Savaysa

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other anti-clotting drugs or platelet aggregattion inhibitors such as warfarin (Coumadin, Jantoven) or clopidogrel (Plavix), ticlopidine (Ticlid), or cilostazol (Pletal)
• aspirin or other non-steroidal antiinflammatory drugs (NSAIDs)such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• rifampin

This is not a complete list of Savaysa drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Savaysa falls into category C.There are no well-controlled studies that have been done in pregnant women. Savaysa should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

If you take too much Savaysa, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Savaysa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Edoxaban is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Edoxaban is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

Edoxaban is also used to treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can sometimes occur after a person has been treated with an injectable blood thinner for 5 to 10 days.

Edoxaban may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take edoxaban with or without food.

Edoxaban increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

Tell any doctor who treats you that you are using edoxaban. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking edoxaban. If you need anesthesia for a medical procedure or surgery, you may need to stop using edoxaban for a short time.

Do not change your dose or stop taking edoxaban without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Use edoxaban regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

In the U.S.

• Savaysa

Available Dosage Forms:

• Tablet

Therapeutic Class: Anticoagulant

Pharmacologic Class: Factor Xa Inhibitor

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• 60 mg, yellow round shaped, film-coated tablets, debossed with DSC L60 on one side
• 30 mg, pink round shaped, film-coated tablets, debossed with DSC L30 on one side
• 15 mg, orange round shaped, film-coated tablets, debossed with DSC L15 on one side

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Advise patients of the following:

• they may bleed more easily, may bleed longer, or bruise more easily when treated with Savaysa
• to report any unusual bleeding immediately to their healthcare provider
• to take Savaysa exactly as prescribed
• to not discontinue Savaysa without talking to the healthcare provider who prescribed it
• to inform their healthcare providers that they are taking Savaysa before any surgery, medical, or dental procedure is scheduled
• to inform their healthcare providers and dentists if they plan to take, or are taking any prescription medications, over-the-counter drugs or herbal products
• to inform their healthcare provider immediately if they become pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed during treatment with Savaysa
• that if a dose is missed, take Savaysa as soon as possible the same day, and resume the normal dosing schedule the following day. The dose should not be doubled to make up for a missing dose
• that if they are having neuraxial anesthesia or spinal puncture, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence. If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning].

Savaysa™ is a trademark of Daiichi Sankyo Co., LTD.

Manufactured by:

Daiichi Sankyo Co., LTD.

Tokyo 103-8426

Japan

Distributed by:

Daiichi Sankyo, Inc.

Parsippany, NJ 07054 USA

Copyright© 2015, Daiichi Sankyo, Inc.

PRINTED IN USA.

MEDICATION GUIDE

Savaysa (sa vaye' sah)

(edoxaban) TABLETS

What is the most important information I should know about Savaysa?

For people who take Savaysa for nonvalvular atrial fibrillation (a type of irregular heartbeat):

People with atrial fibrillation are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Savaysa lowers your chance of having a stroke by helping to prevent clots from forming.

• Your doctor should check your kidney function before you start taking Savaysa. People whose kidneys work really well should not receive Savaysa because it may not work well to prevent stroke.
• Do not stop taking Savaysa without first talking to the doctor who prescribed it for you. Stopping Savaysa increases your risk of having a stroke.

For all people who take Savaysa:

• Savaysa can cause bleeding which can be serious, and sometimes lead to death. This is because Savaysa is a blood thinner medicine that reduces blood clotting. While taking Savaysa you may bruise more easily and bleeding may take longer to stop. You should call your doctor or get medical help right away if you experience bleeding that is severe (for example, coughing up or vomiting blood) or bleeding that cannot be controlled.
  You may have a higher risk of bleeding if you take Savaysa and take other medicines that increase your risk of bleeding, including:
  
  • aspirin or aspirin containing products
  • long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • long-term (chronic) use of blood thinner medicines, such as:
  • warfarin sodium (Coumadin®, Jantoven®)
  • any medicine that contains heparin
  • selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
  • other medicines to prevent or treat blood clots

  Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

• Savaysa is not for people with mechanical heart valves or people who have moderate to severe narrowing (stenosis) of their mitral valve.
• Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like Savaysa, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
  • a thin tube called an epidural catheter is placed in your back to give you certain medicine.
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

  If you take Savaysa and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness (especially in your legs and feet), muscle weakness, loss of control of the bowels or bladder (incontinence).

See “What are the possible side effects of Savaysa?” for more information about side effects.

What is Savaysa?

Savaysa is a prescription medicine used to:

• reduce the risk of stroke and blood clots in people who have atrial fibrillation not caused by a heart valve problem.
• 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.

It is not known if Savaysa is safe and effective in children.

Who should not take Savaysa?

Do not take Savaysa if you currently have certain types of abnormal bleeding.

What should I tell my doctor before taking Savaysa?

Before you take Savaysa, tell your doctor if you:

• have liver or kidney problems
• have ever had bleeding problems
• have a mechanical heart valve
• are pregnant or plan to become pregnant. It is not known if Savaysa will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with Savaysa.
• are breastfeeding or plan to breastfeed. It is not known if Savaysa passes into your breast milk. You and your doctor should decide if you will take Savaysa or breastfeed. You should not do both.

Tell all of your doctors and dentists that you are taking Savaysa. They should talk to the doctor who prescribed Savaysa for you, before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way Savaysa works. Certain medicines may increase your risk of bleeding or stroke when taken with Savaysa. See “What is the most important information I should know about Savaysa?”

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Savaysa?

• 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 atrial fibrillation, stopping Savaysa may increase your risk of having a stroke.
• You can take Savaysa with or without food.
• 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 possible side effects of Savaysa?

Savaysa can cause serious side effects. See “What is the most important information I should know about Savaysa?”

Common side effects in people who take Savaysa include, bleeding and low red blood cell count (anemia).

Talk to your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Savaysa?

• 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.

General information about the safe and effective use of Savaysa

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Savaysa for a condition for which it was not prescribed. Do not give Savaysa to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Savaysa that is written for health professionals.

For more information, call 1-877-437-7763 or go to www.Savaysa.com.

What are the ingredients in Savaysa?

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 (15 mg tablets and 60 mg tablets), and iron oxide red (15 mg tablets and 30 mg tablets).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Daiichi Sankyo Co., LTD.

Tokyo 103-8426

Japan

Distributed by:

Daiichi Sankyo, Inc.

Parsippany, NJ 07054 USA

Copyright© 2015, Daiichi Sankyo, Inc.

The brands listed above are trademarks of their respective owners.

PRINCIPAL DISPLAY PANEL - NDC 65597-201-30 - 15 mg 30 Count Label

PRINCIPAL DISPLAY PANEL - NDC 65597-202-90 - 30 mg 90 Count Carton Label

PRINCIPAL DISPLAY PANEL - NDC 65597-202-10 - 30 mg Carton Label

PRINCIPAL DISPLAY PANEL - NDC 65597-203-30 - 60 mg 500 Count Carton Label

PRINCIPAL DISPLAY PANEL - NDC 65597-203-05 - 60 mg Carton Label

You should not use Savaysa if you have an artificial heart valve, or if you have active or uncontrolled bleeding. You may not be able to use Savaysa if you have normal kidney function (your doctor will check your kidneys before you start taking this medicine).

Savaysa can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Do not stop taking Savaysa without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Usual Adult Dose of Savaysa 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 of Savaysa 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