Dabigatran
Dosing in kidney impairment
Dosage Adjustments Adult patients with renal impairment Assess renal function prior to initiation of treatment with Dabigatran Etexilate Capsules. Periodically assess renal function as clinically indicated (i.e., more frequently in clinical situations that may be associated with a decline in renal function) and adjust therapy accordingly.
Discontinue Dabigatran Etexilate Capsules in patients who develop acute renal failure while on Dabigatran Etexilate Capsules and consider alternative anticoagulant therapy. Generally, in adult patients, the extent of anticoagulation does not need to be assessed. When necessary, use aPTT or ECT, and not INR, to assess for anticoagulant activity in adult patients on Dabigatran Etexilate Capsules [see Warnings and Precautions and Clinical Pharmacology] .
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation In patients with moderate renal impairment (CrCl 30 to 50 mL/min), concomitant use of the P-gp inhibitor dronedarone or systemic ketoconazole can be expected to produce dabigatran exposure similar to that observed in severe renal impairment.
Reduce the dosage of Dabigatran Etexilate Capsules to 75 mg twice daily [see Warnings and Precautions, Drug Interactions, and Clinical Pharmacology] . Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism Dosing recommendations for patients with CrCl≤30 mL/min cannot be provided.
Avoid use of concomitant P-gp inhibitors in patients with CrCl <50 mL/min [see Warnings and Precautions, Drug Interactions and Clinical Pharmacology] . Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery Dosing recommendations for patients with CrCl ≤30 mL/min or on dialysis cannot be provided.
Avoid use of concomitant P-gp inhibitors in patients with CrCl <50 mL/min [see Dosage and Administration, Warnings and Precautions, Drug Interactions, and Clinical Pharmacology (12.2, 12.3)] . Pediatric patients with renal impairment Treatment and reduction in risk of recurrence of VTE in pediatric patients Due to lack of data in pediatric patients with e GFR < 50 m L/min/1.73 m2 and the risk of increased exposure, avoid use of Dabigatran Etexilate Capsules in these patients.
Prior to the initiation of treatment with Dabigatran Etexilate Capsules, estimate the glomerular filtration rate (e GFR) using the Schwartz formula: e GFR (Schwartz) = (0.413 x height in cm) / serum creatinine in mg/d L. Treat patients with an e GFR > 50 m L/min/1.73 m2 with the dosage according to Table 1 [see Dosage and Administration].
| Indication | Dosage | |
| Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF | CrCl >30 mL/min: CrCl 15 to 30 mL/min: CrCl <15 mL/min or on dialysis: | 150 mg twice daily 75 mg twice daily Dosing recommendations cannot be provided |
| CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: CrCl <30 mL/min with concomitant use of P-gp inhibitors: | Reduce dosage to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole. Avoid coadministration | |
| Treatment of DVT and PE Reduction in the Risk of Recurrence of DVT and PE | CrCl >30 mL/min: CrCl ≤30 mL/min or on dialysis: | 150 mg twice daily Dosing recommendations cannot be provided |
| CrCl <50 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
| Prophylaxis of DVT and PE Following Hip Replacement Surgery | CrCl >30 mL/min: | 110 mg for first day, then 220 mg once daily |
| CrCl ≤30 mL/min or on dialysis: | Dosing recommendations cannot be provided | |
| CrCl <50 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
Preparation and administration
Administration Dabigatran Etexilate Capsules should be swallowed whole. Dabigatran Etexilate Capsules should be taken with a full glass of water. Breaking, chewing, or emptying the contents of the capsule can result in increased exposure [ s ee Clinical Pharmacology] . If a dose of Dabigatran Etexilate Capsules is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose.
The dose of Dabigatran Etexilate Capsules should not be doubled to make up for a missed dose. Consider administration with food if gastrointestinal distress occurs with Dabigatran Etexilate Capsules.