| Document Date: 2014-02-13 12:51:13
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City Seville / Reference / / Company Pharmacyclics / / Currency pence / / IndustryTerm grapefruit products / treatment of patients with chronic lymphocytic leukemia / treatment of patients with mantle cell lymphoma / / MedicalCondition malignant / unspecified Second malignancies / Neoplasms / lymphocytic leukemia / lymphoma / headache / Chronic Lymphocytic Leukemia / intracranial hemorrhage / Mantle Cell Lymphoma / Decreased appetite Dehydration / Musculoskeletal pain Muscle spasms / Mantle Cell Lymphoma IMBRUVICA / cellulitis / nausea / stomatitis / thrombocytopenia / Fatigue Pyrexia Peripheral edema Asthenia Chills / fatigue / Injury / Cough Oropharyngeal pain Dyspnea / skin infections / poisoning / Musculoskeletal pain Arthralgia Muscle spasms / diarrhea / sinusitis / constipation / Chronic Lymphocytic Leukemia IMBRUVICA / Infections / upper respiratory tract infection / Dizziness Headache / abdominal pain / Epistaxis / pneumonia / General disorders / Rash Petechiae / hypertension / respiratory tract infection Sinusitis Skin infection Pneumonia Urinary tract infection / rash / abdominal pain / skin infection / disease / arthralgia / dyspnea / hematuria / Carcinogenesis / Chronic / respiratory tract infection Urinary tract infection Pneumonia Skin infections Sinusitis / neutropenia / subdural hematoma / lymphocytosis / fever / lethargy / pain / vomiting / Anxiety Insomnia / skin cancers / atrial fibrillation / infection / histiocytic sarcoma / non-fatal infections / dizziness / subdural hematomas / carcinomas / Cough / renal failure / rash / anemia / dehydration / / MedicalTreatment antibiotics / surgery / dialysis / / Organization CYP3A Inducers Administration of IMBRUVICA / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product itraconazole / carbamazepine / clarithromycin / erythromycin / rifampin / fluconazole / phenytoin / ketoconazole / ciprofloxacin / / Technology Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICATM (ibrutinib) capsules,