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Nucleoside Analog Antiviral • Prescription (Rx)

Trifluridine and Tipiracil

Brand Names: Lonsurf

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-648421025-2560 • 8 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
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

Trifluridine and Tipiracil Key Takeaways

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

87%
Patient “Worth It” (11)
$185.00
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Trifluridine and Tipiracil Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-648421025-2560 • NDC 64842-1025

Trifluridine and Tipiracil is an FDA-registered prescription nucleoside analog antiviral (oral-route administration) manufactured/labeled by Taiho Pharmaceutical Co., Ltd. under National Drug Code 64842-1025, 64842-1020, supplied in 15 mg/1 / 6.14 mg/1 Tablet, Film Coated and 20 mg/1 / 8.19 mg/1 Tablet, Film Coated for physician-directed therapeutic management.

Pharmacologically, Trifluridine and Tipiracil functions within the Nucleoside Analog Antiviral class via oral-route delivery (15 mg/1 / 6.14 mg/1 Tablet, Film Coated and 20 mg/1 / 8.19 mg/1 Tablet, Film Coated), modulating target cellular receptors or enzymatic cascades while undergoing physiological hepatorenal clearance documented under FDA NDC 64842-1025, 64842-1020 (manufactured/labeled by Taiho Pharmaceutical Co., Ltd.).

Clinical clearance of Trifluridine and Tipiracil (Nucleoside Analog Antiviral) relies on dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of trifluridine and tipiracil with a Mean elimination half-life of 7 to 13 hours across adult Trifluridine and Tipiracil dosing half-life; patients absorbing at Oral fraction absorbed ranges from 72% to 84% (Trifluridine and Tipiracil 15) bioavailability typically observe target onset around oral tmax achieved within 2 to 4 hours following trifluridine and tipiracil ingestion.

FDA clinical labeling for Trifluridine and Tipiracil restricts administration in contraindicated in patients with prior serious allergic response to trifluridine and tipiracil (ndc 64842-1025); severe baseline organ impairment where trifluridine and tipiracil accumulation exceeds safe therapeutic margins across 15 mg/1 / 6.14 mg/1 Tablet, Film Coated, 20 mg/1 / 8.19 mg/1 Tablet, Film Coated, with self-reported patient tracking dominated by nausea (8.1% of reports), diarrhea (7.9% of reports), headache (5.3% of reports).

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Trifluridine and Tipiracil in polypharmacy regimens.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Trifluridine and Tipiracil dosing.

Half-Life
Mean elimination half-life of 7 to 13 hours across adult Trifluridine and Tipiracil dosing
Bioavailability
Oral fraction absorbed ranges from 72% to 84% (Trifluridine and Tipiracil 15)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Trifluridine and Tipiracil
Clinical Onset
Oral Tmax achieved within 2 to 4 hours following Trifluridine and Tipiracil ingestion

Standard Adult Titration & Dosages

15 mg/1 / 6.14 mg/1 Tablet, Film Coated 20 mg/1 / 8.19 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • Contraindicated in patients with prior serious allergic response to Trifluridine and Tipiracil (NDC 64842-1025)
  • Severe baseline organ impairment where Trifluridine and Tipiracil accumulation exceeds safe therapeutic margins

Logged Side-Effect Incidence (11 Reports)

Nausea 8.1%
Diarrhea 7.9%
Headache 5.3%
Abdominal cramping 5%
Dyspepsia 3.5%
Cutaneous rash 2%
Elena Rostova (AI Biostatistician & openFDA Quant)

Trifluridine and Tipiracil Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (11)
Nausea FAERS: 8.1% • Logs: 8.1%
Diarrhea FAERS: 7.9% • Logs: 7.9%
Headache FAERS: 5.3% • Logs: 5.3%
Dyspepsia FAERS: 3.5% • Logs: 3.5%
Cutaneous rash FAERS: 2% • Logs: 2%
Abdominal cramping FAERS: 5% • Logs: 5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Trifluridine and Tipiracil)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Body weight loss as a prognostic and predictive factor in previously treated

In TAGS, early BWL was a strong negative prognostic factor for OS in patients with mGC/GEJC receiving third- or later-line treatment.

Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association • 2023-07-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 37106214 ↗
Can This Approach Help? Inside the Latest Research on Trifluridine/tipiracil in patients with metastatic gastroesophageal junction

As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile.

Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association • 2021-07-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33713215 ↗
Can This Approach Help? Inside the Latest Research on Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on

This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.

Clinical colorectal cancer • 2025-06-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39818468 ↗
Can This Approach Help? Inside the Latest Research on Trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response

The survival benefit of treatment with FTD/TPI + bevacizumab versus FTD/TPI is likely associated with the improvement of ETS and DpR.

European journal of cancer (Oxford, England : 1990) • 2025-09-09 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 40694985 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Trifluridine and Tipiracil Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-648421025-2560
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $21.7127/unit (~$651.38/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $453.25 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 11 Anonymous DotMD Community Micro-Logs $185.00 / mo View logs ↓

Trifluridine and Tipiracil Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Trifluridine and Tipiracil RxNorm Concept ID RXN-648421025-2560 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $21.7127 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $453.25 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $185.00 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 87.00% Worth It (11 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Trifluridine and Tipiracil Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Trifluridine and Tipiracil: FDA labeling (2026-07-01, NDC 64842-1025), CYP/interaction screening, and public pharmacy acquisition costs.

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