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Rivaroxaban

Pronunciation

Generic Name: rivaroxaban (RIV-a-ROX-a-ban)
Brand Name: Xarelto

Do not stop taking rivaroxaban without checking with your doctor. This may increase the risk of developing a blood clot, including stroke in certain patients. If you need to stop taking rivaroxaban, follow your doctor's directions carefully.

Tell your doctor you use rivaroxaban before you have any type of spinal or epidural procedure. Patients who have these procedures while they use rivaroxaban are at risk of serious bleeding problems on or near the spine. This could result in long-term or permanent paralysis.

The risk is increased in patients who have a certain type of epidural catheter. It is also increased in patients with a history of traumatic or repeated epidural or spinal puncture, a deformed spine, or spinal surgery. It is also increased in patients who use medicines that may affect blood clotting, such as other anticoagulants (eg, warfarin), aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen).

If you have a spinal or epidural procedure while you use rivaroxaban, tell your doctor at once if you notice any symptoms of nerve problems (eg, back pain, numbness [especially in the legs and feet], tingling, muscle weakness, paralysis, loss of bowel or bladder control).

Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of rivaroxaban and your procedure. Discuss any questions or concerns with your doctor.


Rivaroxaban is used for:

Preventing and treating blood clots in certain patients. It is also used to reduce the risk of stroke and serious blood clots in certain patients with atrial fibrillation.

Rivaroxaban is also used to treat and prevent deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).

Rivaroxaban is a direct factor Xa inhibitor. It works by blocking the formation of blood clots.

Do NOT use rivaroxaban if:

  • you are allergic to any ingredient in rivaroxaban
  • you have certain types of abnormal bleeding (eg, active major bleeding)
  • you have an artificial heart valve, severe kidney problems, moderate to severe liver problems, or bleeding problems caused by liver disease
  • you are taking abciximab, alteplase, other anticoagulants (eg, enoxaparin, heparin, warfarin), bivalirudin, boceprevir, carbamazepine, cobicistat, conivaptan, dabigatran, desirudin, enzalutamide, eptifibatide, hydantoins (eg, phenytoin), indinavir, itraconazole, ketoconazole, lopinavir, nelfinavir, phenobarbital, posaconazole, rifamycins (eg, rifampin), ritonavir, saquinavir, St. John's wort, telaprevir, tirofiban, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using rivaroxaban:

Some medical conditions may interact with rivaroxaban. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of bleeding or clotting problems, high blood pressure, blood vessel problems (especially in the eyes, brain, or spinal column), anemia or other blood problems, low blood platelet levels or other platelet problems, or kidney or liver problems
  • if you have a history of a stroke, especially if it occurred within the last 6 months
  • if you have an active or recent stomach or bowel ulcer, or certain rare hereditary problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
  • if you are at increased risk of bleeding
  • if you have recently had or are scheduled to have certain procedures (eg, surgery, including brain, spine, or eye surgery; dental procedures; a spinal or epidural procedure)
  • if you have kidney problems and are taking amiodarone, azithromycin, chloramphenicol, cimetidine, diltiazem, dronedarone, erythromycin, felodipine, quinidine, ranolazine, or verapamil

Some MEDICINES MAY INTERACT with rivaroxaban. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Abciximab, alteplase , other anticoagulants (eg, enoxaparin, heparin, warfarin), aspirin, bivalirudin, dabigatran, desirudin, eptifibatide, NSAIDs (eg, ibuprofen, ketorolac), platelet inhibitors (eg, clopidogrel, prasugrel, ticlopidine), or tirofiban because the risk of bleeding may be increased
  • Boceprevir, clarithromycin, cobicistat, conivaptan, erythromycin, fluconazole, indinavir, itraconazole, ketoconazole, lopinavir, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, or voriconazole because they may increase the risk of rivaroxaban's side effects, such as bleeding
  • Carbamazepine, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, rifamycins (eg, rifampin), or St. John's wort because they may decrease rivaroxaban's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if rivaroxaban may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use rivaroxaban:

Use rivaroxaban as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rivaroxaban comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get rivaroxaban refilled.
  • Take rivaroxaban by mouth with or without food, as directed by your doctor.
  • Taking rivaroxaban at the same time each day will help you remember to take it.
  • Be sure to take rivaroxaban for the full course of treatment. If you do not, you may be at increased risk of developing blood clots. Keep taking it even if you feel well.
  • If you miss a dose of rivaroxaban, take it as soon as possible on the same day you missed the dose then go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use rivaroxaban.

Important safety information:

  • Do not change your dose or stop taking rivaroxaban without checking with your doctor. Stopping rivaroxaban may increase the risk of developing a blood clot, including stroke in patients with atrial fibrillation. If you need to stop taking rivaroxaban, follow your doctor's directions carefully.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can.
  • Tell your doctor or dentist that you take rivaroxaban before you receive any medical or dental care, emergency care, or surgery. Rivaroxaban may need to be stopped before certain types of surgery, as directed by your doctor. If rivaroxaban is stopped, your doctor will tell you when to start taking rivaroxaban again after your surgery or procedure.
  • If you have any type of spinal or epidural procedure while you are taking rivaroxaban, you may be at risk of serious bleeding problems on or near the spine, especially if you are also taking aspirin, NSAIDs (eg, ibuprofen), or platelet inhibitors (eg, clopidogrel). This could result in long-term or permanent paralysis. Tell your doctor at once if you notice any symptoms of nerve problems (eg, numbness [especially in the legs and feet], tingling, muscle weakness, paralysis).
  • Lab tests, including kidney function, hemoglobin, hematocrit, and blood pressure, may be performed while you use rivaroxaban. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use rivaroxaban with caution in the ELDERLY; they may be more sensitive to its effects.
  • Rivaroxaban should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if rivaroxaban can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using rivaroxaban while you are pregnant. It is not known if rivaroxaban is found in breast milk. Do not breast-feed while taking rivaroxaban.

Possible side effects of rivaroxaban:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild bleeding.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or black, tarry stools; change in the amount of urine produced; coughing up blood; dark urine; fever, chills, or persistent sore throat; pain, swelling, or new drainage at wound sites; pink or red urine; red, swollen, blistered, or peeling skin; stiff, sore, hot, or painful joints; symptoms of anemia (eg, unusual paleness, severe or persistent headache, shortness of breath, fast heartbeat, chest pain, unusual tiredness or weakness); symptoms of bleeding in the brain (eg, sudden, severe headache; one-sided weakness; vision problems; slurred speech; confusion); symptoms of low blood pressure (eg, fainting, dizziness or light-headedness); unexplained swelling; unusual or prolonged bruising or bleeding (eg, abnormal menstrual periods, frequent nosebleeds, unusual bleeding from the gums, vaginal bleeding); vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual bruising or bleeding.

Proper storage of rivaroxaban:

Store rivaroxaban at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep rivaroxaban out of the reach of children and away from pets.

General information:

  • If you have any questions about rivaroxaban, please talk with your doctor, pharmacist, or other health care provider.
  • Rivaroxaban is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take rivaroxaban or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about rivaroxaban. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rivaroxaban. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using rivaroxaban.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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