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تعداد آیتم قابل مشاهده باقیمانده : 2 مورد

Tenecteplase: Drug information

Tenecteplase: Drug information
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For additional information see "Tenecteplase: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • TNKase
Brand Names: Canada
  • TNKase
Pharmacologic Category
  • Thrombolytic Agent
Dosing: Adult
Acute ischemic stroke

Acute ischemic stroke:

Note: Perform non–contrast-enhanced CT or MRI prior to administration. After ensuring eligibility criteria are met, administer within 3 hours of symptom onset (according to manufacturer’s labeling); administration within 4.5 hours of symptom onset has also been evaluated (Ref). Symptom onset is usually defined as the time last seen normal or at baseline; however, some stroke centers use imaging-based criteria for select patients who have unknown time of symptom onset (eg, wake-up or unwitnessed stroke) (Ref). Before starting antiplatelet agents or anticoagulation, wait 24 hours after tenecteplase administration and confirm stroke is stable with no evidence of hemorrhage via a follow-up non-contrast CT (or MRI). The risk of administering antiplatelet or anticoagulant therapy within 24 hours after tenecteplase is uncertain (Ref).

IV: 0.25 mg/kg (maximum dose: 25 mg) once (Ref). The manufacturer’s labeling provides the following dosage recommendations based on patient weight; administer as a bolus over 5 seconds:

Recommended Tenecteplase Dose Based on Patient Weight

Weight (kg)

Tenecteplase IV dose (mg)

Tenecteplase volume to be administered (mL)

<60 kg

15 mg

3 mL

60 to <70 kg

17.5 mg

3.5 mL

70 to <80 kg

20 mg

4 mL

80 to <90 kg

22.5 mg

4.5 mL

≥90 kg

25 mg

5 mL

Myocardial infarction, ST elevation

Myocardial infarction, ST elevation:

Note: Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy. Thrombolytic therapy is an option in centers that do not have PCI capability, followed by transfer to a PCI capable center. Administer thrombolytic therapy within 30 minutes of first medical contact (in ambulance or emergency department) if primary PCI cannot be performed within 120 minutes; if primary PCI is not available, may still consider thrombolysis in patients who present late (within 12 to 24 hours of symptom onset) and have ongoing ischemia or extensive ST elevation. Administer aspirin, clopidogrel, and anticoagulant therapy (ie, unfractionated heparin, enoxaparin, or fondaparinux) in combination with thrombolytic (Ref).

IV: Administer as a single bolus over 5 seconds:

<60 kg: 30 mg

≥60 to <70 kg: 35 mg

≥70 to <80 kg: 40 mg

≥80 to <90 kg: 45 mg

≥90 kg: 50 mg

Pulmonary embolism, acute, hemodynamically stable, intermediate-high risk

Pulmonary embolism, acute, hemodynamically stable, intermediate-high risk (submassive) (off-label use):

Note: For most patients without hypotension, parenteral or oral anticoagulation alone is preferred over thrombolysis and anticoagulation. Systemic thrombolysis may be considered for select, younger patients with low risk of bleeding who deteriorate (eg, progressive increase in heart rate, decrease in BP, signs of shock, worsening gas exchange, progressive right heart dysfunction on echocardiography, increase in cardiac biomarkers) despite parenteral anticoagulation (Ref). In these patients, some experts prefer catheter-directed therapy (CDT) if expertise is available due to lower risk of bleeding (Ref).

IV: Administer dose as a single bolus over 5 to 10 seconds (Ref). Institute or resume parenteral anticoagulation following thrombolytic administration (Ref). Some experts start parenteral anticoagulation following thrombolytic administration when aPTT is less than twice its ULN value (Ref).

<60 kg: 30 mg

≥60 to <70 kg: 35 mg

≥70 to <80 kg: 40 mg

≥80 to <90 kg: 45 mg

≥90 kg: 50 mg

Pulmonary embolism, acute, hemodynamically unstable, high risk

Pulmonary embolism, acute, hemodynamically unstable, high risk (massive) (off-label use):

Note: Consider systemic thrombolytic therapy followed by anticoagulation over anticoagulation alone (Ref). Systemic thrombolysis is generally preferred over CDT since systemic treatment can be completed more rapidly (Ref). Some experts prefer CDT, when expertise is available, if systemic thrombolytic is contraindicated or in patients with an increased bleeding risk or persistent hemodynamic instability despite systemic thrombolysis (Ref).

IV: Administer dose as a single bolus over 5 to 10 seconds (Ref). Institute or resume parenteral anticoagulation following thrombolytic administration (Ref). Some experts start parenteral anticoagulation following thrombolytic administration when aPTT is less than twice its ULN value (Ref).

<60 kg: 30 mg

≥60 to <70 kg: 35 mg

≥70 to <80 kg: 40 mg

≥80 to <90 kg: 45 mg

≥90 kg: 50 mg

Pulmonary embolism associated with cardiac arrest

Pulmonary embolism associated with cardiac arrest (off-label use):

Note: Thrombolytic therapy is not recommended for routine use during cardiopulmonary arrest. May consider on a case-by-case basis (eg, suspected PE-induced cardiac arrest) (Ref).

IV: Administer as a single bolus (Ref). Use therapeutic IV anticoagulation in addition to thrombolytic therapy (Ref):

<60 kg: 30 mg

≥60 to <70 kg: 35 mg

≥70 to <80 kg: 40 mg

≥80 to <90 kg: 45 mg

≥90 kg: 50 mg

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Hemodialysis: Dialyzable: Unknown, but unlikely (Ref)

Dosing: Liver Impairment: Adult

Mild to moderate impairment: No dosage adjustment provided in manufacturer's labeling.

Severe impairment: No dosage adjustment provided in manufacturer's labeling; weigh the risk of bleeding against the benefits with tenecteplase especially in those with a coagulopathy.

Dosing: Older Adult

Refer to adult dosing. Although dosage adjustments are not recommended, older adults have a higher incidence of morbidity and mortality with use of thrombolytics.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%: Cardiovascular: Heart failure (12%)

1% to 10%:

Cardiovascular: Cardiogenic shock (6%)

Hematologic & oncologic: Major hemorrhage (requiring blood transfusion: 1%)

Hypersensitivity: Angioedema (1%)

Nervous system: Cerebral hemorrhage (symptomatic: 3%)

<1%: Immunologic: Antibody development

Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)

Contraindications
Tenecteplase Indication-Specific Contraindications

a STEMI = ST-elevation myocardial infarction; AIS = acute ischemic stroke; LMWH = low-molecular-weight heparin.

b Patients without a history of thrombocytopenia, recent use of oral anticoagulants, or recent use of heparin may receive thrombolysis prior to availability of these laboratory results. Discontinue thrombolysis if platelets <100,000/mm3, INR >1.7, or abnormally elevated PT (AHA/ASA [Powers 2019]).

Treatment of STEMIa

Active internal bleeding; history of cerebrovascular accident (additional guidance provided by ACCF/AHA [O’Gara 2013]); recent (within 2 months) intracranial/intraspinal surgery or trauma; intracranial neoplasm, arteriovenous malformation or aneurysm; known bleeding diathesis; severe uncontrolled hypertension (additional guidance provided by ACCF/AHA [O’Gara 2013]).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to tenecteplase or any component of the formulation.

Additional recommended contraindications (ACCF/AHA [O'Gara 2013 ]): Ischemic stroke within 3 months; prior intracranial hemorrhage; active bleeding (excluding menses); suspected aortic dissection; significant closed head or facial trauma within 3 months; severe uncontrolled hypertension (unresponsive to emergency therapy).

