rivaroxaban

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Pronunciation: RIV a ROX a ban

Brand: Xarelto

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

You should not use this medicine if you have an artificial heart valve, or if you have active or uncontrolled bleeding.

Rivaroxaban 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 rivaroxaban without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

What is rivaroxaban?

Rivaroxaban blocks the activity of certain clotting substances in the blood.

Rivaroxaban is used to prevent or 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 occur after certain types of surgery.

Rivaroxaban is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

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

What should I discuss with my healthcare provider before taking rivaroxaban?

You should not use this medication if you are allergic to rivaroxaban, or if you have:

  • an artificial heart valve; or
  • active or uncontrolled bleeding.

Rivaroxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

  • you have a genetic spinal defect;
  • you have a spinal catheter in place;
  • you have a history of spinal surgery or repeated spinal taps;
  • you have recently had a spinal tap or epidural anesthesia;
  • you are taking an NSAID--Advil, Aleve, Motrin, and others; or
  • you are using other medicines to treat or prevent blood clots.

Rivaroxaban may cause you to bleed more easily, especially if you have:

  • a bleeding disorder that is inherited or caused by disease;
  • hemorrhagic stroke;
  • uncontrolled high blood pressure;
  • stomach or intestinal bleeding or ulcer; or
  • if you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), clopidogrel (Plavix), or certain antidepressants.

To make sure you can safely take rivaroxaban, tell your doctor if you have kidney or liver disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether rivaroxaban passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using rivaroxaban.

How should I take rivaroxaban?

Rivaroxaban is taken either once per day or two times per day, depending on the reason you are using this medication. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Carefully follow your doctor's dosing instructions.

For atrial fibrillation: Rivaroxaban is usually taken once per day with your evening meal.

For blood clots in your legs or lungs: Rivaroxaban is usually taken with food 1 or 2 times per day, at the same time each day.

For hip or knee replacement surgery: Rivaroxaban is usually taken once per day with or without food.

Tell your doctor if you have trouble swallowing a rivaroxaban tablet.

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

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

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take rivaroxaban 1 time each day: Take the missed dose as soon as you remember. Take your next dose the following day and stay on your once-daily schedule. Do not take extra medicine to make up the missed dose.

If you take rivaroxaban 2 times each day: Take the missed dose as soon as you remember. You may take 2 doses at the same time to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause excessive bleeding.

What should I avoid while taking rivaroxaban?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of rivaroxaban?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
  • pain, swelling, or drainage from a wound or where a needle was injected in your skin;
  • bleeding from wounds or needle injections, any bleeding that will not stop;
  • headache, dizziness, weakness, feeling like you might pass out;
  • urine that looks red, pink, or brown; or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • muscle pain;
  • itching; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rivaroxaban?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • erythromycin;
  • rifampin;
  • St. John's wort;
  • antifungal medication --itraconazole or ketoconazole;
  • HIV medication --indinavir, lopinavir, ritonavir; or
  • seizure medication --carbamazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with rivaroxaban, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about rivaroxaban.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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