When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to reteplase. Because this medicine increases the risk of bleeding problems, some medical conditions may make receiving reteplase dangerous. These include any type of bleeding in your body, such as a bleeding ulcer or having had a recent surgery or injury (within the past 6 to 8 weeks). Other medical conditions that may make it unsafe to receive this medicine include a brain tumor, a history of strokes, certain blood vessel problems, or uncontrolled high blood pressure. Since this medicine may save your life, your doctor will weigh the benefits of this medicine against the risks of giving it if you have certain medical problems.

How to Use This Medicine:
Kit

• A nurse or other health provider will give you this medicine. This medicine is given through a needle placed in one of your veins.
• You may also receive blood thinning medicines, such as aspirin and heparin, with reteplase. Reteplase breaks apart blood clots you already have, while other blood thinning medicines help prevent more clots from forming. During this time, you will be watched closely to make sure the medicine is working and is not causing unwanted side effects.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using dipyridamole (Persantine®), a blood thinner such as warfarin (Coumadin®) or heparin, or pain or arthritis medicines such as aspirin, ibuprofen, naproxen, Motrin®, Advil®, or Aleve®. There are other medicines that may interact with reteplase. Make sure your doctor knows about all other medicines you have used recently.

Warnings While Using This Medicine:

• Make sure your doctor knows if you have recently had a baby, or if you are pregnant or breast feeding. Make sure your doctor knows if you have had any recent injury, surgery, medical procedure, or dental work. Make sure your doctor knows if you have stomach problems such as ulcers or colitis. Tell your doctor if you have a history of strokes or brain disease, high blood pressure, heart problems, liver disease, or kidney disease. Make sure your doctor knows if you have diabetes, eye problems, or any condition that increases your risk for bleeding.
• This medicine dissolves blood clots in the body, which increases your risk of bleeding problems. Be extra careful to avoid injuries until the effects of the medicine have worn off. Do not get out of bed without help.
• Watch for any bleeding from any skin punctures, such as around your IV or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you have any bleeding or injuries, tell your doctor or nurse right away.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody urine, or bowel movements that are bloody, black, or tarry (sticky).
• Bloody vomit, or vomit that looks like coffee grounds.
• Chest pain, or a heartbeat that is too fast, too slow, pounding, or irregular.
• Coughing up blood.
• Fever.
• Heavy vaginal bleeding.
• Lightheadedness or fainting.
• New or unexplained bruising, bleeding, swelling, or pain anywhere in your body.
• Numbness (loss of feeling), tingling, pain, or darkening of the skin of your toes.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Sudden or severe headache, problems with vision, speech, or walking.

If you notice these less serious side effects, talk with your doctor:

• Nausea or vomiting.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088