Sugammadex

Structure of Suagammadex

What is Sugammadex?

Bridion is an anesthetic agent indicated for the reversal of neuromuscular blockade in adults and children over 2 years undergoing surgery

What are the uses of Sugammadex?

Bridion is used for the reversal of neuromuscular blockade caused by the anesthetics rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.

Who Should Not Use Sugammadex?

• Those with known hypersensitivity to sugammadex or any of its components.

Sugammadex sodium 3D front view

Is Sugammadex FDA approved?

Yes. It was initially U.S. FDA Approved in 2015

How should Sugammadex be used?

Dosing is based on actual body weight

• Monitor for twitch responses to determine the timing and dose for bridion administration.
• Administer as a single bolus injection.

For rocuronium and vecuronium:

• 4 mg/kg 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.
• 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to tof stimulation.

For rocuronium only:

• 16 mg/kg 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. Immediate reversal in pediatric patients has not been studied.

What are the dosage forms and brand names of Sugammadex?

Dosage forms and strengths Bridion® (sugammadex) injection, for intravenous use

• 200 mg/2 ml (100 mg/ml) in a single-dose vial for bolus injection
• 500 mg/5 ml (100 mg/ml) in a single-dose vial for bolus injection

Estructura 3D de Sugammadex (una gamma-ciclodextrina)

What side effects can Sugammadex cause?

Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg bridion dose and higher than the placebo rate):

• vomiting,
• pain, nausea,
• hypotension, and
• headache.

Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at bridion doses of 2 or 4 mg/kg) were

• pain
• vomiting
• and nausea.

What special precautions should I follow?

• Anaphylaxis: be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions.
• Marked bradycardia: cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after administration. Monitor for hemodynamic changes and administer anticholinergic agents such as atropine if clinically significant bradycardia is observed.
• Respiratory function monitoring: ventilatory support is mandatory until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Provide adequate ventilation if neuromuscular blockade persists after bridion or recurs following extubation.
• Waiting times for re-administration of neuromuscular blocking agents: if re-administration of a neuromuscular blocking agent is required after reversal with bridion, waiting times should be based on the dose of bridion and the renal function of the patient. Consider use of a nonsteroidal neuromuscular blocking agent.

What drug interactions can Sugammadex cause?

• Toremifene: concomitant use can delay recovery.

• Hormonal contraceptives: patients must use an additional, non-hormonal method of contraception for 7 days following bridion administration.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can Sugammadex be used in pregnancy?

No

Can Sugammadex be used in children?

Yes, 2 years and above

What should I know about storage and disposal of Sugammadex?

BRIDION (sugammadex) injection is a clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.

• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Protect from light. When not protected from light, the vial should be used within 5 days.
• Discard unused portion.

What are the active and inactive ingredients in Sugammadex?=

Active ingredient/active moiety

• Sugammadex sodium

Inactive ingredients

• Hydrochloric acid
• Water

Who manufactures and distributes Sugammadex?

• Merck Sharp & Dohme Corp.

• Dailymed label info on Sugammadex
• FDA Sugammadex