Classes
DEA Class; Rx
Common Brand Names; Pradaxa
- Anticoagulants, Cardiovascular;
- Anticoagulants, Hematologic;
- Thrombin Inhibitors
Description
Oral direct thrombin inhibitor
Used in adults for reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for treatment and reduction in risk of recurrence of DVT and PE, and for the prophylaxis of DVT and PE after hip replacement surgery; used in pediatric patients 3 months and older for VTE in patients who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in patients who have been previously treated
No routine monitoring; anticoagulant effect can be reversed with idarucizumab (adults) when clinically indicated
Indications
Prevention of stroke and systemic embolism associated with nonvalvular atrial fibrillation
For stroke and systemic embolism prophylaxis in nonvalvular atrial fibrillation.
For the treatment of venous thromboembolism (VTE), including deep venous thrombosis (DVT), pulmonary embolism (PE), cerebral thromboembolism (e.g., cerebral venous sinus thrombosis), and central line thrombosis.
For thrombosis prophylaxis, including deep venous thrombosis (DVT) prophylaxis and pulmonary embolism prophylaxis.
Contraindications
Hypersensitivity to drug or excipients
Active pathologic bleeding
Adverse Effects
Adults
Dyspepsia and gastritis (35%; compared with warfarin [24%])
Any bleed (16.6%; compared with warfarin [18.4%])
Pediatrics
GI adverse effects (32%; compared with standard of care [SOC] with warfarin, LMWH, or fondaparinux [12%])
Any bleeding (22%; SOC 24%)
Minor bleeding (19%; SOC 23%)
1-10%
Adults
Major bleed (3.47%/y; compared with warfarin [3.58%/y])
GI bleed (1.59%/y; compared with warfarin [1.51%/y])
Pediatrics
Major and clinically relevant nonmajor bleeding (3.4%; SOC 3.3%)
Major bleeding (2.3%; SOC 2.2%)
Clinically relevant nonmajor bleeding (1.1%; SOC 1.1%)
<1%
Adults
Intracranial hemorrhage (0.22%/y; compared with warfarin [0.77%/y])
Hypersensitivity, including urticaria, rash, pruritus (<0.1%)
Warnings
Premature discontinuation of oral anticoagulants (other than pathological bleeding) in the absence of adequate alternative anticoagulation increases risk of thrombotic events
Direct-acting oral anticoagulants (DOACs) not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple-positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy
Pregnancy and Lactation
Limited available data on use in pregnant females are insufficient to determine drug-associated risks for adverse developmental outcomes; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in mother and fetus associated with use of anticoagulants
There are no data on presence of dabigatran in human milk, effects on breastfed child, or on milk production; drug and/or its metabolites were present in rat milk; breastfeeding is not recommended during therapy
Maximum Dosage
300 mg/day PO for capsules; safety and efficacy of oral pellets have not been established.
300 mg/day PO for capsules; safety and efficacy of oral pellets have not been established.
Capsules
weighing 81 kg or more: 520 mg/day PO.
weighing 61 to 80 kg: 440 mg/day PO.
weighing 41 to 60 kg: 370 mg/day PO.
weighing 26 to 40 kg: 300 mg/day PO.
Oral pellets
Safety and efficacy have not been established.
Capsules
8 to 12 years:
weighing 61 to 80 kg: 440 mg/day PO.
weighing 41 to 60 kg: 370 mg/day PO.
weighing 26 to 40 kg: 300 mg/day PO.
weighing 16 to 25 kg: 220 mg/day PO.
weighing 11 to 15 kg: 150 mg/day PO.
1 to 7 years: Safety and efficacy have not been established.
Oral pellets
12 years: Safety and efficacy have not been established.
1 to 11 years:
weighing 41 kg or more: 520 mg/day PO.
weighing 26 to 40 kg: 440 mg/day PO.
weighing 21 to 25 kg:
2 to 11 years: 440 mg/day PO.
18 to 23 months: 360 mg/day PO.
weighing 16 to 20 kg:
2 to 11 years: 340 mg/day PO.
12 to 23 months: 280 mg/day PO.
weighing 13 to 15 kg: 280 mg/day PO.
weighing 11 to 12 kg:
18 months to 11 years: 220 mg/day PO.
12 to 17 months: 200 mg/day PO.
weighing 9 to 10 kg: 180 mg/day PO.
weighing 7 to 8 kg: 140 mg/day PO.
weighing 5 to 6 kg: 100 mg/day PO.
Capsules
Safety and efficacy have not been established.
Oral pellets
3 to 11 months:
weighing 13 to 15 kg:
11 months: 280 mg/day PO.
10 months: 200 mg/day PO.
weighing 11 to 12 kg: 200 mg/day PO.
weighing 9 to 10 kg:
11 months: 180 mg/day PO.
6 to 10 months: 160 mg/day PO.
5 months: 120 mg/day PO.
weighing 7 to 8 kg:
9 to 11 months: 140 mg/day PO.
4 to 8 months: 120 mg/day PO.
3 months: 100 mg/day PO.
weighing 5 to 6 kg:
5 to 11 months: 100 mg/day PO.
3 to 4 months: 80 mg/day PO.
weighing 4 kg: 80 mg/day PO.
weighing 3 kg: 60 mg/day PO.
1 to 2 months: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dabigatran etexilate mesylate
capsule
- 75mg
- 110mg
- 150mg
