Dabigatran

💊 What is Dabigatran used for?

• •To reduce the risk of stroke and systemic embolism (blood clots that travel to other parts of the body) in adults with non-valvular atrial fibrillation (an irregular heartbeat that is not caused by a heart valve problem)
• •To treat deep venous thrombosis (DVT, a blood clot in a deep vein) and pulmonary embolism (PE, a clot in the lungs) in adults who have already had 5 to 10 days of treatment with a parenteral (injected) anticoagulant
• •To reduce the risk of DVT and PE coming back in adults who have been treated before
• •To prevent DVT and PE in adults who have had hip replacement surgery

How it works

The label describes dabigatran as a direct thrombin inhibitor. Thrombin is a substance the body uses to form blood clots, and blocking it makes clots less likely to form.

How it is usually taken

• •The label says to take dabigatran exactly as prescribed. Swallow each capsule whole with a full glass of water. Do not chew, break, or open the capsules, and do not take the pellets alone. Keep the capsules in the original bottle to protect them from moisture, and do not put them in pill boxes or pill organizers. If more than one bottle is supplied, open only one bottle at a time and remove only one capsule at a time, then close the bottle right away and tightly. The label also says the medicine should not be stopped without talking to the prescribing provider. Follow the instructions from your prescriber or pharmacist.

Comes as

• •Capsules in 75 mg, 110 mg, and 150 mg strengths. Each strength has a different capsule size and is printed with its strength on the body. The label says these strengths are not substitutable on a milligram-to-milligram basis with other dabigatran dosage forms.

⚠️ Dabigatran side effects

🛑 Who should not take Dabigatran, and who should be careful

The label says not to take it if

• 🚨You have active bleeding that is caused by a medical problem (the label calls this active pathological bleeding).
• 🚨You have had a serious allergic reaction (such as anaphylaxis) to dabigatran, dabigatran etexilate, or any ingredient in the product.
• 🚨You have a mechanical prosthetic heart valve.
• 🚨The label says dabigatran is not recommended for people with bioprosthetic heart valves or with triple-positive antiphospholipid syndrome.

Tell your doctor before taking it if

• •Tell your healthcare provider about all prescription medicines, over-the-counter medicines, and dietary supplements you take or plan to take, because some can increase bleeding risk or change how much dabigatran is in your body.
• •Tell your provider before any invasive or surgical procedure, including dental procedures. The label says dabigatran may need to be temporarily stopped before these procedures and restarted promptly afterward.
• •Tell your provider if you have had or will have surgery to place a prosthetic heart valve.
• •Tell your provider if you have had a reaction to a blood thinner in the past.
• •Tell your provider about kidney function, since the label says the dose and whether the medicine is appropriate depend on kidney function.
• •Tell your provider if you have had a spinal or epidural procedure, or if one is planned, and about any spinal conditions or spinal surgery you have had.
• •The label says the drug has not been established for use in children with non-valvular atrial fibrillation or after hip replacement surgery.

🔀 Dabigatran with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •Medicines that increase bleeding risk, such as aspirin, NSAIDs (for example, ibuprofen or naproxen), anti-platelet drugs, heparin, fibrinolytic therapy, and long-term NSAID use, can increase bleeding risk.
• •P-gp inducers, such as rifampin, reduce how much dabigatran is in the body. The label says these should generally be avoided.
• •P-gp inhibitors can increase dabigatran exposure. The label names dronedarone and systemic ketoconazole as needing dose changes or avoidance in some kidney-function groups, and says verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor do not require a dose change. The label says these results should not be applied to other P-gp inhibitors.
• •Kidney impairment also increases dabigatran exposure. The label notes that P-gp inhibitors combined with kidney impairment can increase exposure more than either factor alone.
• •Your provider should review every medicine and supplement you take, because the label says they can affect bleeding risk or dabigatran levels.

Alcohol and food

The label does not say.

🤰 Dabigatran in pregnancy and breastfeeding

Pregnancy

The label says there are limited data on dabigatran in pregnant women, and these data are not enough to determine the risk of harm to the baby. It notes risks to the mother from untreated blood clots during pregnancy and a risk of bleeding in the mother and fetus with anticoagulants. In animal studies, dabigatran increased offspring deaths and caused bleeding near birth, and it affected fetal skull and spine bone development in rats. The label says to tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment.

Breastfeeding

The label advises people not to breastfeed while taking dabigatran.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store the capsules at 25°C (77°F), with short excursions allowed between 15°C and 30°C (59°F to 86°F). Keep them in the original bottle to protect them from moisture, and do not put them in pill boxes or pill organizers.

If a dose is missed

The label does not say.

If too much is taken

The label says accidental overdose may lead to bleeding problems. If this happens, the label says the medical team should give appropriate support, stop dabigatran, and look for the source of the bleeding. A specific reversal agent, idarucizumab, is available for adults. Hemodialysis (a blood-filtering procedure) can remove dabigatran, but the label says the supporting data are limited. If you think someone has taken too much, seek emergency medical help right away.

🗒️ Questions to ask about Dabigatran

• Why am I being prescribed dabigatran, and which of its uses applies to my situation?
• What bleeding signs should I watch for, and when should I call you or go to the emergency room?
• Do I need to stop dabigatran before any dental work or surgery, and when should I restart it?
• Which of my current medicines, supplements, or over-the-counter products could affect bleeding or dabigatran levels?
• What should I do if I need a spinal or epidural procedure while taking dabigatran?
• What should I do if I miss a dose or think I have taken too much?
• How will my kidney function be checked, and how might it affect my treatment?

❓ Dabigatran: frequently asked questions