Brief Summary of Prescribing Information for XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban) tablets, for oral use
See package insert for full Prescribing Information
XARELTO® (rivaroxaban) tablets
To reduce the potential risk of bleeding associated with the concurrent
use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal
puncture, consider the pharmacokinetic profile of rivaroxaban [see
Clinical Pharmacology (12.3) in full Prescribing Information]. Placement
or removal of an epidural catheter or lumbar puncture is best performed
when the anticoagulant effect of rivaroxaban is low; however, the exact
timing to reach a sufficiently low anticoagulant effect in each patient is
not known.
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), 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 CrCl <15 mL/min since drug
exposure is increased. Periodically assess renal function as clinically
indicated (i.e., more frequently in situations in which renal function may
decline) and adjust therapy accordingly. Discontinue XARELTO in
patients who develop acute renal failure while on XARELTO [see Use in
Specific Populations]
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 [see Use in Specific Populations].
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
INDICATIONS AND USAGE
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular effects in this patient population. Observe closely and promptly evaluate
Atrial Fibrillation: XARELTO is indicated to reduce the risk of stroke and 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
systemic embolism in patients with nonvalvular atrial fibrillation.
There are limited data on the relative effectiveness of XARELTO and discontinue the treatment [see Use in Specific Populations].
warfarin in reducing the risk of stroke and systemic embolism when Use in Patients with Hepatic Impairment: No clinical data are available
warfarin therapy is well-controlled [see Clinical Studies (14.1) in full for patients with severe hepatic impairment.
Prescribing Information].
Avoid use of XARELTO in patients with moderate (Child-Pugh B) and
Treatment of Deep Vein Thrombosis: XARELTO is indicated for the severe (Child-Pugh C) hepatic impairment or with any hepatic disease
associated with coagulopathy since drug exposure and bleeding risk
treatment of deep vein thrombosis (DVT).
Treatment of Pulmonary Embolism: XARELTO is indicated for the may be increased [see Use in Specific Populations].
Use with P-gp and Strong CYP3A4 Inhibitors or Inducers: Avoid
treatment of pulmonary embolism (PE).
Reduction in the Risk of Recurrence of Deep Vein Thrombosis and of concomitant use of XARELTO with combined P-gp and strong CYP3A4
Pulmonary Embolism: XARELTO is indicated for the reduction in the risk inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir,
of recurrence of deep vein thrombosis and of pulmonary embolism indinavir, and conivaptan) [see Drug Interactions].
Avoid concomitant use of XARELTO with drugs that are combined P-gp
following initial 6 months treatment for DVT and/or PE.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin,
Replacement Surgery: XARELTO is indi 6FVBf