Giotrif (Gilotrif), Afatinib
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Active Substance: afatinib
Common Name: afatinib
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Active Substance: afatinib
Pharmacotherapeutic Group: Antineoplastic agents
Treatment of non-small-cell lung cancer (NSCLC) with epidermal-growth-factor-receptor (EGFR) mutation(s)
What is Giotrif 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 non-small-cell lung cancer that is advanced or has spread in patients with a mutation in the genes for a protein called epidermal-growth-factor receptor (EGFR), which is involved in stimulating cell growth. Giotrif should only be used in adult patients who have not been treated before with medicines called tyrosine-kinase inhibitors.
How is Giotrif used?
Treatment with Giotrif should be started and supervised by a doctor experienced in the use of anticancer medicines. Before starting treatment, the doctor will have to establish that the patient has mutated EGFR genes.
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 three hours before and one 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 specific family of proteins known as ‘ErbB family’, which are found on the surface of cancer cells and are involved in stimulating the cells to divide uncontrollably. 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 have been shown to be 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 one main study, which involved 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 anticancer medicines, pemetrexed and cisplatin.
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, 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 reported 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.