What are the side effects of Sugammadex (Bridion)?

Side Effects of Sugammadex

Sugammadex is generally well tolerated with fewer adverse events than neostigmine, but clinicians must remain vigilant for hypersensitivity reactions (including anaphylaxis occurring in 0.3% at standard doses), cardiac arrhythmias (particularly bradycardia and cardiac arrest), and bronchospasm. 1

Common Side Effects

The most frequently reported adverse events from clinical trials include:

• Gastrointestinal effects: Nausea, vomiting, and dry mouth occur in 1-5% of patients 1
• Cardiovascular effects: Hypertension (5-7%), hypotension (4-5%), tachycardia (2-5%), and bradycardia (1-5%) 1
• Dermatologic reactions: Pruritus (2-3%) and erythema (1-2%) 1
• Procedural complications: Procedural complications and procedural pain occur in 4-7% of patients 1

Importantly, sugammadex demonstrates 40% fewer composite adverse events compared to neostigmine (16% vs 28%, NNTB = 8), with significantly reduced risks of bradycardia (RR 0.16, NNTB 14), postoperative nausea and vomiting (RR 0.52, NNTB 16), and signs of postoperative residual paralysis (RR 0.40, NNTB 13). 2

Serious Adverse Events

Hypersensitivity and Anaphylaxis

• Anaphylaxis occurs in 0.3% of patients at standard doses (4 mg/kg) and 1% at high doses (16 mg/kg) in dedicated hypersensitivity studies 1
• Hypersensitivity reactions range from isolated skin reactions (flushing, urticaria, erythematous rash) to life-threatening systemic reactions including anaphylactic shock 1
• These reactions can occur in patients with no prior exposure to sugammadex 1
• Symptoms may include severe hypotension, tachycardia, tongue/pharyngeal swelling, bronchospasm, and pulmonary obstructive events 1
• The incidence of confirmed hypersensitivity is approximately 5% at standard bariatric surgery doses 3

Cardiac Complications

• Marked bradycardia and bradycardia with cardiac arrest have been observed within minutes of administration 1
• Other cardiac rhythm abnormalities reported include atrial fibrillation, atrioventricular block, cardiac/cardiorespiratory arrest, ST segment changes, supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia 1
• QT interval abnormalities occur in approximately 1-6% of patients 1

Respiratory Complications

• Bronchospasm has been reported, particularly in patients with history of pulmonary complications 1
• Laryngospasm, dyspnea, wheezing, pulmonary edema, and respiratory arrest have been documented in post-marketing surveillance 1
• Recurrence of neuromuscular blockade occurs in <1% of patients when dosed appropriately for depth of block 1

Special Population Considerations

Renal Impairment

• Limited data exists on risk of recurarization in patients with severe renal impairment due to impaired drug elimination 4
• These patients require extended postoperative monitoring for signs of recurarization 4

Pregnancy and Lactation

• Sugammadex is a large, highly polar molecule that theoretically limits placental transfer 5
• It is acceptable for use during breastfeeding due to likely very low milk levels and unlikely oral absorption by the infant 5
• High-dose rocuronium with sugammadex backup is considered a suitable alternative to succinylcholine for rapid sequence induction in obstetric anesthesia 5

Transgender Patients on Hormone Therapy

• Sugammadex binds estrogen, potentially reducing serum estrogen concentrations, though the clinical significance remains unclear 3
• This interaction should be considered in transgender women on estrogen therapy 3

Drug Interactions

• Sugammadex can bind hormonal contraceptives, requiring patients on oral hormonal contraception to use or add non-oral contraception for 4 weeks after administration 3
• Monitor effects on oral medications with narrow therapeutic index (e.g., warfarin) 3

Clinical Context

A retrospective analysis of 89,753 surgeries found composite side effects in 3.4% of sugammadex patients versus 3.0% with neostigmine, with the most common being bradycardia (2.4% vs 2.2%) 6. While this represents a statistically significant difference, the absolute difference of 0.4% is clinically negligible, requiring treatment of 250 patients with neostigmine instead of sugammadex to prevent one minor complication 6.

Serious adverse events occur in less than 1% of patients with both sugammadex and neostigmine, with no significant difference in risk between the two agents 2, 6.

Key Clinical Pitfalls

• Sugammadex is contraindicated in patients with known hypersensitivity to the drug or its components 1
• Ensure appropriate dosing based on depth of neuromuscular blockade to minimize risk of recurarization 1
• Have resuscitation equipment immediately available due to risk of anaphylaxis and cardiac events 1
• Post-marketing reports indicate cases of sugammadex not having the intended effect, emphasizing the need for neuromuscular monitoring 1