Edoxaban

💊 What is Edoxaban used for?

• •To reduce the risk of stroke and systemic embolism (blood clots that travel to other parts of the body) in people with nonvalvular atrial fibrillation (AFib), a type of irregular heartbeat not caused by a heart valve problem.
• •To treat deep vein thrombosis (DVT, a blood clot in the veins of the legs) and pulmonary embolism (PE, a clot in the lungs), after 5 to 10 days of initial treatment with an injectable blood thinner.
• •The label says it is not known if it is safe and effective in children with DVT or PE.

How it works

The label describes edoxaban as a factor Xa inhibitor. The Medication Guide says it is a blood thinner that reduces blood clotting and helps prevent clots from forming.

How it is usually taken

• •The label says it is taken by mouth once daily. It is taken exactly as prescribed, and the prescriber decides how long it is taken. The label says it can be taken with or without food. The label says not to change the dose on your own. Follow the instructions from your prescriber or pharmacist.

Comes as

• •60 mg yellow, round, film-coated tablets (marked DSC L60)
• •30 mg pink, round, film-coated tablets (marked DSC L30)
• •15 mg orange, round, film-coated tablets (marked DSC L15)

⚠️ Edoxaban side effects

🛑 Who should not take Edoxaban, and who should be careful

The label says not to take it if

• 🚨You currently have active pathological (abnormal) bleeding. The label says this is a contraindication.
• 🚨For atrial fibrillation: your creatinine clearance (CrCL) is above 95 mL/min. The label says Savaysa should not be used in this case.
• 🚨You have a mechanical heart valve. The label says use is not recommended.
• 🚨You have moderate to severe narrowing of the mitral valve (mitral stenosis). The label says use is not recommended.
• 🚨You have triple-positive antiphospholipid syndrome. The label says use is not recommended.

Tell your doctor before taking it if

• •Your healthcare provider should check your kidney function before you start taking Savaysa.
• •Tell your provider about all medical conditions, including liver or kidney problems, past bleeding problems, mechanical heart valves, antiphospholipid syndrome, and stomach or intestinal cancer.
• •Tell your provider if you are pregnant, plan to become pregnant, or are breastfeeding.
• •Tell all healthcare providers and dentists that you take Savaysa before any surgery, medical, or dental procedure.
• •Tell your provider about all medicines you take, including over-the-counter medicines, vitamins, and herbal supplements. Keep a list to show your provider and pharmacist.

🔀 Edoxaban with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •Aspirin, other antiplatelet medicines, and other blood thinners: these may increase bleeding risk. The label says long-term use of other anticoagulants is not recommended.
• •Long-term (chronic) use of NSAIDs (such as ibuprofen or naproxen): may increase bleeding risk. The label says to carefully monitor patients who need long-term low-dose aspirin or NSAIDs.
• •Heparin: may increase bleeding risk.
• •SSRIs and SNRIs (certain antidepressants): may increase bleeding risk.
• •Rifampin: the label says to avoid using it with Savaysa.
• •P-gp inhibitors: for atrial fibrillation, the label says no dose reduction is recommended with these medicines. For DVT and PE, the label says a lower dose may be used with certain P-gp inhibitors.

Alcohol and food

The label says Savaysa can be taken without regard to food. The label text provided does not mention alcohol.

🤰 Edoxaban in pregnancy and breastfeeding

Pregnancy

The label says it is not known if Savaysa will harm an unborn baby. Animal studies did not show adverse developmental effects, but human data are insufficient. The label says anticoagulants may increase bleeding risk in the fetus and newborn, so newborns should be monitored for bleeding. Pregnancy also raises clot risk. Talk with your healthcare provider about pregnancy planning and about your risk of severe uterine bleeding while on blood thinners.

Breastfeeding

The label says it is not known if Savaysa passes into breast milk. It says not to breastfeed during treatment with Savaysa.

🗓️ Storage, missed doses and taking too much

Storage

Store at 20 to 25°C (68 to 77°F). Short excursions to 15 to 30°C (59 to 86°F) are permitted. Keep out of the reach of children.

If a dose is missed

The label says to take a missed dose as soon as possible on the same day. Dosing should then resume the next day on the normal schedule. The label says not to double the dose to make up for a missed dose.

If too much is taken

The label says there is no specific reversal agent for edoxaban. An overdose increases the risk of bleeding. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse its effects. Hemodialysis does not significantly remove edoxaban. Get medical help right away if you think you have taken too much.

🗒️ Questions to ask about Edoxaban

• Do I need a kidney function test before starting, and how often will it be checked?
• What bleeding signs should I watch for, and when should I call you?
• What should I do if I need surgery, a dental procedure, or a spinal injection or puncture?
• Which of my current medicines, including aspirin, ibuprofen, or antidepressants, can I keep taking?
• How long will I need to take this medicine, and what should I do if I want to stop?
• What should I do if I become pregnant or am planning a pregnancy while on this medicine?

❓ Edoxaban: frequently asked questions