Edoxaban

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Generic Name: Edoxaban Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Edoxaban used for?

Edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). It is also used to treat certain blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE).

Edoxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

How should I take Edoxaban?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, weight, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have trouble swallowing the tablet whole, you may crush the tablet and mix it with 60 to 90 milliliters of water or applesauce. Drink or eat the entire mixture right away. Do not prepare a supply for future use.

If you are giving this medication through a tube into the stomach (gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

How do I store Edoxaban?

Edoxaban is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Edoxaban in the bathroom or the freezer. There may be different brands of Edoxaban that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Edoxaban down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Edoxaban?

Before taking edoxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), recent major injury/surgery, frequent falls/injuries, stroke.

Before having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking edoxaban before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

This medication can cause bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, contact your doctor right away. Your doctor may need to check you for hidden bleeding that could be serious.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Edoxaban during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Edoxaban. Edoxaban is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Edoxaban?

Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, difficulty swallowing.

Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Edoxaban?

Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as warfarin, enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).

Other medications can affect the removal of edoxaban from your body, which may affect how edoxaban works. One example is rifampin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Edoxaban may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Edoxaban?

Edoxaban may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Edoxaban?

Edoxaban may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Edoxaban.

What is the dose of Edoxaban for an adult?

Usual Adult Dose for Atrial Fibrillation

60 mg orally once a day

Use: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation

Usual Adult Dose for Deep Vein Thrombosis

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Uses: Treatment of deep venous thrombosis and pulmonary embolism following 5-10 days of initial parenteral anticoagulant therapy

Usual Adult Dose for Pulmonary Embolism

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Uses: Treatment of deep venous thrombosis and pulmonary embolism following 5-10 days of initial parenteral anticoagulant therapy

Renal Dose Adjustments

Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation:

CrCl greater than 95 mL/min: Not recommended

CrCl 51 to 95 mL/min: No adjustment recommended

CrCl 15 to 50 mL/min: 30 mg orally once a day

CrCl less than 15 mL/min: Not recommended

Treatment of deep venous thrombosis or pulmonary embolism:

CrCl greater than 50 mL/min: No adjustment recommended

CrCl 15 to 50 mL/min: 30 mg orally once a day

CrCl less than 15 mL/min: Not recommended

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended

Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended

Dose Adjustments

Patients who weigh 60 kg or less:

-Treatment of deep venous thrombosis or pulmonary embolism: 30 mg orally once a day

Patients taking certain concomitant P-gp inhibitors (verapamil and quinidine or short-term azithromycin, clarithromycin, erythromycin, oral itraconazole, or oral ketoconazole):

-Treatment of deep venous thrombosis or pulmonary embolism: 30 mg orally once a day

SWITCHING FROM ANOTHER ANTICOAGULANT TO EDOXABAN:

Switching from vitamin K antagonist (VKA) therapy to edoxaban: Discontinue VKA and start edoxaban when the INR is 2.5 or less

Switching from an oral anticoagulant other than VKA therapy to edoxaban: Discontinue current therapy and start edoxaban at the time of the next scheduled dose of the discontinued anticoagulant

Switching from low molecular weight heparin (LMWH) to edoxaban: Discontinue LMWH and start edoxaban at the time of the next scheduled LMWH dose

Switching from unfractionated heparin to edoxaban: Discontinue the infusion and start edoxaban 4 hours later

SWITCHING FROM EDOXABAN TO ANOTHER ANTICOAGULANT:

Switching from edoxaban to VKA therapy (oral option):

-For patients taking 60 mg of edoxaban, reduce the dose to 30 mg and begin concomitant VKA therapy

-For patients taking 30 mg of edoxaban, reduce the dose to 15 mg and begin concomitant VKA therapy

-Measure INR at least weekly and just prior to the daily dose of edoxaban

-Once INR is stable and measured at 2 or above, discontinue edoxaban and continue VKA therapy

Switching from edoxaban to VKA therapy (parenteral option):

-Discontinue edoxaban and administer a parenteral anticoagulant and VKA therapy at the time of the next scheduled edoxaban dose

-Once INR is stable and measured at 2 or above, discontinue the parenteral anticoagulant and continue VKA therapy

Switching from edoxaban to an oral anticoagulant other than VKA therapy: Discontinue edoxaban and start the other oral anticoagulant at the time of the next scheduled edoxaban dose

Switching from edoxaban to parenteral anticoagulant therapy: Discontinue edoxaban and start the parenteral anticoagulant at the time of the next scheduled edoxaban dose

DISCONTINUATION FOR SURGERY AND OTHER INTERVENTIONS:

-If clinically possible, therapy should be stopped at least 24 hours prior to the procedure and restarted after the procedure as soon as hemostasis has been established.

-If a decision needs to be made whether to delay a procedure until 24 hours after the last dose of this drug, the increased risk of bleeding should be weighed against the urgency of the intervention.

SPINAL OR EPIDURAL ANESTHESIA OR PUNCTURE:

-An epidural catheter must not be removed earlier than 12 hours after the last dose of this drug. The next dose should be administered at least 2 hours after the catheter is removed.

Other Comments

Administration advice:

-May take with or without food.

-If a dose is missed, take the missed dose immediately and continue on the following day as per the regular schedule. The dose should not be doubled within the same day.

-For patients who cannot swallow tablets whole or those who require a gastric tube, this drug may be crushed and combined with 2 to 3 ounces of water and administered immediately thereafter.

General:

-There is no specific agent to reverse the anticoagulant effect of this drug.

-This drug can contribute to an elevated INR; INR measurements made during coadministration with a vitamin K antagonist (VKA) may not be useful for determining the appropriate dose of the VKA.

Monitoring:

-Hematologic: Signs or symptoms of bleeding complications (bruises, bloody noses, bleeding gums, blood in stool or urine).

-Neurologic: Signs or symptoms suggestive of epidural or spinal hematoma (back pain, tingling, numbness, muscle weakness, stool or urine incontinence) in patients undergoing neuraxial anesthesia or spinal puncture.

-Renal: Renal function.

Patient advice:

-Inform the patient that they may bleed and bruise more easily and to notify their healthcare provider immediately of any unusual bleeding.

-Advise the patient to inform their healthcare providers that they are taking this drug prior to any surgery, medical, or dental procedure.

-Advise patient to inform their healthcare provider of any prescription or over-the-counter medications that they are taking or plan to take.

What is the dose of Edoxaban for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Edoxaban available?

Edoxaban is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Edoxaban, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 16, 2018 | Last Modified: August 16, 2018

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