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SAVAYSA- edoxaban tosylate tablet, film coated


  1. Advise Patients Of The Following:
  2. For People Who Take Savaysa For Nonvalvular Atrial Fibrillation (a Type Of Irregular Heartbeat):
  3. Who Should Not Take Savaysa?
  4. Before Taking Savaysa, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Manufactured By:
  8. Distributed By:
  9. Patient Information

Advise Patients Of The Following: ⮝

Instructions for Patient Use

  • Advise patients to take SAVAYSA exactly as prescribed,
  • Remind patients to not discontinue SAVAYSA without talking to the healthcare provider who prescribed it.
  • Instruct patients to keep an adequate supply of tablets to ensure continuous dosing of SAVAYSA.
  • Instruct patients who cannot swallow the tablet whole to crush SAVAYSA, combine with 2 to 3 ounces of water or applesauce and ingest immediately.
  • Instruct patients who require a gastric tube to crush the SAVAYSA tablet and mix it with 2 to 3 ounces of water before administering immediately via the gastric feeding tube.
  • Inform patients that if a dose is missed, they should 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,

Bleeding Risk

  • Advise patients that they may bleed more easily, may bleed longer, or bruise more easily when treated with SAVAYSA.
  • Instruct patients to report any unusual bleeding immediately to their healthcare provider.
  • For patients that 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[

For People Who Take Savaysa For Nonvalvular Atrial Fibrillation (a Type Of Irregular Heartbeat): ⮝


People with nonvalvular 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 reduces your risk 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.
  • SAVAYSA can cause bleedingwhich can be serious, and sometimes lead to death. This is because SAVAYSA is a blood thinner medicine that reduces blood clotting. During treatment with SAVAYSA, you may bleed more easily, bleed longer, or bruise more easily. 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.
  • 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).
  • SAVAYSA is not for people with mechanical heart valves or people who have moderate to severe narrowing (stenosis) of their mitral valve.

    • 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 youcurrently have certain types of abnormal bleeding.

    Before Taking Savaysa, Tell Your Doctor About All Of Your Medical Conditions, Including If You: ⮝

    • have liver or kidney problems
    • have ever had bleeding problems
    • have a mechanical heart valve
    • have cancer of the stomach or intestine (gastrointestinal cancer)
    • 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. Do not breastfeed during treatment with SAVAYSA.
    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 haveanysurgery, medical or dental procedure.
    Tell your doctor about all the medicines you take, includingprescription 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.
    • 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 possible side effects of SAVAYSA?
    SAVAYSA can cause serious side effects.
    • 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. You can ask your pharmacist or doctor for information about SAVAYSA that is written for health professionals.

    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).

    Manufactured By: ⮝

    Daiichi Sankyo Co., LTD., Tokyo 103-8426, Japan

    Distributed By: ⮝

    Daiichi Sankyo, Inc., Basking Ridge, NJ 07920-2311 USA
    Copyright 2019, Daiichi Sankyo, Inc.
    The brands listed above are trademarks of their respective owners.
    USMG-SAV-C7-0819-r100
    For more information, call 1-877-437-7763 or go to www.savaysa.com.

    Patient Information ⮝

    *
    Sections or subsections omitted from the full prescribing information are not listed.

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