Dabigatran

Chemical formula: C₂₅H₂₅N₇O₃  Molecular mass: 627.733 g/mol  PubChem compound: 6445226

Therapeutic indications

Dabigatran is indicated for:

Venous thromboembolic events in total hip replacement surgery or total knee replacement surgery

Population group: only adults (18 years old or older)

Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF)

Population group: only adults (18 years old or older)

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥75 years; heart failure (NYHA Class ≥II); diabetes mellitus; hypertension.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Deep vein thrombosis and pulmonary embolism

Population group: only adults (18 years old or older)

at least one of
Deep venous thrombosis
Pulmonary embolism

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Venous thromboembolic events

Population group: only minors (0 - 18 years old)

Treatment of VTE in paediatric patients from birth to less than 18 years of age.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Recurrent venous thromboembolism

Population group: only minors (0 - 18 years old)

Prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Recurrent deep vein thrombosis and pulmonary embolism

Population group: only adults (18 years old or older)

at least one of
Deep venous thrombosis
Pulmonary embolism

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Dabigatran is contraindicated in the following cases:

Severe renal impairment (CrCL <30 mL/min) in adult patients

at least one of

Renal failure stage 5: Kidney failure (GFR <15 mL/min/1.73 m2 or dialysis)

Active clinically significant bleeding

Bleeding

Prosthetic heart valves requiring anticoagulant treatment

Prosthetic heart valve in situ

Ketoconazole, cyclosporine, itraconazole, dronedarone, fixed-dose combination glecaprevir/pibrentasvir

at least one of
Ketoconazole
Ciclosporin
Itraconazole
Dronedarone
Glecaprevir and pibrentasvir

Hepatic impairment, liver disease

at least one of
Hepatic insufficiency
Hepatopathy

Anticoagulants

Antithrombotic agents

Lesion or condition, if considered a significant risk factor for major bleeding

at least one of
Gastrointestinal ulcer
Spinal injury
Traumatic brain injury
Intracranial hemorrhage
Operation on brain
Operative procedure on spinal structures
Esophageal varices
Aneurysm
Congenital vascular malformation

eGFR <50 mL/min/1.73m² in paediatric patients

at least one of



Renal failure stage 5: Kidney failure (GFR <15 mL/min/1.73 m2 or dialysis)

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