Dabigatran

What is dabigatran?

Dabigatran is an anticoagulant, often referred to as a blood thinner. You may hear dabigatran called by its brand name, Pradaxa. Dabigatran belongs to a family of drugs called direct oral anticoagulants (DOACs) and is used to prevent or treat conditions like deep vein thrombosis (DVT), pulmonary embolism (PE) and other clotting disorders.

Dabigatran comes in capsule form.

Before giving dabigatran to your child

Tell your health-care provider if your child:

• is allergic to dabigatran, or any other drugs, foods or substances
• has any current active bleeding (including throwing up blood or material that looks like coffee grounds or blood in stool)
• has an injury or conditions that increase the risk of bleeding
• has kidney or liver disease
• has any problem absorbing food or medications due to issues with the gut (stomach or intestines)
• is taking other medications specifically for HIV, infections, seizures or any other blood thinners
• has a prosthetic heart valve and takes blood thinners

How to give dabigatran to your child

• Dabigatran is given twice daily by mouth.
• Give dabigatran at the same time(s) each day to maintain consistent blood levels.
• You can give dabigatran with or without food.
• Dabigatran is available as a capsule form.
• Dabigatran capsules cannot be opened or crushed.
• If your child vomits or spits up the medication within 30 minutes of taking it, you should give the dose again. However, if vomiting occurs more than 30 minutes after the dose, do not repeat it, and simply continue with the next scheduled dose. If your child frequently vomits or spits up the medication, contact their health-care provider for guidance.

What to do if you miss a dose of dabigatran

• Give the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Your pharmacist will provide a more specific timeframe according to your child’s schedule.
• Do not give double doses to make up for a missed dose.
• Continue the usual dosing schedule for subsequent doses.

How long does dabigatran take to work?

Dabigatran will start working within hours of taking it. However, consistent daily use is needed to ensure its blood thinning effects are maintained.

What are the possible side effects of dabigatran?

Your child may have some of these side effects while they take dabigatran. Check with your child's health-care provider if your child continues to have any of these side effects and they do not go away, or they bother your child:

• minor bleeding (e.g., nosebleeds, bruising)
• upset stomach
• mild rash
• itchiness
• hives
• longer or heavier menstrual bleeding

Call your child's health-care provider during office hours if your child has any of these side effects:

• back pain
• muscle weakness
• numbness or tingling

The side effects listed below are not common, but they may be a sign of a serious problem. Call the Thrombosis Team or your child's health-care provider right away or take your child to Emergency if your child has any of the following:

• signs of a life-threatening reaction, including sudden onset persistent cough without mucus, with or without wheezing, shortness of breath, chest tightness or chest pain, fever, blue skin colour
• sudden onset progressive itching with or without localized rash, swelling of face, lips, tongue or throat
• severe rash that starts suddenly
• unusual bleeding, for example, a very long nosebleed (more than 15 minutes even with applying local pressure), blood in the urine, coughing or throwing up blood, bleeding or oozing from a cut or surgical site
• coughing up blood
• throwing up blood, or vomit that looks like coffee grounds (dark and brown)
• black, sticky, tarry stools or stools with red streaks
• sudden and/or very severe headache

What safety measures should you take when your child is using dabigatran?

• Talk to your child’s health-care team immediately if your child has a bad fall, especially if your child hits their head.
• Head protection is important for all physical activities that may result in falls, such as bicycling or rollerblading. Do not let your child play contact sports, such as hockey or football. They can get bruised or injured. Speak to your child’s health-care team about which types of activities are appropriate for your child to participate in.
• Before your child has any kind of surgery (including dental work), medical procedure or emergency treatment, tell the health-care or dental team that your child is taking dabigatran. Please call the Thrombosis Service before any planned procedures.
• Some children are advised to wear a medical alert bracelet or necklace while on dabigatran. The Thrombosis Team will tell you depending on how long your child will be on dabigatran.

There are some medicines that should not be taken together with dabigatran. In some cases, the dose of dabigatran or the other medication may need to be adjusted. It is important that you tell your child’s health-care provider and pharmacist if your child takes any other medications (prescription, over the counter or herbal) including:

• non-steroid anti-inflammatory drugs (NSAIDs) such as aspirin (acetylsalicylic acid) and ibuprofen
• common over the counter medications for cold and fever such as Advil, Aleve and Motrin contain NSAIDs and usually cannot be given while on dabigatran
• check with your pharmacist or health-care provider first before giving these medications
• acetaminophen (Tylenol) is safe to give with dabigatran
• any other medications that can affect blood clotting, such as warfarin, clopidogrel (Plavix) or enoxaparin
• medicines to treat epilepsy, such as carbamazepine, oxcarbazepine, phenytoin or phenobarbital
• some types of medications to treat mood, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
• herbal or natural medicines including (but not limited to) St. John’s Wort, activated charcoal, willow bark or Danshen (red sage)
• certain drugs to treat infections including rifampin and clarithromycin
• certain HIV medications
• azole antifungals like ketoconazole
• heart medications including verapamil and amiodarone
• alcohol

What other important information should you know about dabigatran?

• Keep a list of all medications your child is on and show the list to their health-care provider or pharmacist.
• Do not share your child's medicine with others. Do not give anyone else's medicine to your child.
• Make sure you always have enough dabigatran to last through weekends, holidays and vacations. Call your pharmacy at least two days before your child runs out of medicine to order refills.
• Keep dabigatran at room temperature in a cool, dry place away from sunlight.
• Do not keep any medicines that are out of date. Check with your pharmacist about the best way to throw away outdated or leftover medicines.

• American Society of Hematology/International Society on Thrombosis and Haemostasis 2024 updated guidelines for treatment of venous thromboembolism in pediatric patients. Halton, J., et al. (2021). Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): A randomised, controlled, open-label, phase 2b/3, non-inferiority trial. The Lancet Haematology, 8(1), e22–e33.
• Brandao, LR., et al. (2020). Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood, 135(7):491-504.
• Albisetti, M., et al. (2018). Rationale and design of a phase III safety trial of idarucizumab in children receiving dabigatran etexilate for venous thromboembolism. Research and Practice in Thrombosis and Haemostasis, 2(1), 69-76.
• Monagle, P., Chan, A. K., et al. (2018). Management of anticoagulation in children: Current guidelines and future directions. Blood, 132(21), 2339-2348.
• Parikh, S. S., et al. (2020). Practical guidance on oral anticoagulants in pediatrics. Journal of Thrombosis and Haemostasis, 18(11), 2924–2940.
• Pradaxa (dabigatran etexilate) Product Monograph. Boehringer Ingelheim Canada Ltd. (2022).

Keep dabigatran out of your child’s sight and reach and locked up in a safe place. If your child takes too much dabigatran, call your local Poison Information Centre at one of these numbers. These calls are free.

• Call 1-844 POISON-X, or 1-844-764-7669, from anywhere in Canada except Quebec.
• Call 1-800-463-5060 if you live in Quebec.