Sugammadex

Sugammadex is a prescription medication used to reverse the effects of certain neuromuscular blocking drugs used during surgery. Sugammadex belongs to a group of drugs called antidotes. These work by helping patients recover from medications used for intubation or ventilation during surgery.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of sugammadex include vomiting, low blood pressure, and pain.

Sugammadex may be found in some form under the following brand names:

• Bridion

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• toremifene (Fareston)
• hormonal contraceptives (birth control) containing an estrogen or progestogen. Sugammadex will make hormonal contraceptives less effective. If a hormonal contraceptive is taken on the same day that you receive sugammadex, you will need to use an effective back-up method of birth control (such as condoms or spermicides) for the next 7 days.

This is not a complete list of sugammadex drug interactions. Ask your doctor or pharmacist for more information.

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.

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

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

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.

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.

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

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.

• Tell all of your health care providers that you take sugammadex. 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 this medicine. Use some other kind of birth control also, like a condom, for 7 days after getting sugammadex.
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using sugammadex while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take sugammadex or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sugammadex. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

<3 minutes

Half-Life Elimination

Effective: ~2 hours; Prolonged in renal impairment: Mild renal impairment: 4 hours; Moderate renal impairment: 6 hours; Severe renal impairment: 19 hours

Protein Binding

Negligible

Note: Dosing based on actual body weight. Doses and timing of administration based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.

Routine reversal of rocuronium- or vecuronium-induced blockade: IV:

Deep block (at least 1 to 2 post-tetanic counts but prior to appearance of T2): 4 mg/kg as a single dose

Moderate block (after appearance of T2): 2 mg/kg as a single dose

Readministration of rocuronium or vecuronium: Following sugammadex use for routine reversal, waiting times for readministration of rocuronium or vecuronium vary greatly (5 minutes to 24 hours) depending on agent, dose, and renal function (consult product labeling); if immediate neuromuscular blockade is needed, a nonsteroidal neuromuscular-blocking agent may be required.

Immediate reversal of rocuronium-induced blockade: IV: 16 mg/kg as a single dose administered soon (~3 minutes) after administration of a single dose of rocuronium 1.2 mg/kg. Note: This dose of sugammadex has not been evaluated following administration of vecuronium.

Readministration of rocuronium or administration of vecuronium: Following sugammadex use for immediate reversal of rocuronium, wait 24 hours before readministering rocuronium or administering vecuronium. If more immediate neuromuscular blockade is needed, a nonsteroidal neuromuscular-blocking agent may be required.

IV: Administer as rapid IV push over 10 seconds; if administered in same IV line as other products, flush with saline before and after administration of sugammadex.

May interfere with the serum progesterone assay; interaction may be observed for up to 30 minutes after a 16 mg/kg dose of sugammadex.

Severe renal impairment: Use not recommended

-Mild to moderate renal impairment: Minimum wait time for readministration of rocuronium 0.6 mg/kg or vecuronium 0.1 mg/kg after reversal with sugammadex up to 4 mg/kg should be 24 hours; if a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg