ELIQUIS® (apixaban) tablets, for oral use
Spinal/Epidural Anesthesia or Puncture
Brief Summary of Prescribing Information. For complete prescribing information
consult official package insert.
When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is
employed, patients treated with antithrombotic 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.
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].
The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart
valves. Therefore, use of ELIQUIS is not &V6