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Apixaban

(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

(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:

             a. use of indwelling epidural catheters
             b. concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
             c. a history of traumatic or repeated epidural or spinal punctures
             d. a history of spinal deformity or spinal surgery
             e. optimal timing between the administration of ELIQUIS and neuraxial procedures is not known [see Warnings and Precautions (5.3)]

  • Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)].
  • Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)].


Approved Risk Evaluation and Mitigation Strategies (REMS)

 

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Apixaban

Updated January 2018