Reversal agent
available nationwide
PRADAXA—the ONLY NOAC with a specific reversal agent
INDICATIONS AND USAGE
Pradaxa® (dabigatran etexilate mesylate) capsules is
indicated:
• to reduce the risk of stroke and systemic embolism in
patients with non-valvular atrial fibrillation
SELECT SAFETY INFORMATION
BOXED WARNING: (A) PREMATURE DISCONTINUATION OF
PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF PRADAXA
INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant,
including PRADAXA, increases the risk of thrombotic
events. If anticoagulation with PRADAXA is discontinued for
a reason other than pathological bleeding or completion
of a course of therapy, consider coverage with another
anticoagulant
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients
treated with PRADAXA 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 non-steroidal 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 PRADAXA
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
benefits and risks before neuraxial intervention in patients
who are or will be anticoagulated.
CONTRAINDICATIONS
PRADAXA is contraindicated in patients with:
- active pathological bleeding;
- known serious hypersensitivity reaction (e.g., anaphylactic
reaction or anaphylactic shock) to PRADAXA;
- mechanical prosthetic heart valve
WARNINGS & PRECAUTIONS
Increased Risk of Thrombotic Events after Premature
Discontinuation
Premature discontinuation of any oral anticoagulant,
including PRADAXA, in the absence of adequate alternative
anticoagulation increases the risk of thrombotic events. If
PRADAXA is discontinued for a reason other than pathological
bleeding or completion of a course of therapy, consider
coverage with another anticoagulant and restart PRADAXA as
soon as medically appropriate.
NOAC=novel oral anticoagulant.
Please see additional Important Safety Information
about PRADAXA on previous page and accompanying
brief summary of full
Prescribing Information.