Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
Ibrutinib
Janssen-Cilag International NV
L01EL01
ibrutinib
Antineoplastic agents, Protein kinase inhibitors
Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Revision: 31
Authorised
2014-10-21
113 B. PACKAGE LEAFLET 114 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMBRUVICA 140 MG HARD CAPSULES ibrutinib 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 IMBRUVICA is and what it is used for 2. What you need to know before you take IMBRUVICA 3. How to take IMBRUVICA 4. Possible side effects 5. How to store IMBRUVICA 6. Contents of the pack and other information 1. WHAT IMBRUVICA IS AND WHAT IT IS USED FOR WHAT IMBRUVICA IS IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors. WHAT IMBRUVICA IS USED FOR It is used to treat the following blood cancers in adults: Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment. Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment. Waldenström’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy. HOW IMBRUVICA WORKS In MCL, CLL and WM, IMBRUVICA works by blocking Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 140 mg of ibrutinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology _MCL_ The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily. _CLL and WM_ The recommended dose for the treatment of CLL and WM, either as a single agent or in combination, is 420 mg (three capsules) once daily (for details of the combination regimens, see section 5.1). Treatment with IMBRUVICA should continue until disease progression or no longer tolerated by the patient. In combination with venetoclax for the treatment of CLL, IMBRUVICA should be administered as a single agent for 3 cycles Läs hela dokumentet