Edoxaban tablets

What is this medication?

EDOXABAN is an anticoagulant (blood thinner). It is used to lower the chance of stroke in people with a medical condition called atrial fibrillation. It is also used to treat or prevent blood clots in the lungs or in the veins.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Savaysa

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• antiphospholipid antibody syndrome
• artificial heart valve
• bleeding disorders
• bleeding in the brain
• blood in your stools (black or tarry stools) or if you have blood in your vomit
• cancer in the stomach or intestines
• history of blood clots
• history of stomach bleeding
• mechanical heart valve
• kidney disease
• liver disease
• recent injury, recent or planned surgery or procedure
• recent or planned spinal or epidural procedure
• take medicines that treat or prevent blood clots
• an allergic reaction to edoxaban, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Stopping this medicine may increase your risk of a blot clot. Be sure to refill your prescription before you run out of medicine.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• defibrotide

This medicine may also interact with the following medications:

• amiodarone
• aspirin and aspirin-like medicines
• certain antibiotics like azithromycin, clarithromycin, and erythromycin
• certain medicines for fungal infections like ketoconazole and itraconazole
• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• cyclosporine
• dronedarone
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• quinidine
• rifampin
• SSRIs, medicines for depression, like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
• SNRIs, medicines for depression, like desvenlafaxine, duloxetine, levomilnacipran, venlafaxine
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your healthcare professional for regular checks on your progress. You may need blood work done while you are taking this medicine. Your condition will be monitored carefully while you are receiving this medicine. It is important not to miss any appointments.

Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your healthcare professional.

If you are going to need surgery or other procedure, tell your healthcare professional that you are taking this medicine.

Wear a medical ID bracelet or chain. Carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose
• signs and symptoms of a blood clot such as chest pain; shortness of breath; pain, swelling, or warmth in the leg
• signs and symptoms of a stroke such as changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of coordination

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.