Dabigatran (Oral)

As an anticoagulant, Dabigatran works by preventing blood clots from forming in the blood vessels.

Overview

Dabigatran treats blood clots in the legs, known as deep vein thrombosis (DVT), along with pulmonary embolism (a blood clot in the lung), in patients that have already received an injectable anticoagulant treatment. It is also used to prevent DVT and PE from reoccurring after treatment is completed. In some cases, Dabigatran may be used as a blood clot preventative following a hip replacement surgery.

Patients with atrial fibrillation, a serious heart rhythm condition that increases the chance of blood clots, may also be prescribed Dabigatran to prevent strokes. Dabigatran falls into a class of anticoagulant medications known as direct thrombin inhibitors, which work by preventing blood clots from forming.

Conditions Treated:

  • Deep vein thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Atrial fibrillation

Type of Medicine:

  • Anticoagulant

Side Effects:

The most common side effects reported by patients taking Dabigatran include belching, sour stomach, black, tarry or bloody stools, diarrhea, constipation, indigestion, heartburn, vomiting, nausea, burning or pain in the throat and stomach discomfort. Some patients have also experienced:

  • difficulty swallowing
  • cough
  • dizziness or fainting
  • pink or brown urine
  • nosebleeds
  • excessive bleeding from a cut or scrape
  • heavy menstrual bleeding
  • unusually fast heartbeat
  • irregular breathing
  • swelling or puffiness of the eyelids or around the lips, face, or tongue
  • skin redness, hives, rash, welts or skin itching
  • uncharacteristic weakness or fatigue
  • trouble breathing
  • tightness in the chest
  • headache
  • joint pain or swelling

Patients are urged to contact their healthcare professional or seek immediate medical treatment if they experience these or any other medical problems while taking Dabigatran. Some patients have been known to vomit material that is bloody or resembles coffee grounds. Serious allergic reactions to Dabigatran are rare, but medical help should be sought if any symptoms of an allergic reaction should occur. In addition to the above list, additional side effects may occur which require immediate medical attention, or that do not go away after a normal period of time.

Dosage:

As with any medication, it is important to take Dabigatran only as prescribed by a physician. Patients should take this medication exactly as directed and not take it for a longer time period or more often than ordered. Doing so may increase the chance of side effects. Patients should not share medication and Dabigatran should not be taken by anyone to whom it was not prescribed.

The manufacturers of Dabigatran have provided a Medication guide, but a physician may alter recommendations based on the individual needs and circumstances of the patient. A patient taking Dabigatran should take it only as directed by their physician. Patients taking another blood thinning medication will be provided with specific instructions regarding how they should switch to Dabigatrin. These instructions should be followed carefully and any questions referred to the prescribing physician.

Dabigatran may be taken with or without food. The capsule should be swallowed whole with a full glass of water. This medication should not be crushed, broken, chewed or opened. Only one dose should be removed from the medication packaging at one time. Dosage will vary based on the patient and the condition being treated.

The amount of Dabigatran prescribed depends on the strength of the medicine. Also, the number of doses taken each day, the time allowed between doses, and the length of time the medicine is taken depends on the medical problem for which this medication is prescribed. Adult nonvalvular atrial fibrillation patients should be prescribed between 75 and 150 milligrams, to be taken orally, twice per day. For the prevention of blood clots following a hip replacement surgery, adults should be prescribed 110 milligrams to be taken 1 to 4 hours following surgery and then 220 milligrams taken once per day for 28-35 days. To treat and prevent blood clots after an occurrence, adults should be prescribed 150 milligrams, to be taken twice per day.

There are no recommended dosage sizes for children. The administering physician is charged with determining if a child should receive Dabigatran and how it should be prescribed. Safety and efficacy of Dabigatran use by children has not been established.

A missed dose should be taken as soon as possible. However, if the time for the next scheduled dose is within 6 hours, it should be skipped and the regular dosing schedule resumed. Patients are warned against taking double doses.

Periodic laboratory or other medical tests may be performed to monitor progress or check for side effects while taking Dabigatran.

