Brand Name(s):

    
  • Xarelto®
  • IMPORTANT WARNING

    If you have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) and are taking rivaroxaban to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking rivaroxaban without talking to your doctor. Continue to take rivaroxaban even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of rivaroxaban. If you need to stop taking rivaroxaban, your doctor may prescribe another anticoagulant (''blood thinner'') to help prevent a blood clot from forming and causing you to have a stroke.

    If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as rivaroxaban, you are at risk of having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body or have or have ever had repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking anagrelide (Agrylin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); heparin; prasugrel (Effient); ticagrelor (Brilinta); ticlopidine; tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness, numbness or tingling (especially in your legs), loss of control of your bowels or bladder, or inability to move your legs.

    Talk to your doctor about the risk of taking rivaroxaban.

    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rivaroxaban and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

    WHY is this medicine prescribed?

    Rivaroxaban is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung). Rivaroxaban may be continued to prevent DVT and/or PE from happening again after initial treatment is completed. It is also used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Rivaroxaban may reduce the risk of DVT, which can lead to PE in people who are having hip replacement or knee replacement surgery. It is in a class of medications called factor Xa inhibitors. Rivaroxaban works by decreasing the clotting ability of the blood.

    HOW should this medicine be used?

    Rivaroxaban comes as a tablet to take by mouth. For the treatment of a DVT and PE, rivaroxaban is usually taken with food twice daily for 21 days, then once daily. When rivaroxaban is taken to prevent DVT and PE, it is usually taken once daily with food. When rivaroxaban is used to prevent a stroke in those with an irregular heartbeat, it is usually taken once daily with the evening meal. When rivaroxaban is taken to prevent DVT and PE after hip or knee replacement surgery it is usually taken with or without food once daily. The first dose should be taken at least 6 to 10 hours after surgery. Rivaroxaban is usually taken for 35 days after a hip replacement surgery and for 12 days after knee replacement surgery. Take rivaroxaban at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rivaroxaban exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

    If you are unable to swallow the tablets, you can crush them and mix with applesauce. Swallow the mixture right after you prepare it. Rivaroxaban can also be given in certain types of feeding tubes. Ask your doctor if you should take this medication in your feeding tube. Follow your doctor's directions carefully.

    Continue to take rivaroxaban even if you feel well. Do not stop taking rivaroxaban without talking to your doctor. If you stop taking rivaroxaban, your risk of a blood clot may increase.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking rivaroxaban,

        
  • tell your doctor and pharmacist if you are allergic to rivaroxaban, any other medications, or any of the ingredients in rivaroxaban tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone), azithromycin (Zithromax), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, Teril), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cardizem, Dilacor, Tiazac), dronedarone (Multaq), erythromycin (E.E.S., E-Mycin, Erythrocin), felodipine (Plendil), fluconazole (Diflucan), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), lopinavir (in Kaletra), phenobarbital (Solfoton), phenytoin (Dilantin, Phenytek), quinidine, ranolazine (Ranexa), rifampin (Rifadin, in Rifamate, in Rifater, Rimactane), ritonavir (Norvir, in Kaletra), and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you have heavy bleeding anywhere in your body that cannot be stopped. Your doctor will probably tell you not to take rivaroxaban.
  • tell your doctor if you have had a valve in your heart replaced or have or have ever had problems with unusual bleeding, a bleeding disorder, or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking rivaroxaban, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rivaroxaban.
  • What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    If you take rivaroxaban once a day, take the missed dose as soon as you remember it on that day. Resume your regular dosing schedule the next day.

    If you take rivaroxaban twice a day, take the missed dose as soon as you remember it on that day. You may take 2 doses at the same time to make up for the missed dose. Resume your regular dosing schedule on the next day

    What SIDE EFFECTS can this medicine cause?

    Rivaroxaban may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

        
  • muscle spasm
  • Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

        
  • bloody, black, or tarry stools
  • pink, or brown urine
  • coughing up or vomiting blood or material that looks like coffee grounds
  • frequent nosebleeds
  • bleeding from your gums
  • heavy menstrual bleeding
  • weakness
  • tiredness
  • headache
  • dizziness or fainting
  • blurred vision
  • pain in arm or leg
  • rash
  • itching
  • difficulty breathing or swallowing
  • hives
  • pain or swelling at wound sites
  • Rivaroxaban prevents blood from clotting normally so it may take longer than usual for you to stop bleeding if you are cut or injured. This medication may also cause you to bruise or bleed more easily. Call your doctor right away if bleeding or bruising is unusual.

    Rivaroxaban may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include the following:

        
  • unusual bleeding or bruising
  • bloody, black, or tarry stools
  • blood in urine
  • coughing up or vomiting blood or material that looks like coffee grounds
  • What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to rivaroxaban.

    Do not let anyone else take your medication. Your prescription is probably not refillable.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: July 15, 2014.