Rivaroxaban

IMPORTANT WARNING:

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 medications that may cause bleeding including anticoagulants (blood thinners) such as warfarin (Jantoven), heparin, or other medications to treat or prevent blood clots and aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin), ketoprofen, and naproxen (Aleve, Anaprox, others). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness (especially in your legs and feet), 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rivaroxaban and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

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) in adults. Rivaroxaban is also used to prevent DVT and PE from happening again after initial treatment is completed in adults. It is also used to help prevent strokes or serious blood clots in adults 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) that is not caused by heart valve disease. Rivaroxaban is also used to prevent DVT and PE in adults who are having hip replacement or knee replacement surgery or in people who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around or other risk factors. It is also used along with aspirin to lower the risk of a heart attack, stroke, or death in adults 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 also used to treat and prevent DVT and PE from happening again in children and certain infants who have received at least 5 days of initial anticoagulation (blood thinner) treatment. It is also used to prevent DVT and PE after heart surgery in children 2 years of age or older who have congenital heart disease (abnormality in the heart that develops before birth). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Rivaroxaban comes as a tablet and a suspension (liquid) to take by mouth. When rivaroxaban is used to treat DVT or PE in adults, 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 in adults, 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 who have atrial fibrillation, 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 taken to prevent DVT and PE in adults who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around, it is usually taken with or without food once daily starting when you are in the hospital and then continuing for a total of 31 to 39 days. When rivaroxaban is taken along with aspirin in adults with coronary artery disease or peripheral arterial disease, it is usually taken twice daily with or without food. When rivaroxaban is used in children and infants to treat or prevent DVT or PE, it is usually given 1 to 3 times a day with food after at least 5 days of anticoagulation (blood thinner) treatment. When rivaroxaban is taken in children 2 years of age or older who have congenital heart disease, it is usually given 1 to 3 times a day with or without food after heart surgery.

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.

For adults, if you are unable to swallow the tablets, you can crush them and mix with applesauce. Swallow the mixture right after you prepare it. 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.

For children taking rivaroxaban tablets, swallow the tablets whole; do not split them.

If you or your child vomits or spits up within 30 minutes of taking a dose of rivaroxaban oral suspension, take another full dose as soon as possible after the vomiting episode and then take your next dose at the regularly scheduled time.

To measure rivaroxaban oral suspension, follow these steps:

1. Use the oral syringe that came with the medication for measuring the liquid. Do not use a household spoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon.
2. Shake the bottle gently for 10 seconds before use. If there are remaining granules at the bottom of the bottle, shake gently again for another 10 seconds. Do not shake the bottle to avoid foaming.
3. Remove the bottle cap by pushing down on the cap, then turn it counterclockwise (to the left). Do not remove the adaptor from the top of the bottle.
4. Push all the air from the oral syringe into the bottle by pushing down on the plunger. Then insert the open tip of the oral syringe into the adaptor.
5. While holding the oral syringe in place, carefully turn the bottle upside down. Draw some of the medication out of the bottle into the oral syringe by pulling back on the plunger. Be careful not to pull the plunger all the way out.
6. You will see a small amount of air near the end of the plunger in the oral syringe. Push on the plunger so the medication goes back into the bottle and the air disappears. Pull back on the plunger to draw your correct medication dose into the oral syringe.
7. While still holding the oral syringe in the bottle, carefully turn the bottle upwards so the syringe is on top. Remove the oral syringe from the bottle neck adaptor without pushing on the plunger. Take the medication right after you draw it into the oral syringe.
8. Place the open tip of the oral syringe into one side of your child's mouth and push on the plunger slowly as the liquid goes into your child's mouth; have your child swallow the medication slowly as it goes into their mouth.
9. If your dose is more than 5 mL, you will need to use the same syringe more than one time and you will need to repeat steps 3 through 7.
10. Leave the adaptor in the bottle. Place the cap back on the bottle and turn it clockwise (to the right) to tighten it.
11. Rinse the oral syringe with clean tap water and allow it to air dry after each use.

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.

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. 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 an artificial heart valve or recently noticed any unusual bruising or bleeding. Your doctor will probably tell you not to take rivaroxaban.

• tell your doctor if you have or have ever had any type of bleeding problem, antiphospholipid syndrome (APS; a condition that causes blood clots), bleeding or an ulcer in your stomach or intestine, or 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.

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?

Adults:

• 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.

Infants and children:

• 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. Do not take a double dose to make up for a missed one.
• If you take rivaroxaban twice a day, take the missed morning dose as soon as you remember it on that day. You may take 2 doses at the same time in the evening to make up for the missed morning dose. Resume your regular dosing schedule on the next day
• If you take rivaroxaban three times a day and miss a dose, 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?

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

• muscle spasm
• pain in arms or legs (in children)
• vomiting (in children)
• stomach pain
• cough (in children)
• rash (in children)

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
• itching
• difficulty breathing or swallowing
• hives
• pain or swelling at wound sites
• decreased urination
• swelling in your legs, feet, or ankles

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.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

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.

What should I do in case of OVERDOSE?

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.

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.