Tnkase (Intravenous)
- Commonly used brand name (s) In the U.S. Tnkase Available Dosage Forms: Powder for Solution Therapeutic Class: Thrombolytic ...
- Uses for Tnkase Tenecteplase is used to dissolve blood clots that have formed in the blood vessels of the heart and seriously lessen the flow of blood in the heart. ...
- Before using Tnkase ...
- Proper use of Tnkase ...
- Precautions while using Tnkase ...
- Tnkase side effects ...
- Frequently asked questions ...
What is TNKase ® (tenecteplase)?
Provides additional resources and information. TNKase ® (Tenecteplase) is a single-bolus thrombolytic, or clot-busting agent, approved by the U.S. Food and Drug Administration for use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
Is TNKase a thrombolytic?
TNKase is a thrombolytic (THROM-bo-LIT-ik) drug, sometimes called a "clot-busting" drug. It helps your body produce a substance that dissolves unwanted blood clots. TNKase is used to prevent death in people who have had a heart attack (acute myocardial infarction).
What does TNKase stand for?
TNKase 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...
What is tenecteplase used to treat?
Indications and Usage for TNKase TNKase ® (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL STUDIES).
When should I use TNK?
TENECTEPLASE (TEN neck te place) is used to dissolve blood clots that form in certain blood vessels. This medicine is used when a blood clot in a heart artery causes a heart attack.
Is TNKase a blood thinner?
TNKase is a thrombolytic (THROM-bo-LIT-ik) drug, sometimes called a "clot-busting" drug. It helps your body produce a substance that dissolves unwanted blood clots.
What type of medication is TNK?
To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chemical properties that make it a potentially safer and more effective drug for treating stroke.
Do you give heparin with TNKase?
Heparin may contribute to the bleeding risks associated with TNKase. The safety of the use of TNKase with other antiplatelet agents has not been adequately studied. Intramuscular injections and nonessential handling of the patient should be avoided for the first few hours following treatment with TNKase.
When is TNKase given?
TNKase® (Tenecteplase) is a single-bolus thrombolytic, or clot-busting agent, approved by the U.S. Food and Drug Administration for use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
How long does TNK stay in system?
Pharmacokinetics. Tenecteplase has an initial half-life of 20 to 24 minutes with a terminal half-life of 90 to 130 minutes with a mean plasma clearance ranging from 99 to 119 mL/min. The initial volume of distribution approximates plasma volume and the major route of elimination is by hepatic metabolism.
Is TNK better than tPA?
The EXTEND-IA TNK study showed that TNK (0.25 mg/kg) before thrombectomy was associated with a higher rate of reperfusion and better functional outcome than the standard dose of tPA in AIS patients with an large vessel occlusion (LVO), if treated within 4.5 hours of onset.
Is tPA and TNK the same thing?
Tenecteplase (TNKase, TNK-tPA or TNK) is a thrombolytic agent derived from the tissue plasminogen activator (tPA).
How long does tenecteplase take to work?
Tenecteplase can be given by a single bolus injection. This will improve the blood flow through the infarct-related artery in most patients within 90 minutes. The elimination is biphasic with a terminal half-life of approximately two hours.
How fast do you give TNK?
The recommended total dose should not exceed 50 mg and is based upon patient weight. A single bolus dose should be administered over 5 seconds based on patient weight.
How fast do you push TNKase?
ADMINISTER as an IV BOLUS over 5 seconds.
How much does TNKase cost?
The cost for TNKase intravenous powder for injection 50 mg is around $7,305 for a supply of 1 powder for injection, depending on the pharmacy you visit....Intravenous Powder For Injection.QuantityPer unitPrice1$7,304.62$7,304.62
Is tenecteplase an anticoagulant?
mefenamic acid and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
What type of drug is tenecteplase?
Tenecteplase is a thrombolytic (THROM-bo-LIT-ik) drug, sometimes called a "clot-busting" drug. It helps your body produce a substance that dissolves unwanted blood clots. Tenecteplase is used to prevent death in people who have had a heart attack (acute myocardial infarction).
Are TNK and tPA the same?
Tenecteplase (TNKase, TNK-tPA or TNK) is a thrombolytic agent derived from the tissue plasminogen activator (tPA).
Why tenecteplase is better than streptokinase?
The reduction in heart rate from baseline was more in tenecteplase treated patient compared with streptokinase and heparin treated patients. The difference in heart rate reduction in the tenecteplase group compared with streptokinase and heparin was statistically significant (p < . 05).
What is TNKase treated with?
Patients studied in clinical trials of TNKase were routinely treated with heparin and aspirin. During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts.
