alteplase

What is the most important information I should know about alteplase?

What is alteplase?

Alteplase 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.

Alteplase is used to treat a stroke caused by a blood clot or other obstruction in a blood vessel. Alteplase is also used to prevent death from a heart attack (acute myocardial infarction).

Alteplase is also used to treat a blood clot in the lung (pulmonary embolism).

Alteplase is also used to dissolve blood clots that have formed in or around a catheter placed inside a blood vessel. This improve the flow of medicines injected in through the catheter, or blood drawn out through the catheter.

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

What should I discuss with my healthcare provider before I receive alteplase?

• active bleeding inside your body;
• a brain tumor or aneurysm (dilated blood vessel);
• a history of head injury or surgery on your brain or spinal cord within the past 3 months; or
• severe or uncontrolled high blood pressure;
• a bleeding or blood clotting disorder such as hemophilia;
• bleeding inside your brain (if you are receiving alteplase to treat a stroke); or
• a recent history of stroke (if you are receiving alteplase for pulmonary embolism).

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

• any type of stroke;
• bleeding in your brain, stomach, intestines, or urinary tract;
• high blood pressure;
• heart problems;
• an infection of the lining of your heart (also called bacterial endocarditis);
• a serious injury or major surgery;
• severe bruising or infection around a vein where an IV was placed;
• an organ biopsy;
• eye problems caused by diabetes;
• liver or kidney disease; or
• if you are pregnant or breastfeeding.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

How is alteplase given?

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

Alteplase is usually given within 3 hours after the first signs of stroke or heart attack symptoms. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

You will also be watched closely for several hours after receiving alteplase, to make sure you do not have an allergic reaction to the medication.

When used to clear blood clots from a catheter, alteplase is given in 1 or 2 doses.

Your doctor may prescribe a blood thinner or other medication to help prevent future blood clots. Carefully follow all dosing instructions. These medications can make it easier for you to bleed, even from a minor injury.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid after receiving alteplase?

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

What are the possible side effects of alteplase?

• sudden headache, feeling very weak or dizzy;
• bleeding gums, nosebleeds;
• easy bruising;
• 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;
• heavy menstrual periods or abnormal vaginal bleeding; or
• sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
• swelling, rapid weight gain, little or no urination;
• severe stomach pain, nausea, and vomiting;
• darkening or purple discoloration of your fingers or toes;
• very slow heartbeats, shortness of breath, feeling light-headed;
• sudden severe back pain, muscle weakness, numbness or loss of feeling in your arms or legs;
• increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
• pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting.

Bleeding is the most common side effect of alteplase.

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.

What other drugs will affect alteplase?

Tell your doctor about all your other medicines, especially:

• any medication used to treat or prevent blood clots;
• a blood thinner (heparin, warfarin, Coumadin, Jantoven); or
• NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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

Where can I get more information?

Your doctor or pharmacist can provide more information about alteplase.