Treatment of AISa

Active intracranial hemorrhage or other internal bleeding, recent (within 2 months) intracranial/intraspinal surgery or trauma; known bleeding diathesis; current severe uncontrolled hypertension; intracranial condition that may increase risk of bleeding (eg, intracranial neoplasm, arteriovenous malformation, aneurysm).

Additional recommended contraindications based on alteplase (AHA/ASA [Powers 2019]): History of intracranial hemorrhage; subarachnoid hemorrhage (suspicion of or confirmed); recent (within 3 months) intracranial or intraspinal surgery, ischemic stroke, or severe head trauma; acute head trauma; GI malignancy or bleed within previous 21 days; CT scan showing extensive regions of obvious hypodensity consistent with irreversible injury; symptoms consistent with infective endocarditis; AIS symptoms known or suspected to be associated with aortic arch dissection; intra-axial intracranial neoplasm; coagulopathy (platelets <100,000/mm3, INR >1.7, aPTT >40 seconds, or PT >15 seconds)b; current use (eg, within previous 48 hours) of oral anticoagulants with an INR >1.7 or abnormally elevated PT, current use of direct factor Xa or thrombin inhibitors with evidence of anticoagulant effect demonstrated by laboratory test results (eg, aPTT, INR, platelets, ecarin clotting time, thrombin time, appropriate anti-factor Xa assay); administration of full treatment dose LMWHa within previous 24 hours.

Treatment of pulmonary embolism (off label)

Structural intracranial disease, previous intracranial hemorrhage, ischemic stroke within 3 months, active bleeding, recent brain or spinal surgery, recent head trauma with fracture or brain injury, bleeding diathesis.

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmias: Coronary thrombolysis may result in reperfusion arrhythmias (eg, sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia). Antiarrhythmic therapy should be available during therapy.

• Bleeding: Internal bleeding (intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory) or external bleeding (especially at arterial and venous puncture sites) may occur (may be fatal). Monitor all potential bleeding sites; if serious bleeding occurs, the infusion of tenecteplase and any other concurrent anticoagulants (eg, heparin) and antiplatelets should be stopped and the patient should be treated appropriately. Due to higher risk of intracranial hemorrhage in patients treated for acute ischemic stroke, treat with tenecteplase in facilities that can accommodate timely access to evaluation and management of intracranial hemorrhage.

• Cholesterol embolization: Cholesterol embolization has been reported in patients treated with thrombolytic agents; may present as livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, or rhabdomyolysis and can be fatal.

• Hypersensitivity reactions: Hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, laryngeal edema, rash) have been reported after administration. Monitor closely for hypersensitivity reactions during infusion and for several hours after; initiate appropriate therapy if symptoms of hypersensitivity occur.

• Thromboembolic events: Use may increase risk of thromboembolic events in patients with high probability of left heart thrombus (eg, patients with mitral stenosis or atrial fibrillation).

Disease-related concerns:

• Conditions that increase bleeding risk: For the following conditions, the risk of bleeding is higher with use of thrombolytics and should be weighed against the benefits of therapy:

All indications: Recent major surgery or procedure (eg, coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels); cerebrovascular disease, recent trauma, gastrointestinal or genitourinary bleed, or intracranial hemorrhage (if not already contraindicated); systolic BP >175 mm Hg or diastolic BP >110 mm Hg; acute pericarditis; subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; significant hepatic dysfunction; pregnancy; hemorrhagic ophthalmic conditions (including diabetic hemorrhagic retinopathy); septic thrombophlebitis or occluded AV cannula at seriously infected site; advanced age; concomitant use of anticoagulation; any other condition in which bleeding presents a significant hazard or would be difficult to manage due to its location.