What is the most common adverse reaction associated with TNKase?
The most frequent adverse reaction associated with TNKase is bleeding.
What are the complications of TNKase?
The most common complication encountered during TNKase therapy is bleeding. Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately and treated appropriately. In clinical studies of TNKase, patients were treated with both aspirin and heparin.
Does TNKase work with aspirin?
In clinical studies of TNKase, patients were treated with both aspirin and heparin. Heparin may contribute to the bleeding risks associated with TNKase. The safety of the use of TNKase with other antiplatelet agents has not been adequately studied.
Is TNKase therapy contraindicated for AMI?
TNKase therapy in patients with AMI is contraindicated in the following situations because of an increased risk of bleeding: active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension.
Can TNKase cause anaphylactoid reactions?
Anaphylactoid reactions associated with the administration of TNKase are rare and can be caused by hypersensitivity to the active substance tenecteplase or to any of the excipients. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.
What is TNKase used for?
Food and Drug Administration for use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
What is TNKase a thrombolytic?
TNKase is the first thrombolytic that can be administered over five seconds in a single dose, offering physicians the fastest administration of a thrombolytic to date in the treatment of heart attack. TNKase is a bioengineered variant of Activase® (Alteplase, recombinant), which is a recombinant DNA-derived version of naturally occurring tissue plasminogen activator (t-PA). It is constructed with amino acid substitutions at three sites (the letters T, N and K represent the three regions changed from the natural t-PA protein).
How to report TNKase side effects?
Report side effects for your TNKase prescription. Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Get help paying for your TNKase prescription. SUPPORT.
How to contact Genentech about TNKase?
Medicine Information Support. Ask about possible side effects and any other medical questions related to your prescribed Genentech medicine. Call us at (800) 821-8590, Monday-Friday, 5am-5pm PT.
Can TNKase be used for a brain tumor?
TNKase therapy should not be used in the following conditions due to an increased risk of bleeding: active internal bleeding, history of stroke, brain or spinal surgery or a serious head injury within 2 months, brain tumor, an abnormal connection between veins and arteries, or abnormal bulge in the wall of an artery, problems with blood clotting, and severe uncontrolled high blood pressure.
Can TNKase cause irregular heartbeats?
Irregular heart beats can also occur with TNKase therapy. In serious heart attack patients, doctors should choose either drug therapy that dissolves blood clots or a mechanical means to remove the clot as the main treatment strategy.
What is TNKase used for?
TNKase ® (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL STUDIES ).
What are the complications of TNKase?
The most common complication encountered during TNKase therapy is bleeding. The type of bleeding associated with thrombolytic therapy can be divided into two broad categories: Internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
How long to reconstituted TNKase?
Reconstituted TNKase should be administered as a single IV bolus over 5 seconds. 4. Because TNKase contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted TNKase is not used immediately, refrigerate the TNKase vial at 2–8°C (36–46°F) and use within 8 hours.
How much TNKase is weight adjusted?
3 Exploratory analyses suggested that a weight-adjusted dose of 0.5 mg/kg to 0.6 mg/kg of TNKase resulted in a better patency to bleeding relationship than fixed doses of TNKase across a broad range of patient weights.
How many ml of TNKase is in a vial?
TNKase ® (Tenecteplase) is supplied as a sterile, lyophilized powder in a 50 mg vial under partial vacuum. Each 50 mg vial of TNKase is packaged with one 10 mL vial of Sterile Water for Injection, USP for reconstitution, and the B-D ® 10 mL syringe with TwinPak ™ Dual Cannula Device. The following packaging configurations are available:
What is tenecteplase tPA?
General. Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that Tenecteplase conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin.
What is tnase plasminogen?
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.
What is TNKase treated with?
Patients studied in clinical trials of TNKase were routinely treated with heparin and aspirin. During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts.
What is the most common adverse reaction associated with TNKase?
The most frequent adverse reaction associated with TNKase is bleeding.
What are the complications of TNKase?
The most common complication encountered during TNKase therapy is bleeding. Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately and treated appropriately. In clinical studies of TNKase, patients were treated with both aspirin and heparin.
Does TNKase work with aspirin?
In clinical studies of TNKase, patients were treated with both aspirin and heparin. Heparin may contribute to the bleeding risks associated with TNKase. The safety of the use of TNKase with other antiplatelet agents has not been adequately studied.
Is TNKase therapy contraindicated for AMI?
TNKase therapy in patients with AMI is contraindicated in the following situations because of an increased risk of bleeding: active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension.
Can TNKase cause anaphylactoid reactions?
