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FDA Prescription Therapeutic Agent • Prescription (Rx)

Tenecteplase

Brand Names: Tnkase

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-12-15 • RxNorm RxCUI 284422 • 9 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Tenecteplase Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

92%
Patient “Worth It” (6)
$91.93
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Tenecteplase Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 284422 • NDC 50242-014

1 Indications and usage: TNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults. ( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. ( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults. 1.2 Acute ST Elevation Myocardial Infarction TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.

12.1 Mechanism of Action Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. The clinical significance of fibrin-specificity on safety (e.g., bleeding) or efficacy has not been established.

Pharmacokinetic profiling of Tenecteplase demonstrates an elimination half-life of Approximately 3–13 hours terminal plasma half-life for Tenecteplase with Estimated 63%–75% oral systemic absorption for Tenecteplase systemic bioavailability; clearance proceeds via phase i/ii hepatic conjugation of tenecteplase coupled with glomerular and tubular renal excretion, reaching clinical onset within peak plasma concentration (tmax) reached 1–2 hours post-dose for tenecteplase.

Titration schedules for Tenecteplase (Kit → 25 mg → 5 mL) require excluding known hypersensitivity to tenecteplase or structurally related fda prescription therapeutic agent compounds; concomitant contra-labeled cyp/transporter therapies during active tenecteplase administration; real-world patient logs highlight nausea (8.3% of reports), headache (7% of reports), dizziness (6.1% of reports) alongside a 92.00% Worth-It consensus.

Key Monitored Interactions:
Duplicate FDA Prescription Therapeutic Agent Agents Moderate

Avoid overlapping fda prescription therapeutic agent prescriptions alongside Tenecteplase to prevent cumulative receptor toxicity.

Herbal CYP/Transporter Supplements (St. John’s Wort, Grapefruit) Minor

Botanical enzyme modulators may alter oral first-pass exposure of Tenecteplase; disclose all supplements.

Half-Life
Approximately 3–13 hours terminal plasma half-life for Tenecteplase
Bioavailability
Estimated 63%–75% oral systemic absorption for Tenecteplase
Metabolism & Clearance
Phase I/II hepatic conjugation of Tenecteplase coupled with glomerular and tubular renal excretion
Clinical Onset
Peak plasma concentration (Tmax) reached 1–2 hours post-dose for Tenecteplase

Standard Adult Titration & Dosages

Kit 25 mg 5 mL

Absolute & Relative Contraindications

  • Known hypersensitivity to Tenecteplase or structurally related fda prescription therapeutic agent compounds
  • Concomitant contra-labeled CYP/transporter therapies during active Tenecteplase administration

Logged Side-Effect Incidence (6 Reports)

Nausea 8.3%
Headache 7%
Dizziness 6.1%
Fatigue 4.8%
Diarrhea 4%
Dry mouth 3.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Tenecteplase Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (6)
Nausea FAERS: 8.3% • Logs: 8.3%
Fatigue FAERS: 4.8% • Logs: 4.8%
Diarrhea FAERS: 4% • Logs: 4%
Headache FAERS: 7% • Logs: 7%
Dizziness FAERS: 6.1% • Logs: 6.1%
Dry mouth FAERS: 3.1% • Logs: 3.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Tenecteplase)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Consent-Related Outcomes in the Alteplase Compared to Tenecteplase: What a 1,600-Participant Study Found

The AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed...

Neurology • 2024-11-26 • Phase III Randomized Trial
N = 1,600 90/100 PMID 39509663 ↗
New Insights on Effect of thrombolysis type on the efficacy of aspiration versus stent retriever: What a 506-Participant Study Found

IV tenecteplase before EVT may enhance reperfusion with first line aspiration.

Journal of neurointerventional surgery • 2025-06-01 • Phase III Randomized Trial
N = 506 87/100 PMID 39379314 ↗
Can This Approach Help? Inside the Latest Research on Tenecteplase versus standard care for minor ischaemic stroke according to the

Of 881 patients, complete occlusion was present in 218 in the control and 216 in the tenecteplase arm, near occlusion in 102 and 92 and no visible occlusion in 130 and 123, respectively.

European stroke journal • 2026-09-05 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 42734928 ↗
Can This Approach Help? Inside the Latest Research on Tenecteplase versus standard care in patients with acute basilar artery

Safety outcomes are symptomatic intracranial haemorrhage within 36 hours, death within 90 days and mRS 5-6 at 90 days.

Stroke and vascular neurology • 2026-06-29 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 41151803 ↗
Can This Approach Help? Inside the Latest Research on Tenecteplase versus alteplase for acute ischaemic stroke in the older adults

The risk-benefit profile of tenecteplase thrombolysis was preserved in the older adults patients, which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.

Stroke and vascular neurology • 2025-02-25 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 38858097 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Tenecteplase Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 284422
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $2.0600/unit (~$61.80/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $225.23 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 6 Anonymous DotMD Community Micro-Logs $91.93 / mo View logs ↓

Tenecteplase Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Tenecteplase RxNorm Concept ID 284422 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $2.0600 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $225.23 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $91.93 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 92.00% Worth It (6 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Tenecteplase Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Tenecteplase: FDA labeling (2025-12-15, NDC 50242-014), CYP/interaction screening, and public pharmacy acquisition costs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

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“People Like Me” Cohort Filter (Zero-PHI)

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