What is the lowest recommended pediatric age for administration of sugammadex (Bridion)?

Lowest Pediatric Age for Sugammadex Administration

Sugammadex is FDA-approved for adults only and is not approved for use in children under 18 years of age in the United States. 1

FDA-Approved Age Restrictions

• The FDA prescribing information explicitly states: "Safety and effectiveness of BRIDION have not been established in patients ≤ 17 years of age." 1
• This represents the official regulatory position in the United States as of the most recent FDA labeling 1

International Approval Differences

• In Europe, Australia, Iceland, New Zealand, and Norway, sugammadex is approved for children aged 2 years and older for reversal of rocuronium-induced moderate neuromuscular blockade 2
• The European approval specifically covers pediatric patients aged 2-17 years 2
• As of 2018, sugammadex was not approved for children under 2 years of age in France, influencing clinical practice decisions regarding rocuronium use 3

Recent Clinical Trial Evidence in Children Under 2 Years

A 2025 phase IV randomized clinical trial (the most recent high-quality evidence) demonstrated that sugammadex at 2 mg/kg and 4 mg/kg doses is safe and effective in children aged 1 to 720 days (birth to less than 2 years). 4 This represents the strongest evidence to date for use in this age group:

• The trial included 138 participants aged 1 to 720 days 4
• Sugammadex 2 mg/kg reversed moderate neuromuscular blockade faster than neostigmine (median 1.4 vs 4.4 minutes) 4
• Sugammadex 4 mg/kg achieved rapid reversal of deep blockade with median time of 1.1 minutes 4
• No deaths, drug-related serious adverse events, or anaphylaxis events occurred 4
• The safety profile was similar to neostigmine 4

Expert Guideline Recommendations

• The American Society of Anesthesiologists recommends that sugammadex is not used in newborns due to insufficient safety and efficacy data in this population 5
• French guidelines from 2017 recommend that sugammadex should be "rapidly available" when rocuronium is used in pediatric rapid sequence intubation, though approval status varies by country 3

Clinical Practice Considerations

For neonates and infants under 2 years where sugammadex is not approved, neostigmine remains the standard reversal agent:

• Neostigmine 0.04-0.05 mg/kg combined with atropine 0.02 mg/kg is the established approach 5
• Administer only when at least 4 responses to train-of-four stimulation are present 5
• Expect reversal to TOF ratio ≥0.9 in 10-20 minutes 5

Important Caveats

• Off-label use: Any use of sugammadex in children under 18 years in the United States, or under 2 years internationally, represents off-label prescribing 1, 2
• Growing evidence from 2024 systematic reviews suggests that 2-4 mg/kg sugammadex can be safely used in neonates and infants, with non-inferior adverse event profiles compared to neostigmine 6
• Higher doses (8-16 mg/kg) may serve as rescue therapy during "can't intubate, can't ventilate" scenarios in infants, though this is based on limited evidence 6
• The 2025 trial data provides the strongest evidence to date but has not yet resulted in FDA approval changes 4

In summary: The FDA-approved minimum age is 18 years (not approved for pediatrics), while European approval begins at 2 years. Recent 2025 trial data supports safety and efficacy down to 1 day of age, but this remains off-label in most jurisdictions.