An accidental overdose may lead to excess bleeding or hemorrhaging. If the patient experiences any of the symptoms of an overdose (unusual or prolonged bleeding, bloody or tarry stools or pink urine), or any serious symptoms such as fainting or trouble breathing, 911 should be contacted immediately. In the case of an overdose, a reversal agent may be administered. They may also call the poison control center at 1-800-222-1222.

Major Drug Interactions:

Taking another drug may change the way that Dabigatran or the other drug works in the body or affect its removal from the body. It may also increase the risk for serious side effects. Patients who have been prescribed Dabigatran should provide their physician and pharmacist with a complete list of all prescription and non-prescription drugs that they are taking, including herbs and dietary supplements.

Below is a partial list of drugs that may interact with Dabigatran. Patients should notify their physician if taking any of these drugs, prior to their first dose. No new medications should be started while taking Dabigatran, without approval of the patient's physician.

  • Mifepristone
  • Defibrotide
  • Itraconazole
  • Conicistat
  • Cyclosporine
  • Dronedarone
  • Ketoconazole
  • Rifampin
  • Medications containing heparin
  • Prasugrel
  • St. John's wort

Certain drugs may have similar effects to Dabigatran, and can increase the risk of bleeding problems if taken concurrently. A physician may recommend a different drug to treat pain if the patient currently relies on an interacting drug. These include:

  • Aspirin or aspirin-type drugs (salicylates)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen

Using tobacco products is not recommended while taking Dabigatran. Certain types of food may also interact with the medication. Any tobacco use should be discussed with the prescribing patient's physician.

Warnings:

The prescribing doctor should be notified before a patient stops taking this medication. The medication should continue to be taken, even if the patient is feeling well. Prescriptions should be refilled promptly to ensure that no doses are missed. If the medication must be stopped, the prescribing physician may prescribe another anticoagulant to prevent a blood clot from forming.

  • The prescribing physician should be notified if any of the following apply:
  • The patient has had an epidural or spinal anesthesia while taking a blood thinner
  • An epidural catheter is left in the body
  • The patient has a spinal deformity or has had spinal surgery previously
  • The patient has had traumatic or repeated spinal punctures

Epidural or spinal hematomas could occur in patients on Dabigatran who receive spinal anesthesia or undergo a spinal procedure. These risks are significantly higher in individuals who have a history of repeated spinal procedures or epidurals. These hematomas could cause lengthy or permanent paralysis. The optimal timing between taking Dabigatran and future neuraxial procedures is unknown. Patients taking Dabigatran should notify their physician of any signs or symptoms of neurological impairment.

The prescribing physician should be notified if any of the following drugs are currently being taken by the patient:

  • Anagrelide
  • Asprin
  • A nonsteroidal anti-inflammatory drug (NSAID)
  • Cilostazol
  • Clopidogrel
  • Dipyridamole
  • Eptifibatide
  • Heparin
  • Prasugrel
  • Ticagrelor
  • Ticlopidine
  • Tirofiban
  • Warfarin

Before taking Dabigatran, the patient should inform their physician of any allergies. This medication may contain certain inactive ingredients that could cause an allergic reaction or other problem. The prescribing physician should also be made aware of the patient's medical history. It is especially important to include any history including a mechanical heart valve, kidney disease, bleeding problems, liver disease, blood disorders (such as hemophilia or anemia), major surgeries, significant injuries or frequent falls.

Patients using a bioprosthetic heart valve should not use Dabigatran. Using this medication is contradicted in patients with mechanical prosthetic valves.

Patients taking Dabigatran should inform all of their doctors and dentists. Before having any medical or dental procedure, the patient should tell the provider about any medications, herbs or supplements that they may be using. In some cases, this medication must be stopped before surgery. The patient's physician should inform the patient when they should stop and restart Dabigatran. Another medication may be prescribed in the interim, to prevent a blood clot from forming.

Patients should avoid any injections into the muscles, including flu shots. When taking Dabigatran, patients should ask for injections to be given in the arm, making it easier to spot bleeding and apply pressure.

