Pronunciation:

ten-EK-te-plase

Brand Names:

• Tnkase

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Thrombolytic

Pharmacologic—

Tissue Plasminogen Activator

Uses of This Medicine:

Tenecteplase is used to help reduce the risk of death cause by acute ST elevation myocardial infarction (STEMI).

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tenecteplase injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tenecteplase injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, death, stroke, bleeding), which may require caution and an adjustment in the dose for patients receiving tenecteplase injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Alteplase, Recombinant
• Anagrelide
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Betrixaban
• Bivalirudin
• Certoparin
• Cilostazol
• Clopidogrel
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Edoxaban
• Enoxaparin
• Eptifibatide
• Fondaparinux
• Heparin
• Inotersen
• Lepirudin
• Nadroparin
• Parnaparin
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Prasugrel
• Protein C
• Reteplase, Recombinant
• Reviparin
• Rivaroxaban
• Streptokinase
• Sulfinpyrazone
• Ticlopidine
• Tinzaparin
• Tirofiban
• Treprostinil
• Turmeric
• Urokinase
• Vorapaxar
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding, active or known or
• Blood vessel disease or
• Brain cancer or
• Brain or spinal surgery or trauma within 2 months or
• High blood pressure, uncontrolled—Should not be used in patients with these conditions.

• Bleeding, serious or
• Blood clotting problems or
• Heart failure or
• Heart rhythm problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 5 seconds.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause bleeding problems (eg, intracranial hemorrhage). Check with your doctor right away if you have confusion, headache, sudden, nausea or vomiting, or weakness.

Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, severe headache, slurred speech, sudden, unexplained trouble breathing, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes. These may be symptoms of blood clotting problems (eg, thromboembolism).

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, trouble breathing or swallowing, a fast or irregular heartbeat, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, or any swelling of your hands, face, mouth, or throat with this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Back pain or backaches

blood in throat

blood in urine

bloody or black, tarry stools

constipation

cough

coughing up blood

difficulty swallowing

dizziness

fast, slow or irregular breathing

fast, slow or irregular heartbeat

headaches

nosebleeds

skin rash, hives or itching

stomach pain

swelling of the eyes, face, lips, or tongue

trouble breathing

unusual bleeding or bruising, especially around the place of injection

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.