TNKase

Generic name: tenecteplase
Drug class: Thrombolytics

Medically reviewed by  A Ras MD

What is TNKase?

TNKase is clot-busting medication that is used for the treatment of heart attack

Description

TNKase® (Tenecteplase) is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using an established mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527 amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. TNKase is a sterile, white to off-white, lyophilized powder for single intravenous (IV) bolus administration after reconstitution with Sterile Water for Injection (SWFI), USP. Each vial of TNKase nominally contains 52.5 mg Tenecteplase, 0.55 g L-arginine, 0.17 g phosphoric acid, and 4.3 mg polysorbate 20, which includes a 5% overfill. Each vial will deliver 50 mg of Tenecteplase.

Before taking TNKase, tell your doctor:

• If you are allergic to TNKase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Aneurysm, arteriovenous malformations, bleeding problems like bleeding in the brain, brain tumor, or high blood pressure.
• If you have had any of these health problems: Stroke; injury to the head, brain, or spine; or surgery on the brain or spine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take TNKase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take TNKase?

• Tell all of your health care providers that you take TNKase. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use TNKase.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Severe and sometimes deadly bleeding problems have happened with TNKase.
• Use care to prevent injury and avoid falls or crashes.
• People with certain heart problems may have a raised chance of a blood clot with TNKase. If you have questions about whether you may have a raised chance of a blood clot, talk with your doctor.
• If you are 65 or older, use TNKase with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using TNKase while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is TNKase best taken?

Use TNKase as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of TNKase that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling confused.
• A heartbeat that does not feel normal.
• Slow heartbeat.
• Rarely, a health problem called cholesterol embolism has happened with drugs like this one. This problem has also happened with some blood vessel procedures. Sometimes, this can be deadly. Call your doctor right away if you have a change in color of the skin to bluish, black, or purple. Call your doctor right away if you have a change in how much urine is passed; severe headache or dizziness; passing out; chest pain or pressure; change in eyesight; muscle pain or dark urine; or severe stomach pain, back pain, upset stomach, or throwing up.

What are some other side effects of TNKase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out TNKase?

• If you need to store TNKase at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – KIT CARTON

 

• NDC 50242-120-47
• Tenecteplase
  TNKase®
  50 mg
• For use in myocardial infarction
• Kit Contents: Each kit contains one 50 mg vial of TNKase, one 10 mL vial of preservative-free
  Sterile Water for Injection, USP, one BD® 10 mL syringe with TwinPak™ Dual Cannula Device,
  and package insert containing full prescribing information.
• Vial Contents: The preservative-free single-use vial of TNKase contains 52.5 mg
  Tenecteplase, 0.55 g L-arginine, 0.17 g phosphoric acid, and 4.3 mg polysorbate 20,
  under partial vacuum. No U.S. standard of potency.
• Rx only
• US License No.: 1048
• Genentech
• 10200128

SRC: NLM .