Anticoagulation
has come of age
for healthcare
professionals,
like me,
who prescribe
XARELTO®
generation XARELTO
®
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 pulmonary embolism (PE)
For the treatment of deep vein thrombosis (DVT)
For the prophylaxis of DVT, which may lead to PE in
patients undergoing hip replacement surgery
IMPORTANT SAFETY INFORMATION (cont’d)
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to XARELTO®
(eg, anaphylactic reactions)
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events After Premature
Discontinuation: Premature discontinuation of any oral
anticoagulant, including XARELTO®, in the absence of
adequate alternative anticoagulation increases the risk of
thrombotic events. An increased rate of stroke was observed
during the transition from XARELTO® to war farin in clinical
trials in atrial fibrillation patients. If XARELTO® is discontinued
for a reason other than pathological bleeding or completion
of a course of therapy, consider coverage with another
anticoagulant.
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 affecting hemostasis increases
the risk of bleeding. These include aspirin, P2Y12 platelet
inhibitors, other antithrombotic agents, fibrinolytic therapy,
and NSAIDs.
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
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 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),
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.