Rx Prescripttion Only-YMYL Medical Content

Trifluxen 15 mg & 6.14 mg Tablets (Trifluridine & Tipiracil)

Trifluridine 15mg & Tipiracil 6.14mg tablets – Everest Pharmaceuticals Ltd.
Approved for adults with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and (if RAS wild-type) anti-EGFR therapy; also approved for metastatic gastric/GE junction adenocarcinoma after two or more prior chemotherapy regimens.

7.1 mo

Median overall survival vs 5.3 mo placebo, colorectal cancer (RECOURSE trial)

5.7 mo

Median overall survival vs 3.6 mo placebo, gastric cancer (TAGS trial)

2.0 mo

Median progression-free survival, colorectal cancer

Late-line

Used after standard chemotherapy options have been exhausted

1

Trifluxen
Generally used after standard chemotherapy regimens (fluoropyrimidine, oxaliplatin, irinotecan) and targeted therapies have been tried and stopped working.

2

Assess baseline blood counts and bone marrow reserve
Neutrophil count, platelet count, and hemoglobin must be checked before each cycle — this medication can significantly lower blood cell counts.

3

Review kidney function and overall performance status
Dose is adjusted based on kidney function and body surface area; overall fitness level affects tolerance to side effects.

4

Discuss your goals of care
This is a later-line treatment with a modest but meaningful survival benefit — important to weigh against quality of life, monitoring needs, and other options like clinical trials.
Important safety information — boxed warning: Trifluridine/tipiracil carries a boxed warning for severe and sometimes fatal bone marrow suppression (myelosuppression), including severe neutropenia, anemia, and thrombocytopenia. Blood counts must be monitored before starting and before each treatment cycle, with dose adjustments or delays as needed.

MD

Medical Oncologist Review

Board-certified oncologist · 12+ years in thoracic malignancies

“For patients whose colorectal or gastric cancer has progressed through standard chemotherapy lines, trifluridine/tipiracil offers a meaningful option with a manageable oral schedule. The survival gains are modest in absolute terms, which is why this conversation should always include a clear discussion of goals and what ‘success’ looks like at this stage.”

Content reviewed against FDA prescribing information, NCCN Guidelines v2.2024, and published Phase III trial data. Last updated June 2026.

Ready to discuss Tagrisso with your care team?

These steps help you have an informed conversation. A confirmed EGFR mutation result is the starting point for any treatment decision.

Questions to ask my healthcare provider

What questions should I ask my oncologist about starting Trifluxen ?

Before confirming Trifluridine & Tipiracil as your treatment

  • Which prior treatments have I already had, and is Trifluxen being recommended because those options have stopped working or because I couldn’t tolerate them?
  • What other options exist at this point — another line of chemotherapy, a clinical trial, regorafenib (for colorectal cancer), or best supportive care alone?
  • Realistically, what should I expect this treatment to do — slow the cancer’s growth, shrink it, or primarily help manage symptoms?

About the boxed warning — bone marrow suppression

  • How often will my blood counts be checked, and what happens if my neutrophils or platelets drop too low before a cycle?
  • What does it mean if my dose needs to be reduced or delayed — does that affect how well it works overall?
  • What signs of infection (fever, chills, sore throat) should prompt me to call immediately, especially since low white blood cells can make infections harder to fight off and harder to detect (sometimes without a typical fever response)?
  • What symptoms of severe anemia (extreme fatigue, shortness of breath, dizziness) or low platelets (unusual bruising, bleeding gums, nosebleeds) should I watch for?

About the dosing schedule

  • Can you walk me through the on/off schedule — which days I take it, how many times a day, and with or without food?
  • What happens if I miss a dose or vomit shortly after taking it?
  • How is my dose calculated, and could it change over time?

About day-to-day side effects

  • Which of the common side effects (nausea, fatigue, appetite loss, diarrhea) are most likely for me, and what can help manage them?
  • Are there anti-nausea medications I should have on hand from the start, rather than waiting until I need them?
  • How might this affect my energy levels and ability to do daily activities — should I plan around certain days?

About my specific situation

  • How does my kidney function affect my dose or monitoring schedule?
  • How does this interact with my other current medications?
  • If I’m of childbearing potential, what precautions are needed during treatment?

About how we’ll know if it’s working — and what comes next

  • What scans or tests will track whether this is working, and how often?
  • At what point would we consider stopping or switching to something else — and what would that conversation look like?
  • If quality of life becomes a bigger concern than disease control at some point, how do we revisit that together?

A practical tip: Because the survival benefit here is measured in a couple of months on average, it’s worth having an early conversation about what matters most to you — more time, comfort, ability to be at home, specific events or milestones — so your care team can help align the treat

Compare trifluridine&tipiracil vs regorafenib for later-line colorectal cancer treatment

Both trifluridine&tipiracil  and regorafenib (Stivarga) occupy a similar space — third-line-or-later options for metastatic colorectal cancer after standard chemotherapy has stopped working. Unlike some of our earlier comparisons, these two aren’t generational successors to each other; they’re mechanistically different drugs that are often used sequentially, one after the other.

