BEYOND EXTENSIVE RANDOMIZED CLINICAL TRIALS,
PUBLISHED SAFETY OUTCOMES FROM OBSERVATIONAL STUDIES
OF REAL-WORLD PATIENTS*1-11
*Based on the following registries, claims databases, and studies: Optum Labs=16,253; IMS Health LifeLink=1,649; Truven Health=5,563; Danish registry=1,303;
XAMOS=8,778; Symphony=3,654; ORTHO-TEP=1,043; Japanese registry=1,035; Dresden=1,776; DOD database=27,467; XANTUS=6,784.
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.