Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
dabrafenib mesilate
Novartis Europharm Limited
L01EC02
dabrafenib
Antineoplastic agents
Melanoma
MelanomaDabrafenib as monotherapy or in combination with trametinib 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).Adjuvant treatment of melanomaDabrafenib in combination with trametinib 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)Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Revision: 29
Authorised
2013-08-26
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAFINLAR 50 MG HARD CAPSULES TAFINLAR 75 MG HARD CAPSULES dabrafenib 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tafinlar is and what it is used for 2. What you need to know before you take Tafinlar 3. How to take Tafinlar 4. Possible side effects 5. How to store Tafinlar 6. Contents of the pack and other information 1. WHAT TAFINLAR IS AND WHAT IT IS USED FOR Tafinlar is a medicine that contains the active substance dabrafenib. It is used either on its own or in combination with another medicine containing trametinib in adults to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery. Tafinlar in combination with trametinib is also used to prevent melanoma from coming back after it has been removed by surgery. Tafinlar in combination with trametinib 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 TAFINLAR Tafinlar 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 will Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tafinlar 50 mg hard capsules Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib. Tafinlar 75 mg hard capsules Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Tafinlar 50 mg hard capsules Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”. Tafinlar 75 mg hard capsules Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma Dabrafenib as monotherapy or in combination with trametinib 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). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib 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) Dabrafenib in combination with trametinib 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 dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test. The efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC. Dabrafenib should therefore not be used in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC (see sections 4.4 and 5.1). Posology The recommended Læs hele dokumentet