Sugammadex reverses the effects of certain medications that are given during surgical procedures to relax your muscles.

Sugammadex is used at the end of surgery, to help restore muscle function that has been blocked during surgery by the other medicines.

Sugammadex may also be used for purposes not listed in this medication guide.

Before you receive sugammadex, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

Sugammadex is injected into a vein through an IV. A healthcare provider will give you this medicine in a single injection.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving sugammadex.

Usual Adult Dose for Reversal of Nondepolarizing Muscle Relaxants:

Routine reversal (rocuronium or vecuronium):
4 mg/kg IV once if recovery has reached at least 1 to 2 posttetanic counts (PTC) and no twitch responses to train-of-four (TOF) stimulation
2 mg/kg IV once if recovery has reached reappearance of second twitch response to TOF stimulation

Immediate reversal (rocuronium only):
16 mg/kg IV once

Comments:
-Dosing is based on actual body weight; the recommended dose does not depend on the anesthetic regimen.
-Satisfactory recovery should be determined by skeletal muscle tone assessments and respiratory measurements in addition to the response to peripheral nerve stimulation.
-The efficacy of the 16 mg/kg dose following vecuronium-induced neuromuscular blockade has not been studied.

Uses: For the reversal of different levels of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

You should not use sugammadex if you are allergic to it.

To make sure sugammadex is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• liver disease;

• a bleeding or blood clotting disorder such as hemophilia;

• low levels of platelets in blood; or

• a breathing disorder.

It is not known whether sugammadex will harm an unborn baby. Tell your doctor if you are pregnant.

Sugammadex can make hormonal birth control less effective. For at least 7 days after you receive sugammadex, use a non-hormonal back-up birth control (condom or diaphragm with spermicide) to prevent pregnancy. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during this time.

It is not known whether sugammadex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since sugammadex is used as a single dose, it does not have a daily dosing schedule.

Since sugammadex is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, skin rash or redness; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• flushing (warmth, redness, or tingly feeling);

• itching;

• eye pain, itching, or discomfort; or

• extreme weakness, weak or shallow breathing.

Common side effects of sugammadex may include:

• slow heartbeats;

• nausea, vomiting;

• pain;

• headache; or

• a light-headed feeling, like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines, especially:

• toremifene;

• a blood thinner--warfarin (Coumadin, Jantoven);

• hormonal birth control--birth control pills, injections, implants, skin patches, vaginal rings; or

• medicine to prevent blood clots--dabigatran (Pradaxa), rivaroxaban (Xarelto), and others.

Other drugs may interact with sugammadex, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.