TNKase Side Effects
Please note - some side effects for TNKase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
TNKase Side Effects - for the Professional
TNKase
Bleeding
The most frequent adverse reaction associated with TNKase is bleeding.
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-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.
In the ASSENT-2 study, the following bleeding events were reported.
| TNKase (n = 8461) |
Accelerated Activase (n = 8488) |
Relative Risk for TNKase/Activase (95% CI) | |
|---|---|---|---|
|
|||
| Major bleeding* | 4.7% | 5.9% | 0.78 (0.69, 0.89) |
| Minor bleeding | 21.8% | 23.0% | 0.94 (0.89, 1.00) |
| Units of transfused blood | |||
| Any | 4.3% | 5.5% | 0.77 (0.67, 0.89) |
| 1–2 | 2.6% | 3.2% | |
| >2 | 1.7% | 2.2% | |
Non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with TNKase.
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 Reactions
Allergic-type reactions (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria) have rarely (< 1%) been reported in patients treated with TNKase. Anaphylaxis was reported in < 0.1% of patients treated with TNKase; 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 in clinical trials. These reactions are frequent sequelae of the underlying disease, and the effect of TNKase 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.
TopSide Effects by Body System
Hematologic
Major hematological side effects including hematoma (1.7%), gastrointestinal bleeding (>1%), urinary tract bleeding (<1%), puncture site bleeding (<1%), retroperitoneal bleeding (<1%), respiratory tract bleeding (<1%), and unspecified bleeding (<1%) have been reported. Intracranial hemorrhage (ICH) has also been reported. In one study, ICH occurred in 1%, 1.9%, and 3.8% of patients treated with 30, 40, and 50 mg of tenecteplase, respectively (patients were also receiving heparin).
Minor hematological side effects including hematoma (12.3%), urinary tract bleeding (3.7%), pharyngeal (3.1%), gastrointestinal tract bleeding (1.9%), epistaxis (1.5%), and unspecified bleeding (1.3%) have been reported.
Cardiovascular
Cardiovascular side effects including cardiogenic shock, arrhythmias, atrioventricular block, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, electromechanical dissociation, and hypotension have been reported.
Local
Local side effects including bleeding from the puncture side have been reported.
Respiratory
Respiratory side effects including pulmonary edema have been reported.
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