Bridion

Generic name: sugammadex
Drug class: Miscellaneous central nervous system agents

Medically reviewed by  A Ras MD.

What is Bridion?

Bridion is a prescription medicine that is used to reverse the effects of some drugs.

Description

BRIDION (sugammadex) injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:

BRIDION is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg.

BRIDION may contain up to 7 mg/mL of the mono OH-derivative of sugammadex . This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:

Mechanism of Action

BRIDION is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

Before taking Bridion, tell your doctor:

• If you are allergic to Bridion; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease or are on dialysis.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Bridion with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Bridion?

• Tell all of your health care providers that you take Bridion. This includes your doctors, nurses, pharmacists, and dentists.
• Unsafe allergic effects may happen. You will be closely watched by your doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy after getting Bridion. Use some other kind of birth control also, like a condom, for 7 days after getting Bridion.
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use Bridion.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Bridion best taken?

Use Bridion as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• This medicine is used during surgery. Talk with your doctor.

What are the side effects of Bridion that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Flushing.
• Skin irritation.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Chest pain.
• Fever or chills.
• Mouth or throat pain or irritation.

What are some other side effects of Bridion?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.
• Stomach pain.
• Dizziness.
• Cough.
• Trouble sleeping.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Bridion?

• If you need to store Bridion at home, talk with your doctor, nurse, or pharmacist about how to store it.

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Label

PRINCIPAL DISPLAY PANEL – 2 ML VIAL CARTON

• NDC 0006-5423-12
• Bridion®
  (sugammadex) Injection
  200 mg/2 mL (100 mg/mL)
• Rx only
  10 Single-Dose 2 mL Vials
• For Intravenous Use Only