"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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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.
Rare but serious side effects may include:
Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Tnkase Information
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