Tenecteplase Injection

WHY is this medicine prescribed?

Tenecteplase is used to treat a certain type of heart attack to reduce the risk of death. It is also used to treat strokes. Tenecteplase is in a class of medications called thrombolytics. It works by helping the body to dissolve blood clots and restoring blood flow.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Tenecteplase comes as a powder to mix with liquid to inject intravenously (into a vein) by a healthcare provider. It is usually given as a single dose as soon as possible after the symptoms of a heart attack begin and within 3 hours of when stroke symptoms begin.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tenecteplase,

• tell your doctor and pharmacist if you are allergic to tenecteplase, any other medications, or any of the ingredients in tenecteplase injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take when receiving tenecteplase. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you if you have had a stroke, a serious head injury, or surgery on your spine or brain in the last 2-3 months, or if you have problems in your brain such as bleeding, a tumor, arteriovenous malformation (AVM), or aneurysm (weakening of a blood vessel wall). Also tell your doctor if you have very high blood pressure that is not controlled by medications or any condition that may cause an increased risk of bleeding or bruising. Your doctor will probably not give you tenecteplase.

• tell your doctor if you have or have ever had heart valve problems or atrialfibrillation (Afib; a type of irregular heartbeat).

• tell your doctor if you are pregnant or are breast-feeding.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Tenecteplase may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bleeding

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• itching, rash, hives
• swelling of face, eyelids, lips, mouth, tongue or throat
• trouble breathing, throat or chest tightness, feeling faint
• changes in heartbeat
• vomiting blood, blood in the urine or stool
• severe headache, nausea, vomiting
• changein consciousness or wakefulness
• weakness or numbness in face, arm or leg (usually on one side)
• loss of vision
• seizures
• skin or toes that are purple in color
• changes in vision
• decrease in amount of urine
• chest pain, trouble breathing
• nausea, vomiting, abdominal pain that goes around your to your back

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will/may order certain lab tests to check your body's response to tenecteplase.

Before having any laboratory test, tell your doctor and the laboratory personnel that you received tenecteplase.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.