Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
brigatinib
Takeda Pharma A/S
L01XE43
brigatinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.
Revision: 9
Authorised
2018-11-22
57 B. PACKAGE LEAFLET 58 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALUNBRIG 30 MG FILM-COATED TABLETS ALUNBRIG 90 MG FILM-COATED TABLETS ALUNBRIG 180 MG FILM-COATED TABLETS brigatinib 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alunbrig is and what it is used for 2. What you need to know before you take Alunbrig 3. How to take Alunbrig 4. Possible side effects 5. How to store Alunbrig 6. Contents of the pack and other information 1. WHAT ALUNBRIG IS AND WHAT IT IS USED FOR Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor. Alunbrig is used to treat adults with advanced stages of a LUNG CANCER called non-small cell lung cancer. It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase ( _ALK_ ). HOW ALUNBRIG WORKS The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells. Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALUNBRIG _ _ DO NOT TAKE ALUNBRIG • if you are ALLERGIC to brigatinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Alunbrig or during treatment if you have: • LUNG OR BREATHING PROBLEMS Lung problems, some severe, are more frequent within the first 7 days of treatment. Symptoms may be similar to symptoms from lung cancer. Tell your doctor of Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Alunbrig 30 mg film-coated tablets Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alunbrig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of brigatinib. _Excipient with known effect _ Each film-coated tablet contains 56 mg of lactose monohydrate. Alunbrig 90 mg film-coated tablets Each film-coated tablet contains 90 mg of brigatinib. _Excipient with known effect _ Each film-coated tablet contains 168 mg of lactose monohydrate. Alunbrig 180 mg film-coated tablets Each film-coated tablet contains 180 mg of brigatinib. _Excipient with known effec_ t Each film-coated tablet contains 336 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Alunbrig 30 mg film-coated tablets Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side. Alunbrig 90 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side. Alunbrig 180 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. 3 Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK-positive NSCLC status should be known prior to i Przeczytaj cały dokument