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
indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE),
in patients who have undergone hip or knee replacement surgery.
Treatment of Deep Vein Thrombosis—ELIQUIS is indicated for the treatment of DVT.
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