(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 (2.4), Warnings and Precautions (5.1), and Clinical Studies (14.1)].

(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)].