Lonsurf (trifluridine/tipiracil)

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Lonsurf (trifluridine/tipiracil)

Lonsurf (trifluridine / tipiracil) is a medication used for the treatment of advanced (metastatic) colorectal cancer.

Oncology Colorectal Cancer
Marketing Authorisation Holder Les Laboratoires Servier
Mode of Action Cytotoxic agent (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia

What is Lonsurf (trifluridine/tipiracil) for?

Lonsurf (trifluridine/tipiracil) is a chemotherapy indicated for the treatment of people with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy1,2.

How does Lonsurf (trifluridine/tipiracil) work?

Lonsurf (trifluridine/tipiracil) is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells). It contains two active substances: trifluridine and tipiracil. In the body, trifluridine is converted into an active form that is incorporated directly into DNA, the genetic material of cells. As a result, trifluridine interferes with DNA function and prevents the cells from dividing and multiplying. The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This results in a reduced growth of cancer cells, while normal cells are only slightly affected. Tipiracil increases the level of trifluridine in the blood by slowing its breakdown. This, therefore, boosts trifluridine’s effect2.

Where has Lonsurf (trifluridine/tipiracil) been approved?

Lonsurf (trifluridine/tipiracil) was approved for previously treated advanced (metastatic) colorectal cancer by:

  • Food and Drug Administration (FDA), USA, September 22, 2015

  • European Medical Agency (EMA), European Union, April 25, 2016

  • Therapeutic Goods Administration (TGA), Australia, May 23, 2017

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Lonsurf (trifluridine/tipiracil) taken?

The standard dosage is3,4,6:

  • 35 mg/m2/dose orally twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle.

Take trifluridine/tipiracil within 1 hour after completion of morning and evening meals.

Complete information about Lonsurf (trifluridine/tipiracil) dosage and administration can be found in the official prescribing information listed in our resources section3,4,6.

It is recommended that healthcare providers obtain complete blood counts prior to starting each treatment cycle of Lonsurf and monitor patients throughout treatment, as trifluridine/tipiracil may cause a severe decrease in blood cell and platelet production (myelosuppression)1,4.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Lonsurf (trifluridine/ tipiracil)?

Common side effects

The most common side effects listed in the prescribing information include3,4,6:

  • Abnormal blood counts (anemia, neutropenia, thrombocytopenia)

  • asthenia/fatigue (lack of energy, tiredness)

  • nausea

  • decreased appetite

  • diarrhea

  • vomiting

  • pyrexia (fever)

Serious side effects

The serious side effects listed in the prescribing information include3,4,6:

  • bone marrow suppression (myelosuppression including anaemia, neutropenia,
    leucopenia, and thrombocytopenia)

  • gastrointestinal toxicity (severe or persistent nausea, vomiting, diarrhoea, or abdominal pain)

Use in specific populations

As Lonsurf (trifluridine / tipiracil) can be fatal for a fetus, it is not advised to for women who are pregnant or breast-feeding.

Avoid use in patients with moderate to severe hepatic impairment (liver dysfunction), and in patients with moderate renal impairment (kidney dysfunction)3,4,6.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information3,4,6.

More Information
Working ingredient trifluridine/tipiracil
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Oncology
Oncology Colorectal Cancer
Indication Metastatic colorectal cancer
Administration Oral
Mode of Action Cytotoxic agent (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Les Laboratoires Servier
HS Code 29335995
CAS Number 183204-74-2

Clinical trials – Lonsurf (trifluridine / tipiracil)

Approvals by the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, of Lonsurf (trifluridine / tipiracil) for metastatic colorectal cancer in previously treated patients were based on one randomised, double-blind phase III study (RECOURSE). This study involved a total of 800 patients with previously treated metastatic colorectal cancer. Patients received either Lonsurf plus best supportive care or placebo plus best supportive care. Patients continued therapy until disease progression or unacceptable toxicity3,4,6.

Results

Among the major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS).

The median OS was3,4,6:

  • 7.1 months [95% CI: 6.5, 7.8] with Lonsurf (trifluridine/tipiracil)

    • Rate of deaths: 68.2%

  • 5.3 months [95% CI: 4.6, 6.0] with placebo

    • Rate of deaths: 78.9%

The median PFS was3,4,6:

  • 2.0 months [95% CI: 1.9, 2.1] with Lonsurf (trifluridine/tipiracil)

    • Rate of progressions or deaths: 88.4%

  • 1.7 months [95% CI: 1.7, 1.8] with placebo

    • Rate of progressions or deaths: 94.4%

Shipping Type Standard
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.