Tenecteplase

TNKASE

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Pronunciation: ten-EK-te-plays

Tenecteplase ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Tenecteplase ballicule

What it isBioengineered tPA variant with greater fibrin specificity and a longer half-life; STEMI and, increasingly, ischemic stroke.

Why this oneA single bolus replaces alteplase’s infusion, which matters when transferring a stroke patient.

What limits itSame hemorrhage risk and same time window. Dosing differs from alteplase — the two are not interchangeable by volume.

FDA label

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FDA dosing	Population	Start	Target	Max
Acute ischemic stroke (AIS)	Adults	Weight-based single IV bolus over 5 sec (<60 kg 15 mg; 60–<70 17.5 mg; 70–<80 20 mg; 80–<90 22.5 mg; ≥90 25 mg), within 3 h of symptom onset	Single bolus	25 mg
Acute ST elevation myocardial infarction (STEMI)	Adults	Weight-based single IV bolus over 5 sec (<60 kg 30 mg; 60–<70 35 mg; 70–<80 40 mg; 80–<90 45 mg; ≥90 50 mg)	Single bolus	50 mg

Renal Undefined

Hepatic Undefined

Single-dose only

Instructions

IV single bolus over 5 seconds
Reconstitute to 5 mg/mL with supplied Sterile Water; do not shake
Flush dextrose-containing IV lines with 0.9% NaCl before and after (incompatible with dextrose)
AIS: initiate within 3 h of symptom onset; frequently monitor and control blood pressure

Available strengths

inj 25, 50 mg

Contraindications

Active internal bleeding
Intracranial or intraspinal surgery or trauma within 2 months
Known bleeding diathesis
Current severe uncontrolled hypertension
Presence of intracranial conditions that may increase the risk of bleeding (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm)
AIS: Active intracranial hemorrhage
STEMI: History of intracranial hemorrhage
STEMI: History of ischemic stroke within 3 months

Cautions

Bleeding (can be significant and fatal); avoid IM injections and minimize punctures
Hypersensitivity, including anaphylaxis; monitor during and for several hours after
Thromboembolism in patients with high likelihood of left heart thrombus
Cholesterol embolization
Arrhythmias with reperfusion
STEMI with planned PCI: increased heart failure and recurrent ischemia

Adverse reactions

Bleeding (most common)
Symptomatic intracerebral hemorrhage
Extracranial bleeding requiring transfusion
Orolingual angioedema

Pregnancy No human data; related thrombolytics not shown to increase birth defects; STEMI/AIS are life-threatening emergencies — do not withhold life-sustaining therapy

Lactation No data on presence in milk; weigh benefits of breastfeeding against clinical need

Cost

Tenecteplase (TNKASE)

Strength		#/mo	generic $/unit	CostPlus
25 mg	inj	per unit		not offered
50 mg	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Tenecteplase is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskIntracranial hemorrhage; dosing differs from alteplase

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryC

Defining liabilityMajor bleeding including intracranial hemorrhage

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