XARELTO Rivaroxaban Kit — NDC 50458-584-51 (Billing 50458-0584-51)

1 INDICATIONS AND USAGE XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) 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 ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 )

1.1Reduction 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 [see Clinical Studies (14.1) ].

1.2Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT).

1.3Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE).

1.4Reduction 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.

1.5Prophylaxis 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.

1.6Prophylaxis 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 [see Warnings and Precautions (5.2) and Clinical Studies (14.5) ] .

1.7Reduction 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.

1.8Reduction 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.

1.9Treatment 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 antico… [Excerpted — this section continues on DailyMed.]

2 DOSAGE AND ADMINISTRATION Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food ( 2.1 ) Treatment of DVT and/or PE : 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment ( 2.1 ) Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE : 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment ( 2.1 ) Prophylaxis of DVT Following Hip or Knee Replacement Surgery : 10 mg orally once daily with or without food ( 2.1 ) Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days ( 2.1 ) CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily ( 2.1 ) Pediatric Patients: See dosing recommendations in the Full Prescribing Information ( 2.2 )

2.1Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations Calculate CrCl based on actual weight [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ] . Dosage Food/Timing [See Clinical Pharmacology (12.3) ] . Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation CrCl >50 mL/min 20 mg once daily Take with evening meal CrCl ≤50 mL/min Patients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6) ] .

15 mg once daily Take with evening meal Treatment of DVT and/or PE CrCl ≥15 mL/min 15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily Take with food, at the same time each day CrCl <15 mL/min Avoid Use Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE CrCl ≥15 mL/min 10 mg once daily, after at least 6 months of standard anticoagulant treatment Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of DVT Following: - Hip Replacement Surgery CrCl ≥15 mL/min 10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use - Knee Replacement Surgery [See Dosage and Administration (2.4) ] .

CrCl ≥15 mL/min 10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding CrCl ≥15 mL/min 10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days Take with or without food CrCl <15 mL/min Avoid Use Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily.

When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food

2.2Recommended Dosage in Pediatric Patients Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTE Initiate XARELTO treatment following at least 5 days of initial parenteral anticoagulation therapy. , Patients <6 months of age should meet t… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS 2.5 mg tablets: Round, light yellow, and film-coated with a triangle pointing down above a "2.5" marked on one side and "Xa" on the other side 10 mg tablets: Round, light red, biconvex and film-coated with a triangle pointing down above a "10" marked on one side and "Xa" on the other side 15 mg tablets: Round, red, biconvex, and film-coated with a triangle pointing down above a "15" marked on one side and "Xa" on the other side 20 mg tablets: Triangle-shaped, dark red, and film-coated with a triangle pointing down above a "20" marked on one side and "Xa" on the other side For oral suspension: white to off-white granules; once reconstituted, provide flavored white to off-white opaque liquid with a concentration of 1 mg/mL.

Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg ( 3 ) For oral suspension: 1 mg/mL once reconstituted ( 3 )

17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). For the suspension, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions for Patient Use Advise patients to take XARELTO only as directed.

Remind patients to not discontinue XARELTO without first talking to their healthcare professional. Adults Advise patients with atrial fibrillation to take XARELTO once daily with the evening meal. Advise patients for initial treatment of DVT and/or PE to take XARELTO 15 mg or 20 mg tablets with food at approximately the same time every day [see Dosage and Administration (2.1) ] .

Advise patients who are at a continued risk of recurrent DVT and/or PE after at least 6 months of initial treatment, to take XARELTO 10 mg once daily with or without food [see Dosage and Administration (2.1) ]. Advise patients who cannot swallow the tablet whole to crush XARELTO and combine with a small amount of applesauce followed by food [see Dosage and Administration (2.6) ] . For patients requiring an NG tube or gastric feeding tube, instruct the patient or caregiver to crush the XARELTO tablet and mix it with a small amount of water before administering via the tube [see Dosage and Administration (2.6) ] .

If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5) ] . Pediatric Patients The adult caregiver should administer the dose. Advise caregivers to use the syringes provided in the original carton.

Advise the caregiver whether the dose needs to be taken with food or not [see Dosage and Administration (2.2) ] . Advise the caregiver the tablet must not be split in an attempt to provide a fraction of a tablet dose [see Dosage and Administration (2.2) ] . If a child vomits or spits up the dose within 30 minutes after receiving the dose, a new dose should be given.

However, if the child vomits more than 30 minutes after the dose is taken, the dose should not be re-administered and the next dose should be taken as scheduled. If a child vomits or spits up the dose repeatedly, the caregiver should contact the child's doctor right away [see Dosage and Administration (2.2) ] . For children who are unable to swallow whole tablets, XARELTO oral suspension may be used.

