuromuscular blockade; use appropriate pharmacologic treatment (eg, atropine) if significant bradycardia occurs.

Serious hypersensitivity reactions (including anaphylaxis and anaphylactic shock) have been reported (uncommonly). May occur in patients without prior exposure to sugammadex.

Recurrence of neuromuscular blockade has occurred in controlled trials, usually associated with suboptimal dosing. After initial reversal with sugammadex, continue respiratory monitoring and ensure adequate ventilator support remains accessible following extubation. Potentiation of neuromuscular blockade by other drugs used in the post-operative period should also be considered for the possibility of recurrence. Disease-related concerns:

Use caution in patients with cardiovascular disease.

Use caution in patients with hepatic impairment, particularly if accompanied by coagulopathy or severe edema.

Use caution in patients with or at risk for impaired hemostasis (eg, coagulopathies, severe liver impairment, or concurrent use of anticoagulants at therapeutic doses). Dose-dependent transient increases in activated partial thromboplastin time (aPTT) and normalized prothrombin time (PT [INR]) have been observed. In clinical trials, significant effects on bleeding were not observed with low-dose sugammadex alone or in conjunction with therapeutic anticoagulation; high risk patients and those receiving high-dose sugammadex were not adequately studied. Careful monitoring of hemostatic and coagulation parameters is recommended.

Use is not recommended in patients with severe renal impairment (CrCl Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use caution in elderly patients; reversal time may be delayed. Other warnings/precautions:

Use in intensive care (ICU) setting has not been evaluated. Do not use sugammadex for neuromuscular blockade induced by nonsteroidal neuromuscular blocking agents (eg, succinylcholine or benzylisoquinolinium compounds) or steroidal agents other than rocuronium or vecuronium.

Must be administered under supervision of experienced health care provider familiar with its use.

Signs of light anesthesia (eg, coughing, grimacing, movement, or suckling of tracheal tube) may become apparent when neuromuscular blockade is reversed intentionally in the middle of anesthesia.

Since other drugs (eg, opioids) used in the peri- and post-operative period may depress respiratory function, ventilatory support is mandatory until adequate spontaneous respiration is restored and ability to maintain a patent airway is assured. In addition, some patients experience a delayed or minimal response to recommended doses of sugammadex.