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Guide, Feedback, and Issue Reporting
 * Prescribing Information
 * Important Safety Information
 * Medication Guide
 * For Healthcare Professionals
 * For Non-US Visitors
 * Español

Choose Your Condition
1-888-XARELTO
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 * About XARELTO®
 * Savings & Support

 * Prescribing Information
 * Important Safety Information
 * Medication Guide
 * For Healthcare Professionals
 * For Non-US Visitors

1-888-XARELTO

Once you and your doctor have decided that XARELTO® is right for you, we provide

Support for moments that matter



We’re here for you. With personalized support, XARELTO withMe may be able to
help you save on out-of-pocket costs for XARELTO®. And if you become eligible
for cost support later on, we’ll stay in touch. Plus, we’ll provide resources to
help you better understand your condition and treatment.

The support and resources provided by XARELTO withMe are not intended to provide
medical advice, replace a treatment plan you receive from your doctor or nurse,
or serve as a reason for you to start or stay on treatment.


NO MATTER WHAT TYPE OF INSURANCE YOU HAVE, WE’LL FIND OPTIONS THAT MAY HELP YOU
PAY FOR XARELTO® (RIVAROXABAN)

Select your prescription drug insurance type

 * Commercial
 * Government
 * No Insurance
 * I'm Not Sure

Commercial insurance is insurance you get through your job or your spouse’s job.
You can also purchase it from an insurance carrier, Healthcare.gov, or an
insurance broker. It is not offered by the government.

Sign Up for Support

If you use commercial insurance, you may be eligible for either:

XARELTO withMe Savings Card (formerly  Janssen CarePath Savings Card)

Get your Savings Card instantly after sign-up

Pay as little as $10 for each prescription (up to 90-day supply)

What is a savings card?

XARELTO withMe Savings Card

If you are using commercial or private insurance to pay for your XARELTO®
prescription, you may be eligible to pay as little as $10 per fill. There is a
limit to savings per fill. Savings may apply to co-pay, co-insurance or
deductible. Participate without sharing your income information. Your final
out-of-pocket cost after the Savings Card is applied will depend on your
insurance plan and pharmacy.

Enrolled patients will receive personalized refill notifications for their
XARELTO® prescriptions based on information collected about them and can opt out
of refill notifications at any time by calling 888-XARELTO (888-927-3586).

We provide cost support directly to patients through the XARELTO withMe Savings
Program. This benefit is intended to help eligible patients afford their
out-of-pocket obligations as set by their health plans. The cost support is
meant solely for patients—not health plans and/or their partners. If you are
having any difficulty accessing cost support through the XARELTO withMe Savings
Program, please contact us at 888-XARELTO (888-927-3586).

See program requirements below.

XARELTO withMe Savings Card Program Requirements

You may be eligible for the XARELTO withMe Savings Card if you:

 * Use commercial or private health insurance to pay for your XARELTO®
   prescription
 * Are being treated with XARELTO®, except if you are prescribed XARELTO® 10 mg
   because of a recent non-surgical hospital discharge or because you have
   recently undergone hip or knee replacement surgery

Other requirements

The XARELTO withMe Savings Card is only for people using commercial or private
health insurance for XARELTO®. This includes plans from the Health Insurance
Marketplace. The XARELTO withMe Savings Card is not for people who use any state
or federal government-funded healthcare program. Examples of these programs are
Medicare, Medicaid, TRICARE, Department of Defense, and Veterans Administration.
You may not seek payment for the value received from the XARELTO withMe Savings
Card from any health plan, patient assistance foundation, flexible spending
account, or healthcare savings account.

You must meet the Savings Card requirements every time you use the card. Terms
will expire at the end of each calendar year. The XARELTO withMe Savings Card
may change or end without notice, including in specific states.

To use the XARELTO withMe Savings Card, you must follow any health plan
requirements, including telling your health plan how much co-payment support you
get from the XARELTO withMe Savings Card. By using the Savings Card, you confirm
that you have read, understand, and agree to the requirements on this page, and
you are giving permission for information related to your Savings Program
transactions to be shared with your healthcare provider(s). These transactions
include rebates and any funds placed on the card or balance remaining on the
card.

Before you enroll for the XARELTO withMe Savings Card, you will be asked to
provide personal information that may include your name, address, phone number,
email address, and information related to your prescription medication insurance
and treatment. This information is needed for Johnson & Johnson Health Care
Systems Inc. and our service providers to enroll you for the XARELTO withMe
Savings Card. We may also use the information you give us to learn more about
the people who use XARELTO® and to improve the information we give them. Johnson
& Johnson Health Care Systems Inc. will not share your information with anyone
else except where legally allowed.

This offer may not be used with any other coupon, discount, prescription savings
card, free trial, or other offer. Offer good only in the United States and its
territories, including Puerto Rico. Void where prohibited, taxed, or limited by
law.

