Generic Name and Formulations:
Dabigatran etexilate mesylate 75mg, 110mg, 150mg; caps.
Boehringer Ingelheim Pharmaceuticals
Indications for PRADAXA:
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.
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: consider reducing dose to 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.
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: not recommended. Avoid lapses in therapy. Monitor renal function prior to initiation, then periodically as clinically indicated; discontinue if acute renal failure develops and consider alternate 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. Nursing mothers: not recommended.
Direct thrombin inhibitor.
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.
Gastritis-like symptoms (eg, GERD, esophagitis, erosive gastritis, gastric hemorrhage, ulcer), bleeding (may be fatal).
Sign Up for Free e-newsletters
- Study Finds Association Between Folate Intake and Risk of Cutaneous Melanoma
- Qualitative Analysis of Myeloma Patients' Experience Following Hematopoietic Stem Cell Transplant
- Melanoma Outcomes Improved With Nivolumab Alone or Plus Ipilimumab
- Involved-Field Radiotherapy Plus Chemotherapy Prolonged PFS in Follicular Lymphoma
- Patient Fears of Placebo Use in Clinical Trials
- Implementing an Ambulatory Adherence Program May Improve Oral Anticancer Medications Compliance
- Exercise Habits Influence Mortality in Adult Survivors of Childhood Cancer
- Managing Dyspnea With Fentanyl in Patients With Cancer at End of Life
- CALM: A Depression Intervention for Cancer Patients at the End of Life
- High BMI Among Premenopausal Women May Improve Risk for Breast Cancer
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|