Imbruvica® ibrutinib 140 mg capsules. IMBRUVICA 140/ 280/ 420/ 560 mg film-coated tablets. I: Adults with mantle cell lymphoma (MCL), characterised by translocation t(11;14) and/or cyclin D1 expression in whom no partial response was attained with prior therapy, or who exhibited progression after prior therapy. Adults with chronic lymphocytic leukemia (CLL) who have not been treated previously and for whom fludarabine based full-dose immunochemotherapy is not appropriate, or who have received at least one prior therapy, or who exhibit a 17p deletion or a TP53 mutation. Adults ≤ 70 years with previously untreated CLL without del 17p and without TP53 mutation incombination with Rituximab. Adults with Waldenström's disease who have received at least one prior therapy, or for first-line therapy in patients for whom chemoimmunotherapy is not appropriate. Adults with symptomatic MW in combination with Rituximab starting from the first line D: Once a day, orally. MCL: 560 mg, CLL and Waldenström's disease: 420 mg. CI: Hypersensitivity to the active substance or any of the excipients. SP: events due to bleeding; leukostasis; splenic rupture; tumor lysis syndrome; infections; cytopenia; interstitial lung disease; heart rhythm disorders and cardiac failure; cerebrovascular incidents; non melanomatous skin cancer; virus reactivation; arterial hypertension. Should not be used during pregnancy. For further SPs, see www.swissmedicinfo.ch; excipients: sodium, lactose. ADR: Very common: neutropenia, thrombocytopenia, diarrhoea, vomiting, stomatitis, nausea, constipation, peripheral oedema, fever, upper respiratory tract infection, pneumonia, musculoskeletal pain, muscle cramps, arthralgia, headache, bleeding, bruising, skin rash, skin infection, blood creatinine increased, hyperuricaemia, lymphocytosis, dizziness. Common: non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, febrile neutropenia, leucocytosis, hypertension, epistaxis, sinusitis, petechiae, hypokalemia, peripheral neuropathy, atrial fibrillation, ventricular tachyarrhythmia, heart failure, sepsis, urinary tract infection, interstitial lung disease, onychoclasis, urticaria, erythema, blurred vision. For further ADRs, see Compendium. IA: including CYP3A inhibitors and inducers; grapefruit juice. Packages: Ibrutinib 140 mg capsules à 90, 120 (currently not available). IMBRUVICA 140/ 280/ 420/ 560 mg film coated tablets à 28. Reimbursed: L Dispensing category: A. Detailed information: www.swissmedic.ch or www.swissmedicinfo.ch Marketing authorisation holder: Janssen-Cilag AG, Gubelstrasse 34, 6300 Zug (FKI_CH_CP_220547).