Tenecteplase

Tenecteplase is used in adults to treat a stroke caused by a clot (acute ischemic stroke) and to reduce the risk of death from a certain type of heart attack.

Tenecteplase may also be used for reasons not mentioned in this medication guide.

Tenecteplase is injected into a vein by a healthcare provider.

Tenecteplase is usually given as soon as possible after the first signs of a heart attack or stroke occur.

You will be monitored for a certain amount of time to make sure you do not have an allergic reaction. You may receive other medications to help treat serious side effects or allergic reactions.

Your breathing, blood pressure, oxygen levels, and other vital signs will be closely monitored.

Tenecteplase can affect the results of certain medical tests. Inform any doctor who treats you that you are using tenecteplase.

If you can, before you get tenecteplase, inform your doctor if you have or have ever had: high blood pressure, active bleeding or bleeding in your brain, a bleeding disorder, any issue with blood vessels in your brain (like an aneurysm), a brain tumor, a past stroke, or a recent surgery or injury to your brain or spine.

If you get tenecteplase in an emergency, make sure any doctor you see afterward knows you were given tenecteplase.

Tenecteplase can lead to serious, sometimes life-threatening bleeding. Contact your doctor or get emergency medical help if you experience any bleeding that does not stop.

Do not use this medicine for a stroke if you have bleeding in your brain now, or for a heart attack if you have ever had bleeding in your brain or an ischemic stroke in the last 3 months.

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

• active bleeding inside your body;
• severe or uncontrolled high blood pressure;
• certain brain conditions that increase bleeding risk (such as a brain tumor, an aneurysm, or other abnormal blood vessel problems);
• a bleeding or blood clotting disorder (such as hemophilia); or
• if you had a brain or spine injury or surgery within the past 2 months.

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

• bleeding in your brain, stomach, intestines, or urinary tract;
• heart problems, high blood pressure;
• a history of stroke;
• an infection of the lining of your heart (subacute bacterial endocarditis);
• inflammation around the heart (acute pericarditis);
• if you are using a blood thinner or medicine used to prevent blood clots;
• bleeding in the eye caused by diabetes or other eye problems;
• severe inflammation or infection around a vein where an IV was placed;
• a recent serious injury, surgery, or procedure (for example, heart bypass, organ biopsy, or puncture of a large blood vessel); or
• severe liver or kidney disease.

If possible during an emergency, tell your medical caregivers if you are pregnant, recently delivered a baby, or are breastfeeding.

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 even 1 or more days after receiving tenecteplase, which can be severe or life-threatening. Get emergency medical help if bleeding will not stop.

Tenecteplase may cause serious side effects. Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or injection site);
• bleeding inside your body--weakness, pink or brown urine, abnormal vaginal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg; or
• very slow or fast heartbeats, shortness of breath, or feeling light-headed.

Common side effects of tenecteplase may include:

• bleeding.

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.

Usual Adult Dose for Myocardial Infarction:

less than 60 kg: 30 mg IV bolus administered over 5 seconds. 60 to less than 70 kg: 35 mg IV bolus administered over 5 seconds70 to less than 80 kg: 40 mg IV bolus administered over 5 seconds80 to less than 90 kg: 45 mg IV bolus administered over 5 seconds90 kg or greater: 50 mg IV bolus administered over 5 seconds

In an emergency medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

Ask your doctor before taking aspirin, ibuprofen, naproxen, or another nonsteroidal anti-inflammatory drug (NSAID) soon after you receive tenecteplase. These medicines 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.

Tell your doctor about all your other medicines, especially:

• a blood thinner--heparin, warfarin, Coumadin, Jantoven;
• medicine used to prevent blood clots--alteplase, clopidogrel, dipyridamole, ticlopidine, and others; 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 tenecteplase, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.