Lonsurf

trifluridine / tipiracil

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This is a summary of the European public assessment report (EPAR) for Lonsurf. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lonsurf.

For practical information about using Lonsurf, patients should read the package leaflet or contact their doctor or pharmacist.

What is Lonsurf and what is it used for?

Lonsurf is a cancer medicine used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). It is used in patients who have already been treated with, or who cannot be given, other available treatments including chemotherapy based on medicines called fluoropyrimidines, oxaliplatin or irinotecan and treatment with other cancer medicines known as anti‑VEGF and anti‑EGFR.

Lonsurf contains the active substances trifluridine and tipiracil.

How is Lonsurf used?

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 to be taken is calculated based on the patient’s body surface area (calculated using the patient’s height and weight). The tablets are taken twice a day on days 1 to 5 and days 8 to 12 of each treatment cycle. They should be taken within one hour after morning and evening meals. The doctor may need to 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 further information, see the summary of product characteristics (also part of the EPAR).

How does Lonsurf work?

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 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.

What benefits of Lonsurf have been shown in studies?

Lonsurf has been shown to prolong overall survival of patients with metastatic colorectal cancer who previously received other treatments. 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 in the study received supportive care.

What are the risks associated with Lonsurf?

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), nausea, tiredness, anaemia (low red blood cell counts) and leucopenia (low white blood cell counts). The most serious side effects are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicity (injury to the lining of the gut such as ulcers).

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

Why is Lonsurf approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Lonsurf’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal cancer who have received previous treatment was clinically relevant.

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

What measures are being taken to ensure the safe and effective use of Lonsurf?

A risk management plan has been developed to ensure that Lonsurf is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lonsurf, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Lonsurf

The European Commission granted a marketing authorisation valid throughout the European Union for Lonsurf on 25 April 2016.

For more information about treatment with Lonsurf, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Lonsurf : EPAR - Summary for the public BG = bălgarski 2016-05-12  
Lonsurf : EPAR - Summary for the public ES = español 2016-05-12  
Lonsurf : EPAR - Summary for the public CS = čeština 2016-05-12  
Lonsurf : EPAR - Summary for the public DA = dansk 2016-05-12  
Lonsurf : EPAR - Summary for the public DE = Deutsch 2016-05-12  
Lonsurf : EPAR - Summary for the public ET = eesti keel 2016-05-12  
Lonsurf : EPAR - Summary for the public EL = elliniká 2016-05-12  
Lonsurf : EPAR - Summary for the public EN = English 2016-05-12  
Lonsurf : EPAR - Summary for the public FR = français 2016-05-12  
Lonsurf : EPAR - Summary for the public IT = italiano 2016-05-12  
Lonsurf : EPAR - Summary for the public LV = latviešu valoda 2016-05-12  
Lonsurf : EPAR - Summary for the public LT = lietuvių kalba 2016-05-12  
Lonsurf : EPAR - Summary for the public HU = magyar 2016-05-12  
Lonsurf : EPAR - Summary for the public MT = Malti 2016-05-12  
Lonsurf : EPAR - Summary for the public NL = Nederlands 2016-05-12  
Lonsurf : EPAR - Summary for the public PL = polski 2016-05-12  
Lonsurf : EPAR - Summary for the public PT = português 2016-05-12  
Lonsurf : EPAR - Summary for the public RO = română 2016-05-12  
Lonsurf : EPAR - Summary for the public SK = slovenčina 2016-05-12  
Lonsurf : EPAR - Summary for the public SL = slovenščina 2016-05-12  
Lonsurf : EPAR - Summary for the public FI = suomi 2016-05-12  
Lonsurf : EPAR - Summary for the public SV = svenska 2016-05-12  
Lonsurf : EPAR - Summary for the public HR = Hrvatski 2016-05-12  

This EPAR was last updated on 12/05/2016 .

Authorisation details

Product details

Product details for Lonsurf
NameLonsurf
Agency product numberEMEA/H/C/003897
Active substance

trifluridine / tipiracil hydrochloride

International non-proprietary name (INN) or common name

trifluridine / tipiracil

Therapeutic area Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code L01BC
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Lonsurf
Marketing-authorisation holder

Les Laboratoires Servier

Revision0
Date of issue of marketing authorisation valid throughout the European Union25/04/2016

Contact address:

Les Laboratoires Servier
50 rue Carnot 
92284 Suresnes cedex 
France

Product information

Product information

25/04/2016  Lonsurf -EMEA/H/C/003897 --

Name Language First published Last updated
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - Product Information HR = Hrvatski 2016-05-12  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  
Lonsurf : EPAR - All Authorised presentations HR = Hrvatski 2016-05-12  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lonsurf : EPAR - Public assessment report HR = Hrvatski 2016-05-12  
CHMP summary of positive opinion for Lonsurf HR = Hrvatski 2016-02-26  

Authorised

This medicine is approved for use in the European Union