Pradaxa (dabigatran etexilate) Indications

Pradaxa is a type of anticoagulant, or blood thinner, known as a direct thrombin inhibitor. It is used to lower the chance of blood clots forming in your body by blocking thrombin, the blood’s central clotting agent.

Pradaxa was introduced in 2010 as the first FDA-approved alternative to warfarin to reduce the risk of stroke in atrial fibrillation (a type of irregular heartbeat) not caused by a heart valve problem. People with atrial fibrillation are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.

Pradaxa is also approved:

• To treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) following treatment with blood thinner injections
• To reduce the risk of DVT and PE occurring again

Pradaxa (dabigatran etexilate) Use and Dosage

It is important to take Pradaxa exactly as prescribed by your healthcare provider and not to discontinue taking it without first talking with your healthcare provider. Stopping Pradaxa may increase your risk of having a stroke or forming blood clots.

Your dosage of Pradaxa will be determined according to the condition being treated and your creatinine clearance, which is a measure of kidney function.

Following are some things to keep in mind while taking Pradaxa Capsules:

• Take Pradaxa Capsules twice a day, approximately every 12 hours
• If you miss a dose, take it as soon as you remember. If the next dose is within 6 hours, skip the missed dose and avoid taking two doses at the same time.
• Swallow Pradaxa Capsules whole; do not break, chew, or empty the pellets from the capsule.
• You can take Pradaxa Capsules with or without food, accompanied by a full glass of water.
• Make sure to refill your Pradaxa prescription before you run out.
• Inform your healthcare provider if you have upcoming surgery, medical procedures, or dental work, because you may need to stop taking Pradaxa for a brief time.
• If you take too many Pradaxa Capsules, go to the nearest hospital emergency room, or contact your healthcare provider.
• Promptly notify your healthcare provider if you experience a fall or injury, particularly if you hit your head.
• Pradaxa Capsules are available in bottles or blister packages.
• Open only one bottle of Pradaxa Capsules at a time and finish the opened bottle before opening a new one.
• Use an opened bottle of Pradaxa Capsules within 4 months.
• When it is time to take a dose, remove only the prescribed amount from the open bottle or blister package; close the bottle of Pradaxa Capsules tightly after taking your dose.

Pradaxa (dabigatran etexilate) Side Effects

Common side effects of Pradaxa in adults and children include:

• Indigestion, upset stomach, or a burning sensation
• Stomach-area (abdominal) pain or discomfort

Pradaxa can cause bleeding, which can be serious and sometimes lead to death. Do not take Pradaxa if you:

• Currently experience abnormal bleeding
• Have had a serious allergic reaction to any of the ingredients in Pradaxa (ask your healthcare provider if you are not sure)
• Have had or plan to have a valve in your heart replaced with a mechanical prosthetic heart valve

If you experience any of the following signs or symptoms of bleeding, contact your healthcare provider or get medical help right away:

• Unexpected, severe, or uncontrollable bleeding, or bleeding that persists for an extended period
• Unusual or unexpected bruising, such as bleeding from the gums, frequent nosebleeds, and heavier than normal menstrual/vaginal bleeding
• Coughing up or vomiting blood, or vomiting that resembles coffee grounds
• Pink or brown urine, or red or black stools (resembling tar)
• Unexpected pain, swelling, or joint pain
• Headaches, dizziness, or weakness

Inform your healthcare provider if you experience any side effect that bothers you or does not resolve.

Pradaxa (dabigatran etexilate) Precautions

Factors that may increase your risk of bleeding with Pradaxa include:

• Being 75 years old or older
• Having kidney problems
• Having recent or recurrent episodes of stomach or intestinal bleeding or having a stomach ulcer
• Taking other medicines that can increase your risk of bleeding, such as aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs), and blood thinners
• Taking dronedarone or ketoconazole tablets

Inform your healthcare provider about all your medical conditions, including kidney problems, bleeding problems, stomach ulcers, or antiphospholipid syndrome (APS).

Notify your healthcare provider if you are pregnant or planning to become pregnant. The potential impact of Pradaxa on the unborn baby is uncertain. Contact your doctor immediately if you become pregnant while on Pradaxa treatment.

Additionally, if you are planning to get pregnant while taking Pradaxa, you should discuss pregnancy planning with your healthcare provider.

Since it is not known if Pradaxa passes into breast milk, tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Inform your healthcare provider about all medications (prescription and over-the-counter), vitamins, and supplements you are taking, as some medications can interact with Pradaxa.

Pradaxa (dabigatran etexilate) Form and Strengths

Pradaxa is available in the following formulation and strengths:

• Pradaxa capsules:
  • 75mg
  • 110mg
  • 150mg

• Dabigatran etexilate capsules:
  • 75 mg
  • 110mg
  • 150mg

FAQs

How does Pradaxa work?

Pradaxa works by attaching itself to thrombin, the central clotting agent, to reduce the ability of thrombin to form a clot. . Since Pradaxa functions to reduce clot formation, stopping this medication increases your risk of developing DVT and PE.

How should I store Pradaxa?

When storing Pradaxa, it is important to carefully adhere to these instructions:

• Keep Pradaxa at room temperature, ranging between 68°F to 77°F (20°C to 25°C).
• Once the bottle is opened, use Pradaxa Capsules within a period of 4 months. After this time, safely dispose of any unused Pradaxa Capsules.
• Store Pradaxa Capsules in their original bottle or blister package to maintain dryness and protect them from moisture. Avoid placing Pradaxa Capsules in pill boxes or organizers.
• Immediately close the bottle of Pradaxa Capsules tightly after each dose is taken.
• Ensure that Pradaxa Capsules, as well as all medications, are kept out of the reach of children.

What if I miss a dose of Pradaxa?

You should not take two doses of Pradaxa Capsules at the same time. If you miss a dose of Pradaxa Capsules, take the dose as soon as you remember, but you should skip the missed dose if your next dose is less than 6 hours away.

Resources

1. https://patient.boehringer-ingelheim.com/us/pradaxa/
2. https://content.boehringer-ingelheim.com/DAM/c669f898-0c4e-45a2-ba55-af1e011fdf63/pradaxa%20capsules-us-pi.pdf