Patient Medication Information: uses, side effects, how to take - Trasylol
ABOUT THIS MEDICATION
What the medication is used for:
TRASYLOL® is used to help reduce the amount of bleeding and the need for a blood transfusion during coronary artery bypass graft (CABG) surgery in patients at increased risk of bleeding and needing a blood transfusion.
What it does:
TRASYLOL® is a drug that stops bleeding from an open wound and helps maintain a balance between bleeding and blood clotting. It is derived from bovine (cow) lung.
When it should not be used:
You should not use TRASYLOL® if you are hypersensitive to this drug or to any other ingredient in the TRASYLOL® container.
You should not use TRASYLOL® if you have received TRASYLOL® or any products containing aprotinin (such as fibrin sealant) in the previous 12 months. Products containing aprotinin (such as fibrin sealants) are sometimes used in other surgeries.
What the medicinal ingredient is:
Aprotinin
What the nonmedicinal ingredients are:
Sodium Chloride
Water for Injection
What dosage forms it comes in:
intravenous solution
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- An association between TRASYLOL® use and increased mortality has been reported in some published studies. TRASYLOL® should only be used as authorized in heart bypass surgery, after careful consideration of the potential risks and benefits.
- TRASYLOL® can affect certain laboratory tests for blood clotting. In patients who receive TRASYLOL® during heart bypass surgery, specific methods are recommended to monitor blood clotting. These recommendations need to be followed to ensure an adequate amount of medication designed to limit clotting (sometimes called “blood thinners”) is administered during treatment with TRASYLOL®.
- The use of TRASYLOL® may lead to kidney problems and there may be a need for dialysis after surgery. Patients who may already have kidney problems, or receive other drugs during surgery that can harm the kidney, are at higher risk of developing kidney problems when given TRASYLOL®.
- TRASYLOL® may cause fatal anaphylactic reactions resulting in death (fatal reactions). Fatal reactions have occurred when an initial (test) dose was given as well as in situations where the initial (test) dose was tolerated, and after that, TRASYLOL® was given. Please see “PROPER USE OF THIS MEDICATION” for explanation of doses.
Allergic or anaphylactic reactions are immune reactions that can damage the body’s own tissues. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent aprotinin exposure.
TRASYLOL® may increase the risk that your kidneys may not function as well as before. It may also increase the risk that you may need to have dialysis in the time period immediately after your surgery until you are discharged home. Dialysis is the process of cleansing the blood by passing it through a special machine.
BEFORE you use TRASYLOL® talk to your doctor if you have or have had any of the following conditions:
- are taking any other medications, especially aminoglycosides (a type of antibiotic)
- significant kidney problems
are pregnant or nursing
- have ever received TRASYLOL® or any products containing aprotinin (such as fibrin sealant)
in the previous 12 months
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with TRASYLOL® include:
- thrombolytic agents (ie, drugs that break up or dissolve clots. Examples include: streptokinase, tPA and urokinase)
- captopril (a medication for high blood pressure)
See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.
PROPER USE OF THIS MEDICATION
Usual dose
This medication is given at the time of your surgery. A 1 mL test dose is given through an intravenous (IV) line to test to see if you have an allergic reaction to this medication. This is done before the anesthetic is given to you. After the anesthetic is given and you are lying down, a second larger dose (200 mL) is given over a 20 to 30 minute period. This is called the loading dose, and it is given before the start of your surgery. As your surgery involves your blood circulating through a mechanical pump to bypass the heart, 200 mL of TRASYLOL® will also be added to this pump. In addition, 50 mL of TRASYLOL® will be administered to you through the IV pump each hour until the surgery is completed.
Overdose
Although TRASYLOL® has been used extensively in clinical medicine, no symptoms of overdosing are known.
Missed Dose
Not applicable.
Stopped Treatment
If allergic reactions occur during administration, TRASYLOL® will be stopped immediately. Standard emergency treatment will be available.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Generally, TRASYLOL® is well tolerated. It is possible that you could experience an allergic reaction to TRASYLOL®. If an allergic reaction occurs, you could develop low blood pressure, a skin rash, breathing difficulty, rapid heart rate, itching, or nausea. A severe allergic reaction could even result in death. The following events have occurred in some patients after receiving TRASYLOL®: abnormal kidney function test results which may or may not return to normal over time, kidney failure which may or may not return to normal, and heart attack (both fatal and non-fatal).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom/ Effect | Talk with your doctor | ||||
| Only if severe | In all cases | ||||
| Uncommon | |||||
| Allergic reaction (skin rash, breathing difficulty, rapid heart rate, itching, nausea, low blood pressure) | ✓ | ||||
| Heart attack (chest pain, nausea) | ✓ | ||||
This is not a complete list of side effects. For any unexpected effects while taking TRASYLOL®, contact your doctor or pharmacist.
HOW TO STORE IT
The hospital stores TRASYLOL® in sealed vials at room temperature. It is not stored above 25˚C or frozen. If a precipitate or particulate matter is present, or if the contents are cloudy, the drug should not be used. Once a vial has been opened, it should be used immediately.
If you think you have taken too much TRASYLOL®, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
REPORTING SUSPECTED SIDE EFFECTS
Reporting Side Effects You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
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| NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Methapharm Inc. You can report any suspected adverse reactions associated with the use of health products to Methapharm Inc. by:
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MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the distributor, Methapharm Inc., at: 1-800-287-7686.
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario N3S 7X6
Canada
Last revised: September 19, 2014
2014, Nordic Group