Edoxaban

What is Edoxaban?

• Edoxaban (Savaysa) is a factor Xa inhibitor used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

What are the uses of this medicine?

• This medicine is used to reduce the risk of stroke and blood clots in people who have atrial fibrillation not caused by a heart valve problem.
• To treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), after you have been treated with an injectable blood thinner medicine for 5 to 10 days.

Limitation of Use for NVAFː

• Savaysa should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg).
• Savaysa is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

How does this medicine work?

• Edoxaban (e dox' a ban) is a selective inhibitor of the coagulation factor Xa, the last and rate controlling step in the generation of thrombin, the final intermediate in blood coagulation.
• Inhibiting thrombin prevents the conversion of fibrinogen to fibrin and subsequent cross linking of fibrin monomers, platelet activation and amplification of coagulation activation.
• Edoxaban has been shown to be as effective as warfarin in preventing stroke and systemic embolization in patients with atrial fibrillation. Clinical trials have also shown that edoxaban can decrease the risk of complications of deep vein thrombosis and pulmonary embolism.

Who Should Not Use this medicine ?

This medicine caanot be used in patients who:

• currently have certain types of abnormal bleeding.

What drug interactions can this medicine cause?

• Co-administration of anticoagulants, antiplatelet drugs, thrombolytics and SSRIs or SNRIs may increase the risk of bleeding.
• Avoid the concomitant use of Savaysa with rifampin.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: Nonvalvular Atrial Fibrillationː

• Assess creatinine clearance, as calculated using the Cockcroft-Gault equation*, before initiating therapy with Savaysa. Do not use Savaysa in patients with CrCL > 95 mL/min.
• The recommended dose of Savaysa is 60 mg taken orally once daily.
• Reduce Savaysa dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min.

Treatment of Deep Vein Thrombosis and Pulmonary Embolismː

• The recommended dose of Savaysa is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant.
• Reduce Savaysa dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications.

Administration

• Take Savaysa exactly as prescribed by your doctor.
• Your doctor will decide how long you should take Savaysa. Do not change your dose or stop taking Savaysa unless your doctor tells you to. If you are taking Savaysa for nonvalvular atrial fibrillation, stopping Savaysa may increase your risk of having a stroke.
• Take Savaysa with or without food.
• If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Savaysa.
• If you miss a dose of Savaysa, take it as soon as you remember on the same day. Take your next dose at your usual time the next day. Do not take more than one dose of Savaysa at the same time to make up for a missed dose.
• Do not run out of Savaysa. Refill your prescription before you run out. If you take too much Savaysa, go to the nearest hospital emergency room or call your doctor right away.
• Call your doctor right away if you fall or injure yourself, especially if you hit your head. Your doctor may need to check you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 60 mg, 30 mg, and 15 mg

This medicine is available in fallowing brand namesː

• Savaysa

What side effects can this medication cause?

The most common side effects in people who take Savaysa for nonvalvular atrial fibrillation include:

• bleeding
• low red blood cell count (anemia)

The most common side effects in people who take Savaysa for deep vein thrombosis and pulmonary embolism include:

• bleeding
• rash
• abnormal liver function tests
• low red blood cell count (anemia)

Savaysa can cause serious side effects:

• bleeding
• Spinal or epidural blood clots (hematoma)

What special precautions should I follow?

• Savaysa increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss.
• The safety and efficacy of Savaysa has not been studied in patients with mechanical heart valves or moderate to severe mitral stenosis. The use of Savaysa is not recommended in these patients.
• Direct-acting oral anticoagulants (DOACs), including Savaysa, are not recommended for use in patients with triple positive antiphospholipid syndrome (APS).
• Savaysa should not be used in patients with CrCL > 95 mL/min.
• Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events.

What to do in case of emergency/overdose?

• Overdose of Savaysa increases the risk of bleeding.

Management for overdosage:

• A specific reversal agent for edoxaban is not available.
• The following are not expected to reverse the anticoagulant effects of edoxaban: protamine sulfate, vitamin K, and tranexamic acid.
• Hemodialysis does not significantly contribute to edoxaban clearance.

Can this medicine be used in pregnancy?

• Available data about Savaysa use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: edoxaban tosylate monohydrate
• Inactive ingredients: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).

Who manufactures and distributes this medicine?

• Manufactured by: Daiichi Sankyo Co., LTD., Tokyo 103-8426, Japan
• Distributed by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920-2311 USA

The brands listed above are trademarks of their respective owners. Copyright© 2020, Daiichi Sankyo, Inc.

What should I know about storage and disposal of this medication?

• Store Savaysa at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Savaysa and all medicines out of the reach of children.

• Dailymed label info on Edoxaban
• FDA Edoxaban