Dabigatran Etexilate

What it is and how it works

Mechanism of Action 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.

Indications

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 • 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 • 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 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atri…

Dosage and administration (summary)

• Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o 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 : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily • Treatment of Pediatric VT…

Contraindications

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 • Active pathological bleeding • History of serious hypersensitivity reaction to dabigatran etexilate capsules • Mechanical prosthetic heart valve

Warnings and precautions

Bleeding: Dabigatran etexilate can cause serious and fatal bleeding Bioprosthetic heart valves: Dabigatran etexilate use not recommended Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: Dabigatran etexilate use not recommended Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including dabigatran etexilate, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events.

Pregnancy

Pregnancy Risk Summary The limited available data on dabigatran etexilate use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.

Storage and supply

Dabigatran etexilate capsules 75 mg are with 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.

Source: Dabigatran Etexilate (Dabigatran Etexilate) — US FDA prescribing information, 2025-11-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.