Retavase is a thrombolytic (THROM-bo-LIT-ik) drug, sometimes called a "clot-busting" drug. It helps your body produce a substance that dissolves unwanted blood clots.

Retavase is used to improve heart function and prevent congestive heart failure or death in people who have had a heart attack (acute myocardial infarction).

Retavase may also be used for purposes not listed in this medication guide.

If possible before you receive Retavase, tell your doctor if you have a brain tumor or aneurysm, high blood pressure, hemophilia or other bleeding disorder, a history of stroke, or if you have recently had a head injury or surgery on your brain or spinal cord.

Retavase is given as an infusion into a vein. A healthcare provider will give you this injection.

Retavase is usually given in two injections 30 minutes apart.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Retavase.

You should not be treated with Retavase if you are allergic to it, or if you have:

• active bleeding inside your body;

• a bleeding or blood clotting disorder such as hemophilia;

• a brain tumor or blood vessel disorder;

• a brain aneurysm (dilated blood vessel);

• severe uncontrolled high blood pressure;

• a history of stroke; or

• a recent history of head injury, or surgery on your brain or spinal cord.

If possible before you receive Retavase, tell your doctor if you have ever had:

• a major surgery, medical trauma, or injury;

• bleeding in your brain, stomach, intestines, or urinary tract;

• a stroke; or

• high blood pressure.

In an emergency, you may not be able to tell caregivers about your health conditions. Make sure any doctor caring for you afterward knows you received Retavase.

If possible before you receive Retavase, tell your caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Because you will receive Retavase in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Ask your doctor before taking aspirin or ibuprofen (Motrin, Advil) shortly after you have received Retavase. These medications can increase your risk of bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching, skin redness; difficult breathing; swelling of your face, lips, tongue, or throat.

Retavase increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop. Bleeding may occur from a surgical incision, or from the skin where a needle was inserted during a blood test or while receiving injectable medication. You may also have bleeding on the inside of your body, such as in your stomach or intestines, kidneys or bladder, brain, or within the muscles.

Call your doctor at once if you have signs of bleeding inside your body, such as:

• easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection);

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• red or pink urine; or

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Also call your doctor at once if you have:

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• severe headache, blurred vision, pounding in your neck or ears;

• swelling, rapid weight gain, little or no urinating;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• darkening or purple discoloration of your fingers or toes;

• very slow heartbeats, shortness of breath, feeling light-headed; or

• sudden severe back pain, muscle weakness, numbness or loss of feeling in your arms or legs.

Common side effects may include nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner (warfarin, Coumadin, Jantoven).

This list is not complete. Other drugs may affect Retavase, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.