TNKase
Generic: TENECTEPLASE
Basic Information
Manufacturer
Genentech, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
e647640d-c395-4b4b-a0be-1162f9c21d84
Indications & Usage
1 INDICATIONS AND USAGE TNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults.
( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults.
1.2 Acute ST Elevation Myocardial Infarction TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults.
1.2 Acute ST Elevation Myocardial Infarction TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.2) ] Thromboembolism [see Warnings and Precautions (5.3) ] Cholesterol Embolization [see Warnings and Precautions (5.4) ] Arrhythmias [see Warnings and Precautions (5.5) ] Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI [see Warnings and Precautions (5.6) ] The most common adverse reaction is bleeding.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequent adverse reaction associated with TNKase in all approved indications is bleeding.
Acute Ischemic Stroke In Trial 1, the safety of TNKase for the treatment of acute ischemic stroke (AIS) was evaluated in 592 patients who received TNKase at the recommended dosage within 0 to 3 hours of the onset of stroke symptoms (Alteplase compared to Tenecteplase (AcT); Trial 1) [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] .
Table 3 describes the incidence of adverse reactions in patients with AIS in Trial 1.
Table 3 Incidence of Adverse Reactions in Trial 1 in Patients Treated for Acute Ischemic Stroke Within 0 to 3 Hours from Symptom Onset Adverse Reaction TNKase N=592 % Activase N= 555 % Death 15.0 15.0 Symptomatic intracerebral hemorrhage intracerebral hemorrhage that, in the opinion of the investigator, was temporally related to and directly responsible for worsening of the neurological condition 3.4 3.1 Extracranial (peripheral) bleeding requiring blood transfusion 1.0 0.7 Orolingual angioedema 1.0 1.4
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequent adverse reaction associated with TNKase in all approved indications is bleeding.
Acute Ischemic Stroke In Trial 1, the safety of TNKase for the treatment of acute ischemic stroke (AIS) was evaluated in 592 patients who received TNKase at the recommended dosage within 0 to 3 hours of the onset of stroke symptoms (Alteplase compared to Tenecteplase (AcT); Trial 1) [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] .
Table 3 describes the incidence of adverse reactions in patients with AIS in Trial 1.
Table 3 Incidence of Adverse Reactions in Trial 1 in Patients Treated for Acute Ischemic Stroke Within 0 to 3 Hours from Symptom Onset Adverse Reaction TNKase N=592 % Activase N= 555 % Death 15.0 15.0 Symptomatic intracerebral hemorrhage intracerebral hemorrhage that, in the opinion of the investigator, was temporally related to and directly responsible for worsening of the neurological condition 3.4 3.1 Extracranial (peripheral) bleeding requiring blood transfusion 1.0 0.7 Orolingual angioedema 1.0 1.4