Rivaroxaban

What it is used for

XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled. 1.2 Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT). 1.3 Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE).

1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. 1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.

1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding.

1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.

1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.

1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years

The most important thing to know

XARELTO may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.

XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

Increased risk of bleeding. XARELTO can cause bleeding which can be serious and may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and have certain other medical problems.

You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding, including: aspirin or aspirin containing products long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) warfarin sodium (Coumadin ®, Jantoven ® ) any medicine that contains heparin clopidogrel (Plavix ® ) selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines.

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as: nose bleeds that happen often unusual bleeding from the gums menstrual bleeding that is heavier than normal or vaginal bleeding bleeding that is severe or you cannot control red, pink or brown urine bright red or black stools (looks like tar) cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" headaches, feeling dizzy or weak pain, swelling, or new drainage at wound sites left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort (these may be symptoms of rupture of the spleen) Spinal or epidural blood clots (hematoma).

People who take a blood thinner medicine (anticoagulant) like XARELTO, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: a thin tube called an epidural catheter is placed in your back to give you certain medicine you take NSAIDs or a medicine to prevent blood from clotting you have a history of difficult or repeated epidural or spinal punctures you have a history of problems with your spine or have had surgery on your spine If you take XARELTO and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.

Tell your doctor right away if you have: back pain tingling numbness muscle weakness (especially in your legs and feet) loss of control of the bowels or bladder (incontinence) XARELTO is not for use in people with artificial heart valves. XARELTO is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.

What is XARELTO? XARELTO is a prescription medicine used to: reduce the risk of stroke and blood clots in adults who have a medical cond

How to take it

Take XARELTO exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO unless your doctor tells you to. Your doctor may change your dose if needed. Your doctor will decide how long you should take XARELTO. XARELTO may need to be stopped for one or more days before any surgery or medical or dental procedure.

Your doctor will tell you when to stop taking XARELTO and when to start taking XARELTO again after your surgery or procedure. If you need to stop taking XARELTO for any reason, talk to the doctor who prescribed XARELTO to you to find out when you should stop taking it. Do not stop taking XARELTO without first talking to the doctor who prescribes it to you.

If you have difficulty swallowing XARELTO tablets whole, talk to your doctor about other ways to take XARELTO. Do not run out of XARELTO. Refill your prescription of XARELTO before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO available to avoid missing any doses.

If you take too much XARELTO, go to the nearest hospital emergency room or call your doctor right away. If you take XARELTO for: Atrial fibrillation that is not caused by a heart valve problem: Take XARELTO 1 time a day with your evening meal. If you miss a dose of XARELTO, take it as soon as you remember on the same day.

Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs: Take XARELTO 1 or 2 times a day as prescribed by your doctor. For the 10 mg dose, take XARELTO with or without food. For the 15 mg and 20 mg doses, take XARELTO with food at the same time each day. If you miss a dose: ⮚ If you take the 15 mg dose of XARELTO 2 times a day (a total of 30 mg of XARELTO in 1 day): Take XARELTO as soon as you remember on the same day.

You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. ⮚ If you take XARELTO 1 time a day: Take XARELTO as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Hip or knee replacement surgery: Take XARELTO 1 time a day with or without food.

If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in people hospitalized for an acute illness: Take XARELTO 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor.

If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease: Take XARELTO 2.5 mg 2 times a day with or without food. If you miss a dose of XARELTO, take your next dose at your regularly scheduled time.

Take aspirin 75 to 100 mg once daily as instructed by your doctor. Reducing the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in people with peripheral artery disease including those who have recently had a procedure to improve blood flow to the legs: Take XARELTO 2.5 mg 2 times a day with or without food.

If you miss a dose of XARELTO, take your next dose at your regularly scheduled time. Take aspirin 75 mg to 100 mg 1 time a day as instructed by your doctor. For children who take XARELTO: The dose of XARELTO depends on your child's body weight and will be calculated by your child's doctor. Your child's doctor will tell you if XARELTO can be given to your child with or without food.

The adult caregiver should give the dose. If your child is taking the tablet, the tablet should be taken whole and should not be split in an attempt to provide a lower dose of XARELTO. If your child is taking the oral suspension, use the syringes provided in the original carton. The suspension will be prepared by the pharmacy.

See the Instructions for Use included in the carton o

Side effects, and when to stop

XARELTO may cause serious side effects: The most common side effect of XARELTO in adults was bleeding. The most common side effects of XARELTO in children include: bleeding vomiting cough inflamed stomach and gut Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800-FDA-1088.

Who should not take it

Do not take XARELTO if you or your child: currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. are allergic to rivaroxaban or any of the ingredients in XARELTO. See the end of this Medication Guide for a complete list of ingredients in XARELTO.

Before taking XARELTO, tell your doctor about all of your medical conditions, including if you or your child: have or ever had bleeding problems have liver or kidney problems have antiphospholipid syndrome (APS) are pregnant or plan to become pregnant. It is not known if XARELTO will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with XARELTO.

Taking XARELTO while you are pregnant may increase the risk of bleeding in you or in your unborn baby. Females who are able to become pregnant: Talk with your doctor about pregnancy planning during treatment with XARELTO. Talk with your doctor about your risk for severe uterine bleeding if you are treated with blood thinner medicines, including XARELTO.

If you take XARELTO during pregnancy tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. for signs and symptoms of bleeding. are breastfeeding or plan to breastfeed. XARELTO can pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO.

Tell all of your doctors and dentists that you or your child are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some of your other medicines may affect the way XARELTO works, causing side effects. Certain medicines may increase your risk of bleeding. Especially tell your doctor if you or your child take: ketoconazole erythromycin phenytoin St. John's wort ritonavir carbamazepine rifampin

Storing it

Store XARELTO tablets and suspension at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Store syringes and bottle upright in the original carton for XARELTO suspension. Do not freeze XARELTO suspension. Keep XARELTO and all medicines out of the reach of children. Discard XARELTO suspension after "Discard after" date written on the bottle.