Tenecteplase 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.

Tenecteplase is used to prevent death in people who have had a heart attack (acute myocardial infarction).

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

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

• active bleeding inside your body;
• a recent history of medical trauma or injury;
• severe or uncontrolled high blood pressure;
• a genetic disorder affecting the blood vessels in your brain;
• a brain tumor, blood vessel disorder, or aneurysm (dilated blood vessel);
• a bleeding or blood clotting disorder (such as hemophilia);
• a history of stroke; or
• if you have had brain or spinal cord injury or surgery within the past 2 months.

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

• a 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);
• liver or kidney disease;
• eye problems caused by diabetes;
• severe bruising or infection around a vein where an IV was placed;
• a serious injury or major surgery;
• an organ biopsy; or
• if you are pregnant or have recently had a baby.

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

Use Tnkase (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Tenecteplase 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:

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

Common side effects may include:

• bleeding;
• nausea, vomiting; or
• fever.

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.

Ask your doctor before taking aspirin or ibuprofen (Motrin, Advil) shortly after you have received tenecteplase. 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.