What Is Tenalase IV 5 mg/ml Indications and Uses?

Tenalase is a tissue plasminogen activator (tPA) indicated: For the treatment of acute ischemic stroke (AIS) in adults. To reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.

Pharmacology (Source, Chemical and Physical Composition) Of Tenalase IV 5 mg/ml

Tenalase IV 5 mg/ml (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. 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 will deliver 50 mg of Tenecteplase.

Drug Interactions of Tenalase IV 5 mg/ml

Formal interaction studies of Tenalase with other drugs have not been performed. Patients studied in clinical trials of Tenalase were routinely treated with heparin and aspirin. Anticoagulants (such as heparin and vitamin K antagonists) and drugs that alter platelet function (such as acetylsalicylic acid, dipyridamole, and GP llb/llla inhibitors) may increase the risk of bleeding if administered prior to, during, or after Tenalase therapy.

Side Effects of Tenalase IV 5 mg/ml

The most frequent adverse reaction associated with Tenalase is bleeding. If serious bleeding occurs, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes.For Tenalase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9% and any stroke was 1.8%. The incidence of all strokes, including intracranial bleeding, increases with increasing age. Non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with Tenalase.Types of major bleeding reported in 1% or more of the patients were hematoma (1.7%) and gastrointestinal tract (1%). Types of major bleeding reported in less than 1% of the patients were urinary tract, puncture site (including cardiac catheterization site), retroperitoneal, respiratory tract, and unspecified. Types of minor bleeding reported in 1% or more of the patients were hematoma (12.3%), urinary tract (3.7%), puncture site (including cardiac catheterization site) (3.6%), pharyngeal (3.1%), gastrointestinal tract (1.9%), epistaxis (1.5%), and unspecified (1.3%). The following adverse reactions have been reported among patients receiving Tenalase in clinical trials. These reactions are frequent sequelae of the underlying disease, and the effect of Tenalase on the incidence of these events is unknown. These events include cardiogenic shock, arrhythmias, atrioventricular block, pulmonary edema, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, embolism, and electromechanical dissociation. These events can be life-threatening and may lead to death. Nausea and/or vomiting, hypotension, and fever have also been reported.

Precautions And Warnings for Tenalase IV 5 mg/ml

General : Standard management of myocardial infarction should be implemented concomitantly with Tenalase treatment. Arterial and venous punctures should be minimized.Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from the noncompressible sites. In the event of serious bleeding, heparin and antiplatelet agents should be discontinued immediately. Heparin effects can be reversed by protamine. Readministration : Readministration of plasminogen activators, including Tenalase, to patients who have received prior plasminogen activator therapy has not been systematically studied. Three of 487 patients tested for antibody formation to Tenalase had a positive antibody titer at 30 days. The data reflect the percentage of patients whose test results were considered positive for antibodies to Tenalase in a radioimmunoprecipitation assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, 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 Tenalase with the incidence of antibodies to other products may be misleading. Although sustained antibody formation in patients receiving one dose of Tenalase has not been documented, readministration should be undertaken with caution.

Use During Pregnancy and Lactation

Pregnancy : Tenalase IV 5 mg/ml (Tenecteplase) has been shown to elicit maternal and embryo toxicity in rabbits given multiple IV administrations. In rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths. Subsequent embryonic deaths were secondary to maternal hemorrhage and no fetal anomalies were observed. Tenecteplase does not elicit maternal and embryo toxicity in rabbits following a single IV administration. Thus, in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of Tenecteplase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for AMI. There are no adequate and well-controlled studies in pregnant women. Tenecteplase should be given to pregnant women only if the potential benefits justify the potential risk to the fetus. Nursing Mothers : It is not known if Tenecteplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenecteplase is administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment of Fertility : Studies in animals have not been performed to evaluate the carcinogenic potential, mutagenicity, or the effect on fertility.

Therapeutic Class

Fibrinolytics (Thrombolytics)

Storage Conditions of It

Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children. Must be reconstituted before use. Dissolve the content of vial with 10 mL sterile water for injection. Pack Image: Tenalase 5 mg/ml Injection Thanks for using MedEx! How would you rate your experience so far?