You may end your participation in XARELTO withMe at any time by calling
888-XARELTO (888-927-3586), Monday–Friday, 8 AM to 8 PM ET.

Sign Up as a Caregiver

Healthcare Professionals: Sign Up a Patient

XARELTO withMe Coverage Gap Support (formerly Janssen Select)

<span class='april-first'>Opens April 1:</span> <span class='december'> <span
class='nowrap'>XARELTO withMe</span> Coverage Gap Support registration will be
open April 1—December 31. Sign up now, and we will notify you if and when you
become eligible to register. </span>

Insurance started charging you more for XARELTO®?
We’ve got you covered.

Order XARELTO® directly:
$89* per 30-day supply

*Plus sales tax if applicable.

What is a coverage gap?

Has your insurance started charging you more for XARELTO®?

If your out-of-pocket costs for XARELTO® go up because of a coverage gap in your
insurance, you may qualify for XARELTO withMe Coverage Gap Support. With
Coverage Gap Support, you’ll pay $89 for a 30-day supply or $250 for a 90-day
supply, plus sales tax if applicable, for XARELTO®.

Why XARELTO withMe Coverage Gap Support?

 * Helps lower XARELTO® costs during a coverage gap (if you’re eligible)
 * Alerts you if you do enter a coverage gap
 * Delivers your prescription conveniently to your door
 * Participate without sharing your income information
 * Receive automatic refills

If you have insurance covering a portion of XARELTO® and you pay more than $89
monthly for XARELTO®, you may qualify.

See program requirements below.

XARELTO withMe Coverage Gap Support Program Requirements

You may be eligible for XARELTO withMe Coverage Gap Support if you:

 * Have insurance covering a portion of the cost of XARELTO®
 * Are being asked to pay more than $89 monthly for XARELTO® through your
   insurance

Other requirements

XARELTO withMe Coverage Gap Support is only available for people who are taking
XARELTO® as prescribed for FDA-approved, on-label use. It is not valid for any
prescription written with off-label dosing.

XARELTO withMe Coverage Gap Support is not insurance and should not take the
place of insurance.

To register, you must have insurance covering a portion of the cost for
XARELTO®, and you are being asked to pay more than $89 monthly for XARELTO®
through your insurance. The amount you pay ($89 or $250, plus sales tax if
applicable) will not count toward your deductible or cumulative out-of-pocket
spend. The amount you pay may not be submitted as a claim for payment to any
third-party payer or pharmaceutical patient assistance foundation. If you
choose, you may submit the amount you pay to a Flexible Spending Account (FSA)
or a Health Savings Account (HSA). Check with your employer if the amount you
pay may be submitted to a Health Reimbursement Account (HRA).

Registration begins April 1 each year and refills are available through December
31. Terms expire at the end of each calendar year and may change.

Before you register for XARELTO withMe Coverage Gap Support, it is important you
understand that you will be asked to provide personal information that may
include your name, address, phone number, email address, and information related
to your prescription insurance and treatment. This information will be used by
the mail-order pharmacy for Coverage Gap Support, in accordance with their
privacy practices, to determine your eligibility, and, if eligible, enroll you
in XARELTO withMe Coverage Gap Support, and administer XARELTO withMe Coverage
Gap Support. The information will also be used to learn more about the people
who use XARELTO withMe Coverage Gap Support and improve the information we give
them. It will be shared with companies supporting XARELTO withMe Coverage Gap
Support and your insurance provider, as required by law.

XARELTO withMe Coverage Gap Support may not be used with any other coupon,
discount, prescription savings card, free trial, or other offer. Offer good only
in the United States and Puerto Rico. Void where prohibited or limited by law.

You may end your participation in XARELTO withMe at any time by calling
888-XARELTO (888-927-3586), Monday–Friday, 8 AM to 8 PM ET.


XARELTO WITHME EDUCATIONAL SUPPORT

Get personalized educational content delivered right to your inbox.

 * Learn more about your condition and why it comes with a risk of blood clots
 * Understand how XARELTO® works to help protect you from serious blood
   clot-related events
 * Discover ideas to support your treatment path and set goals related to your
   condition

We currently don’t offer educational content for those prescribed XARELTO® after
a non-surgical hospitalization, children taking XARELTO® for venous
thromboembolism, or those taking XARELTO® for thromboprophylaxis after the
Fontan procedure.

When you click the "Sign Up for Support" button, your information will be used
to determine your eligibility for XARELTO withMe cost support options. You can
also sign up for XARELTO withMe Educational Support.

