IMPORTANT SAFETY INFORMATION
WARNINGS: (A) DISCONTINUING ELIQUIS ® (apixaban) IN PATIENTS WITH NONVALVULAR
ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES
RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA
(A) Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased
rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients
with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for
a reason other than pathological bleeding, coverage with another anticoagulant should be
strongly considered.
(B) When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed,
patients anticoagulated or scheduled to be anticoagulated with low molecular weight
heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications
are at risk of developing an epidural or spinal hematoma which can result in long-term or
permanent paralysis.
The risk of these events may be increased by the use of indwelling epidural catheters for
administration of analgesia or by the concomitant use of drugs affecting hemostasis such
as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other
anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or
spinal puncture.
Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is
noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial
intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
T:13”
B:14.25”
S:11.75”
CONTRAINDICATIONS
• Active pathological bleeding
• Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
• Increased Risk of Stroke with Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial Fibrillation:
Discontinuing ELIQUIS in the absence of adequate alternative anticoagulation increases the risk of thrombotic
events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical
trials in patients with nonvalvular atrial fibrillation. If ELIQUIS must be discontinued for a reason other than
pathological bleeding, consider coverage with another anticoagulant.
Bleeding Risk:
• ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Concomitant
use of drugs affecting hemostasis increases the risk of bleeding including aspirin and other anti-platelet
agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. Patients should be
made aware of signs or symptoms of blood loss and instructed to immediately report to an emergency
room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
• There is no established way