Sugammadex Intravenous

In the U.S.

• Bridion

Available Dosage Forms:

• Solution

Therapeutic Class: Nondepolarizing Muscle Relaxant Antagonist

Sugammadex injection is used to reverse the effects of the muscle relaxants rocuronium and vecuronium, which are given to adult patients during surgery.

sugammadex is to be given by or under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sugammadex, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sugammadex or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sugammadex injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sugammadex injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving sugammadex.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving sugammadex, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sugammadex with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Mestranol
• Norethindrone
• Norgestimate
• Norgestrel
• Toremifene

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sugammadex. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Bradycardia (slow heartbeat)—May increase risk for more serious side effects.

• Kidney disease, severe—Use is not recommended in these patients.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Blurred vision
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness

• Chest pain or discomfort
• chills
• fever
• shortness of breath

• Blue lips and fingernails
• confusion
• cough
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with breathing
• difficulty with swallowing
• feeling of warmth
• hives or welts, itching, or rash
• hoarseness
• increased sweating
• irritation
• joint pain, stiffness, or swelling
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• severe, sudden headache
• swelling in the legs and ankles
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• cough
• headache
• nausea
• pain at the injection site
• pain in the arms or legs
• vomiting

• Bloated
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dry mouth
• feeling sad or empty
• full feeling
• irritability
• joint or muscle pain
• lack of appetite
• loss of interest or pleasure
• passing gas
• restlessness
• sore throat
• tiredness
• trouble concentrating
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.