Dabigatran

PRADAXA Capsules is a direct thrombin inhibitor 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 5-10 days. To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated. For the prophylaxis of DVT and PE 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. 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 and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Non-valvular Atrial Fibrillation in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily. For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily. Treatment of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation. Reduction in the Risk of Recurrence of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after previous treatment. Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients: For patients with CrCl > 30 mL/min: 110 mg orally first day, then 220 mg once daily. Treatment of Pediatric VTE: For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant.

PRADAXA is 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 Active pathological bleeding. History of serious hypersensitivity reaction to PRADAXA. Mechanical prosthetic heart valve

Boxed warning: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Bleeding: PRADAXA can cause serious and fatal bleeding. Bioprosthetic heart valves: PRADAXA use not recommended. Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: PRADAXA use not recommended

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation Risk of Bleeding Spinal/Epidural Anesthesia or Puncture Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome The most serious adverse reactions reported with PRADAXA were related to bleeding. Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding

P-gp inducers: Avoid coadministration with PRADAXA. P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid. P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Blisters Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.