FDA Approves Xarelto

The U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban tablets), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

Xarelto is approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.

Xarelto is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. Xarelto belongs to a group of medicines called anticoagulants. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.

Xarelto Medication Guide

Read this Medication Guide before you start taking Xarelto and before each treatment. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is Xarelto?

Xarelto (rivaroxaban tablets) is a prescription medicine used to help prevent blood clots from forming in patients after hip or knee replacement surgery.

Important Information About Xarelto

• You should take Xarelto exactly as directed by your doctor
• Do not skip a dose or stop taking Xarelto unless you are advised to do so by your doctor. Stopping may increase your risk of a blood clot
• If a dose is missed, take Xarelto as soon as possible and continue on the following day, taking Xarelto as directed by your doctor. Do not take two doses at the same time
• Xarelto can cause bleeding, which can sometimes be serious, even life-threatening. You may find you bruise or bleed more easily while you take it. It might take longer than usual to stop bleeding
• Alert your doctor right away if you develop any:
  • Tingling, numbness or muscle weakness, especially in your legs. This is particularly important if you had a procedure called spinal or epidural puncture as part of your anesthesia for your hip or knee replacement surgery.
  • Unusual bleeding or bruising (bruises that develop without an injury or grow in size)
  • New bleeding (for example, nose bleeds, bleeding gums, red urine, bright red blood in your stool, coughing up or vomiting blood)
  • Bleeding that is heavier than usual (for example, from cuts or menstruation)
  • Dizziness, weakness, or tiredness, all of which could indicate a loss of blood
  • Pain, swelling, or new fluid leakage in or around the surgical incision

Who Should Not Take Xarelto?

Tell your doctor if you have:

• Unusual bleeding
• Ever had an allergic-type (hypersensitivity) reaction to Xarelto

Before Taking Xarelto

• Tell your doctor or dentist about all the medicines you take.
  • This includes Xarelto, any other prescription and nonprescription medicines, over-the-counter medications, and herbal supplements.
• Tell your doctor if you:
  • Have a bleeding disorder or have problems with unusual bleeding
  • Have any problems with your kidneys or liver
  • Are pregnant or planning to become pregnant
  • Are breast-feeding or are planning to breast-feed

Xarelto Side Effects

• Xarelto may increase your chance of bleeding. This bleeding can sometimes be serious (and even life-threatening)
• In studies side effects with Xarelto included fluid leakage from a wound, itching, pain in arms or legs, blisters, fainting, and muscle spasm.
• Discuss any side effects with your doctor. 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 (526-7736)

This is a summary of important information about Xarelto. If you would like more information, talk with your doctor.