Uses for dabigatran

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat and prevent blood clots (eg, deep vein thrombosis, pulmonary embolism) from occurring again in patients who already have received other medicines. It is also used to prevent deep vein thrombosis and pulmonary embolism after hip replacement surgery. It works by preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before using dabigatran

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dabigatran capsules or oral pellets in children with heart rhythm problems or who had hip replacement surgery. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dabigatran capsules in children 8 years of age and older or dabigatran oral pellets in children younger than 12 years of age with blood clotting problems. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dabigatran in the elderly. However, elderly patients are more likely to have age-related stroke, bleeding, or kidney problems, which may require caution and an adjustment in the dose for patients receiving dabigatran.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide
• Itraconazole
• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apalutamide
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Capmatinib
• Carbamazepine
• Carvedilol
• Celecoxib
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Collagenase, Clostridium histolyticum
• Conivaptan
• Cyclosporine
• Dalteparin
• Danaparoid
• Darunavir
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Dronedarone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fondaparinux
• Fosphenytoin
• Heparin
• Ibrutinib
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lenacapavir
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Lovastatin
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methotrexate
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Nirmatrelvir
• Omadacycline
• Orlistat
• Oxaliplatin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Quinidine
• Ranolazine
• Reteplase, Recombinant
• Rifampin
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Sarecycline
• Selexipag
• Simvastatin
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Telaprevir
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tipranavir
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Urokinase
• Valdecoxib
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Sodium Zirconium Cyclosilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Antiphospholipid syndrome or
• Bleeding problems, history of or
• Kidney problems or
• Stomach bleeding or ulcers, recent—May have an increase risk of bleeding.

• Bleeding, active or
• Prosthetic (artificial) mechanical heart valve—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of dabigatran

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Also, do not stop using this medicine without checking first with your doctor.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole with a full glass of water. Do not crush, break, chew, or open it.

If you are taking another medicine to thin the blood, (eg, heparin, warfarin, Coumadin®), your doctor will give you very specific instructions about how to switch to dabigatran. Carefully follow the instructions and ask your doctor if you have any questions.

To use the oral pellets:

• If you take this medicine directly in your mouth, drink apple juice after swallowing the pellets.
• You may mix the oral pellets with 1 to 2 ounces of apple juice or with 2 teaspoons of soft foods at room temperature (including apple sauce, mashed banana, or mashed carrots). Take the mixture within 30 minutes.
• Throw away the mixture if you have not taken it within 30 minutes of mixing.
• Do not mix this medicine together with milk or foods containing milk. Do not give this medicine through syringes or feeding tubes.
• Take this medicine before meals to make sure you get the full dose.

If you are taking this medicine 2 times a day, take one dose in the morning and one dose in the evening, at least 12 hours apart. Take it at the same time everyday.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prevention of stroke and blood clots in patients with nonvalvular atrial fibrillation:
    • Adults—75 to 150 milligrams (mg) 2 times a day.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of blood clots after hip replacement surgery:
    • Adults—110 milligrams (mg) taken 1 to 4 hours after hip surgery. Then, 220 mg taken once a day for 28 to 35 days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment and prevention of blood clots from occurring again:
    • Adults—150 milligrams (mg) 2 times a day.
    • Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing more than 81 kilograms (kg)—260 milligrams (mg) 2 times a day (one 150 mg capsule plus one 110 mg capsule 2 times a day or one 110 mg capsule plus two 75 mg capsules two times a day).
      • Weighing 61 to less than 81 kg—220 mg 2 times a day (two 110 mg capsules 2 times a day).
      • Weighing 41 to less than 61 kg—185 mg 2 times a day (one 110 mg capsule plus one 75 mg capsule 2 times a day).
      • Weighing 26 to less than 41 kg—150 mg 2 times a day (one 150 mg capsule or two 75 mg capsules 2 times a day).
      • Weighing 16 to less than 26 kg—110 mg 2 times a day (one 110 mg capsule 2 times a day).
      • Weighing 11 to less than 16 kg—75 mg 2 times a day (one 75 mg capsule 2 times a day).
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.

