WARNINGS AND PRECAUTIONS (cont’d)
Use in Patients With Renal Impairment:
Nonvalvular Atrial Fibrillation: Avoid the use of XARELTO®
in patients with creatinine clearance (CrCl) <15 mL/min since
drug exposure is increased. Discontinue XARELTO® in patients
who develop acute renal failure while on XARELTO®.
• Treatment of Deep Vein Thrombosis (DVT), Pulmonary
Embolism (PE), and Reduction in the Risk of Recurrence of
DVT and of PE: Avoid the use of XARELTO® in patients with
CrCl <30 mL/min due to an expected increase in rivaroxaban
exposure and pharmacodynamic effects in this patient
population.
• Prophylaxis of Deep Vein Thrombosis Following Hip or
Knee Replacement Surgery: Avoid the use of XARELTO® in
patients with CrCl <30 mL/min due to an expected increase in
rivaroxaban exposure and pharmacodynamic effects in this
patient population. Observe closely and promptly evaluate
any signs or symptoms of blood loss in patients with CrCl 30
to 50 mL/min. Patients who develop acute renal failure while
on XARELTO® should discontinue the treatment.
Use in Patients With Hepatic Impairment: No clinical data are
available for patients with severe hepatic impairment. Avoid
use of XARELTO® in patients with moderate (Child-Pugh B)
and severe (Child-Pugh C) hepatic impairment or with any
hepatic disease associated with coagulopathy, since drug
exposure and bleeding risk may be increased.
Use With P-gp and Strong CYP3A4 Inhibitors or Inducers:
Avoid concomitant use of XARELTO® with combined P-gp and
strong 5