Description
Sugammadex injection is used to reverse the effects of the muscle relaxants rocuronium and vecuronium, which are given to patients during surgery.
This medicine is to be given by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 children younger than 2 years of age. 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 this medicine.
Breastfeeding
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.
Drug Interactions
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 this medicine, 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 this medicine 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
- Medroxyprogesterone
- Mestranol
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Segesterone
- Toremifene
- Ulipristal
Other Interactions
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 this medicine. 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.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
Precautions
It is important that your doctor check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control, including condoms and spermicides along with your pills. Use an effective form of birth control for at least 7 days after receiving sugammadex.
This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Bradycardia may occur after receiving this medicine. Tell your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.
This medicine may increase your risk of bleeding problems. Tell your doctor right away if you have sudden or severe headache, problems with vision, speech, or walking, or unusual bleeding or bruising.
Before you have any medical tests, tell the medical doctor in charge that you were given this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
More common
- 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
Less common
- Chest pain or discomfort
- chills
- fever
- trouble breathing
Incidence not known
- Blue lips and fingernails
- confusion
- cough
- difficult, fast, noisy breathing
- 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:
More common
- Cough
- headache
- nausea
- pain at the injection site
- pain in the arms or legs
- stomach pain
- vomiting
Less common
- 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.
CON-XXXXXXXX
