Lonsurf 20mg 60 TAB

What is Lonsurf 20mg 60 TAB (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 therapy

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, 2015²
• European Medical Agency (EMA), European Union, April 25, 2016³
• Therapeutic Goods Administration (TGA), Australia, May 23, 2017⁶
• Health Canada, January 23, 2018⁷

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 is^3,4,6:

• 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 references section^3,4,6.

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 adverse reactions or side effects of Lonsurf (trifluridine/ tipiracil)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^3,4,6:

• Abnormal blood counts (anemia, neutropenia, thrombocytopenia)
• asthenia/fatigue (lack of energy, tiredness)
• nausea
• decreased appetite
• diarrhea
• vomiting
• pyrexia (fever)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^3,4,6:

• 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 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 information^3,4,6.

References

1. FDA approves new oral medication to treat patients with advanced colorectal cancer
   FDA, Sept 2015
2. Human Medicines: Lonsurf (trifluridine/tipiracil)
   EMA, March 2017
3. Summary of Product Characteristics [FDA]: Lonsurf (trifluridine/tipiracil)[PDF]
   Taiho Oncology Inc., Mar. 2017
4. Summary of Product Characteristics [EMA]: Lonsurf (trifluridine/tipiracil)[PDF]
   Les Laboratoires Servier, Sep. 2017
5. PMDA. Report on deliberation results[PDF]
   Feb 2014