• For oral dosage form (pellets):
  • For treatment and prevention of blood clots from occurring again:
    • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor.
      • Weighing more than 41 kilograms (kg)—260 milligrams (mg) 2 times a day (one 110 mg packet plus one 150 mg packet 2 times a day).
      • Weighing 21 to less than 41 kg—220 mg 2 times a day (two 110 mg packets 2 times a day).
      • Weighing 16 to less than 21 kg—170 mg 2 times a day (one 20 mg packet plus one 150 mg packet 2 times a day).
      • Weighing 13 to less than 16 kg—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
      • Weighing 11 to less than 13 kg—110 mg 2 times a day (one 110 mg packet 2 times a day).
      • Weighing 9 to less than 11 kg—90 mg 2 times a day (one 40 mg packet plus one 50 mg packet 2 times a day).
      • Weighing 7 to less than 9 kg—70 mg 2 times a day (one 30 mg packet plus one 40 mg packet 2 times a day).
    • Children younger than 2 years of age—Dose is based on body weight and must be determined by your doctor.
      • Children 18 to less than 24 months of age weighing 21 to less than 26 kilograms (kg)—180 milligrams (mg) 2 times a day (one 30 mg packet plus one 150 mg packet 2 times a day).
      • Children 12 to less than 24 months of age weighing 16 to less than 21 kg—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
      • Weighing 13 to less than 16 kg—
        • Children 11 to less than 24 months of age—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
        • Children 10 to less than 11 months of age—100 mg 2 times a day (two 50 mg packets 2 times a day).
      • Weighing 11 to less than 13 kg—
        • Children 18 to less than 24 months of age—110 mg 2 times a day (one 110 mg packet 2 times a day).
        • Children 8 to less than 18 months of age—100 mg 2 times a day (two 50 mg packets 2 times a day).
      • Weighing 9 to less than 11 kg—
        • Children 11 to less than 24 months of age—90 mg 2 times a day (one 40 mg packet plus one 50 mg packet 2 times a day).
        • Children 6 to less than 11 months of age—80 mg 2 times a day (two 40 mg packets 2 times a day).
        • Children 5 to less than 6 months of age—60 mg 2 times a day (two 30 mg packets 2 times a day).
      • Weighing 7 to less than 9 kg—
        • Children 9 to less than 24 months of age—70 mg 2 times a day (one 30 mg packet plus one 40 mg packet 2 times a day).
        • Children 4 to less than 9 months of age—60 mg 2 times a day (two 30 mg packets 2 times a day).
        • Children 3 to less than 4 months of age—50 mg 2 times a day (one 50 mg packet 2 times a day).
      • Weighing 5 to less than 7 kg—
        • Children 5 to less than 24 months of age—50 mg 2 times a day (one 50 mg packet 2 times a day).
        • Children 3 to less than 5 months of age—40 mg 2 times a day (one 40 mg packet 2 times a day).
      • Children 3 to less than 10 months of age weighing 4 to less than 5 kg—40 mg 2 times a day (one 40 mg packet 2 times a day).
      • Children 3 to less than 6 months of age weighing 3 to less than 4 kg—30 mg 2 times a day (one 30 mg packet 2 times a day).

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have less than 6 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

If you have only taken a part of your dose of the oral pellets, do not take another dose right away. Take your next dose at your regular dosing schedule, at least 12 hours after.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep your medicine in the original package (blister package or bottle for the capsules or aluminum bag for the packets of oral pellets) until you are ready to use it. Do not store the capsules in any other container (eg, pill boxes or pill organizers). After you open a bottle for the first time, you must take all of the capsules within 4 months. If you have not used the capsules within 4 months, you must dispose of the remaining capsules and start a new bottle.

Use each packet of oral pellets within 6 months of opening the aluminum bag. Throw away any unused medicine. Do not store and reuse any leftover mixture.

Precautions while using dabigatran

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant may increase the risk of severe bleeding from your uterus.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Do not suddenly stop using this medicine without asking first your doctor. Doing so may increase risk of blood clots and stroke.

This medicine may increase your risk of developing spinal or epidural blood clot. This usually occurs if you have an epidural catheter placed in your back to give you certain medicine, are taking NSAIDs or medicine to prevent blood clotting, or have a history of spinal problems or have had surgery on your spine. Check with your doctor if you have midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness of your legs or feet while you are using this medicine.

Check with your doctor right away if you have stomach pain or upset, nausea, heartburn, or indigestion while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of dabigatran

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Acid or sour stomach
• belching
• black, tarry stools
• bloody stools
• constipation
• diarrhea
• heartburn
• indigestion
• nausea
• pain or burning in the throat
• stomach discomfort, upset, burning, or pain
• vomiting
• vomiting of blood or material that looks like coffee grounds

Rare

• Chest pain, discomfort, or tightness
• cough
• difficulty with swallowing
• dizziness
• fainting or loss of consciousness
• fast or irregular breathing
• pain or discomfort in the arms, jaw, back, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash, hives, welts, or itching skin
• sweating
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Bleeding gums
• blood in the urine
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.