Pradaxa (dabigatran etexilate mesylate) capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
- Table 2 (Bleeding Events) - values are changed in most cells of table. See PI for details
Note: changes also made to 14 CLINICAL STUDIES, 14.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation, see Tables 7 and 8.
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation
- *ticagrelor was added to the list of P-gp inhibitors that do not require a dose adjustment.*
- Esophageal ulcers
WARNINGS AND PRECAUTIONS
- Increased Risk of Stroke with Discontinuation of Pradaxa - Discontinuing Pradaxa in absence of adequate alternative anticoagulation increases the risk of thrombotic events…
What is the most important information I should know about Pradaxa?
- People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body…
WARNINGS AND PRECAUTIONS
Risk of Bleeding:
- Hemodialysis can remove dabigatran; however the clinical experience supporting the use of hemodialysis as a treatment for bleeding is limited.
Patients with Prosthetic Heart Valves
- The safety and efficacy of PRADAXA has not been studied in patients with prosthetic heart valves. Therefore, use of PRADAXA is not recommended in these patients.
5 WARNING AND PRECAUTIONS
5.1 Risk of Bleeding
- Pradaxa’s anticoagulant activity and half-life are increased in patients with renal impairment.
- Lack of a specific reversal agent; futility of using vitamin K to affect anticoagulant effect
5.2 Temporary Discontinuation of PRADAXA
- Discontinuing anticoagulants, including PRADAXA, for active bleeding, elective surgery, or invasive procedures, places patients at an increased risk of stroke. Minimize lapses in therapy.
5.3 Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure
- Consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA in patients with moderate renal impairment (CrCl 30-50 mL/min). Avoid use of PRADAXA and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) [see Drug Interactions (7) and Use in Specific Populations (8.6)].”
How should I take PRADAXA?
- Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you
Impact of Other Drugs on Dabigatran/P-gp Inhibitors
- Dronederone: Exposure to dabigatran is higher when it is administered with dronedarone than when it is administered alone