Anaphylactoid reactions associated with the administration of TNKase are rare and can be caused by hypersensitivity to the active substance tenecteplase or to any of the excipients. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.
What is the generic name for TNKase?
The generic name for Retavase is reteplase, and the generic name for TNKase is tenecteplase. Both Retavase and TNKase are indicated only for managing acute myocardial infarction, and are not FDA-approved for acute ischemic stroke or pulmonary embolism. "tPA" is the abbreviation commonly used for the drug class that encompasses all tissue ...
What is Activase used for?
Activase is indicated for managing acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism. Other tissue plasminogen activators—Retavase® and TNKase—were FDA-approved later, in 1996 and in 2000.
Why is TPA used in healthcare?
However, healthcare professionals sometimes use "tPA" to refer to Activase because it was the first tissue plasminogen activator that was approved. Because all three drugs—Activase, TNKase, and Retavase—are tissue plasminogen activators, referring to any one of these products as "tPA" may lead to confusion about the intended product.
What is the abbreviation for TNK?
Two additional reports stated that the prescriptions were verbally ordered as "TNK.". Although the complete drug name is TNKase, healthcare professionals sometimes use the shortened abbreviation "TNK.". This is problematic because "TNK" can be confused as "tPA.".
Can you use tPA to prescribe activase?
Do not use the abbreviation "tPA" to prescribe Activase. Use either the brand name Activase or the generic name alteplase on written prescriptions and verbal orders.
Is TNK a tPA?
This is problematic because "TNK" can be confused as "tPA.". In fact, the abbreviation "TNK" is listed on the Institute for Safe Medication Practices (ISMP) List of Error-Prone Abbreviations, Symbols, and Dose Designations. Furthermore, ISMP published an article earlier this year about the confusion between Activase and TNKase.
Can TNKase be overdosed?
Because the dose of Activase is often higher than the maximum labeled TNKase dose, TNKase overdose may occur if a patient inadvertently receives TNKase instead of Activase. An overdose of TNKase may increase the risk for intracranial hemorrhage, retroperitoneal bleeding, extended hospitalization, and death.
What is Tenecteplase used for?
Tenecteplase is used to dissolve blood clots that have formed in the blood vessels of the heart and seriously lessen the flow of blood in the heart. This medicine is used to improve survival after a heart attack.
Can Tenecteplase cause bleeding?
Tenecteplase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your health care professional. Also, move around and be handled as little as possible, and do not get out of bed on your own, unless your health care professional tells you it is all right to do so.
Tnkase Description
- TNKase® (Tenecteplase) is a single-bolus thrombolytic, or clot-busting agent, approved by the U.S. Food and Drug Administration for use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
Tnkase - Clinical Pharmacology
Clinical Studies
Indications and Usage For Tnkase
Contraindications
- General
Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that Tenecteplase conversion of plasminogen to plasmin is increased relative to its conversion in th… - Pharmacokinetics
In patients with acute myocardial infarction (AMI), TNKase administered as a single bolus exhibits a biphasic disposition from the plasma. Tenecteplase was cleared from the plasma with an initial half-life of 20 to 24 minutes. The terminal phase half-life of Tenecteplase was 90 to 130 minutes…
Warnings
- ASSENT-2 was an international, randomized, double-blind trial that compared 30-day mortality rates in 16,949 patients assigned to receive an IV bolus dose of TNKase or an accelerated infusion of Activase® (Alteplase).1 Eligibility criteria included onset of chest pain within 6 hours of randomization and ST-segment elevation or left bundle branch block on electrocardiogram (E…
Precautions
- TNKase® (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL STUDIES).
Adverse Reactions
- TNKase therapy in patients with acute myocardial infarction is contraindicated in the following situations because of an increased risk of bleeding (see WARNINGS): 1. Active internal bleeding 2. History of cerebrovascular accident 3. Intracranial or intraspinal surgery or trauma within 2 months 4. Intracranial neoplasm, arteriovenous malformation, or aneurysm 5. Known bleeding di…
Tnkase Dosage and Administration
- Bleeding
The most common complication encountered during TNKase therapy is bleeding. The type of bleeding associated with thrombolytic therapy can be divided into two broad categories: 1. Internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitouri… - Thromboembolism
The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation.
How Is Tnkase Supplied
- General
Standard management of myocardial infarction should be implemented concomitantly with TNKase treatment. Arterial and venous punctures should be minimized. Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoid… - Readministration
Readministration of plasminogen activators, including TNKase, to patients who have received prior plasminogen activator therapy has not been systematically studied. Three of 487 patients tested for antibody formation to TNKase had a positive antibody titer at 30 days. The data reflec…