Giotrif

afatinib

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

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

What is Giotrif and what is it used for?

Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer. It is used specifically in adults with advanced cancer in the following situations:

  • when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
  • when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.

Giotrif contains the active substance afatinib.

How is Giotrif used?

Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.

Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription. The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.

The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.

How does Giotrif work?

The active substance in Giotrif, afatinib, is an ErbB family blocker. This means that it blocks the action of a group of proteins known as ‘ErbB family’ which are found on the surface of cancer cells and are involved in stimulating the cells to divide. By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.

EGFR proteins are part of the ErbB family. Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.

What benefits of Giotrif have been shown in studies?

Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.

In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.

In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.

What are the risks associated with Giotrif?

The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin. For the full list of all side effects and restrictions with Giotrif, see the package leaflet.

Why is Giotrif approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU. The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients. In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.

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

A risk management plan has been developed to ensure that Giotrif 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 Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Giotrif

The European Commission granted a marketing authorisation valid throughout the European Union for Giotrif on 25 September 2013.

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

Name Language First published Last updated
Giotrif : EPAR - Summary for the public BG = bălgarski 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public ES = español 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public CS = čeština 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public DA = dansk 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public DE = Deutsch 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public ET = eesti keel 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public EL = elliniká 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public EN = English 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public FR = français 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public IT = italiano 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public LV = latviešu valoda 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public LT = lietuvių kalba 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public HU = magyar 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public MT = Malti 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public NL = Nederlands 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public PL = polski 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public PT = português 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public RO = română 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public SK = slovenčina 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public SL = slovenščina 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public FI = suomi 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public SV = svenska 16/10/2013 24/05/2016
Giotrif : EPAR - Summary for the public HR = Hrvatski 16/10/2013 24/05/2016

This EPAR was last updated on 24/05/2016 .

Authorisation details

Product details

Product details for Giotrif
NameGiotrif
Agency product numberEMEA/H/C/002280
Active substance

afatinib

International non-proprietary name (INN) or common name

afatinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XE13
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 Giotrif
Marketing-authorisation holder

Boehringer Ingelheim International GmbH

Revision5
Date of issue of marketing authorisation valid throughout the European Union25/09/2013

Contact address:

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim
Germany

Product information

Product information

31/03/2016  Giotrif -EMEA/H/C/002280 -II/0012

Name Language First published Last updated
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016
Giotrif : EPAR - Product Information HR = Hrvatski 16/10/2013 24/05/2016

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
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014
Giotrif : EPAR - All Authorised presentations HR = Hrvatski 16/10/2013 27/03/2014

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Giotrif as monotherapy is indicated for the treatment of

  • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
  • locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Giotrif : EPAR - Public assessment report HR = Hrvatski 16/10/2013  
CHMP summary of positive opinion for Giotrif HR = Hrvatski 26/07/2013