ASH Clinical News October 2015 | Page 12

IMBRUVICA® (ibrutinib) capsules Renal Impairment: Less than 1% of ibrutinib is excreted renally. Ibrutinib exposure is not altered in patients with Creatinine clearance (CLcr) > 25 mL/min. There are no data in patients with severe renal impairment (CLcr < 25 mL/min) or patients on dialysis [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in ibrutinib exposure. Following single dose administration, the AUC of ibrutinib increased 2.7-, 8.2- and 9.8-fold in subjects with mild (Child-Pugh class A), moder ate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment compared to subjects with normal liver function. The safety of IMBRUVICA has not been evaluated in patients with hepatic impairment. Monitor patients for signs of IMBRUVICA toxicity and follow dose modification guidance as needed. It is not recommended to administer IMBRUVICA to patients with moderate or severe hepatic impairment (Child-Pugh classes B and C) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) in Full Prescribing Information]. Females and Males of Reproductive Potential: Advise women to avoid becoming pregnant while taking IMBRUVICA because IMBRUVICA can cause fetal harm [see Use in Specific Populations]. Plasmapheresis: Management of hyperviscosity in patients with WM may include plasmapheresis before and during treatment with IMBRUVICA. Modifications to IMBRUVICA dosing are not required. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). • Hemorrhage: Inform patients of the possibility of bleeding, and to report any signs or symptoms (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]. • Atrial Fibrillation: Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort [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 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 hazard to a fetus and to avoid becoming pregnant [see Warnings and Precautions]. • Inform patients to take IMBRUVICA orally once daily according to their physician’s instructions and that the capsules should be swallowed whole with a glass of water without being opened, broken, or chewed at 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 capsules to make up the missed dose [see Dosage and Administration (2.5) 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. Active ingredient made in China. Distributed and Marketed by: Pharmacyclics LLC Sunnyvale, CA USA 94085 and Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044 Patent http://www.imbruvica.com IMBRUVICA® is a registered trademark owned by Pharmacyclics LLC © Pharmacyclics LLC 2015 © Janssen Biotech, Inc. 2015 Editor’s Corner An Unabashed Rehash of the ASH Dash (Or, How to Write an Abstract Guaranteed to be Selected for a Plenary Presentation at the Annual Meeting*) 6 :15 a.m. (EST), August 4, 2015: My alarm clock goes off. This is the day: the abstract deadline for the ASH annual meeting. I get out of bed and stand in front of my bedroom mirror to perform my daily positive affirmation exercises (the ones I learned from Stuart Smalley, the self-help addict portrayed by Al Franken on “Saturday Night Live”). I look at my reflection, and I repeat the following mantra: Today, I will write an abstract that will be accepted by ASH to be a plenary presentation at this year’s annual meeting. Because I’m good enough to write this abstract. I’m smart enough to write this abstract. And, doggone it, people like me! 7:00 a.m.: I drive to work. Lots of construction; it’s orange-barrel season. When I arrive, I will open my email inbox to find the message that my statistician has been promising me – the one with results that will change the way we treat acute leukemia. My hypothesis is so maddeningly simple, I can’t believe nobody has thought of it previously. It all has to do with the chloride. A patient’s baseline chloride should be able to predict that patient’s response to induction chemotherapy and overall survival! The mechanistic biology is painfully obvious: chloride channels in blasts. It’ll be a call to arms for recommending more aggressive therapy in certain patient subsets. How could it not be accepted as a plenary presentation? I start practicing my introductory comments for when I walk on stage for the plenary session at the annual meeting, in my head: “I’d like to thank the president of ASH, Dr. Williams, and the incoming president, Dr. Abrams, and the selection committee …” 7:20 a.m.: I open my email inbox. Nothing from the statistician. Really? I sent him my Excel spreadsheets of all the data I abstracted from patient charts two days ago, along with my request to also analyze 78 other baseline variables. What’s taking him so long? I start writing the introduction to the abstract. 7:21 a.m.: I check my inbox again. No email. 7:22 a.m.: I check my inbox again. Still no email. 10 ASH Clinical News October 2015