Rivaroxaban

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

Rivaroxaban is sometimes used to reduce the chance of a blood clot returning after you have been treated 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 with aspirin to reduce the risk of stroke, heart attack, or other serious heart and blood circulation issues 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 who cannot move normally during and after a hospital stay or after hip or knee replacement surgery.

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

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

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

Follow all instructions 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, inform 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).

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

Some medicines can increase your risk of bleeding when taken with rivaroxaban. Inform your doctor about all other medications you are using.

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

Rivaroxaban can cause a very serious blood clot around your spinal cord if you have a spinal tap or receive spinal anesthesia (epidural). Inform any doctor who treats you that you are 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 won’t 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 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 make you bleed more easily. Call your doctor right away if you notice 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 faint;
• urine that appears 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 can report side effects to the FDA at 1-800-FDA-1088.

If you take rivaroxaban 1 time each day: Take the medicine as soon as you remember, then return to your regular schedule. Do not take two doses in the same day.

If you take the 15-milligram tablet 2 times each day: Take the missed dose on the same day you remember it. You can take the missed morning dose with the evening dose. Take your next dose at the regular time and continue your two times a day schedule.

If you take the 2.5-milligram tablet 2 times each day: Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.

If your child takes rivaroxaban 2 times each day: give the missed morning dose as soon as you remember. You can give the missed morning dose with the evening dose. If you miss an evening dose, skip the missed dose and return to the regular schedule.

If your child takes rivaroxaban 3 times each day: skip the missed dose and give the next dose at the regular time. Do not give two doses at one time.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• An overdose may cause excessive bleeding.
• Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs, which may increase side effects or make the medicines work less effectively.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect rivaroxaban, especially:

• ketoconazole;
• ritonavir;
• erythromycin, rifampin;
• carbamazepine, phenytoin;
• St. John's wort;
• medicines 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.