ADVERSE REACTIONS
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 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.
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REPORTS OF SUSPECTED TNKASE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Tnkase. The information is not vetted and should not be considered as verified clinical evidence.
Possible Tnkase side effects / adverse reactions in 50 year old female
Reported by a pharmacist from United States on 2011-11-28
Patient: 50 year old female weighing 100.0 kg (220.0 pounds)
Reactions: NO Adverse Event, Overdose, Wrong Drug Administered
Adverse event resulted in: hospitalization
Suspect drug(s):
Tnkase
Possible Tnkase side effects / adverse reactions in 80 year old female
Reported by a pharmacist from United States on 2012-02-21
Patient: 80 year old female weighing 63.9 kg (140.6 pounds)
Reactions: Haemorrhage Intracranial, Headache, Hemiparesis, Wound Secretion, Haemoglobin Decreased, Pulse Absent, Platelet Count Decreased, Cold Sweat, Haematoma
Adverse event resulted in: death
Suspect drug(s):
Tnkase
Dosage: 0.15-0.3 mg/hr continuous directed catherter thrombolysis
Indication: Vascular Graft Occlusion
Start date: 2012-02-01
End date: 2012-02-04
Tnkase
Dosage: 0.15-0.3 mg/hr continuous directed catherter thrombolysis
Indication: Peripheral Vascular Disorder
Start date: 2012-02-01
End date: 2012-02-04
Other drugs received by patient: Cryoprecipitated AHF; Amlodipine; RED Blood Cells; Metoprolol Succinate; Fresh Frozen Plasma
Possible Tnkase side effects / adverse reactions in 45 year old female
Reported by a pharmacist from Canada on 2012-05-17
Patient: 45 year old female
Reactions: Brain Injury, Haemorrhage Intracranial, Brain Scan Abnormal
Adverse event resulted in: death
Suspect drug(s):
Tnkase
Other drugs received by patient: Insulin; Norepinephrine Bitartrate; Dopamine HCL; Sodium Bicarbonate; Heparin Sodium; Ranitidine
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