For appropriate patients with DVT/PE
Choose ELIQUIS
from the START
DVT: deep vein thrombosis; PE: pulmonary embolism.
INDICATIONS
ELIQUIS is indicated for the treatment of deep vein thrombosis
(DVT) and pulmonary embolism (PE), and to reduce the risk of
recurrent DVT and PE following initial therapy.
IMPORTANT SAFETY INFORMATION
WARNING: (A) PREMATURE DISCONTINUATION OF
ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
(A) 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.
(B) 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-infl ammatory 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
Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is
noted, urgent treatment is necessary.
Consider the benefi ts and risks before neuraxial intervention
in patients anticoagulated or to be anticoagulated.
CONTRAINDICATIONS
• Active pathological bleeding
• Severe hypersensitivity reaction to ELIQUIS
(e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
• Increased Risk of Thrombotic Events after Premature
Discontinuation: Premature discontinuation of any oral
anticoagulant, including 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 atrial
fi brillation patients. If ELIQUIS is discontinued for a reason
other than pathological bleeding or completion of a course
of therapy, 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 antiplatelet
agents, other anticoagulants, heparin, thrombolytic agents,
SSRIs, SNRIs, and NSAIDs.
– Advise patients of signs and symptoms of blood loss and
to report them immediately or go to an emergency room.
Discontinue ELIQUIS in patients with active pathological
hemorrhage.
– There is no established way to reverse the anticoagulant
effect of apixaban, which can be expected to persist for at
least 24 hours after the last dose (i.e., about two half-lives).
A specifi c antidote for ELIQUIS is not available.
• Spinal/Epidural Anesthesia or Puncture: Patients treated
with ELIQUIS undergoing spinal/epidural anesthesia or
puncture may develop an epidural or spinal hematoma
which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative
use of indwelling epidural catheters or the concomitant use of
medicinal products affecting hemostasis. Indwelling epidural
or intrathecal catheters should not be removed earlier than
24 hours after the last administration of ELIQUIS.