Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 50mg
Acute MI
Administer ASAP (within 30 minutes) after onset of acute MI
30-50 mg IV bolus over 5 sec once (based on weight)
- <60 kg: 30 mg
- 60-70 kg: 35 mg
- 70-80 kg: 40 mg
- 80-90 kg: 45 mg
- >90 kg: 50 mg
Restore Function to Hemodialysis Catheters (Orphan)
Indicated to restore function to hemodialysis catheters
Orphan indication sponsor
- Genentech, Inc; 1 DNA Way; South San Francisco, CA 94080-4990
Safety & efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- defibrotide
defibrotide increases effects of tenecteplase by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.
- prothrombin complex concentrate, human
tenecteplase, prothrombin complex concentrate, human. pharmacodynamic antagonism. Contraindicated.
Serious - Use Alternative (4)
- apixaban
tenecteplase and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.
- caplacizumab
caplacizumab, tenecteplase. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- reteplase
reteplase and tenecteplase both increase anticoagulation. Avoid or Use Alternate Drug.
- zanubrutinib
tenecteplase, zanubrutinib. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.
Monitor Closely (77)
- agrimony
tenecteplase and agrimony both increase anticoagulation. Modify Therapy/Monitor Closely.
- alfalfa
tenecteplase and alfalfa both increase anticoagulation. Modify Therapy/Monitor Closely.
- alteplase
alteplase and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- American ginseng
tenecteplase and American ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- anamu
tenecteplase and anamu both increase anticoagulation. Use Caution/Monitor.
- antithrombin alfa
antithrombin alfa and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- antithrombin III
antithrombin III and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- argatroban
argatroban and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- aspirin
aspirin, tenecteplase. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- aspirin rectal
aspirin rectal and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate, tenecteplase. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- azficel-T
azficel-T, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- bivalirudin
bivalirudin and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- celecoxib
celecoxib and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- choline magnesium trisalicylate
choline magnesium trisalicylate and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- cinnamon
tenecteplase and cinnamon both increase anticoagulation. Modify Therapy/Monitor Closely.
- cordyceps
tenecteplase and cordyceps both increase anticoagulation. Modify Therapy/Monitor Closely.
- dabigatran
dabigatran and tenecteplase both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.
- dalteparin
dalteparin and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- danshen
tenecteplase and danshen both increase anticoagulation. Use Caution/Monitor.
- devil's claw
tenecteplase and devil's claw both increase anticoagulation. Use Caution/Monitor.
- diclofenac
diclofenac and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- diflunisal
diflunisal and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- dong quai
tenecteplase and dong quai both increase anticoagulation. Modify Therapy/Monitor Closely.
- enoxaparin
enoxaparin and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- epoprostenol
tenecteplase and epoprostenol both increase anticoagulation. Modify Therapy/Monitor Closely.
- etodolac
etodolac and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- fennel
tenecteplase and fennel both increase anticoagulation. Modify Therapy/Monitor Closely.
- fenoprofen
fenoprofen and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- feverfew
tenecteplase and feverfew both increase anticoagulation. Modify Therapy/Monitor Closely.
- fish oil
fish oil, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of tenecteplase by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- flurbiprofen
flurbiprofen and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- fondaparinux
fondaparinux and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- forskolin
tenecteplase and forskolin both increase anticoagulation. Modify Therapy/Monitor Closely.
- garlic
tenecteplase and garlic both increase anticoagulation. Modify Therapy/Monitor Closely.
- ginger
tenecteplase and ginger both increase anticoagulation. Modify Therapy/Monitor Closely.
- ginkgo biloba
tenecteplase and ginkgo biloba both increase anticoagulation. Modify Therapy/Monitor Closely.
- green tea
green tea, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of bleeding.
- heparin
heparin and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- horse chestnut seed
tenecteplase and horse chestnut seed both increase anticoagulation. Modify Therapy/Monitor Closely.
- ibrutinib
ibrutinib will increase the level or effect of tenecteplase by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.
- ibuprofen
ibuprofen and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ibuprofen IV
ibuprofen IV and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- imatinib
imatinib, tenecteplase. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents.
- indomethacin
indomethacin and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketoprofen
ketoprofen and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketorolac
ketorolac and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketorolac intranasal
ketorolac intranasal and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- meclofenamate
meclofenamate and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- mefenamic acid
mefenamic acid and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- melatonin
melatonin increases effects of tenecteplase by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.
- meloxicam
meloxicam and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- mistletoe
tenecteplase increases and mistletoe decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.
- nabumetone
nabumetone and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- naproxen
naproxen and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- nettle
tenecteplase increases and nettle decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.
- nitroglycerin rectal
nitroglycerin rectal decreases effects of tenecteplase by Other (see comment). Use Caution/Monitor. Comment: Caution should be observed in patients receiving nitroglycerin during t-PA therapy. IV administration of nitroglycerin decreases the thrombolytic effect of tissue-type plasminogen activator (t-PA). Plasma levels of t-PA are reduced when coadministered with nitroglycerin. .
- omega 3 carboxylic acids
omega 3 carboxylic acids, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- omega 3 fatty acids
omega 3 fatty acids, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- oxaprozin
oxaprozin and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- panax ginseng
tenecteplase and panax ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- pau d'arco
tenecteplase and pau d'arco both increase anticoagulation. Modify Therapy/Monitor Closely.
- phytoestrogens
tenecteplase and phytoestrogens both increase anticoagulation. Modify Therapy/Monitor Closely.
- piroxicam
piroxicam and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- reishi
tenecteplase and reishi both increase anticoagulation. Modify Therapy/Monitor Closely.
- rivaroxaban
rivaroxaban, tenecteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.
