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