Brief Summary of Prescribing Information for XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban) tablets, for oral use
See package insert for full Prescribing Information
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO
INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE
RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including
XARELTO, increases the risk of thrombotic events. If anticoagulation
with XARELTO is discontinued for a reason other than pathological
bleeding or completion of a course of therapy, consider coverage
with another anticoagulant [see Dosage and Administration (2.2, 2.6)
in full Prescribing Information, Warnings and Precautions, and
Clinical Studies (14.1) in full Prescribing Information].
B. SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas have occurred in patients treated with
XARELTO who are receiving neuraxial anesthesia or undergoing
spinal puncture. These hematomas may result in long-term or
permanent paralysis. Consider these risks when scheduling patients
for spinal procedures. Factors that can increase the risk of
developing epidural or spinal hematomas in these patients include:
• use of indwelling epidural catheters
• concomitant use of other drugs that affect hemostasis, such as
non-steroidal anti-inflammatory drugs (NSAIDs), platelet
inhibitors, other anticoagulants
• a history of traumatic or repeated epidural or spinal punctures
• a history of spinal deformity or spinal surgery
• optimal timing between the administration of XARELTO and
neuraxial procedures is not known
[see Warnings and Precautions and Adverse Reactions].
Monitor patients frequently for signs and symptoms of neurological
impairment. If neurological compromise is noted, urgent treatment is
necessary [see Warnings and Precautions].
Consider the benefits and risks before neuraxial intervention in
patients anticoagulated or to be anticoagulated for
thromboprophylaxis [see Warnings and Precautions].
INDICATIONS AND USAGE
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular
Atrial Fibrillation: XARELTO is indicated to reduce the risk of stroke and
systemic embolism in patients with nonvalvular atrial fibrillation.
There are limited data on the relative effectiveness of XARELTO and
warfarin in reducing the risk of stroke and systemic embolism when
warfarin therapy is well-controlled [see Clinical Studies (14.1) in full
Prescribing Information].
Treatment of Deep Vein Thrombosis: XARELTO is indicated for the
treatment of deep vein thrombosis (DVT).
Treatment of Pulmonary Embolism: XARELTO is indicated for the
treatment of pulmonary embolism (PE).
Reduction in the Risk of Recurrence of Deep Vein Thrombosis and of
Pulmonary Embolism: XARELTO is indicated for the reduction in the risk
of recurrence of deep vein thrombosis and of pulmonary embolism
following initial 6 months treatment for DVT and/or PE.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee
Replacement Surgery: XARELTO is indicated for the prophylaxis of DVT,
which may lead to PE in patients undergoing knee or hip replacement
surgery.
CONTRAINDICATIONS
XARELTO is contraindicated in patients with:
• active pathological bleeding [see Warnings and Precautions]
• severe hypersensitivity reaction to XARELTO (e.g., anaphylactic
reactions) [see Adverse Rea