Xarelto (rivaroxaban)

Generic name: rivaroxaban (RIV a ROX a ban)
Brand name: Xarelto
Drug class: Factor Xa inhibitors

Xarelto (rivaroxaban) blocks the activity of certain clotting substances in the blood.

Xarelto is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).

Blood clots can develop when you are very ill and cannot move around as much as normal, such as during or after a stay in the hospital. Blood clots may also develop after knee or hip replacement surgery.

Xarelto is sometimes used to lower your risk of a DVT or PE coming back after you have received treatment for blood clots for at least 6 months.

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

Xarelto is used to help prevent blood clots in certain people hospitalized for an acute illness who are at risk of getting blood clots and who do not have a high risk of bleeding.

Xarelto is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart problems in people with coronary artery disease (decreased blood flow to the heart) or peripheral artery disease (decreased blood flow to the legs).

Warnings

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

Xarelto can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, headaches, or dizziness/fainting.

You should not use Xarelto if you have an artificial heart valve.

Many other drugs can increase your risk of bleeding when used with rivaroxaban. Tell your doctor about all medicines you have recently used.

Xarelto can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking rivaroxaban.

Before taking this medicine

You should not use Xarelto if you are allergic to rivaroxaban, or if you have active or uncontrolled bleeding.

Xarelto 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 a NSAID - Advil, Aleve, Motrin, and others; or
  • you are using other medicines to treat or prevent blood clots.

Xarelto 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.

Tell your doctor if you have ever had:

  • antiphospholipid syndrome (also called Hughes syndrome or "sticky blood syndrome"), an immune system disorder that increases the risk of blood clots;
  • an artificial heart valve; or
  • liver or kidney disease.

Taking Xarelto during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

If you need surgery, tell your doctor you are taking Xarelto. If possible, Xarelto should be stopped at least 24 hours prior to surgery to reduce bleeding risk. Do not stop taking Xarelto without speaking with your doctor first.

How should I take Xarelto?

Take Xarelto exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

The number of times you take Xarelto each day will depend on the reason you are using this medication.

For some conditions, Xarelto should be taken with food. Whether you take the medicine with or without food may also depend on the tablet strength you take. Follow your doctor's dosing instructions very carefully.

Tell your doctor if you have trouble swallowing a Xarelto tablet. You can crush Xarelto and mix with applesauce if necessary. Take the medication immediately after crushing and mixing.

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 this medicine for a short time.

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 Xarelto 1 time each day: Take the medicine as soon as you remember, and then go back to your regular schedule. Do not take two doses on the same day.

If you take the Xarelto 2.5mg tablet 2 times each day: Skip the missed dose and take your next dose at the regular time.

If you take the Xarelto 15mg tablet 2 times each day: Take Xarelto immediately to ensure that you get 2 tablets in one day. You can take both tablets at one time.

Get your prescription refilled before you run out of medicine completely.

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 to avoid

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

Xarelto side effects

Get emergency medical help if you have signs of an allergic reaction to Xarelto: 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.

Rivaroxaban can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
  • pain, swelling, new drainage, or excessive bleeding from a wound or where a needle was injected in your skin;
  • any bleeding that will not stop;
  • headaches, 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.

Bleeding is the most common side effect of rivaroxaban.

Common Xarelto 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 Xarelto?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Xarelto, especially:

  • NSAID medications including aspirin, ibuprofen, acetaminophen, naproxen, celecoxib, diclofenac, indomethacin, meloxicam, and others and others).
  • blood thinners including warfarin (Coumadin, Jantoven) and others;
  • 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.