Dabigatran may cause stomach bleeding. The use of alcoholic beverages should be limited. A doctor or pharmacist should be consulted before consuming alcoholic beverages.

Since this medication can cause excess bleeding, extra care should be given while using sharp objects such as razors or nail cutters, or while playing certain sports. A soft toothbrush should be used while brushing teeth. If an injury occurs, medical treatment should be sought immediately.

The prescribing physician should be informed if the patient has kidney problems, recurrent intestinal bleeding or a stomach ulcer. Certain medications for the treatment of kidney problems have been known to interact with Dabigatran. Prior use of blood thinners could affect the results experienced by users of Dabigatran.

Adults over the age of 60 may have a higher risk of renal bleeding or a major gastrointestinal bleed when using Dabigatran. Patients aged 75 or older may be at significantly higher risk of bleeding. The use of Dabigatran by older patients should be closely monitored by a physician.

Pregnant women should only use Dabigatran when clearly needed and under the direct supervision of a physician. There is an increased bleeding risk during labor and delivery for patients using Dabigatran. It is unknown if Dabigatran is passed into breast milk, so a physician should be consulted before breastfeeding. Patients who are pregnant, or plan to become pregnant, should inform their physician before taking Dabigatran. There are benefits and risks of taking Dabigatran while pregnant.

Immediate medical attention should be sought if the patient experiences back pain, numbness or tingling, muscle weakness, loss of muscle control in the face, blurred eyesight, confusion or loss of control of the bowels or bladder. It is particularly important to report any pain or numbness in the lower legs or feet. All patient appointments with the prescribing physician, along with laboratory appointments should be kept.

Storage:

Dabigatran should be stored in a closed container kept at room temperature, or approximately 77°F, and away from moisture, heat and direct light. This medication should not be frozen or stored in temperatures below 59° or exceeding 86°. All capsules should be taken within four months of opening a new bottle.

This medication should be kept in the original packaging until ready to use. Dabigatran is administered in either a bottle or blister package. Capsules should not be stored in any other type of container, such as a pill box. The bottle should be kept tightly closed to protect the medication from moisture. Dabigatran should be kept out of the reach of children and pets and any outdated or unused medication should be properly discarded. The patient should contact their physician for instructions on how to dispose of this medication.

Summary:

While Dabigatran can prevent the occurrence and reoccurrence of blood clots and strokes, it should only be used under the close supervision of a physician. As an anticoagulant falling into the class of medications known as direct thrombin inhibitors, Dabigatran prevents blood clots from forming. It is typically indicated for the treatment of deep vein thrombosis and pulmonary embolism, along with prevention of blood clots in patients with atrial fibrillation, a heart rhythm condition. Dabigatran is also used for patients who have recently had a hip replacement surgery.

This medication can cause side effects including an upset stomach, constipation, unusual urine color and nausea. Because stomach bleeding may also occur, it is important for patients to consult with a physician before consuming any alcoholic beverages. Excess bleeding may also occur when taking Dabigatran. It should not be used with other medications that thin the blood, including aspirin, without prior consultation with a physician. Dabigatran is not for use by patients with a prosthetic heart valve. Other drugs may interact with Dabigatran, so patients should provide their physician and pharmacist with a complete list of drugs taken, including herbs and dietary supplements.

Pregnant patients, people over the age of 75, patients with a prior history of kidney problems, or those who have ever been diagnosed with a spinal condition or had spinal surgery, should consult with their physician before taking Dabigatran. Patients taking this medication should avoid injections in the muscles and use care when using sharp objects such as razors to avoid excess bleeding. Any allergies should be reported to the prescribing physician. Dabigatran should be stopped under the supervision of a physician before having certain medical or dental procedures.

When taken correctly, Dabigatran can prevent blood clots and stroke. Dosage of this medication is determined by the needs of the patient and the condition for which they are being treated. The prescribing physician should work closely with the patient to evaluate their prior medical history, any medications taken, and allergy risk prior to administering Dabigatran. Every dose should be taken to gain the full effect of Dabigatran, which can be taken with or without food.