Acute ischemic stroke: Serious trauma or major surgery in previous 14 days, history of gastrointestinal bleeding (remote) or genitourinary bleeding, seizure at stroke onset with postictal neurologic impairment, arterial puncture at noncompressible site in previous 7 days, serum glucose <50 mg/dL (thrombolysis may be administered to patients presenting with initial blood glucose concentrations <50 mg/dL that are subsequently normalized) (Oliveira-Filho 2025a). While guidelines recommend against thrombolysis in patients presenting with a mild nondisabling stroke (NIH 0 to 5), some experts suggest patients with a persistent neurologic deficit that is potentially disabling, even in the context of improvement, should receive IV thrombolysis if otherwise eligible (AHA/ASA [Powers 2019], Oliveira-Filho 2025a).

PE: Systolic BP >180 mm Hg or diastolic BP >110 mm Hg; recent bleeding (nonintracranial); recent surgery or invasive procedure; ischemic stroke >3 months previously; anticoagulated (eg, VKA therapy); traumatic CPR; pericarditis or pericardial fluid; diabetic retinopathy; age >75 years; low body weight (<60 kg); patients who are female; patients who are Black (Kearon 2012; Kearon 2016); lumbar puncture within 10 days (ASRA [Horlocker 2012]).

STEMI: History of chronic, severe, poorly controlled hypertension; significant hypertension on presentation (systolic BP >180 mm Hg or diastolic BP >110 mm Hg); history of prior ischemic stroke >3 months; dementia; traumatic or prolonged CPR (>10 minutes); major surgery (<3 weeks); recent internal bleeding (within 2 to 4 weeks); noncompressible vascular punctures; active peptic ulcer; oral anticoagulant therapy (ACC/AHA [O’Gara 2013]); lumbar puncture within 10 days (ASRA [Horlocker 2012]).

Special populations:

• Older adult: For all indications, use with caution in patients with advanced age due to an increased risk of bleeding. The 30-day mortality in the ASSENT-2 trial of AMI patients was 2.5% for patients <65 years of age, 8.5% for patients 65 to 74 years, and 16.2% for patients ≥75 years. The intracranial hemorrhage rate was 0.4% for patients <65 years, 1.6% for patients 65 to 74 years, and 1.7% for patients ≥75 years. The risks and benefits of use should be weighed carefully in older adults.

Other warnings/precautions:

• Administration: Avoid IM injections and trauma to the patient during treatment. Venipunctures should be performed carefully and only when necessary, avoiding noncompressible sites (eg, internal jugular and subclavian venous punctures). If arterial puncture is necessary, use an upper extremity vessel that can be manually compressed, apply pressure for ≥30 minutes, and monitor closely. Caution with readministration of tenecteplase.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Intravenous:

TNKase: 50 mg

Generic Equivalent Available: US

No

Pricing: US

Kit (TNKase Intravenous)

50 mg (per each): $9,956.71

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Intravenous:

TNKase: 50 mg

Administration: Adult

IV: Tenecteplase is incompatible with dextrose solutions. Dextrose-containing lines must be flushed with a saline solution before and after administration. Administer as a single IV bolus over 5 seconds. Avoid IM injections and trauma to patient.

PE, acute (off-label use): Administer as an IV bolus over 5 to 10 seconds using a peripheral vein (Ref).

Use: Labeled Indications

Acute ischemic stroke: Treatment of acute ischemic stroke in adults.

ST-elevation myocardial infarction: Management of ST-elevation myocardial infarction for the lysis of thrombi in the coronary vasculature to restore perfusion and reduce mortality.

Use: Off-Label: Adult

Pulmonary embolism, acute, hemodynamically unstable, high risk (massive); Pulmonary embolism, acute, hemodynamically stable, intermediate-high risk (submassive); Pulmonary embolism associated with cardiac arrest

Medication Safety Issues
Sound-alike/look-alike issues:

TNKase may be confused with Activase, t-PA

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (thrombolytic agent) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care Settings).

