Brand Name(s):

• Xarelto®

IMPORTANT WARNING

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as rivaroxaban, you are at risk for 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); other anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin, ibuprofen (Advil, Motrin, others), indomethacin (Indocin), ketoprofen (Oruvail), naproxen (Aleve, Anaprox, Naprelan), or other nonsteroidal anti-inflammatory drugs (NSAIDs); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); prasugrel (Effient); sulfinpyrazone (Anturane); ticlopidine (Ticlid); and tirofiban (Aggrastat). If you experience any of the following symptoms, call your doctor immediately: muscle weakness, numbness or tingling (especially in your legs), or inability to move your legs.

Talk to your doctor about the risk of taking rivaroxaban.

WHY is this medicine prescribed?

Rivaroxaban is used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg), which can lead to pulmonary embolism (PE; a blood clot in the lung), in people who are having hip replacement or knee replacement surgery. Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by decreasing the clotting ability of the blood.

HOW should this medicine be used?

Rivaroxaban comes as a tablet to take by mouth. It is usually taken once a day. The first dose should be taken at least 6 to 10 hours after surgery. Rivaroxaban can be taken with or without food, unless you are told specifically to take it with food by your doctor or pharmacist. When rivaroxaban is taken after hip replacement surgery, it is usually taken for 35 days. When rivaroxaban is taken after knee replacement surgery, it is usually taken for 12 days. 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.

Rivaroxaban tablets can be crushed and 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), azithromycin (Zithromax), carbamazepine (Carbatrol, Epitol, Tegretol), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cardizem, Dilacor, Tiazac), dronaderone (Multaq), erythromycin (E.E.S., E-Mycin, Erythrocin), felodipine (Plendil), indinavir (Crixivan), itraconazole (Sporanox), ketoconazole (Nizoral), 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 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 breast-feeding. 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?

Take the missed dose as soon as you remember it that day. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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: August 15, 2012.