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TNKASE is a brand name for Tenecteplase, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 2025-10 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7
1 Adverse Reaction Overview Bleeding The most frequent adverse reaction associated with TNKase (tenecteplase for injection) is bleeding (see 7 WARNINGS AND PRECAUTIONS). 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. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 5 hours of symptom onset and eligible for intravenous thrombolysis as per current guidelines (see 14 CLINICAL TRIALS).
8% were male, and the median NIHSS score was 9. The rates of 24-hour symptomatic intracerebral hemorrhage were similar between the TNKase and ACTIVASE treatment groups. Rates of imaging-identified hemorrhage (assessed blinded to symptom status and treatment allocation) were comparable between the two groups.
There was no difference in the mortality rate between groups. Orolingual angioedema and peripheral bleeding requiring blood transfusion were similar in both groups (see Table 6). Table 6 describes the incidence of key safety outcomes (adverse drug reactions) in patients with AIS in the AcT trial.
8%. 4 Geriatrics). 2% *defined as bleeding requiring blood transfusion or leading to hemodynamic compromise TNKase (tenecteplase for injection) Page 14 of 34 The incidence of non-intracranial major bleeding and the need for blood transfusions were statistically lower in patients treated with TNKase compared to an accelerated infusion of ACTIVASE.
4 Geriatrics 2025-10 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS .................................................................................
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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. 3%).
Other Adverse Reactions The following serious adverse reactions have been reported among patients receiving TNKase in the ASSENT-2 clinical trial. These reactions are frequent sequelae of the underlying disease, and the effect of TNKase on the incidence of these events is unknown.
These events can be life-threatening and may lead to death. 5 Post-Market Adverse Reactions Adverse events that have been reported during the post-marketing period are consistent with those seen in clinical trials with TNKase.
1 Special Populations .............................................................................................. 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
11 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions........................................................................... 15 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................
15 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ..............................................................................................
3 Pharmacokinetics ................................................................................................. 16 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 16 PART II: SCIENTIFIC INFORMATION .....................................................................................
17 13 PHARMACEUTICAL INFORMATION .......................................................................... 17 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .................................................................................. 17 Acute Ischemic Stroke (AIS) .............................................................................................
17 Acute Myocardial Infarction (AMI) .................................................................................. 18 15 MICROBIOLOGY ......................................................................................................
20 16 NON-CLINICAL TOXICOLOGY .................................................................................... 20 PATIENT MEDICATION INFORMATION ................................................................................ 31 TNKase (tenecteplase for injection) Page 4 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TNKase (tenecteplase for injection) is indicated for: • intravenous use in adults for […]