Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
trametinib
Novartis Europharm Limited
L01EE01
trametinib
Antineoplastic agents
Melanoma
MelanomaTrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).Adjuvant treatment of melanomaTrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.Non-small cell lung cancer (NSCLC)Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Revision: 29
Authorised
2014-06-30
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEKINIST 0.5 MG FILM-COATED TABLETS MEKINIST 2 MG FILM-COATED TABLETS trametinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mekinist is and what it is used for 2. What you need to know before you take Mekinist 3. How to take Mekinist 4. Possible side effects 5. How to store Mekinist 6. Contents of the pack and other information 1. WHAT MEKINIST IS AND WHAT IT IS USED FOR Mekinist is a medicine that contains the active substance trametinib. It is used either on its own or in combination with another medicine containing dabrafenib to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery. Mekinist in combination with dabrafenib is also used to prevent melanoma from coming back after it has been removed by surgery. Mekinist in combination with dabrafenib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). Both cancers have a particular change (mutation) in a gene called BRAF at the V600 position. This mutation in the gene may have caused the cancer to develop. Your medicine targets proteins made from this mutated gene and slows down or stops the development of your cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEKINIST Mekinist should only be used to treat melanomas and NSCLC with the BRAF mutation. Therefore, before starting treatment your doctor will test for this mutation. If your doctor decides that you wi Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 x 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). Adjuvant treatment of melanoma Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with trametinib should only be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products. Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated tes Przeczytaj cały dokument