Sign Up for Support


INSURED PATIENTS MAY BE ELIGIBLE FOR ADDITIONAL SUPPORT FROM JANSSEN

Patient assistance from Janssen is available if you have commercial,
employer-sponsored, or government coverage that does not fully meet your needs.
You may be eligible to receive your Janssen medication free of charge for up to
one year. You must meet eligibility and income requirements for the Janssen
Patient Assistance Program. See terms and conditions at
PatientAssistanceInfo.com.

Government Coverage is coverage from government-funded healthcare programs like
Medicare, Medicaid, the Department of Defense TRICARE (DoD TRICARE), or VA
Health Care from the Veterans Health Administration.

Sign Up for Support

If you use government coverage, you may be eligible for:

XARELTO withMe Coverage Gap Support (formerly Janssen Select)

Opens April 1: XARELTO withMe Coverage Gap Support registration will be open
April 1—December 31. Sign up now, and we will notify you if and when you become
eligible to register.

Insurance started charging you more for XARELTO®?
We’ve got you covered.

Order XARELTO® directly:
$89* per 30-day supply

*Plus sales tax if applicable.

What is a coverage gap?

Has your insurance started charging you more for XARELTO®?

If your out-of-pocket costs for XARELTO® go up because of a coverage gap in your
insurance, you may qualify for XARELTO withMe Coverage Gap Support. With
Coverage Gap Support, you’ll pay $89 for a 30-day supply or $250 for a 90-day
supply, plus sales tax if applicable, for XARELTO®.

Why XARELTO withMe Coverage Gap Support?

 * Helps lower XARELTO® costs during a coverage gap (if you’re eligible)
 * Alerts you if you do enter a coverage gap
 * Delivers your prescription conveniently to your door
 * Participate without sharing your income information
 * Receive automatic refills

If you have insurance covering a portion of XARELTO® and you pay more than $89
monthly for XARELTO®, you may qualify.

See program requirements below.

XARELTO withMe Coverage Gap Support Program Requirements

You may be eligible for XARELTO withMe Coverage Gap Support if you:

 * Have insurance covering a portion of the cost of XARELTO®
 * Are being asked to pay more than $89 monthly for XARELTO® through your
   insurance

Other requirements

XARELTO withMe Coverage Gap Support is only available for people who are taking
XARELTO® as prescribed for FDA-approved, on-label use. It is not valid for any
prescription written with off-label dosing.

XARELTO withMe Coverage Gap Support is not insurance and should not take the
place of insurance.

To register, you must have insurance covering a portion of the cost for
XARELTO®, and you are being asked to pay more than $89 monthly for XARELTO®
through your insurance. The amount you pay ($89 or $250, plus sales tax if
applicable) will not count toward your deductible or cumulative out-of-pocket
spend. The amount you pay may not be submitted as a claim for payment to any
third-party payer or pharmaceutical patient assistance foundation. If you
choose, you may submit the amount you pay to a Flexible Spending Account (FSA)
or a Health Savings Account (HSA). Check with your employer if the amount you
pay may be submitted to a Health Reimbursement Account (HRA).

Registration begins April 1 each year and refills are available through December
31. Terms expire at the end of each calendar year and may change.

Before you register for XARELTO withMe Coverage Gap Support, it is important you
understand that you will be asked to provide personal information that may
include your name, address, phone number, email address, and information related
to your prescription insurance and treatment. This information will be used by
the mail-order pharmacy for Coverage Gap Support, in accordance with their
privacy practices, to determine your eligibility, and, if eligible, enroll you
in XARELTO withMe Coverage Gap Support, and administer XARELTO withMe Coverage
Gap Support. The information will also be used to learn more about the people
who use XARELTO withMe Coverage Gap Support and improve the information we give
them. It will be shared with companies supporting XARELTO withMe Coverage Gap
Support and your insurance provider, as required by law.

XARELTO withMe Coverage Gap Support may not be used with any other coupon,
discount, prescription savings card, free trial, or other offer. Offer good only
in the United States and Puerto Rico. Void where prohibited or limited by law.

You may end your participation in XARELTO withMe at any time by calling
888-XARELTO (888-927-3586), Monday–Friday, 8 AM to 8 PM ET.


XARELTO WITHME EDUCATIONAL SUPPORT

Get personalized educational content delivered right to your inbox.

 * Learn more about your condition and why it comes with a risk of blood clots
 * Understand how XARELTO® works to help protect you from serious blood
   clot-related events
 * Discover ideas to support your treatment path and set goals related to your
   condition

We currently don’t offer educational content for those prescribed XARELTO® after
a non-surgical hospitalization, children taking XARELTO® for venous
thromboembolism, or those taking XARELTO® for thromboprophylaxis after the
Fontan procedure.

When you click the "Sign Up for Support" button, your information will be used
to determine your eligibility for XARELTO withMe cost support options. You can
also sign up for XARELTO withMe Educational Support.

