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Should serious bleeding occur, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes.
For TNKase (tenecteplase) -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 (see PRECAUTIONS: Geriatric Use).
In the ASSENT-2 study, the following bleeding events were reported (see Table 3).
Table 3: ASSENT-2
Non-ICH Bleeding Events
|Relative Risk for TNKase/Activase
|Units of transfused blood|
|a Major bleeding is defined as bleeding requiring blood transfusion or leading to hemodynamic compromise.|
Non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with TNKase (tenecteplase) .
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%).
Allergic-type reactions (e.g., anaphylaxis, angioedema, laryngeal edema,rash, and urticaria) have rarely ( < 1%) been reported in patients treated with TNKase (tenecteplase) .Anaphylaxis was reported in < 0.1% of patients treated with TNKase (tenecteplase) ; however, causality was not established. When such reactions occur, they usually respond to conventional therapy.
Other Adverse Reactions
The following adverse reactions have been reported among patients receiving TNKase (tenecteplase) in clinical trials. These reactions are frequent sequelae of the underlying disease, and the effect of TNKase (tenecteplase) 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.
Read the Tnkase (tenecteplase) Side Effects Center for a complete guide to possible side effects
Formal interaction studies of TNKase (tenecteplase) with other drugs have not been performed. Patients studied in clinical trials of TNKase (tenecteplase) 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 IIb/IIIa inhibitors) may increase the risk of bleeding if administered prior to, during, or after TNKase (tenecteplase) therapy.
Drug/Laboratory Test Interactions
During TNKase (tenecteplase) 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/6/2008
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