TNKase

TNKase 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.

TNKase is used to treat acute ischemic stroke (AIS) in adults or to reduce the risk of death associated with a heart attack (acute ST elevation myocardial infarction [STEMI]).

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

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

In an emergency, you may be unable to tell caregivers about your health conditions. Make sure any doctor caring for you afterward knows you received TNKase.

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

• active bleeding inside your body
• head or spinal surgery or trauma within 2 months
• known tendency towards bleeding
• current severe or uncontrolled high blood pressure
• presence of a brain condition that may increase the risk of bleeding (such as a brain tumor, blood vessel disorder, or aneurysm [dilated blood vessel]).

Additional contraindications include:

• AIS: active bleeding inside the brain
• Acute STEMI: a history of bleeding inside the brain or an ischemic stroke within 3 months.

If possible, before you receive TNKase, 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.

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

TNKase 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 of TNKase 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.

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

TNKase is usually given as soon as possible after the first signs of heart attack occur.

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

Since TNKase is used as a single dose, it does not have a daily dosing schedule.

Since TNKase 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 TNKase. 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.

Tell your doctor about all your other medicines, especially:

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

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