Brand Names:

• Trasylol

Dosage Forms:

• Solution

Warnings:

Aprotinin administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to aprotinin administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Aprotinin should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. The benefit of aprotinin to patients undergoing primary CABG (coronary artery bypass graft) surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin .

May cause fatal anaphylactic or anaphylactoid reactions with the initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to administration. Aprotinin should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated .

Classifications:

Therapeutic

Hemostatic

Uses of This Medicine:

Aprotinin is used to prevent blood loss and reduce the need for blood transfusions during and after heart bypass operations .

This medicine was available only with your doctor's prescription .

Products containing aprotinin (Trasylol®) were withdrawn from the U.S. market by Bayer Pharmaceuticals on November 5, 2007. This medicine is only available on a very limited basis for patients who are at increased risk of blood loss during heart bypass surgery and who have no other treatment choices..

Before Using This Medicine:

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.

Children

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

Older adults

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of aprotinin in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Other medicines

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.

• Tretinoin

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:

• Kidney disease Use with caution. This medicine may make this condition worse .

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. Aprotinin is given through a needle placed into one of your veins .

Precautions While Using This Medicine:

This medicine might cause a serious allergic reaction. Your doctor will check to see if you are allergic to this medicine and will treat you for the allergy right away .

The risk of having a serious allergic reaction is higher for patients who have received this medicine in the past, especially within the last 12 months. Make sure your doctor knows if you have received this medicine in the past .

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine .

Side Effects of This Medicine:

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

Dizziness

fainting

fast, pounding, or irregular heartbeat or pulse

fever

Less common

Chest pain

confusion

decreased urine output

dilated neck veins

extreme fatigue

irregular breathing

palpitations

shortness of breath

swelling of face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

weakness

weight gain

wheezing

Rare

Agitation

bloody or cloudy urine

difficult or painful urination

difficulty swallowing

coma

cough

depression

headache

hives

hostility

irritability

itching

lethargy

muscle twitching

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures (convulsions)

skin rash

stupor

sudden decrease in amount of urine

swelling of the ankles or hands

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

unusual tiredness or weakness

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:

Less common

Diarrhea

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