TNKASE SIDE EFFECTS
- Generic Name: tenecteplase
- Brand Name: Tnkase
- Drug Class: Thrombolytics
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label:
- Hypersensitivity
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 (see Table 1).
Table 1
ASSENT-2
Non-ICH Bleeding Events
| TNKase (n = 8461) |
Accelerated Activase (n = 8488) |
Relative Risk TNKase/Activase (95% CI) |
|
| Major bleedinga | 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% | |
| 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.
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%).
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.
SRC: NLM .