rivaroxaban (Xarelto, Xarelto Starter Pack)

Brand Names: Xarelto, Xarelto Starter Pack

Generic Name: rivaroxaban

• What is rivaroxaban (Xarelto, Xarelto Starter Pack)?
• What are the possible side effects of rivaroxaban (Xarelto, Xarelto Starter Pack)?
• What is the most important information I should know about rivaroxaban (Xarelto, Xarelto Starter Pack)?
• What should I discuss with my healthcare provider before taking rivaroxaban (Xarelto, Xarelto Starter Pack)?
• How should I take rivaroxaban (Xarelto, Xarelto Starter Pack)?
• What happens if I miss a dose (Xarelto, Xarelto Starter Pack)?
• What happens if I overdose (Xarelto, Xarelto Starter Pack)?
• What should I avoid while taking rivaroxaban (Xarelto, Xarelto Starter Pack)?
• What other drugs will affect rivaroxaban (Xarelto, Xarelto Starter Pack)?
• Where can I get more information (Xarelto, Xarelto Starter Pack)?

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).

Blood clots can develop when you are very ill and cannot move around as much as normal, such as during or after a stay in the hospital. Blood clots may also develop after knee or hip replacement surgery.

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.

Rivaroxaban is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

Rivaroxaban is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart problems in people with coronary artery disease (decreased blood flow to the heart) or peripheral artery disease (decreased blood flow to the legs).

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

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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 or 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:

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
• pain, swelling, new drainage, or excessive bleeding from a wound or where a needle was injected in your skin;
• any bleeding that will not stop;
• 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.

Bleeding is the most common side effect of rivaroxaban.

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.

Do not stop taking rivaroxaban without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Call your doctor at once if you 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 or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with rivaroxaban. Tell your doctor about all medicines you have recently used.

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.

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

Rivaroxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a genetic spinal defect;
• you have a spinal catheter in place;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you are taking an NSAID--Advil, Aleve, Motrin, and others; or
• you are using other medicines to treat or prevent blood clots.

Rivaroxaban may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;
• hemorrhagic stroke;
• uncontrolled high blood pressure;
• stomach or intestinal bleeding or ulcer; or
• if you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), clopidogrel (Plavix), or certain antidepressants.

Tell your doctor if you have ever had:

• antiphospholipid syndrome (also called Hughes syndrome or "sticky blood syndrome"), an immune system disorder that increases the risk of blood clots;
• an artificial heart valve; 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 this medicine. Ask your doctor about any risks.

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.

The number of times you take rivaroxaban each day will depend on the reason you are using this medication.

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.

Tell your doctor if you have trouble swallowing a rivaroxaban tablet.

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.

Do not change your dose or stop taking this medication without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Store at room temperature away from moisture and heat.

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

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.

If you take the 15-milligram tablet 2 times each day: Take the missed dose on the same day you remember it. You may take 2 doses at the same time to make up a missed dose.

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

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

Overdose may cause excessive bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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

Other drugs may affect rivaroxaban, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about rivaroxaban.

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