b'IMBRUVICA (ibrutinib) Reduce the recommended dose when administering IMBRUVICA to patientswith mild or moderate hepatic impairment (Child-Pugh class A and B). Monitor patients more frequently for adverse reactions of IMBRUVICA [see Dosage and Administration (2.4), Clinical Pharmacology (12.3) in Full Prescribing Information].Plasmapheresis:ManagementofhyperviscosityinWMpatientsmay includeplasmapheresisbeforeandduringtreatmentwithIMBRUVICA. Modifications to IMBRUVICA dosing are not required.PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information).Hemorrhage: Inform patients of the possibility of bleeding, and to report any signs or symptoms (severe headache, blood in stools or urine, prolonged or uncontrolled bleeding). Inform the patient that IMBRUVICA may need to be interrupted for medical or dental procedures [see Warnings and Precautions]. Infections: Inform patients of the possibility of serious infection, and to report any signs or symptoms (fever, chills, weakness, confusion) suggestive of infection [see Warnings and Precautions]. Cardiac arrhythmias: Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort [see Warnings and Precautions]. Hypertension: Inform patients that high blood pressure has occurred in patients taking IMBRUVICA, which may require treatment with anti-hypertensive therapy [see Warnings and Precautions]. Second primary malignancies: Inform patients that other malignancies have occurred in patients who have been treated with IMBRUVICA, including skin cancers and other carcinomas [see Warnings and Precautions]. Tumor lysis syndrome: Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions]. Embryo-fetal toxicity: Advise women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions, Use in Specific Populations]. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [see Use in Specific Populations]. Advise males with female partners of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [see Use in Specific Populations, Nonclinical Toxicology (13.1) in Full Prescribing Information]. Lactation: Advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose[see Use in Specific Populations]. Inform patients to take IMBRUVICA orally once daily according to their physicians instructions and that the oral dosage (capsules or tablets) should be swallowed whole with a glass of water without opening, breaking or chewing the capsules or cutting, crushing or chewing the tablets approximately the same time each day [see Dosage and Administration (2.1) in Full Prescribing Information]. Advise patients that in the event of a missed daily dose of IMBRUVICA, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Patients should not take extra doses to make up the missed dose [see Dosage and Administration (2.1) in Full Prescribing Information]. Advise patients of the common side effects associated with IMBRUVICA[see Adverse Reactions]. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. Advise patients to inform their health care providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions]. Advise patients that they may experience loose stools or diarrhea and should contact their doctor if their diarrhea persists. Advise patients to maintain adequate hydration [see Adverse Reactions].Active ingredient made in China.Distributed and Marketed by:Pharmacyclics LLCSunnyvale, CA USA 94085andMarketed by:Janssen Biotech, Inc.Horsham, PA USA 19044Patent http://www.imbruvica.comIMBRUVICA is a registered trademark owned by Pharmacyclics LLC Pharmacyclics LLC 2020 Janssen Biotech, Inc. 2020PRC-06963'