- salicylates (non-asa)
salicylates (non-asa) and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- salsalate
salsalate and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- Siberian ginseng
tenecteplase and Siberian ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- sulindac
sulindac and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ticagrelor
ticagrelor, tenecteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.
- tolmetin
tolmetin and tenecteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- tranexamic acid oral
tranexamic acid oral, tenecteplase. Either decreases effects of the other by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- vorapaxar
tenecteplase, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vortioxetine
tenecteplase, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.
- warfarin
tenecteplase increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (1)
- ceftaroline
ceftaroline increases effects of tenecteplase by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
Adverse Effects
>10%
Minor bleeding (22%)
Frequency Not Defined
Reperfusion arrhythmias
MI
Fever
Nausea
Vomiting
Cholesterol embolization
Allergic reaction
Warnings
Contraindications
Hypersensitivity
Active bleeding, history of CVA, recent (within 2 months) intracranial or intraspinal surgery or trauma, intracranial neoplasm, AVM, aneurysm, bleeding diathesis, severe uncontrolled HTN, recent (within 3 mth) facial trauma, suspected aortic dissection
Cautions
Hypersensitivity, including urticarial/anaphylactic reactions, reported after administration of TNKase (eg, 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
Standard management of myocardial infarction should be implemented concomitantly with TNKase treatment; arterial and venous punctures should be minimized; noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from the non-compressible sites
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
Readministration of plasminogen activators, including TNKase, to patients who have received prior plasminogen activator therapy has not been systematically studied; although sustained antibody formation in patients receiving one dose of TNKase has not been documented,readministration should be undertaken with caution
Cholesterol embolism
- Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown; this serious condition, which can be lethal, is also associated with invasive vascular procedures (eg, cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy
- Clinical features of cholesterol embolism may include livedo reticularis, “purple toe” syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis
Arrhythmias
- Coronary thrombolysis may result in arrhythmias associated with reperfusion; these arrhythmias (such as sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) are not different from those seen in ordinary course of acute myocardial infarction and may be managed with standard anti-arrhythmic measures
- Recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered
Bleeding
- The type of bleeding associated with thrombolytic therapy can be divided into two broad categories, internal bleeding, involving intracranial and retroperitoneal sites, or gastrointestinal, genitourinary, or respiratory tracts and superficial or surface bleeding, observed mainly at vascular puncture and access sites (eg, venous cutdowns, arterial punctures) or sites of recent surgical intervention
- Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin and antiplatelet agents should be discontinued immediately; heparin effects can be reversed by protamine
- In clinical studies of TNKase, patients were treated with both aspirin and heparin; heparin may contribute to bleeding risks associated with TNKase; the safety of the use of TNKase with other antiplatelet agents has not been adequately studied
- Intramuscular injections and nonessential handling of the patient should be avoided for the first few hours following treatment with TNKase; venipunctures should be performed and monitored carefully
- Should an arterial puncture be necessary during first few hours following TNKase therapy, it is preferable to use an upper extremity vessel that is accessible to manual compression; pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding
- Each patient being considered for therapy with TNKase should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy
-
In the following conditions, the risk of TNKase therapy may be increased and should be weighed against the anticipated benefits
- Recent major surgery, eg, coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels
- Cerebrovascular disease
- Recent gastrointestinal or genitourinary bleeding
- Recent trauma
- Hypertension: systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg
- Acute pericarditis
- Subacute bacterial endocarditis
- Hemostatic defects, including those secondary to severe hepatic or renal disease
- Severe hepatic dysfunction
- Pregnancy
- Diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
- Septic thrombophlebitis or occluded AV cannula at seriously infected site
- Advanced age (see PRECAUTIONS: Geriatric Use)
- Patients currently receiving oral anticoagulants, e.g., warfarin sodium
- Recent administration of GP IIb/IIIa inhibitors
- Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location
Drug interaction overview
- 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 risk of bleeding if administered prior to, during, or after therapy
Pregnancy & Lactation
Pregnancy
There are risks to mother and fetus from acute ST-elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (
Published data consisting of a small number of case reports involving use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects; there are no data on use of tenecteplase during pregnancy to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Myocardial infarction is a medical emergency which can be fatal if left untreated; life-sustaining therapy for pregnant woman should not be withheld because of potential concerns regarding effects of tenecteplase on the fetus
Animal data
- This drug does not elicit maternal and direct embryotoxicity in rabbits following a single IV administration; in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of TNKase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for STEMI
Lactation
There are no data on presence of this drug in either human or animal milk, effects on breastfed infant, or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from this medication or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Genetically engineered variant of alteplase with multiple point mutations of tPA molecule resulting in longer plasma half-life, enhanced fibrin specificity, & increased resistance to inactivation by plasminogen activator inhibitor 1 (PAI-1) compared to alteplase
Promotes thrombolysis by converting plasminogen to plasmin which degrades fibrin & fibrinogen
Pharmacokinetics
Half-Life: 90-130 min
Onset: 30 min
Metabolism: Liver
Metabolites: Degradation products (constituent amino acids of tenecteplase)
Total Body Clearance: 99-119 mL/min
Administration
IV Preparation
Add 10 mL SWI to a 50 mg vial using TwinPak® device directing stream of diluent into powder. If foaming (usually slight) occurs, leave vial undisturbed for several minutes to allow dissipation of any large bubbles. Gently swirl (do not shake) until contents are completely dissolved.
Do not discard shield assembly
Use immediately or may be refrigerated up to 8 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| TNKase intravenous - | 50 mg vial |  | |
| TNKase intravenous - | 50 mg vial |  | |
| TNKase intravenous - | 50 mg kit |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tenecteplase intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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