ELIQUIS® (apixaban) tablets, for oral use
Brief Summary of Prescribing Information. For complete prescribing information consult
official package insert.
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF
THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC
EVENTS
Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases
the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for
a reason other than pathological bleeding or completion of a course of therapy,
consider coverage with another anticoagulant [see Dosage and Administration,
Warnings and Precautions, and Clinical Studies (14.1) in full Prescribing Information].
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with ELIQUIS 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 nonsteroidal
anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated epidural or spinal punctures
• a history of spinal deformity or spinal surgery
• optimal timing between the administration of ELIQUIS and neuraxial procedures
is not known
[see Warnings and Precautions]
Monitor patients frequently for signs and symptoms of neurological impairment.
If neurological compromise is noted, urgent treatment is necessary [see Warnings
and Precautions].
Consider the benefits and risks before neuraxial intervention in patients
anticoagulated or to be anticoagulated [see Warnings and Precautions].
INDICATIONS AND USAGE
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
ELIQUIS® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients
with nonvalvular atrial fibrillation.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery
ELIQUIS is i