Lonsurf

Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.

Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days. The dose is calculated using the patient’s height and weight. The tablets are taken twice a day on certain days of each treatment cycle. They should be taken within one hour after morning and evening meals. The doctor may reduce the dose or interrupt treatment if certain side effects develop. Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable.

For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist.

Lonsurf 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 into DNA, the genetic material of cells. As a result, trifluridine interferes with DNA function and prevents the cells from dividing to make more cells.

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 reduces the 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 effect.

Lonsurf prolonged overall survival of patients with metastatic colorectal cancer and in patients with metastatic gastric cancer. All patients had previously received other treatments.

Colorectal cancer

In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment). All patients received supportive care.

Gastric cancer

In a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo. All patients received supportive care.

The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts). The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).

For the full list of side effects and restrictions of Lonsurf, see the package leaflet.

The European Medicines Agency decided that Lonsurf’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.

Regarding its safety, although Lonsurf’s side effects can be serious they are in line with what can be expected for this type of medicine. The Agency considered that the measures put in place are adequate to manage these risks.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonsurf have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lonsurf are continuously monitored. Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients.

Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016.