Tnkase

DRUG 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. Cell culture is carried out in nutrient medium containing the antibiotic gentamicin (65 mg/L). However, the presence of the antibiotic is not detectable in the final product (limit of detection is 0.67 (µg/vial). TNKase (tenecteplase) 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.

What are the possible side effects of tenecteplase (TNKase)?

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

Tell your caregivers at once if you have a serious side effect such as:

  • blood in your urine or stools;
  • nosebleed, coughing up blood;
  • bleeding from a recent injury or surgery incision;
  • bleeding around the IV needle;
  • fast, slow, or uneven heart rate; or
  • feeling like you might pass out.

...

Read All Potential Side Effects and See Pictures of Tnkase »

What are the precautions when taking tenecteplase (Tnkase)?

Before using tobramycin with dexamethasone, tell your doctor or pharmacist if you are allergic to either drug; or to other aminoglycoside antibiotics (e.g., gentamicin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when...

Read All Potential Precautions of Tnkase »


Tnkase Consumer (continued)

SIDE EFFECTS: Eye redness, eye discomfort, and eyelid itching/swelling may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts). Do not use this medication for longer than prescribed. Tell your doctor immediately if you notice any of the following: new or worsening eye symptoms (e.g., discharge, swelling), vision changes, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tobramycin with dexamethasone, tell your doctor or pharmacist if you are allergic to either drug; or to other aminoglycoside antibiotics (e.g., gentamicin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Tnkase Patient Information Including Side Effects

Brand Names: TNKase

Generic Name: tenecteplase (Pronunciation: ten EK te plase)

  • What is tenecteplase (Tnkase)?
  • What are the possible side effects of tenecteplase (Tnkase)?
  • What is the most important information I should know about tenecteplase (Tnkase)?
  • What should I discuss with my health care provider before I receive tenecteplase (Tnkase)?
  • How is tenecteplase given (Tnkase)?
  • What happens if I miss a dose (Tnkase)?
  • What happens if I overdose (Tnkase)?
  • What should I after receiving tenecteplase (Tnkase)?
  • What other drugs will affect tenecteplase (Tnkase)?
  • Where can I get more information?

What is tenecteplase (Tnkase)?

Tenecteplase is in a group of drugs called tissue plasminogen activators (TPAs). It works by causing the body to over-produce a substance called plasmin to dissolve unwanted blood clots.

Tenecteplase is used to prevent death from a heart attack (acute myocardial infarction).

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

What are the possible side effects of tenecteplase (Tnkase)?

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

Tell your caregivers at once if you have a serious side effect such as:

  • blood in your urine or stools;
  • nosebleed, coughing up blood;
  • bleeding from a recent injury or surgery incision;
  • bleeding around the IV needle;
  • fast, slow, or uneven heart rate; or
  • feeling like you might pass out.

Rare but serious side effects may include:

  • purple discoloration of your legs or toes;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • swelling, weight gain, feeling short of breath, urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • muscle pain or tenderness with fever or flu symptoms and dark colored urine;
  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use; or
  • loss of bowel or bladder control.

Less serious side effects may include mild nausea or dizziness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tenecteplase (Tnkase)?

You should not receive this medication if you have internal bleeding, brain cancer or aneurysm, a history of stroke, a bleeding or blood clotting disorder, or if you have had brain or spinal cord injury or surgery within the past 2 months.

Before you are treated with tenecteplase, tell your doctor if you have a blood vessel disorder of the eye, severe liver or kidney disease, high blood pressure, an infection of the lining of your heart (also called bacterial endocarditis), a recent history of stomach or urinary bleeding, if you have recently had a baby, or if you have recently had a serious injury or major surgery.

Also tell your doctor if you take a blood thinner such as warfarin (Coumadin), or other medications to treat or prevent blood clots.

Tell your caregivers at once if you have a serious side effect such as blood in your urine or stools, nosebleed, coughing up blood, bleeding from a skin wound or the IV needle, fast or slow heart rate, or feeling like you might pass out.

Tenecteplase may cause rare but serious side effects such as: purple discoloration of your legs or toes, sudden numbness or weakness, problems with vision or speech, chest pain or heavy feeling, urinating less than usual or not at all, muscle pain or tenderness, dark colored urine, unusual sensations in your back, numbness or tingling in your legs or feet, muscle weakness or loss of use, or loss of bowel or bladder control.

Tenecteplase can cause you to have unusual results with blood tests. Tell any doctor who treats you that you have recently received tenecteplase.

Related Drug Centers
  • Tnkase


Related Drugs Index: