Rivaroxaban

Generic name: Rivaroxaban
Drug class: Factor Xa inhibitors

Usage of Rivaroxaban

Rivaroxaban is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).

Rivaroxaban is sometimes used to lower your risk of a blood clot coming back after you have received treatment for blood clots for at least 6 months in adults, and at least 5 days in children from birth to less than 18 years of age.

Rivaroxaban is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart and blood circulation problems in adults with coronary artery disease (clogged arteries) or peripheral artery disease (reduced blood flow to the legs), including adults who recently had a procedure to improve blood flow to the legs.

Rivaroxaban can also be used to prevent blood clots in adults that are not able to move as normal during and after a hospital stay or after a hip or knee replacement surgery.

Rivaroxaban can be used to prevent blood clots in children 2 years and older that have undergone surgery for a heart disease present at birth.

Rivaroxaban is also used to lower the risk of stroke and blood clots in adults with atrial fibrillation (a heart rhythm disorder).

Rivaroxaban may also be used for purposes not listed in this medication guide.

Rivaroxaban side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness, tingling, muscle weakness in your lower body, or loss of bladder or bowel control.

Rivaroxaban can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual bleeding);

pain, swelling, new drainage, or excessive bleeding from a wound;

headaches, dizziness, weakness, feeling like you might pass out;

urine that looks red, pink, or brown; or

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of rivaroxaban may include:

bleeding;

vomiting;

cough; or

stomach or gut inflammation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Rivaroxaban

You should not use rivaroxaban if you are allergic to it, or if you have active or uncontrolled bleeding.

Rivaroxaban can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop.

Rivaroxaban can cause a serious blood clot if you undergo a procedure such as a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause permanent or long-term paralysis.

Tell your doctor if you have or ever had:

a history of problems with your spine or a spinal surgery;

a history of difficult or repeated spinal taps;

a thin tube (catheter) placed in your back to give you certain medicine;

bleeding problems;

an artificial heart valve;

antiphospholipid syndrome, an immune system disorder that increases the risk of blood clots;

taken NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and other medicines that prevent blood from clotting; or

liver or kidney disease.

Taking rivaroxaban during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed a baby while you are using rivaroxaban. Ask your doctor about the risks.

Relate drugs

How to use Rivaroxaban

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not change your dose or stop taking this medication without your doctor's advice. Stopping suddenly can increase your risk of blood clots or stroke.

Tell any doctor who treats you that you are using rivaroxaban. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using rivaroxaban for a short time.

For some conditions, rivaroxaban should be taken with food. Whether you take the medicine with or without food may also depend on the tablet strength you take. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a rivaroxaban tablet whole, crush it and mix the medicine with a small amount of applesauce. Swallow the mixture right away without chewing. If you are taking the 15 mg or 20 mg tablet, the dose should be immediately followed by food.

Follow your healthcare provider's instructions about giving rivaroxaban through a feeding tube if needed.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

If your child is taking the tablet, make sure it is swallowed whole. Rivaroxaban should not be split to provide a smaller dose. Talk to your doctor about switching to the oral suspension (liquid).

If your child vomits within 30 minutes of taking the oral suspension (liquid), give a new full dose. If your child vomits more than 30 minutes after taking the oral suspension (liquid), do not give another dose. Give the next dose as scheduled.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Store at room temperature away from moisture and heat. Do not freeze the oral suspension (liquid).

Warnings

Do not stop taking rivaroxaban without your doctor's advice. Stopping it suddenly can increase your risk of blood clots or stroke.

Some drugs can increase your risk of bleeding when used with rivaroxaban. Tell your doctor about all other medicines you use.

Call your doctor at once if you or your child have signs of bleeding such as: headaches, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, vomit that looks like coffee grounds or any bleeding that will not stop.

Rivaroxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking rivaroxaban.

What other drugs will affect Rivaroxaban

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect rivaroxaban, especially:

ketoconazole;

ritonavir;

erythromycin, rifampin;

Carbamazepine, phenytoin;

St. John's wort;

medicine used to prevent blood clots--enoxaparin, warfarin, alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or

NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect rivaroxaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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