Pradaxa Generic Name & Formulations
Dabigatran etexilate mesylate 75mg, 110mg, 150mg; caps.
Direct thrombin inhibitor.
To reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients treated with parenteral anticoagulant for 5–10 days. To reduce risk of recurrent DVT/PE in patients who have been previously treated. Prophylaxis of DVT/PE after hip replacement surgery.
Pradaxa Dosage and Administration
Swallow whole. Non-valvular AF: CrCl>30mL/min: 150mg twice daily. Severe renal impairment (CrCl 15–30mL/min): 75mg twice daily; CrCl<15mL/min or on dialysis: not recommended. Moderate renal impairment (CrCl 30–50mL/min) with concomitant dronedarone or systemic ketoconazole: 75mg twice daily. CrCl <30mL/min with concomitant P-gp inhibitors: avoid. DVT/PE treatment, recurrence: CrCl>30mL/min: 150mg twice daily (if treatment, give after 5–10 days of parenteral anticoagulation). CrCl ≤30mL/min or on dialysis: not recommended. CrCl <50mL/min with concomitant P-gp inhibitors: avoid. Prophylaxis after hip surgery: CrCl>30mL/min: 110mg for first day (given 1–4hrs post surgery and after hemostasis achieved), then 220mg daily for 28–35 days. CrCl ≤30mL/min or on dialysis: not recommended. CrCl <50mL/min with concomitant P-gp inhibitors: avoid. Converting from/to warfarin or parenteral anticoagulants, discontinuation for surgery and other interventions: see full labeling.
Active pathological bleeding. Mechanical prosthetic heart valve.
Pradaxa Boxed Warnings
Premature discontinuation of Pradaxa increases the risk of thrombotic events. Spinal/epidural hematoma.
Premature discontinuation increases risk of thrombotic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant and restart dabigatran as soon as appropriate. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Increased risk of serious bleeding. Promptly evaluate signs/symptoms of blood loss (eg, a drop in hemoglobin and/or hematocrit or hypotension). Use specific reversal agent (idarucizumab) to reverse anticoagulant effect of dabigatran as needed (eg, emergency surgery/urgent procedures, life-threatening/uncontrolled bleeding). Suspend treatment before invasive therapy or surgery, including dental procedures (see full labeling); restart promptly. Bioprosthetic heart valve or triple-positive antiphospholipid syndrome: not recommended. Monitor renal function prior to initiation, then periodically as clinically indicated; discontinue if acute renal failure develops and consider alternate therapy. Avoid lapses in therapy. Severe renal impairment. Bleeding risk can be assessed by ecarin clotting time (ECT), or if not available, aPTT. Elderly (>75yrs). Labor & delivery. Neonates. Pregnancy. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended.
Antagonized by P-gp inducers (eg, rifampin); avoid. Increased dabigatran levels in renal impairment with concomitant P-gp inhibitors (eg, [dronedarone, systemic ketoconazole; reduce dabigatran dose], verapamil, amiodarone, quinidine, clarithromycin, ticagrelor). Concomitant NSAIDs, platelet inhibitors, heparin, fibrinolytic therapy: increased risk of bleeding. Switching to or from warfarin: monitor closely.
Pradaxa Adverse Reactions
Gastritis-like symptoms (eg, GERD, esophagitis, erosive gastritis, gastric hemorrhage, ulcer), bleeding (may be fatal).
Pradaxa Clinical Trials
Pradaxa Patient Counseling