Xarelto (Rivaroxaban)

(riv'' a rox' a ban)

If you have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) and are taking rivaroxaban to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking rivaroxaban without talking to your doctor. Continue to take rivaroxaban even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of rivaroxaban. If you need to stop taking rivaroxaban, your doctor may prescribe another anticoagulant (''blood thinner'') to help prevent a blood clot from forming and causing you to have a stroke. If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as rivaroxaban, you are at risk of 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); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); heparin; prasugrel (Effient); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Savella), and venlafaxine (Effexor); ticagrelor (Brilinta); ticlopidine; tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness, numbness or tingling (especially in your legs), loss of control of your bowels or bladder, or inability to move your legs. Talk to your doctor about the risk of taking rivaroxaban.

Rivaroxaban is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung). Rivaroxaban may be continued to prevent DVT and/or PE from happening again after initial treatment is completed. It is also used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Rivaroxaban may reduce the risk of DVT, which can lead to PE in people who are having hip or knee replacement surgery. It is also used to prevent blood clots in certain people while hospitalized and after going home from the hospital who cannot move around and are also not at a high risk of bleeding. Rivaroxaban is also used along with aspirin to lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that supply blood to the heart) or peripheral arterial disease (poor circulation in the blood vessels that supply blood to the arms and legs). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by decreasing the clotting ability of the blood.

Rivaroxaban comes as a tablet to take by mouth. When rivaroxaban is used to treat a DVT or PE, it is usually taken with food twice daily for 21 days, then once daily with food. When rivaroxaban is used to prevent DVT or PE, it is usually taken once daily with or without food after at least 6 months of anticoagulation (blood thinner) treatment. When rivaroxaban is used to prevent a stroke in those with an irregular heartbeat, it is usually taken once daily with the evening meal. When rivaroxaban is taken to prevent DVT and PE after hip or knee replacement surgery, it is usually taken with or without food once daily. The first dose should be taken at least 6 to 10 hours after surgery. Rivaroxaban is usually taken for 35 days after a hip replacement surgery and for 12 days after knee replacement surgery. When rivaroxaban is used to prevent a blood clot in certain hospitalized people and after going home who are not at risk for bleeding, it is usually taken with or without food once daily for 31 to 39 days. When rivaroxaban is taken along with aspirin in people with coronary artery disease or peripheral arterial disease, it is usually taken twice daily with or without food. Take rivaroxaban at around the same time(s) 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. If you are unable to swallow the tablets, you can crush them and mix with applesauce. Swallow the mixture right after you prepare it. If the mixture is not used within 4 hours after preparing it, discard the mixture. Rivaroxaban can also be 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.

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 (Pacerone), azithromycin (Zithromax), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, Teril), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cardizem, Dilacor, Tiazac), dronedarone (Multaq), erythromycin (E.E.S., E-Mycin, Erythrocin), felodipine (Plendil), fluconazole (Diflucan), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), lopinavir (in Kaletra), phenobarbital , phenytoin (Dilantin, Phenytek), quinidine, ranolazine (Ranexa), rifampin (Rifadin, in Rifamate, in Rifater, Rimactane), ritonavir (Norvir, in Kaletra), and verapamil (Calan, 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 had a valve in your heart replaced or have or have ever had antiphospholipid syndrome (an autoimmune disorder that causes blood clots), problems with unusual bleeding or a bleeding disorder, or lung, kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking rivaroxaban, call your doctor.
• talk to your doctor about the risks and benefits of taking rivaroxaban if you are 75 years of age or older.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rivaroxaban. Your doctor may tell you to stop taking rivaroxaban at least 24 hours before your surgery.

Unless your doctor tells you otherwise, continue your normal diet.

If you take rivaroxaban once a day, take the missed dose as soon as you remember it on that day. Resume your regular dosing schedule the next day. If you take rivaroxaban twice a day for the treatment of a DVT or PE, take the missed dose as soon as you remember it on that day. You may take 2 doses at the same time to make up for the missed dose. Resume your regular dosing schedule on the next day If you have CAD or PAD and take rivaroxaban twice a day to reduce the risk of DVT and PE and miss a dose, just continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rivaroxaban may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• muscle spasm

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• bloody, black, or tarry stools
• pink, or brown urine
• coughing up or vomiting blood or material that looks like coffee grounds
• frequent nosebleeds
• bleeding from your gums
• heavy menstrual bleeding
• weakness
• tiredness
• headache
• dizziness or fainting
• blurred vision
• pain in arm or leg
• rash, alone or with a fever
• blisters or peeling skin
• itching
• difficulty breathing or swallowing
• hives
• pain or swelling at wound sites

Rivaroxaban prevents blood from clotting normally so it may take longer than usual for you to stop bleeding if you are cut or injured. This medication may also cause you to bruise or bleed more easily. Call your doctor right away if bleeding or bruising is unusual. Rivaroxaban may cause other side effects. Call your doctor if you have any unusual problems while taking 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). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.