Other safety concerns:

TNK (abbreviation for TNKase) is an error-prone abbreviation (mistaken as TPA)

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aducanumab: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk for hemorrhage may be increased. Management: Avoid use of thrombolytic agents in patients being treated with aducanumab when possible. If concurrent use is necessary, monitor closely for evidence of intracerebral hemorrhage or other bleeding. Risk D: Consider Therapy Modification

Agents with Antiplatelet Effects: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of bleeding may be increased. Risk C: Monitor

Anticoagulants: Tenecteplase may increase anticoagulant effects of Anticoagulants. Risk X: Avoid

Aprotinin: May decrease therapeutic effects of Thrombolytic Agents. Risk C: Monitor

Defibrotide: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of hemorrhage may be increased. Risk X: Avoid

Donanemab: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of hemorrhage may be increased. Management: Avoid use of thrombolytic agents in patients being treated with donanemab when possible. If concurrent use is necessary, monitor closely for evidence of intracerebral hemorrhage or other bleeding. Risk D: Consider Therapy Modification

Herbal Products with Anticoagulant/Antiplatelet Effects: May increase adverse/toxic effects of Thrombolytic Agents. Bleeding may occur. Risk C: Monitor

Lecanemab: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of hemorrhage may be increased. Management: Avoid use of thrombolytic agents in patients being treated with lecanemab when possible. If concurrent use is necessary, monitor closely for evidence of intracerebral hemorrhage or other bleeding. Risk D: Consider Therapy Modification

Limaprost: May increase adverse/toxic effects of Thrombolytic Agents. The risk for bleeding may be increased. Risk C: Monitor

Protein C Concentrate (Human): May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of bleeding may be increased. Risk C: Monitor

Therapeutic Antiplatelets: May increase adverse/toxic effects of Thrombolytic Agents. Specifically, the risk of bleeding may be increased. Risk C: Monitor

Tranexamic Acid: May decrease therapeutic effects of Thrombolytic Agents. Thrombolytic Agents may decrease therapeutic effects of Tranexamic Acid. Risk X: Avoid

Pregnancy Considerations

Bleeding may occur with tenecteplase therapy and the risk of bleeding complications may be increased in pregnant patients; however, use may be considered if other treatment options are not feasible or appropriate (Alameh 2021; ESC [Regitz-Zagrosek 2018]; Ismail 2017; Merlo 2022).

Breastfeeding Considerations

It is not known if tenecteplase is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Blood pressure, CBC, aPTT, signs and symptoms of bleeding, ECG monitoring.

Acute ischemic stroke (based on American Heart Association/American Stroke Association recommendations for alteplase monitoring) (AHA/ASA [Powers 2019]):

Baseline: Neurologic examination, head CT (without contrast), blood pressure, CBC, aPTT, PT/INR, glucose.

During and after initiation: Bleeding complications, signs/symptoms of intracranial hemorrhage (eg, severe headache, acute hypertension, nausea, vomiting, or worsening neurological exam). Measure BP and perform neurological assessments every 15 minutes for the first 2 hours of initiation then every 30 minutes for the next 6 hours, then hourly until 24 hours after initiation of alteplase. Increase frequency if a systolic BP is ≥175 mm Hg or if a diastolic BP is ≥110 mm Hg; administer antihypertensive medications to maintain BP at or below these levels.

Mechanism of Action

Promotes initiation of fibrinolysis by binding to fibrin and converting plasminogen to plasmin. Tenecteplase is essentially alteplase with the exception of 3 point mutations and is more fibrin specific, more resistant to plasminogen activator inhibitor -1 (PAI-1), with a longer duration of action compared to alteplase. Produced by recombinant DNA technology using a mammalian cell line (Chinese hamster ovary cells).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd (central compartment): 4.22 to 5.43 L; approximates plasma volume. Vdss: 6.12 to 8.01 L.

Metabolism: Primarily hepatic.

Half-life elimination: Terminal: 90 to 130 minutes.

Excretion: Clearance: Plasma: 99 to 119 mL/minute

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Total body weight accounted for 19% variability in plasma clearance and 11% variability in Vd.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Metalyse
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