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
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO
puncture, consider the pharmacokinetic profile of rivaroxaban [see
INCREASES THE RISK OF THROMBOTIC EVENTS,
Clinical Pharmacology (12.3) in full Prescribing Information]. Placement
(B) SPINAL/EPIDURAL HEMATOMA
or removal of an epidural catheter or lumbar puncture is best performed
A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE
when the anticoagulant effect of rivaroxaban is low; however, the exact
RISK OF THROMBOTIC EVENTS
timing to reach a sufficiently low anticoagulant effect in each patient is
Premature discontinuation of any oral anticoagulant, including
not known.
XARELTO, increases the risk of thrombotic events. If anticoagulation
An epidural catheter should not be removed earlier than 18 hours after
with XARELTO is discontinued for a reason other than pathological
the last administration of XARELTO. The next XARELTO dose is not to be
bleeding or completion of a course of therapy, consider coverage
administered earlier than 6 hours after the removal of the catheter. If
with another anticoagulant [see Dosage and Administration (2.2, 2.6)
traumatic puncture occurs, the administration of XARELTO is to be
in full Prescribing Information, Warnings and Precautions, and
delayed for 24 hours.
Clinical Studies (14.1) in full Prescribing Information].
Should the physician decide to administer anticoagulation in the context
B. SPINAL/EPIDURAL HEMATOMA
of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor
Epidural or spinal hematomas have occurred in patients treated with
frequently to detect any signs or symptoms of neurological impairment,
XARELTO who are receiving neuraxial anesthesia or undergoing
such as midline back pain, sensory and motor deficits (numbness,
tingling, or weakness in lower limbs), bowel and/or bladder dysfunction.
spinal puncture. These hematomas may result in long-term or
Instruct patients to immediately report if they experience any of the
permanent paralysis. Consider these risks when scheduling patients
above signs or symptoms. If signs or symptoms of spinal hematoma are
for spinal procedures. Factors that can increase the risk of
suspected, initiate urgent diagnosis and treatment including
developing epidural or spinal hematomas in these patients include:
consideration for spinal cord decompression even though such
• use of indwelling epidural catheters
treatment may not prevent or reverse neurological sequelae.
• concomitant use of other drugs that affect hemostasis, such as
non-steroidal anti-inflammatory drugs (NSAIDs), platelet
Use in Patients with Renal Impairment: Nonvalvular Atrial Fibrillation:
inhibitors, other anticoagulants
Avoid the use of XARELTO in patients with CrCl <15 mL/min since drug
• a history of traumatic or repeated epidural or spinal punctures
exposure is increased. Periodically assess renal function as clinically
• a history of spinal deformity or spinal surgery
indicated (i.e., more frequently in situations in which renal function may
• optimal timing between the administration of XARELTO and
decline) and adjust therapy accordingly. Discontinue XARELTO in
neuraxial procedures is not known
patients who develop acute renal failure while on XARELTO [see Use in
[see Warnings and Precautions and Adverse Reactions].
Specific Populations]
Monitor patients frequently for signs and symptoms of neurological
Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE),
and Reduction in the Risk of Recurrence of DVT and of PE: Avoid the use
impairment. If neurological compromise is noted, urgent treatment is
of XARELTO in patients with CrCl <30 mL/min due to an expected
necessary [see Warnings and Precautions].
increase in rivaroxaban exposure and pharmacodynamic effects in this
Consider the benefits and risks before neuraxial intervention in
patient population [see Use in Specific Populations].
patients anticoagulated or to be anticoagulated for thromboProphylaxis of Deep Vein Thrombosis Following Hip or