Tenecteplase
Generic Name: tenecteplase
Brand Names:
Tnkase
11 DESCRIPTION Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a 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 ac...
Overview
11 DESCRIPTION Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a 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 ac...
Uses
1 INDICATIONS AND USAGE TNKase ® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). TNKase is a tissue plasminogen activator, indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Initiate treatment as soon as possible after the onset of STEMI symptoms. ( 2.1 ) TNKase is for intravenous administration only, administered as a single bolus over 5 seconds. Individualize dosage based on patient's weight. ( 2.1 ) 2.1 Recommended Dosage Initiate treatment as soon as possible after the onset of STEMI symptoms. TNKase is for intravenous (IV) administration only, administered as a single bolus over 5 seconds. Individualize dosage based on the patient's weight (see Table 1 ). Table 1: Recommended Dosage Patient Weight (kg) TNKase (mg) Volume TNKase From one vial of TNKase reconstituted with 10 mL Sterile Water for Injection.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Roche at 1-800-526-6367 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Immunogenicity Four of 625 (0.64%) patients tested for antibody formation to TNKase had a positive antibody titer at 30 days in studies with TNKase. The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease.
Interactions
7 DRUG INTERACTIONS 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. ( 7.1 ) 7.1 Drug/Laboratory Test Interactions 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. Tenecteplase is an enzyme that, when present in blood in pharmacologic concentrations, remains active under in vitro conditions. This can lead to degradation of fibrinogen in blood samples removed for analysis.
Warnings
5 WARNINGS AND PRECAUTIONS Bleeding: Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. ( 5.1 ) Thromboembolism: The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus. ( 5.2 ) Cholesterol Embolization: Has been reported in patients treated with thrombolytic agents. ( 5.3 ) Arrhythmias: It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. 4 CONTRAINDICATIONS TNKase is contraindicated in patients with [see Warnings and Precautions (5.1) ] : 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 Severe uncontrolled hypertension Active internal bleeding ( 4 ) History of cerebrovasc...
Pregnancy
8.1 Pregnancy Risk Summary There are risks to the mother and fetus from acute ST elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see Clinical Considerations ). Published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. There are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage
16.2 Stability and Storage Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the vial.
Frequently Asked Questions
What is Tenecteplase used for?▼
1 INDICATIONS AND USAGE TNKase ® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). TNKase is a tissue plasminogen activator, indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). ( 1 )
What are the side effects of Tenecteplase?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Roche at 1-800-526-6367 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Immunogenicity Four of 625 (0.64%) patients tested for antibody formation to TNKase had a positive antibody titer at 30 days in studies with TNKase. The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease.
Can I take Tenecteplase during pregnancy?▼
8.1 Pregnancy Risk Summary There are risks to the mother and fetus from acute ST elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see Clinical Considerations ). Published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. There are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
What are the important warnings for Tenecteplase?▼
5 WARNINGS AND PRECAUTIONS Bleeding: Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. ( 5.1 ) Thromboembolism: The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus. ( 5.2 ) Cholesterol Embolization: Has been reported in patients treated with thrombolytic agents. ( 5.3 ) Arrhythmias: It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. 4 CONTRAINDICATIONS TNKase is contraindicated in patients with [see Warnings and Precautions (5.1) ] : 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 Severe uncontrolled hypertension Active internal bleeding ( 4 ) History of cerebrovasc...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.