IMPORTANT SAFETY INFORMATION

WHAT IS XARELTO®?

XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.

XARELTO® is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months.

XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

  • For people taking XARELTO® for atrial fibrillation: 

    People with atrial fibrillation (an irregular heart beat) 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. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood. 

    Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.

    If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

  • XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop.


    You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

    • Aspirin or aspirin-containing products
    • Non-steroidal anti-inflammatory drugs (NSAIDs)
    • Warfarin sodium (Coumadin®, Jantoven®)
    • Any medicine that contains heparin
    • Clopidogrel (Plavix®)
    • 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. ​

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

  • Unexpected bleeding or bleeding that lasts a long time, such as:

    • Nosebleeds that happen often
    • Unusual bleeding from gums
    • Menstrual bleeding that is heavier than normal, or vaginal bleeding
  • Bleeding that is severe or you cannot control
  • Red, pink, or brown urine
  • Bright red or black stools (looks like tar)
  • Cough up blood or blood clots
  • Vomit blood or your vomit looks like “coffee grounds”
  • Headaches, feeling dizzy or weak
  • Pain, swelling, or new drainage at wound sites
  • Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine like XARELTO®, 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 XARELTO® 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, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).

  • XARELTO® is not for people with artificial heart valves.

​​Do not take XARELTO® if you:

  • Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
  • Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.

    • Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
    • If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.
  • Are breastfeeding or plan to breastfeed.  XARELTO® may pass into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® 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 XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

HOW SHOULD I TAKE XARELTO®?

  • Take XARELTO® exactly as prescribed by your doctor.
  • Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
  • Your doctor may change your dose if needed.
  • If you take XARELTO® for:​

    •   Atrial Fibrillation:

      • Take XARELTO® 1 time a day with your evening meal.
      • If you miss a dose of XARELTO®, take it as soon as you remember on the same day.  Take your next dose at your regularly scheduled time.
    • Blood clots in the veins of your legs or lungs:

      • Take XARELTO®  1 or 2 times a day as prescribed by your doctor.
      • For the 15-mg and 20-mg doses, XARELTO®  should be taken with food.
      • For the 10-mg dose, XARELTO® may be taken with or without food.
      • Take your XARELTO® dose(s) at the same time each day.
      • If you miss a dose:

        • If you take the 15-mg dose of XARELTO® 2 times a day (a total of 30 mg of XARELTO® in 1 day)Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
        • If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.​
    • Hip or knee replacement surgery:

      • Take XARELTO® 1 time a day with or without food.
      • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • If you have difficulty swallowing the XARELTO® tablet whole, talk to your doctor about other ways to take XARELTO®.
  • Your doctor will decide how long you should take XARELTO®.
  • Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
  • Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
  • If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

 

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

  • See “What is the most important information I should know about XARELTO®?”

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please see  Prescribing Information, including Boxed Warnings, and Medication Guide.

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