dabigatran (Pradaxa)

• Dabigatran is an oral drug used to treat and prevent blood clots (an anticoagulant or blood thinner) in the hearts of patients with atrial fibrillation. These clots are likely to break into pieces and travel to the brain to cause strokes.
• Similarly, it is used to treat and prevent blood clots in the deep veins of the legs (deep venous thrombosis or DVT) and blood clots in the lungs. Blood clots in the deep veins of the legs are likely to break into pieces and travel to the lungs to block arteries in the lungs (pulmonary embolus or PE). Dabigatran works by blocking the action of thrombin a protein that is necessary for the coagulation of blood that results in blood clots. Reducing the action of thrombin reduces the ability of blood to clot.
• Dabigatran was approved by the FDA on October 2010.

What brand names are available for dabigatran?

Pradaxa

Is dabigatran available as a generic drug?

Do I need a prescription for dabigatran?

Yes

• Dabigatran is used for reducing the risk of blood clots in the heart, and resulting strokes in patients with atrial fibrillation who have no problems with their heart valves (nonvalvular atrial fibrillation). It also is used for treating and preventing deep venous thrombosis and pulmonary embolism.

Common side effects of dabigatran include:

• Bleeding
• Symptoms of gastritis

Other serious side effects include:

• The most serious side effect is major bleeding. Major bleeding includes hemorrhagic stroke, intracranial hemorrhage, fatal bleeding, and gastrointestinal bleeds.
• Dabigatran increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. All signs or symptoms of blood loss such as a drop in hemoglobin and/or hematocrit or low blood pressure should be evaluated and dabigatran should be discontinued in patients with active bleeding.

• The recommended dose of dabigatran for non-valvular atrial fibrillation is 75 to 150 mg twice daily. The recommended dose for preventing or treating DVT or PE is 150 mg twice daily.

• P glycoprotein (P-gp) inhibitors (for example, dronedarone or ketoconazole [Nizoral, Extina, Xolegel, Kuric]) increase blood levels of dabigatran.
• The dose of dabigatran should be reduced to 75 mg twice daily when administered with P-gp inhibitors in patients with moderate renal impairment (a creatinine clearance of 30-50 mL/min).
• Dabigatran should not be combined with P-gp inhibitors in patients with severe renal impairment (creatinine clearance of 15-30 mL/min).
• Combining dabigatran with P-gp inducers (for example, rifampin) reduces dabigatran blood levels and should generally be avoided.

• There are no adequate or well-controlled trials of dabigatran use in pregnant women.
• It is not known if dabigatran is excreted into human milk.

What preparations of dabigatran are available?

• Capsules: 75 and 150 mg

How should I keep dabigatran stored?

• Dabigatran should be stored at 15 C to 30 C (59 F to 86 F).
• Once opened, it must be used within 4 months.
• The container should be kept tightly closed. Drug should be stored in the original package to protect it from moisture.