1
#
PRESCRIBED
NOAC IN THE US*1
†2-13
BEYO
OND EXTENSIVE RANDOMIZED CLINICAL TRIALS,
PUBLISHED SAFEETY OUTCOMES FROM OBSERVATIONAL STUDIES
OF REALL-WORLD PATIEENTS†2-13
NOAC = non-vitamin K antagonist oral anticoa
oagu
gulant.
*Among Factor Xa inhibitors and di
dire
rect
ct thrombin inhibitors.
Based on the fo
follllow
owin
ingg registries, claims databases, and studies: Optum Labs=16,253; IMSS He
H al
a th LifeLink=1,649; Truven Health=5,5563
63;; Da
Dani
nish
s reggistry=1,303;
XAMO
XA
MOSS=88,7778; Symphony=3,654; ORTHO-TEP=1,043; Japanese registry=1,035; Dresden NOA
AC=
C=1,776; XALIA=2,505; DOD database=27,467; XAN
ANTU
TUSS=66,78
7844.
†
IMPORTANT SAFETY 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.
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, see
Drug Interactions
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
Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is
noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial
intervention in patients anticoagulated or to be
anticoagulated for thromboprophylaxis.
Please see Important Safety Information throughout.
Please see accompanying Brief Summary of full Prescribing Information,
including Boxed WARNINGS, or visit www.XareltoHCP.com/PI.