ASH Clinical News November 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), moderate (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 appr oximately 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
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