Patient Medication Information: uses, side effects, how to take - Sugammadex Injection (Sandoz Canada)
What is SUGAMMADEX INJECTION used for?
SUGAMMADEX INJECTION is used to reverse the effects of certain muscle relaxants (i.e., rocuronium and vecuronium) used during an operation or surgery.
How does SUGAMMADEX INJECTION work?
When you have surgery you are given drugs that help your muscles relax completely. These types of drugs are known as muscle relaxants. Rocuronium and vecuronium are a type of muscle relaxant that the healthcare professional may give to you before your surgery. When your muscles are relaxed it makes it easier for the healthcare professional to do the surgery. At the end of your surgery, SUGAMMADEX INJECTION is given to help get rid of the effects of these muscle relaxants.
What are the ingredients in SUGAMMADEX INJECTION?
Medicinal ingredient: sugammadex (as sugammadex sodium).
Non-medicinal ingredients: hydrochloric acid, sodium hydroxide, and water for injection.
SUGAMMADEX INJECTION comes in the following dosage forms:
Solution for Injection: 100 mg/mL of sugammadex (as sugammadex sodium).
Serious Warnings and Precautions
- This drug should be administered only by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
- This drug may cause allergic reactions. Severe allergic or allergic-like reactions can be life threatening.
Do not use SUGAMMADEX INJECTION if:
- you are allergic to sugammadex or to any of the other ingredients in SUGAMMADEX INJECTION. Tell your healthcare professional who will be giving you the anesthesia if you have any allergies. This includes any allergies to food or other drugs.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SUGAMMADEX INJECTION. Talk about any health conditions or problems you may have, including if you:
- have heart problems
- have liver disease or have had it in the past
- have fluid retention (edema)
- have kidney disease or have had it in the past or are on dialysis. This is important as SUGAMMADEX INJECTION is removed from your body by the kidneys. Tell your healthcare professional who will be giving you the anesthesia if this applies to you.
are pregnant or might be pregnant
- are breastfeeding
- have diseases which are known to give an increased risk of bleeding (trouble with blood clotting)
- have a history of airway or lung problems
Other warnings you should know about:
Driving and using machines: Your healthcare professional will tell you when it is safe to drive or use machines after you have been given SUGAMMADEX INJECTION. SUGAMMADEX INJECTION is not expected to have an effect on alertness or concentration.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SUGAMMADEX INJECTION:
- toremifene (used to treat breast cancer)
- fusidic acid (used to treat infections)
It is important that you tell your healthcare professional who will be giving you the anesthesia if you have recently taken these medicines.
SUGAMMADEX INJECTION can affect hormonal contraceptives used for birth control:
SUGAMMADEX INJECTION can make birth control methods less effective because it reduces how much you get of the hormone progestogen. Tell your healthcare professional if you are currently using any of the following:
- the ‘Pill’
- vaginal ring
- implants
- hormonal Intra Uterine Device (IUD)
If you are:
- taking the “Pill” on the same day as SUGAMMADEX INJECTION is given to you, follow the instructions for a missed dose in the Pill’s package insert.
- using other non-oral contraceptive methods (for example a vaginal ring, implant or IUD, you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days.
Effects on blood tests:
In general, SUGAMMADEX INJECTION does not have an effect on laboratory tests. However, it may change the results of a blood test for progesterone (a hormone).
How to take SUGAMMADEX INJECTION:
SUGAMMADEX INJECTION will be given to you by a healthcare professional who is trained in giving drugs used when you are having surgery. It is given through your vein as a single injection.
Usual dose:
Your healthcare professional will determine the dose of SUGAMMADEX INJECTION you need. It is based on your weight and how much the muscle relaxant drugs are still affecting you.
Usual dose: 2 mg to 4 mg per kg of body weight. The healthcare professional will determine exactly how much you will be given.
Overdose:
Your healthcare professional will be monitoring you carefully. SUGAMMADEX INJECTION is for hospital use only.
What are possible side effects from using SUGAMMADEX INJECTION?
These are not all the possible side effects you may have when taking SUGAMMADEX INJECTION. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of SUGAMMADEX INJECTION include:
- cough
- nausea
- vomiting
- incision site pain
- fever
- return of muscle relaxation after the operation
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Bradycardia (abnormally slow heartbeat) | X | ||
| UNKNOWN FREQUENCY | |||
| Allergic reaction: difficulty swallowing, difficulty breathing, wheezing, shortness of breath, drop in blood pressure, nausea, vomiting, hives, rash, red skin, or swelling of the face, lips, tongue or throat. | X | ||
| Breathing problems: coughing, mild bucking, difficulty breathing, wheezing, feeling of choking, hoarse or strained voice, shortness of breath, or bluish skin. | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when going from lying or sitting to standing up). | X | ||
| Other heart problems: abnormal heart rhythm, chest discomfort or pain, palpitations, fainting, shortness of breath, weakness, fatigue, dizziness, lightheadedness, bluish skin, sweating, or nausea. | X | ||
| Tachycardia (abnormally fast heartbeat) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
The hospital will store SUGAMMADEX INJECTION according to the correct storage conditions (15°C to 30 °C, and protect from light).
Kept out of reach and sight of children.
If you want more information about SUGAMMADEX INJECTION:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.