Lonsurf (trifluridine / tipiracil)

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Lonsurf (trifluridine / tipiracil)

How to buy Lonsurf: You can order Lonsurf (trifluridine / tipiracil) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSoclalMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Taiho Pharmaceuticals
Disease Colorectal Cancer
Indication Advanced (metastatic) colorectal cancer
Mode of Action Cytotoxic agent (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA); PMDA approved (JAP)
CAS Number 183204-74-2
HS Code 29335995
Strength 15 mg / 6.14 mg, 20 mg / 8.19 mg

Who is trifluridine/tipiracil for?

Trifluridine/tipiracil is an oral medication intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy [1][2].

Recommended dose

Complete information about trifluridine/tipiracil dosage and administration can be found here [3][4][6].
  • The recommended therapy consists of 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.
Consult your treating doctor for personalised dosing.

What is trifluridine/tipiracil and how does it work?

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 the growth of cancer cells being reduced, 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 effect [2].

What is trifluridine/tipiracil's approval status?

Trifluridine/tipiracil was approved by
  • PMDA (JAP) on February 3, 2016
  • FDA (USA) on September 22, 2015
  • EMA (EU) on April 25, 2016
  • TGA (AUS) on May 23, 2017
for advanced (metastatic) colorectal cancer who have been previously treated with, or who cannot be given, other available treatments [1][2][5][6].

The efficacy and safety of Lonsurf were evaluated in an international, randomized, double-blind study involving 800 patients with previously treated metastatic colorectal cancer. The EMA, FDA, and TGA approvals were based on this study. The Japanese approval was based on previous studies which had to be confirmed by the results of the above-mentioned international study.
Study participants received Lonsurf plus best supportive care, or placebo plus best supportive care until their disease worsened or side effects became intolerable. The primary endpoint of the study was overall survival and the secondary endpoint was progression-free survival. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo [1][2]. On average, the time to disease progression was 2 months for patients on Lonsurf compared to 1.7 months for patients receiving placebo [1].

The most common side effects of treatment with Lonsurf are anemia, a decrease in infection-fighting white blood cells (neutropenia) or blood platelets (thrombocytopenia), physical weakness, extreme tiredness and lack of energy (fatigue), nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever [3][4].

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].
References
[1] FDA News Release: FDA approves new oral medication to treat patients with advanced colorectal cancer. 22/09/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm
[2] EMA. Human Medicines: Lonsurf (trifluridine / tipiracil), 12/05/2016 (last update: 31/05/2017), cited on 16/03/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003897/human_med_001975.jsp&mid=WC0b01ac058001d124
[3] Summary of Product Characteristics [FDA]: Lonsurf (trifluridine / tipiracil), Taiho Oncology Inc., Sep. 2015.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf
[4] Summary of Product Characteristics [EMA]: Lonsurf (trifluridine / tipiracil), Les Laboratoires Servier, Sep. 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003897/WC500206246.pdf
[5] PMDA. Report on deliberation results. 07/02/2014.
http://www.pmda.go.jp/files/000207987.pdf
[6] Summary of Product Characteristics [TGA]: Lonsurf (trifluridine / tipiracil), Servier Laboratories (Aust.) Pty Ltd,May 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01847-1









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