Dabigatran etexilate (Pradaxa®) is a prescription blood thinner medicine that lowers the chance of blood clots forming in the body.

Dabigatran etexilate (Pradaxa®) is used to:
 

• Reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke.
• Treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

Dabigatran etexilate (Pradaxa®) is not for use in people with artificial (prosthetic) heart valves.
 

For people taking Dabigatran etexilate (Pradaxa®) for atrial fibrillation: Patients should not stop taking Dabigatran etexilate (Pradaxa®) without talking to the doctor who prescribed it. Discontinuation of Dabigatran etexilate (Pradaxa®) without doctor's advice increases risk of having a stroke. Dabigatran etexilate (Pradaxa®) may need to be stopped prior to surgery or a medical or dental procedure. Physician should inform patients when to stop taking Dabigatran etexilate (Pradaxa®) and when patients may start taking it again. If patients have to stop taking Dabigatran etexilate (Pradaxa®), physician may prescribe another medicine to help prevent a blood clot from forming.

As with all anticoagulants, Dabigatran etexilate (Pradaxa®) should be used with caution in conditions with an increased risk of bleeding. Bleeding can occur at any site during therapy with Dabigatran etexilate (Pradaxa®). It is contraindicated for patients who:
 

• Currently have abnormal bleeding.
• Have ever had an allergic reaction to it
• Have had or plan to have a valve in your heart replaced

Caution should be taken when taking Dabigatran etexilate (Pradaxa®) if patients:
 

• Are 75 years old or older
• Have kidney problems
• Have stomach or intestine bleeding that is recent or keeps coming back or have a stomach ulcer
• Take other medicines that increase risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and other blood thinners
• Have kidney problems and take dronedarone or ketoconazole tablets

For pregnant patients or patients who plan to get pregnant, no clinical data on exposed pregnancies are available. The potential risks for humans is unknown. Patients should inform their doctors right away if they become pregnant during treatment. Pregnant patients should not be treated with Dabigatran etexilate (Pradaxa®) unless the expected benefit is greater than the risk.
For breastfeeding or patients planning to breastfeed, it is not known if Dabigatran etexilate (Pradaxa®) passes into the breast milk. As precaution, breast-feeding should be stopped.

Please see full prescribing information before prescribing.

Reference:
1. Prescribing information, Boehringer Ingelheim Malaysia
2. Medication guide, Pradaxa® USPI.