What they are and how they work

 Trifluridine&tipiracil (Trifluxen)Regorafenib (Stivarga)
Drug classNucleoside analog + thymidine phosphorylase inhibitorOral multikinase inhibitor (targets VEGFR, KIT, RET, and others)
MechanismGets incorporated into cancer cell DNA, disrupting replicationBlocks multiple signaling pathways involved in tumor growth and blood vessel formation
Approved2015 (FDA)2012 (FDA)
Pivotal trialRECOURSECORRECT

Efficacy comparison

 Trifluxen (RECOURSE)Regorafenib (CORRECT)
Median OS vs placebo7.1 mo vs 5.3 mo6.4 mo vs 5.0 mo
Median PFS vs placebo2.0 mo vs 1.7 mo1.9 mo vs 1.7 mo

Both show a modest but statistically significant survival benefit over placebo/best supportive care — in the same general range. Neither has been shown in head-to-head trials to be clearly superior to the other for overall survival, so the choice often comes down to side effect profile and how it fits the patient’s situation rather than one being definitively “better.”

Dosing schedule — a meaningful practical difference

 TrifluxenRegorafenib
FormOral, twice dailyOral, once daily
ScheduleDays 1–5 and 8–12 of a 28-day cycle (with two rest periods)Days 1–21 of a 28-day cycle (3 weeks on, 1 week off)

Some patients find regorafenib’s once-daily, more continuous schedule simpler to follow, while others find Trifluxen’s structure easier because of the built-in rest days each week.

Side effect profiles — quite different

 TrifluxenRegorafenib
Boxed warningSevere bone marrow suppression (neutropenia, anemia, thrombocytopenia)Severe hepatotoxicity (liver injury, including fatal cases)
Most distinctive side effectLow blood counts, infection riskHand-foot skin reaction (painful blistering/peeling on palms and soles)
HypertensionNot typicalCommon — requires blood pressure monitoring
FatigueCommonCommon
GI effectsNausea, diarrhea, appetite lossDiarrhea, mucositis
Liver monitoringLess centralCentral — LFTs checked regularly, especially early on

This is often where the decision actually lands: a patient with bone marrow reserve concerns (low baseline counts, prior heavy chemo) might be steered toward regorafenib, while a patient with liver function concerns or at higher risk of hand-foot skin reactions (e.g., from physically demanding work) might be steered toward Trifluxen.

Sequencing — using both

Because they work through different mechanisms and don’t share major toxicities, it’s common for patients to receive both drugs sequentially — one after the other — rather than choosing permanently between them. The order isn’t rigidly defined by guidelines; it often depends on which side effect profile is more manageable given the patient’s current health status at the time each decision point arises.

Bottom line

Neither drug is “later generation” than the other in the way osimertinib succeeded earlier EGFR TKIs — they’re parallel options with similar modest survival benefits but very different toxicity patterns (bone marrow suppression vs liver/skin/blood pressure effects). The conversation with your oncologist often centers on which side-effect profile is more compatible with your current health status, and whether using both, in sequence, makes sense for your overall plan.

 

What does the dosing schedule for Trifluxen look like and what monitoring is needed?

Here’s how the dosing and monitoring schedule typically works for Trifluridine & Tipiracil:

The basic schedule — a 28-day cycle

Each treatment cycle is 28 days long, but you’re not taking the medication every day within it:

  • Days 1–5: Take the medication twice daily
  • Days 6–7: Rest (no medication)
  • Days 8–12: Take the medication twice daily again
  • Days 13–28: Rest (no medication)

Then the cycle repeats. So out of each 4-week cycle, you’re actively taking the drug for 10 days total, spread across two 5-day blocks with a 2-day break in between, followed by a longer 16-day break before the next cycle starts.


How each dose is taken

  • Twice daily — typically morning and evening
  • Within 1 hour after completing a meal — this affects absorption, so timing relative to food matters
  • The dose itself is calculated based on your body surface area (using your height and weight), which is why your specific dose may differ from someone else’s even at the same tablet strength

Blood count monitoring — the core safety requirement

Given the boxed warning for bone marrow suppression, blood counts are checked at defined points:

  • Before starting treatment — baseline complete blood count (CBC)
  • Before each new cycle begins — to confirm counts have recovered enough to start the next cycle safely
  • Mid-cycle (around day 15) — an additional check partway through, since blood counts often dip lowest about 1–2 weeks after the dosing days

If neutrophil counts, platelet counts, or hemoglobin are too low at any of these checkpoints, your oncologist may delay the start of the next cycle, reduce your dose, or in some cases skip a dose until counts recover.


Other monitoring

  • Kidney function — checked periodically, since this affects how the drug is processed and may influence dosing
  • Liver function tests — less central than with regorafenib, but still part of routine bloodwork
  • Symptom check-ins — nausea, diarrhea, appetite, and fatigue are typically discussed at each visit, since these affect quality of life and may prompt supportive medications (anti-nausea drugs, for example)

What dose adjustments look like in practice

It’s common for the dose to be reduced over the course of treatment if side effects (especially low blood counts) occur — this is a normal part of managing the medication, not a sign that it’s “failing.” Your oncologist will balance maintaining enough dose intensity to be effective against keeping side effects manageable.


A practical note on timing

Because the schedule has specific “on” days that don’t align neatly with calendar weeks, many patients find it helpful to use a pill calendar or phone reminders marking exactly which days are dosing days versus rest days — especially since missing the meal-timing window (within 1 hour after eating) is easy to do without a visual reminder.

This is a sensitive topic where individual factors — your baseline blood counts, kidney function, and how you tolerate the first cycle — will shape how closely your actual schedule follows this template, so your oncology team’s specific instructions for your case should always take priority over general guidance like this.

Medical disclaimer: This page is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Osimertinib is a prescription medication that must only be used under the supervision of a qualified oncologist. Clinical outcomes data is drawn from published Phase III trials; individual results vary. Always consult your healthcare provider and refer to the full prescribing information before making any treatment decisions. Emergency: call your local emergency services or poison control immediately if you experience serious adverse effects.