If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5) ] . Bleeding Risks Advise patients to report any unusual bleeding or bruising to their physician. Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with XARELTO [see Warnings and Precautions (5.2) ] .

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence. If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning ] . Invasive or Surgical Procedures Instruct patients to inform their healthcare professional that they are taking XARELTO before any invasive procedure (including dental procedures) is scheduled.

Concomitant Medication and Herbals Advise patients to inform their physicians and dentists if they are taking, or plan to take, any prescription or over-the-counter drugs or herbals, so their healthcare professionals can evaluate potential interactions [see Drug Interactions (7) ] . Pregnancy and Pregnancy-Related Hemorrhage Advise patients to inform their physician immediately if they become pregnant or in… [Excerpted — this section continues on DailyMed.]

MEDICATION GUIDE XARELTO ® (zah-REL-toe) (rivaroxaban) tablets XARELTO ® (zah-REL-toe) (rivaroxaban) oral suspension This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 06/2025 What is the most important information I should know about XARELTO? 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 wit… [Excerpted — this section continues on DailyMed.]

Instructions for Use XARELTO ® (zah-REL-toe) (rivaroxaban) for oral suspension This Instructions for Use contains information on how to give a dose of XARELTO oral suspension. Read this Instructions for Use before giving XARELTO and each time you get a refill. There may be new information.

This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment. Important information: XARELTO suspension is for oral use only. Give XARELTO to your child exactly as prescribed by your doctor.

The adult caregiver should give the dose. If you have questions, contact your doctor or pharmacist for more information on giving a dose. Only use the oral dosing syringe provided with XARELTO oral suspension.

Contact your doctor or pharmacist if the oral dosing syringe is missing, lost or damaged. Storage information Store XARELTO oral suspension at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Do not freeze.

Store the bottle upright with the oral dosing syringes in the original carton. Keep XARELTO and all medicines out of reach of children. XARELTO Oral Dosing Syringe: Side 1: Dosing in milliliters (mL) Side 2: Dosing with color band The color band is an aid to withdraw the prescribed dose.

(mL) XARELTO Bottle Step 1 Get ready Check "Discard after" date on the XARELTO bottle. If "Discard after" date has passed, do not use and call your doctor or pharmacist. Wash hands.

Wash your hands well with soap and warm water. Step 2 Prepare XARELTO Shake bottle slowly for 10 seconds before each use. Do not shake the bottle too fast to avoid foaming.

Foaming may lead to giving the wrong dose. Check XARELTO oral suspension. If there are lumps or granules at the bottom of the bottle, shake the bottle slowly again for 10 seconds .

Step 3 Check the prescribed dose Find your dose line. You can use either side of the syringe to set your dose. If using mL side of syringe: Top of the plunger should line up with the prescribed mL.

If using color side of syringe: Top of the plunger should line up with the prescribed mL dose line at the bottom of the color band. Only use the oral dosing syringe provided with XARELTO oral suspension. If your dose is more than 5 mL.

You will need to use the same syringe more than one time. Repeat Steps 4 and 5 to complete your dose. Ask your pharmacist if you are not sure.

Step 4 Set prescribed dose Push plunger all the way in to remove air. Insert oral dosing syringe into bottle adaptor. Twist off the cap from the bottle.

Do not remove the bottle adaptor from the bottle. Insert the syringe tip into the bottle adaptor. Fill oral dosing syringe.

Turn the bottle upside down, as shown. Pull the plunger to fill the oral dosing syringe slightly past your prescribed dose line to help remove any air bubbles. CAUTION: Make sure you have enough medicine for a full dose.

Do not take a partial dose. Tap syringe to move air bubbles to the top. Doing this helps set the correct dose.

Adjust to your prescribed dose. If using mL side of syringe: Push plunger to align with the prescribed dose line. If using color side of syringe: Push plunger to align with the prescribed mL dose line at the bottom of the color band.

Remove oral dosing syringe. Place the bottle on a flat surface. Remove the oral dosing syringe from the bottle.

Step 5 Give the dose Give the dose. Place the oral dosing syringe gently into the child's mouth with the tip of the syringe pointing toward the cheek and slowly press the plunger. This allows the child to swallow naturally.

Make sure the child swallows the full dose. If your child vomits or spits out the medicine repeatedly, contact your child's doctor right away. If your dose is more than 5 mL , you will need to use the same syringe more than one time.

Repeat Steps 4 and 5 to complete your dose. Step 6 Rinse and store Close XARELTO bottle and rinse oral dosing syringe. Rinse the oral dosing syringe with tap water and let it air dry.

Do not place the oral dosing syringe in… [Excerpted — this section continues on DailyMed.]