A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tnkase Side Effects, and Drug Interactions - Tenecteplase
Tnkase Side Effects, and Drug Interactions - Tenecteplase
SIDE EFFECTS
Bleeding
The most frequent adverse reaction associated with TNKase is bleeding (see
WARNINGS ).
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 (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
|
|
TNKase
(N=8461) |
Accelerated Activase
(N=8488) |
Relative Risk
TNKase/Activase
(95% CI) |
|
Major bleeding a
|
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%).
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.
DRUG INTERACTIONS
Formal interaction studies of TNKase with other drugs have not been performed.
Patients studied in clinical trials of TNKase 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 therapy.
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