tnkase
Pharmaranks rates Tnkase 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tnkase (Tenecteplase) is a medication used to treat Coronary Thrombosis, Myocardial Infarction.
Tenecteplase · by Genentech Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tenecteplase
- Form
- Kit
- Strength
- Tenecteplase 50MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- coronary thrombosis, myocardial infarction
- Manufacturer
- Genentech Inc
- FDA application
- BLA103909
What is Tnkase?
From the FDA label:Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.
How to use
Initiate treatment as soon as possible after the onset of STEMI symptoms. ( 2.1 ) TNKase is for intravenous administration only, administered as a single bolus over 5 seconds. Individualize dosage based on patient's weight. ( 2.1 ) 2.1 Recommended Dosage Initiate treatment as soon as possible after the onset of STEMI symptoms. TNKase is for intravenous (IV) administration only, administered as a single bolus over 5 seconds. Individualize dosage based on the patient's weight (see Table 1 ). Table 1: Recommended Dosage Patient Weight (kg) TNKase (mg) Volume TNKase From one vial of TNKase reconstituted with 10 mL Sterile Water for Injection. to be administered (mL) < 60 30 6 ≥ 60 to < 70 35 7 ≥ 70 to < 80 40 8 ≥ 80 to < 90 45 9 ≥ 90 50 10 2.2 Preparation Follow the below steps to prepare TNKase for administration: Remove the shield assembly from the supplied B-D ® 10 mL syringe with TwinPak™ Dual Cannula Device (see Figure 1 ) and aseptically withdraw 10 mL of Sterile Water for Injection, USP, from the supplied diluent vial using the red hub cannula syringe filling device. Only use the supplied Sterile Water for Injection, USP for reconstitution. Note: Do not discard the shield assembly. Aseptically reconstitute the vial with 10 mL Sterile Water for Injection, USP by directing the stream into the lyophilized powder to obtain a final concentration of 5 mg/mL. Slight foaming upon…
Side effects
The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Roche at 1-800-526-6367 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Immunogenicity Four of 625 (0.64%) patients tested for antibody formation to TNKase had a positive antibody titer at 30 days in studies with TNKase. The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to TNKase with the incidence of antibodies to other products may be misleading.
Warnings
Important safety information
Bleeding: Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. ( 5.1 ) Thromboembolism: The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus. ( 5.2 ) Cholesterol Embolization: Has been reported in patients treated with thrombolytic agents. ( 5.3 ) Arrhythmias: It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. ( 5.4 ) Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI: In patients with a large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate. ( 5.5 ) Hypersensitivity: Monitor patients treated with TNKase during and for several hours after infusion. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids). ( 5.6 ) 5.1 Bleeding TNKase can cause bleeding, including intracranial hemorrhage and fatal bleeding. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. Should serious bleeding that is not controlled by local pressure occur, discontinue any concomitant heparin or antiplatelet agents immediately and treat appropriately. Avoid intramuscular injections and nonessential handling of the patient for the first few hours following treatment with TNKase. Perform arterial and venous punctures carefully and only as required. To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures. If an arterial puncture is necessary during TNKase infusion, use an upper extremity vessel that is accessible to manual compression. Apply pressure for at least 30 minutes. 5.2 Thromboembolism The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation. 5.3 Cholesterol Embolization Cholesterol embolism has been reported in patients treated with thrombolytic agents. Investigate cause of any new embolic event and treat appropriately. 5.4 Arrhythmias Coronary thrombolysis may result in arrhythmias associated with reperfusion. These arrhythmias (such as sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) may be managed with standard anti-arrhythmic measures. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. 5.5 Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI. In a trial of patients with STEMI, there were trends toward worse outcomes in the individual components of the primary endpoint between TNKase plus PCI versus PCI alone (mortality 6.7% vs. 4.9%, respectively; cardiogenic shock 6.3% vs. 4.8%, respectively; and CHF 12% vs. 9.2%, respectively). In addition, there were trends towards worse outcomes in recurrent MI (6.1% vs. 3.7%, respectively; p = 0.03) and repeat target vessel revascularization (6.6% vs. 3.4%, respectively; p = 0.0045) in patients receiving TNKase plus PCI versus PCI alone [see Clinical Studies (14.1) ] . In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate; however, the optimal use of adjunctive antithrombotic and antiplatelet therapies in this setting is unknown. 5.6 Hypersensitivity Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of TNKase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with TNKase during and for several hours after infusion. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids).
Who should not take Tnkase
TNKase is contraindicated in patients with [see Warnings and Precautions (5.1) ] : Active internal bleeding History of cerebrovascular accident Intracranial or intraspinal surgery or trauma within 2 months Intracranial neoplasm, arteriovenous malformation, or aneurysm Known bleeding diathesis Severe uncontrolled hypertension Active internal bleeding ( 4 ) History of cerebrovascular accident ( 4 ) Intracranial or intraspinal surgery or trauma within 2 months ( 4 ) Intracranial neoplasm, arteriovenous malformation, or aneurysm ( 4 ) Known bleeding diathesis ( 4 ) Severe uncontrolled hypertension ( 4 )
Interactions
During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts. ( 7.1 ) 7.1 Drug/Laboratory Test Interactions During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts. Tenecteplase is an enzyme that, when present in blood in pharmacologic concentrations, remains active under in vitro conditions. This can lead to degradation of fibrinogen in blood samples removed for analysis.
Storing Tnkase, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “If the reconstituted TNKase is not used immediately, refrigerate the TNKase vial at 2°C to 8°C (36°F to 46°F) and use within 8 hours.”
- “Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F).”
- “Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F).”
- “For storage information for reconstituted TNKase, see Dosage and Administration (2.”
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Tnkase treat?
- Tnkase (Tenecteplase) may be used to treat coronary thrombosis, myocardial infarction, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Tnkase rated?
- pharmaranks gives Tnkase a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Tnkase?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tnkase. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tnkase?
- Tnkase is marketed by Genentech Inc. You can see Genentech Inc's full profile, rating, and other products on pharmaranks.
- Is Tnkase a brand-name or generic drug?
- Tnkase is a brand-name product with the active ingredient Tenecteplase.
- Is Tnkase available over the counter?
- No. Tnkase is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tnkase come in?
- Tnkase is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Tnkase FDA-registered?
- Tnkase is on record with the U.S. FDA under application number BLA103909. You can verify this on its official FDA label.
- Has Tnkase been recalled by the FDA?
- Tnkase has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Tnkase safe?
- There's no single safe-or-not verdict. pharmaranks gives Tnkase a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Tnkase?
- Tnkase's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
lidocaine hydrochloride preservative free
Lidocaine Hydrochloride
activase
Alteplase
akten
Lidocaine Hydrochloride
betimol
Timolol
cathflo activase
Alteplase
inderal la
Propranolol Hydrochloride
Compare Tnkase head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
tnkase
70/100