COMMITTED TO PATIENT SAFETY...
XARELTO® establishing real-world outcomes
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Spinal/Epidural Anesthesia or Puncture (cont’d): An
epidural catheter should not be removed earlier than
18 hours after the last administration of XARELTO®.
The next XARELTO® dose is not to be administered
earlier than 6 hours after the removal of the catheter.
If traumatic puncture occurs, the administration of
XARELTO® is to be delayed for 24 hours. Should the
physician decide to administer anticoagulation in the
context of epidural or spinal anesthesia/analgesia or
lumbar puncture, monitor frequently to detect any
signs or symptoms of neurological impairment, such as
midline back pain, sensory and motor deficits (numbness,
tingling, or weakness in lower limbs), or bowel and/or
bladder dysfunction. Instruct patients to immediately
report if they experience any of the above signs or
symptoms. If signs or symptoms of spinal hematoma
are suspected, initiate urgent diagnosis and treatment
including consideration for spinal cord decompression
even though such treatment may not prevent or
reverse neurological sequelae.
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 CYP3A4 inhibitors
(eg, ketoconazole, itraconazole, lopinavir/ritonavir,
ritonavir, indinavir, and conivaptan). Avoid concomitant
use of XARELT