TNKase^®

tenecteplase

Indications & Important Safety Information

What it Treats

TNKase^® (tenecteplase) is a prescription medicine for use in adults:

• for the treatment of acute ischemic stroke (AIS)
• to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).

Important Safety Information

• TNKase therapy should not be used in any patients with: active internal bleeding, brain or spinal surgery or a serious head injury within 2 months, a condition that increases your risk of bleeding more than normal, severe uncontrolled high blood pressure, the following conditions due to an increased risk of bleeding (brain tumor, an abnormal connection between veins and arteries in the brain or spinal cord, or abnormal bulge in the wall of an artery). Additional contraindications for the treatment of AIS includes active brain bleeding, and for the treatment of STEMI they include a history of brain bleeding, and a history of ischemic stroke within 3 months.
• Bleeding: TNKase therapy may cause internal bleeding, including bleeding in the brain. Bleeding can also happen from parts of the body where needles have been injected or parts of the body that have had recent surgery. Blood thinners may increase the risk of bleeding if taken before, during, or after TNKase therapy.

Bleeding can occur 1 or more days after administration of TNKase. Patients should tell their healthcare provider if they experience signs or symptoms consistent with bleeding (e.g., unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds) or symptoms of a stroke. Patients should inform their doctor of all prescription and over-the-counter drugs they are currently taking.

• Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly and have been reported after use of TNKase.
• Migrated blood clot (thromboembolism): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms.
• Cholesterol embolization: A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported in patients treated with all types of clot dissolving agents. This is a serious condition which can be lethal.
• Arrhythmias: Irregular heartbeats can also occur after TNKase therapy.

In patients with serious heart attacks, doctors should choose either drug therapy that dissolves blood clots or a mechanical procedure to open clogged arteries as the main treatment strategy.

• The most common side effect with TNKase therapy is bleeding.

You may report side effects to the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555

Please see full Prescribing Information for additional Important Safety Information.