Imbruvica Patient Counseling Information

Advise 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 Hemorrhage under 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 Infections under Precautions].
Cardiac arrhythmias, cardiac failure, and sudden death: Inform patients of the possibility of irregular heart rhythm, heart failure and sudden death. Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort, or edema [see Cardiac Arrhythmias, Cardiac Failure, and Sudden Death under Precautions].
Hypertension: Inform patients that high blood pressure has occurred in patients taking IMBRUVICA, which may require treatment with anti-hypertensive therapy [see Hypertension under 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 Second Primary Malignancies under 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 Tumor Lysis Syndrome under 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 Use in Pregnancy: Embryo-Fetal Toxicity under Precautions].
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 under Dosage & Administration].
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 under Dosage & Administration and Pharmacology: Toxicology: Preclinical Safety data under Actions].
Lactation: Advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose [see Use in Specific Populations under Dosage & Administration].
Other Important information: Inform patients to take IMBRUVICA orally once daily according to their physician's instructions and that the oral dosage (capsules) should be swallowed whole with a glass of water without opening, breaking or chewing the capsules approximately the same time each day [see Recommended Dosage under Dosage & Administration].
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 Recommended Dosage under Dosage & Administration].
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 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 Clinical Trials Experience under Adverse Reactions].