Sugammadex

Sugammadex is used in adults and children during surgery to reverse the effects of certain muscle-relaxing medicines, such as rocuronium and vecuronium.

Sugammadex helps restore muscle function that was blocked during surgery.

Sugammadex may also be used for reasons not mentioned in this medication guide.

Sugammadex is given as an injection into a vein through an IV. A healthcare provider will administer this medicine as a single injection.

Your breathing, blood pressure, oxygen levels, heart rate, and other vital signs will be monitored closely while you are receiving sugammadex.

Before you get sugammadex, inform your doctor about all your medical conditions or allergies, as well as all the medicines you are currently taking. Also, make sure your doctor is aware if you are pregnant or breastfeeding.

Your medical team will monitor you closely for any breathing issues, slow heart rates, or signs of an allergic reaction after you receive sugammadex.

You should not be treated with sugammadex if you are allergic to it.

Tell your doctor if you have or have ever had:

• a bleeding or blood clotting disorder such as hemophilia;
• low levels of platelets in your blood;
• a breathing disorder;
• liver disease; or
• kidney disease (or if you are on dialysis).

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. Tell your doctor if you are breastfeeding.

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

Tell your medical caregivers right away if you have:

• flushing (sudden warmth, redness, or tingly feeling);
• itching;
• wheezing, trouble breathing;
• weak or shallow breathing; or
• slow heartbeats.

Common side effects of sugammadex may include:

• nausea, vomiting;
• pain;
• headache; or
• low blood pressure.

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.

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) stimulation2 mg/kg IV once if recovery has reached reappearance of second twitch response to TOF stimulationImmediate reversal (rocuronium only):16 mg/kg IV onceComments: -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.

Sugammadex is taken as a single dose and does not require daily dosing.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Tell your doctor about all the medicines you are currently taking, especially:

• toremifene;
• hormonal birth control, including birth control pills, injections, implants, skin patches, vaginal rings, or hormonal IUDs; or
• medicine used to prevent blood clots, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto), and others.

This list does not include everything. Other drugs may affect sugammadex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.