SIX INDICATIONS STRONG
To reduce the risk of stroke and systemic embolism
in patients with nonvalvular atrial fibrillation (AF).
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
For the treatment of deep vein thrombosis (DVT)
For the reduction in the risk of recurrence of DVT and
of PE following initial 6 months treatment for DVT
and/or PE
For the prophylaxis of DVT, which may lead to PE in
patients undergoing knee replacement surgery
For the prophylaxis of DVT, which may lead to PE in
patients undergoing hip replacement surgery
For the treatment of pulmonary embolism (PE)
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Bleeding: XARELTO® increases the risk of
bleeding and can cause serious or fatal bleeding.
Promptly evaluate any signs or symptoms of blood
loss and consider the need for blood replacement.
Discontinue XARELTO® in patients with active
pathological hemorrhage.
•
A specific antidote for rivaroxaban is not available.
Because of high plasma protein binding, rivaroxaban
is not expected to be dialyzable.
•
Concomitant use of other drugs that impair hemostasis
increases the risk of bleeding. These include aspirin,
P2Y12 platelet inhibitors, other antithrombotic agents,
fibrinolytic therapy, and NSAIDs.
Spinal/Epidural Anesthesia or Puncture: When
neuraxial anesthesia (spinal/epidural anesthesia)
or spinal puncture is employed, patients treated
with anticoagulant agents for prevention of
thromboembolic complications are at risk of
developing an epidural or spinal hematoma, which
can result in long-term or permanent paralysis. 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. Placement or removal of an epidura