Sugammadex

Sugammadex
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]

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Overview

Sugammadex is a modified gamma cyclodextrin that is FDA approved for the of reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Common adverse reactions include vomiting, pain, nausea, hypotension, and headache (≥10%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Dosage

Sugammadex injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.

Doses and timing of Sugammadex administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.

Administer Sugammadex intravenously as a single bolus injection. The bolus injection may be given over 10 seconds, into an existing intravenous line. Sugammadex has only been administered as a single bolus injection in clinical trials.

From the time of Sugammadex administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.

The recommended dose of Sugammadex does not depend on the anesthetic regimen.

• Recommended Dosing

Sugammadex can be used to reverse different levels of rocuronium- or vecuronium-induced neuromuscular blockade.

• For rocuronium and vecuronium:

• A dose of 4 mg/kg Sugammadex is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade [see WARNINGS AND PRECAUTIONS (5.8)].
• A dose of 2 mg/kg Sugammadex is recommended if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade.

• For rocuronium only:

• A dose of 16 mg/kg Sugammadex is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. The efficacy of the 16 mg/kg dose of Sugammadex following administration of vecuronium has not been studied.

Sugammadex dosing is based on actual body weight.

• Drug Compatibility

May inject Sugammadex into the intravenous line of a running infusion with the following intravenous solutions:

• 0.9% sodium chloride
• 5% dextrose
• 0.45% sodium chloride and 2.5% dextrose
• 5% dextrose in 0.9% sodium chloride
• isolyte P with 5% dextrose
• Ringer's lactate solution
• Ringer's solution

Ensure the infusion line is adequately flushed (e.g., with 0.9% sodium chloride) between administration of Sugammadex and other drugs.

Do not mix Sugammadex with other products except those listed above.

Sugammadex is physically incompatible with verapamil, ondansetron, and ranitidine.

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and efficacy of Sugammadex in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Contraindications

Sugammadex is contraindicated in patients with known hypersensitivity to Sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to Sugammadex.

Warnings

There is limited information regarding Sugammadex Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sugammadex Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sugammadex Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sugammadex Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sugammadex in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sugammadex in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sugammadex during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sugammadex in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sugammadex in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sugammadex in geriatric settings.

Gender

There is no FDA guidance on the use of Sugammadex with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sugammadex with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sugammadex in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sugammadex in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sugammadex in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sugammadex in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sugammadex Administration in the drug label.

Monitoring

There is limited information regarding Sugammadex Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sugammadex and IV administrations.

Overdosage

There is limited information regarding Sugammadex overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sugammadex Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sugammadex Mechanism of Action in the drug label.

Structure

There is limited information regarding Sugammadex Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sugammadex Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sugammadex Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sugammadex Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sugammadex Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sugammadex How Supplied in the drug label.

Storage

There is limited information regarding Sugammadex Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sugammadex Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sugammadex interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

BRIDION®

Look-Alike Drug Names

There is limited information regarding Sugammadex Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.