ity of serious infection, and to report any signs or symptoms (fever, chills) suggestive of infection [see Warnings and Precautions (5.2)].
Renal toxicity:
Inform patients of the possibility of renal toxicity. Advise patients to maintain adequate hydration [see Warnings and Precautions (5.4)].
Second primary malignancies:
Inform patients that other malignancies have occurred in patients with MCL who have been treated with IMBRUVICA, including skin cancers and other carcinomas [see Warnings and Precautions (5.5)].
Embryo-fetal toxicity:
Advise women of the potential hazard to a fetus and to avoid becoming pregnant [see Warnings and Precautions (5.6)].
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)].
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)].
Advise patients of the common side effects associated with IMBRUVICA [see Adverse Reactions (6)]. 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 (7)].
Advise patients that they may experience loose stools or diarrhea, and should contact their doctor if their diarrhea persists.
Active ingredient made in China.
Distributed and Marketed by:
Pharmacyclics, Inc.
Sunnyvale, CA USA 94085
and
Marketed by:
Janssen Biotech, Inc.
Horsham, PA USA 19044
Patent http://www.imbruvica.com
IMBRUVICA™ is a trademark owned by Pharmacyclics, Inc.
©Pharmacyclics, Inc. 2013 Issued: November 2013
Patient Information
IMBRUVICA (im-BRU-vih-kuh)
(ibrutinib) capsules
What is IMBRUVICA?
IMBRUVICA is a prescription medicine used to treat people with mantle cell lymphoma (MCL) who have received at least one prior treatment.
It is not known if IMBRUVICA is safe and effective in children.
What should I tell my healthcare provider before taking IMBRUVICA?
Before you take IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:
have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
have bleeding problems
have liver problems
are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. You should not become pregnant while taking IMBRUVICA.
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.
How should I take IMBRUVICA?
Take IMBRUVICA exactly as your healthcare provider tells you to take it.
Take IMBRUVICA |
