Brand Name

TNKase

Generic Name
Tenecteplase
View Brand Information
FDA approval date: November 07, 2018
Form: Kit

What is TNKase (Tenecteplase)?

TNKase ® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction . TNKase is a tissue plasminogen activator, indicated to reduce the risk of death associated with acute ST elevation myocardial infarction .

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Brand Information

TNKase (tenecteplase)
1INDICATIONS AND USAGE
TNKase
2DOSAGE FORMS AND STRENGTHS
For injection: 50 mg as a white to pale yellow lyophilized powder in a single-dose vial for reconstitution with the co-packaged 10 mL single-dose vial of Sterile Water for Injection, USP (diluent).
3CONTRAINDICATIONS
TNKase is contraindicated in patients with
  • 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
4ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the label:
  • Bleeding
  • Hypersensitivity
4.1Immunogenicity
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. For these reasons, comparison of the incidence of antibodies to TNKase with the incidence of antibodies to other products may be misleading.
5DESCRIPTION
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 acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an
TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.
6PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 50242-120-47
Tenecteplase
For use in myocardial infarction
Kit Contents: Each kit contains one 50 mg vial of TNKase, one 10 mL vial of preservative-free
Vial Contents: The preservative-free single-use vial of TNKase contains 52.5 mg
Rx only
US License No.: 1048
Genentech
10200128
PRINCIPAL DISPLAY PANEL - Kit Carton