Reversal available nationwide for PRADAXA—
the ONLY NOAC with a specific reversal agent
SELECT SAFETY INFORMATION
WARNINGS & PRECAUTIONS
Risk of Bleeding
• PRADAXA increases the risk of bleeding and can cause
significant and, sometimes, fatal bleeding. Promptly
evaluate any signs or symptoms of blood loss (e.g., a drop in
hemoglobin and/or hematocrit or hypotension). Discontinue
PRADAXA in patients with active pathological bleeding.
• Risk factors for bleeding include concomitant use of
medications that increase the risk of bleeding (e.g.,
anti-platelet agents, heparin, fibrinolytic therapy, and chronic
use of NSAIDs). PRADAXA’s anticoagulant activity and half-life
are increased in patients with renal impairment.
• Reversal of Anticoagulant Effect: A specific reversal agent
(idarucizumab) for dabigatran is available when reversal of
the anticoagulant effect of dabigatran is needed:
• For emergency surgery/urgent procedures
• In life-threatening or uncontrolled bleeding
Hemodialysis can remove dabigatran; however clinical
experience for hemodialysis as a treatment for bleeding is
limited. Prothrombin complex concentrates or recombinant
Factor VIIa may be considered but their use has not
been evaluated. Protamine sulfate and vitamin K are
not expected to affect dabigatran anticoagulant activity.
Consider administration of platelet concentrates where
thrombocytopenia is present or long-acting antiplatelet drugs
have been used.
Thromboembolic and Bleeding Events in Patients with
Prosthetic Heart Valves
The use of PRADAXA is contraindicated in patients with
mechanical prosthetic valves due to a higher risk for
thromboembolic events, especially in the post-operative period,
and an excess of major bleeding for PRADAXA vs. warfarin. Use
of PRADAXA for the prophylaxis of thromboembolic events in
patients with AFib in the setting of other forms of valvular heart
disease, including bioprosthetic heart valve, has not been
studied and is not recommended.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
Concomitant use of PRADAXA with P-gp inducers (e.g.,
rifampin) reduces exposure to dabigatran and should generally
be avoided. P-gp inhibition and impaired renal function are
major independent factors in increased exposure to dabigatran.
Concomitant use of P-gp inhibitors in patients with renal
impairment is expected to increase exposure of dabigatran
compared to either factor alone.
Reduction of Risk of Stroke/Systemic Embolism in NVAF
• For patients with moderate renal impairment (CrCl 30-50 mL/
min), reduce the dose of PRADAXA to 75 mg twice daily when
dronedarone or systemic ketoconazole is coadministered
with PRADAXA.
• For patients with severe renal impairment (CrCl 15-30 mL/min),
avoid concomitant use of PRADAXA and P-gp inhibitors.
ADVERSE REACTIONS
The most serious adverse reactions reported with PRADAXA
were related to bleeding.
• Most frequent adverse reactions leading to discontinuation of
PRADAXA were bleeding & gastrointestinal (GI) events.
• PRADAXA 150 mg result VB