Rivaroxaban

Why is this medicine prescribed?

Rivaroxaban is used to:

• prevent and treat deep vein thrombosis (DVT; a blood clot) and pulmonary embolism (PE; a blood clot in the lung).
• lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that bring blood to the heart) or peripheral arterial disease (poor blood flow to the arms and legs).

Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking a 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. It is taken 1 to 2 times daily with or without food as prescribed by your doctor. Take at the same time(s) each day. Follow the instructions on your prescription label carefully and take exactly as directed. Do not take more or less than prescribed.

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.

If a child is unable to swallow rivaroxaban tablets, talk to their doctor about rivaroxaban suspension. Rivaroxaban tablets should not be crushed, split or chewed.

If you vomit 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.
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 too fast 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 or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had
• 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.
• you should know the herbal product St. John's wort may interact with rivaroxaban. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking rivaroxaban. Do not start this medication while taking rivaroxaban without discussing with your healthcare provider.
• tell your doctor if you have an artificial heart valve or recently noticed any strange 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.
• 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 before the surgery or procedure. Your doctor will tell you when you should start taking rivaroxaban again after your surgery.

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?

If you take rivaroxaban once a day, take the missed dose as soon as you remember it on that 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 normal dosing schedule. If you take rivaroxaban twice a day to prevent DVT or PE, just continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If a child takes rivaroxaban three times a day and misses a dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for the missed one.

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 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 or pain in arms or legs
• vomiting, stomach pain
• cough

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 or vomiting blood or material that looks like coffee grounds; frequent nosebleeds; bleeding gums; heavy menstrual bleeding
• weakness, tiredness; headache; dizziness or fainting; blurred vision; pain in arm or leg
• rash, itching, hives; difficulty breathing or swallowing
• pain or swelling at wound sites
• urinating less than normal
• swelling in your legs, feet, or ankles

Rivaroxaban prevents blood from clotting so it may take longer than normal 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 ( https://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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.