国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ibrutinib
JOHNSON & JOHNSON SDN. BHD.
ibrutinib
30 Tablets
Cilag AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IMBRUVICA TM Ibrutinib (140 mg), capsules Ibrutinib (140 mg, 280 mg, 420 mg) film-coated tablets 1 WHAT IS IN THIS LEAFLET 1. What IMBRUVICA is used for 2. How IMBRUVICA works 3. Before you use IMBRUVICA 4. How to use IMBRUVICA 5. While you are using it 6. Side effects 7. Storage and Disposal of IMBRUVICA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMBRUVICA IS USED FOR IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors. 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 lymphocyte 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. • IMBRUVICA is also used to treat chronic graft versus host disease, a condition in which transplanted cells from another person (the donor) attack the body (the host) causing organ damage. HOW IMBRUVICA WORKS In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer. BEFORE YOU USE IMBRUVICA - _When you must not use it _ _Do not take IMBRUVICA _ • if you are allergic 完全なドキュメントを読む
1 1. NAME OF THE MEDICINAL PRODUCT Capsules IMBRUVICA 140 mg hard capsules. Tablets IMBRUVICA 140mg film-coated tablets IMBRUVICA 280mg film-coated tablets IMBRUVICA 420mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140mg hard capsules Each hard capsule contains 140 mg of ibrutinib. IMBRUVICA 140mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib. Excipients with known effect Each 140mg film-coated tablet contains 28mg of lactose monohydrate. IMBRUVICA 280mg film-coated tablets Each film-coated tablet contains 280mg of ibrutinib. Excipients with known effect Each 280mg film-coated tablet contains 56mg of lactose monohydrate. IMBRUVICA 420mg film-coated tablets Each film-coated tablet contains 420mg of ibrutinib. Excipients with known effect Each 420mg film-coated tablet contains 84mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules IMBRUVICA 140mg hard capsules Hard capsule (capsule). White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink. Tablets IMBRUVICA 140mg film-coated tablets Yellow-green to green round tablets (9mm), debossed with “ibr” on one side and "140" on the other side. IMBRUVICA 280mg film-coated tablets Purple oblong tablets (15mm in length and 7mm in width), debossed with "ibr" on one side and "280" on the other side. IMBRUVICA 420mg film-coated tablets Yellow-green to green oblong tablets (17.5mm in length and 7.4mm in width), debossed with "ibr" on one side and "420" on the other side. 2 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 bendamustin 完全なドキュメントを読む