Dabigatran Etexilate Prescribing Information
Dabigatran etexilate capsules are a direct thrombin inhibitor indicated:
• To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (
Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
• For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (
Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
• To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (
Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated.
• For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (
Dabigatran etexilate capsules are indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery.
• For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (
Dabigatran etexilate capsules are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (
Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated
•
o For patients with CrCl >30 mL/min: 150 mg orally, twice daily (
Indication | Dosage | |
Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF | CrCl >30 mL/min: | 150 mg twice daily |
| CrCl 15 to 30 mL/min: | 75 mg twice daily | |
| CrCl <15 mL/min or on dialysis: | Dosing recommendations cannot be provided | |
| CrCl 30 to 50 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. | |
| CrCl <30 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
Treatment of DVT and PE Reduction in the Risk of Recurrence of DVT and PE | CrCl >30 mL/min: | 150 mg twice 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 | |
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 | |
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients
For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 150 mg taken orally, twice daily. For patients with severe renal impairment (CrCl 15 to 30 mL/min), the recommended dosage of dabigatran etexilate capsules are 75 mg twice daily
For patients with CrCl >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 150 mg taken orally, twice daily, after 5 to 10 days of parenteral anticoagulation. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided
For patients with CrCl >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 150 mg taken orally, twice daily after previous treatment. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided
For patients with CrCl >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 110 mg taken orally 1 to 4 hours after surgery and after hemostasis has been achieved, then 220 mg taken once daily for 28 to 35 days. If dabigatran etexilate capsules is not started on the day of surgery, after hemostasis has been achieved initiate treatment with 220 mg once daily. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided
o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily
•
o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation
•
o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment
•
o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily
• Treatment of Pediatric VTE:
o For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant (
Dabigatran etexilate capsules can be used in pediatric patients aged 8 to less than 18 years of age who are able to swallow the capsules whole. Other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age. For the treatment of VTE in pediatric patients, initiate treatment following treatment with a parenteral anticoagulant for at least 5 days. For reduction in risk of recurrence of VTE, initiate treatment following previous treatment.
Dabigatran etexilate capsules are dosed orally twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.
The recommended dosage of dabigatran etexilate capsules for the treatment of or reducing the risk of VTE in pediatric patients 8 to less than 18 years of age is based on the patient’s actual weight as shown in Table 1 below. Administer dabigatran etexilate capsules twice daily. Adjust the dosage according to actual weight as treatment progresses
Actual Weight (kg) | Dosage (mg) | Number of Capsules Needed |
| 11 kg to less than 16 kg | 75 mg twice daily | one 75 mg capsule twice daily |
| 16 kg to less than 26 kg | 110 mg twice daily | one 110 mg capsule twice daily |
| 26 kg to less than 41 kg | 150 mg twice daily | one 150 mg capsule twice daily or two 75 mg capsules twice daily |
| 41 kg to less than 61 kg | 185 mg twice daily | one 110 mg capsule plus one 75 mg capsule twice daily |
| 61 kg to less than 81 kg | 220 mg twice daily | two 110 mg capsule twice daily |
| 81 kg or greater | 260 mg twice daily | one 150 mg capsule plus one 110 mg capsule twice daily or one 110 mg capsule plus two 75 mg capsules twice daily |
• Reduction in the Risk of Recurrence of Pediatric VTE:
o For pediatric patients: weight-based dosage, twice daily after previous treatment
• Dabigatran etexilate capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms
• Review recommendations for converting to or from other oral or parenteral anticoagulants (
When converting patients from warfarin therapy to dabigatran etexilate capsules, discontinue warfarin and start dabigatran etexilate capsules when the INR is below 2.
When converting from dabigatran etexilate capsules to warfarin, adjust the starting time of warfarin as follows:
- For CrCl ≥50 mL/min, start warfarin 3 days before discontinuing dabigatran etexilate capsules.
- For CrCl 30 to 50 mL/min, start warfarin 2 days before discontinuing dabigatran etexilate capsules.
- For CrCl 15 to 30 mL/min, start warfarin 1 day before discontinuing dabigatran etexilate capsules.
- For CrCl <15 mL/min, no recommendations can be made.
• For eGFR ≥ 50 mL/min/1.73 m2, start warfarin 3 days before discontinuing dabigatran etexilate capsules.
• Pediatric patients with an eGFR < 50 mL/min/1.73 m2have not been studied. Avoid use of dabigatran etexilate capsules in these patients.
Because dabigatran etexilate capsules can increase INR, the INR will better reflect warfarin’s effect only after dabigatran etexilate capsules has been stopped for at least 2 days
For adult and pediatric patients currently receiving a parenteral anticoagulant, start dabigatran etexilate capsules 0 to 2 hours before the time that the next dose of the parenteral drug was to have been administered or at the time of discontinuation of a continuously administered parenteral drug (e.g., intravenous unfractionated heparin).
For adult patients currently taking dabigatran etexilate capsules wait 12 hours (CrCl ≥30 mL/min) or 24 hours (CrCl <30 mL/min) after the last dose of dabigatran etexilate capsules before initiating treatment with a parenteral anticoagulant
For pediatric patients currently taking dabigatran etexilate capsules, wait 12 hours after the last dose before switching to a parenteral anticoagulant.
• Temporarily discontinue dabigatran etexilate capsules before invasive or surgical procedures when possible, then restart promptly (
If possible, discontinue dabigatran etexilate capsules in adults 1 to 2 days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before invasive or surgical procedures because of the increased risk of bleeding. Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required
For pediatric patients, discontinue dabigatran etexilate capsules 24 hours before an elective surgery (eGFR > 80 mL/min/1.73 m2) or 2 days before an elective surgery (eGFR 50 to 80 mL/min/1.73 m2). Pediatric patients with an eGFR <50 mL/min/1.73 m2have not been studied, avoid use of dabigatran etexilate capsules in these patients.
If surgery cannot be delayed, there is an increased risk of bleeding
75 mg capsules: White opaque cap / white opaque body, size ‘2’ HPMC capsules having imprinting “A” on cap with black ink and “329” on body with black ink filled with off white to yellowish pellets.
110 mg capsules: Light blue opaque cap / light blue opaque body, size ‘1’ HPMC capsules having imprinting “A” on cap with black ink and “192” on body with black ink filled with off white to yellowish pellets.
150 mg capsules: Light blue opaque cap/ white opaque body, size ‘0’ HPMC capsules having imprinting “A” on cap with black ink and “316” on body with black ink filled with off white to yellowish pellets.
Lactation: Breastfeeding not recommended (
There are insufficient data to assess the presence of dabigatran in human milk. There are no data on the effects of dabigatran on the breastfed child or on milk production. Dabigatran and/or its metabolites were present in rat milk. Breastfeeding is not recommended during treatment with dabigatran etexilate.
Geriatric Use: Risk of bleeding increases with age (
Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups
Dabigatran etexilate capsules are contraindicated in patients with:
• Active pathological bleeding
• History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock)
• Mechanical prosthetic heart valve