What is Giotrif - afatinib used for and what is it used for?
Giotrif is an anticancer medicine that contains the active substance afatinib . It is used to treat a type of lung cancer known as non-small cell lung cancer. Giotrif is used specifically for late-stage or metastatic non-small cell lung cancer in patients with a gene mutation for a protein called "epidermal growth factor" (EGFR), which is implicated in stimulating cell growth. Giotrif should not be used in adult patients who have not previously been treated with medicines called tyrosine kinase inhibitors.
How is Giotrif - afatinib used?
Treatment with Giotrif should be started and supervised by a doctor experienced in the use of anticancer medicines. Before starting therapy, the doctor will have to check that the patient presents a mutation of the EGFR genes. Giotrif is available as tablets (20, 30, 40 and 50 mg) and can only be obtained with a prescription. The recommended dose is 40 mg once a day, but can be increased up to a maximum of 50 mg a day in patients who tolerate the 40 mg dose, or discontinued and reduced in subjects where undesirable effects are observed. The treatment should be continued for as long as possible, until the disease gets worse or until the side effects become too severe.
The tablets should be taken without food. Food should not be taken in the 3 hours before and in the hour after taking the tablets.
How does Giotrif - afatinib work?
The active substance in Giotrif, afatinib, is a blocker of the ErbB family. This means that it blocks the action of a specific family of proteins known as the "ErbB family", which are present on the surface of tumor cells and which stimulate cells to divide uncontrollably. By inhibiting the action of these proteins, afatinib allows the control of cell division and, consequently, slows down the growth and spread of non-small cell lung cancer. The EGFR proteins belong to the ErbB family. Lung carcinoma cells with mutated EGFR proteins have been shown to be particularly sensitive to afatinib
What benefit has Giotrif - afatinib shown during the studies?
Giotrif has been shown to significantly slow the progression of the disease in patients with non-small cell lung cancer. In one main study involving 345 patients with tumors with mutation of EGFR genes, patients treated with Giotrif survived on average 11 months without disease progression compared to 7 months in patients treated with two other anticancer medicines, pemetrexed and cisplatin.
What is the risk associated with Giotrif - afatinib?
The most common side effects of Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), decreased appetite, epistaxis (nose bleeding), diarrhea, stomatitis (inflammation of the lining of the oral cavity), skin rash, acneiform dermatitis (acne-like skin rash), itching and dry skin. For the full list of all side effects reported with Giotrif, see the package leaflet.
Why has Giotrif - afatinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Giotrif's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (survival time without signs of worsening of the disease) was a significant benefit for patients. Furthermore, the side effects of the medicine are considered manageable and similar to those observed with medicines of the same class.
What measures are being taken to ensure the safe and effective use of Giotrif - afatinib?
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.
More information on Giotrif - afatinib
On 25 September 2013, the European Commission issued a marketing authorization for Giotrif, valid throughout the European Union. For more information on treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 10-2013.
