Rivaroxaban

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 medication 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.

🔔 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.

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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.