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Tenecteplase: Drug information

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

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

Acute ischemic stroke (off-label use):

Note: Perform non–contrast-enhanced CT or MRI prior to administration. After ensuring eligibility criteria are met, administer within 4.5 hours of symptom onset (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 total dose: 25 mg) once (Ref).

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

Pulmonary embolism, acute, hemodynamically stable, intermediate to 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). Some experts prefer catheter-directed therapy (CDT) if the expertise is available and the patient has a low risk of bleeding; or may consider CDT over systemic in patients with an increased risk of bleeding or with contraindications to systemic thrombolytic therapy (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 (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 (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

ST-elevation myocardial infarction

ST-elevation myocardial infarction:

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

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: Hepatic 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, elderly patients 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%)

<1%: Immunologic: Antibody development

Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis and angioedema)

Contraindications
Tenecteplase Indication-Specific Contraindications

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

b Thrombolysis may be administered to patients presenting with initial blood glucose concentrations <50 that are subsequently normalized (Oliveira-Filho 2023).

c Patients without a history of thrombocytopenia or suspicion of bleeding diathesis, 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, aPTT >40 seconds, or PT >15 seconds (Oliveira-Filho 2023).

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 (off label)

Intracranial hemorrhage (history of or current); subarachnoid hemorrhage (suspicion of or confirmed); active internal bleeding; recent (within 3 months) intracranial or intraspinal surgery, ischemic stroke, or severe head trauma; known bleeding diathesis; GI malignancy or bleed within previous 21 days; persistent BP >185 mm Hg systolic or >110 mm Hg diastolic; 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; blood glucose concentration <50 mg/dLb; coagulopathy (platelets <100,000/mm3, INR >1.7, aPTT >40 seconds, or PT >15 seconds)c; current use (eg, within previous 48 hours) of oral anticoagulants with an INR >1.7 or PT >15 seconds, 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 (Haley 2010; Oliveira-Filho 2023).

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.

• 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:

• 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, intracranial aneurysm (eg, large [≥10 mm], untreated, unruptured), intracranial vascular malformation (untreated) (Oliveira-Filho 2023). 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 2023).

• 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); female; 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: Use with caution in patients with advanced age; 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 the elderly.

Other warnings/precautions:

• Administration: Avoid intramuscular injections and nonessential handling of the patient for a few hours after administration. Venipunctures should be performed carefully and only when necessary. If arterial puncture is necessary, use an upper extremity vessel that can be manually compressed. 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): $9,119.53

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 nonessential handling of patient.

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

Use: Labeled Indications

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

Acute ischemic stroke; Pulmonary embolism, acute, hemodynamically unstable, high risk (massive); Pulmonary embolism, acute, hemodynamically stable, intermediate to 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

TNK (occasional abbreviation for TNKase) is an error-prone abbreviation (mistaken as TPA or TXA, error-prone abbreviation for tranexamic acid)

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication (IV) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Anticoagulants: Thrombolytic Agents may enhance the anticoagulant effect of Anticoagulants. Management: Monitor for signs and symptoms of bleeding if these agents are combined. For the treatment of acute ischemic stroke, avoidance with anticoagulants is often recommended, see full drug interaction monograph for details. Risk C: Monitor therapy

Aprotinin: May diminish the therapeutic effect of Thrombolytic Agents. Risk C: Monitor therapy

Dabigatran Etexilate: Thrombolytic Agents may enhance the anticoagulant effect of Dabigatran Etexilate. Management: Carefully monitor for bleeding. Dabigatran Canadian labeling recommends avoiding use with thrombolytic agents. Consider avoiding alteplase treatment of acute ischemic stroke in patients receiving dabigatran (see full drug monograph for details). Risk C: Monitor therapy

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

Desirudin: Thrombolytic Agents may enhance the anticoagulant effect of Desirudin. Management: Discontinue treatment with thrombolytic agents prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Herbal Products with Anticoagulant/Antiplatelet Effects (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Thrombolytic Agents. Bleeding may occur. Risk C: Monitor therapy

Lecanemab: May enhance the adverse/toxic effect of Thrombolytic Agents. Specifically, the risk of hemorrhage may be increased. Risk C: Monitor therapy

Limaprost: May enhance the adverse/toxic effect of Thrombolytic Agents. The risk for bleeding may be increased. Risk C: Monitor therapy

Prostacyclin Analogues: Thrombolytic Agents may enhance the adverse/toxic effect of Prostacyclin Analogues. Specifically, the antiplatelet effects of prostacyclin analogues may lead to an increased risk of bleeding when combined with thrombolytic agents. Risk C: Monitor therapy

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

Salicylates: May enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Risk C: Monitor therapy

Tranexamic Acid: May diminish the therapeutic effect of Thrombolytic Agents. Thrombolytic Agents may diminish the therapeutic effect of Tranexamic Acid. Risk X: Avoid combination

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

CBC, aPTT, signs and symptoms of bleeding, ECG monitoring

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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