COMMITTED TO PATIENT SAFETY...
XARELTO® establishing real-world outcomes
WARNINGS AND PRECAUTIONS (cont’d)
Patients With Prosthetic Heart Valves: The safety and
efficacy of XARELTO® have not been studied in patients
with prosthetic heart valves. Therefore, use of XARELTO®
is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients/Patients
Who Require Thrombolysis or Pulmonary Embolectomy:
Initiation of XARELTO® is not recommended acutely as
an alternative to unfractionated heparin in patients with
pulmonary embolism who present with hemodynamic
instability or who may receive thrombolysis or pulmonary
embolectomy.
DRUG INTERACTIONS
T:14 in
B:14.25 in
S:13 in
Avoid concomitant use of XARELTO® with other
anticoagulants due to increased bleeding risk, unless
benefit outweighs risk. Promptly evaluate any signs
or symptoms of blood loss if patients are treated
concomitantly with aspirin, other platelet aggregation
inhibitors, or NSAIDs.
XARELTO® should not be used in patients with CrCl 15
to <80 mL/min who are receiving concomitant combined
P-gp and moderate CYP3A4 inhibitors (eg, diltiazem,
verapamil, dronedarone, and erythromycin) unless
the potential benefit justifies the potential risk.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C: XARELTO® should be used during
pregnancy only if the potential benefit justifies the
potential risk to mother and fetus. There are no adequate
or well-controlled studies of XARELTO® in pregnant
women, and dosing for pregnant women has not been
established. Use XARELTO® with caution in pregnant
patients because of the potential for pregnancyrelated hemorrhage and/or emergent delivery with
an anticoagulant that is not readily reversible. The
anticoagulant effect of XARELTO® cannot be reliably
monitored with standard laboratory testing.
Labor and Delivery: Safety and effectiveness of
XARELTO® during labor and delivery have not been
studied in clinical trials.
Nursing Mothers: It is not known if rivaroxaban is
excreted in human milk.
Pediatric Use: Safety and effectiveness in pediatric
patients have not been established.
Females of Reproductive Potential: Females of
reproductive potential requiring anticoagulation
should discuss pregnancy planning with their physician.
OVERDOSAGE
Discontinue XARELTO® and initiate appropriate therapy
if bleeding complications associated with overdosage
occur. A specific antidote for rivaroxaban is not
available. The use of activated charcoal to reduce
absorption in case of XARELTO® overdose may be
considered. Due to the high plasma protein binding,
rivaroxaban is not expected to be dialyzable.
ADVERSE REACTIONS IN CLINICAL STUDIES
The most common adverse reactions with XARELTO®
were bleeding complications.
Please see accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS, or visit www.XareltoHCP.com/PI.
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