Sign Up for Support


INSURED PATIENTS MAY BE ELIGIBLE FOR ADDITIONAL SUPPORT FROM JANSSEN

Patient assistance from Janssen is available if you have commercial,
employer-sponsored, or government coverage that does not fully meet your needs.
You may be eligible to receive your Janssen medication free of charge for up to
one year. You must meet eligibility and income requirements for the Janssen
Patient Assistance Program. See terms and conditions at
PatientAssistanceInfo.com.


THANKS FOR YOUR INTEREST...

If you don’t have insurance, you’re not currently eligible for XARELTO withMe
cost support. However, if your insurance situation changes, you may become
eligible later. Sign up and we’ll notify you if and when you become eligible.

Alternatively, those without insurance may be eligible for other financial
support options


JOHNSON & JOHNSON PATIENT ASSISTANCE FOUNDATION, INC. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an
independent, nonprofit organization. JJPAF gives eligible patients free
prescription medicines donated by Johnson & Johnson companies. You may be
eligible if you don’t have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).


XARELTO WITHME EDUCATIONAL SUPPORT

Get personalized educational content delivered right to your inbox.

 * Learn more about your condition and why it comes with a risk of blood clots
 * Understand how XARELTO® works to help protect you from serious blood
   clot-related events
 * Discover ideas to support your treatment path and set goals related to your
   condition

We currently don’t offer educational content for those prescribed XARELTO® after
a non-surgical hospitalization, children taking XARELTO® for venous
thromboembolism, or those taking XARELTO® for thromboprophylaxis after the
Fontan procedure.

When you click the "Sign Up for Support" button, your information will be used
to determine your eligibility for XARELTO withMe cost support options. You can
also sign up for XARELTO withMe Educational Support.

Sign Up for Support


UNSURE OF WHICH TYPE OF COVERAGE YOU HAVE?

Share a few details with us and we’ll help you find out what you might be
eligible for.

Check If You Are Eligible


XARELTO WITHME EDUCATIONAL SUPPORT

Get personalized educational content delivered right to your inbox.

 * Learn more about your condition and why it comes with a risk of blood clots
 * Understand how XARELTO® works to help protect you from serious blood
   clot-related events
 * Discover ideas to support your treatment path and set goals related to your
   condition

We currently don’t offer educational content for those prescribed XARELTO® after
a non-surgical hospitalization, children taking XARELTO® for venous
thromboembolism, or those taking XARELTO® for thromboprophylaxis after the
Fontan procedure.

When you click the "Sign Up for Support" button, your information will be used
to determine your eligibility for XARELTO withMe cost support options. You can
also sign up for XARELTO withMe Educational Support.

Sign Up for Support


XARELTO WITHME FREQUENTLY ASKED QUESTIONS


WHO CAN JOIN XARELTO WITHME?

You can enroll in XARELTO withMe if you are taking XARELTO® as prescribed for
FDA-approved, on-label use. Eligibility for program components may vary.


DOES XARELTO WITHME HAVE A FEE?

No, there are no costs or hidden fees to enroll in XARELTO withMe.


WHAT HAPPENED TO JANSSEN SELECT AND JANSSEN CAREPATH FOR XARELTO®? WHY IS THE
NAME CHANGING?

As part of our continuing efforts to deliver support that best meets the needs
of patients, Janssen is pleased to introduce XARELTO withMe—a customized support
experience for patients who are prescribed XARELTO®. XARELTO withMe brings
together our patient support resources for XARELTO®—including the Janssen
CarePath Savings Program, Janssen Select, and educational content from
XARELTO.com

The new name, XARELTO withMe, reflects Janssen’s commitment to offering a
personalized support experience that’s focused on you.

During this transition, you may continue to see the Janssen CarePath name on
some resources and communications.

Read full FAQs

WHAT IS XARELTO® (rivaroxaban)?

XARELTO® is a prescription medicine used to:

 * reduce the risk of stroke and blood clots in adults who have a medical
   condition called atrial fibrillation that is not caused by a heart valve
   problem. With atrial fibrillation, part of the heart does not beat the way it
   should. This can lead to the formation of blood clots, which can travel to
   the brain, causing a stroke, or to other parts of the body
 * treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or
   lungs (pulmonary embolism or PE)
 * reduce the risk of blood clots from happening again in adults who continue to
   be at risk for DVT or PE after receiving treatment for blood clots for at
   least 6 months
 * help prevent a blood clot in the legs and lungs of adults who have just had
   hip or knee replacement surgery
 * help prevent blood clots in certain adults hospitalized for an acute illness
   and after discharge, who are at risk of getting blood clots because of the
   loss of or decreased ability to move around (mobility) and other risks for
   getting blood clots, and who do not have a high risk of bleeding

XARELTO® is used with low dose aspirin to:

 * reduce the risk of serious heart problems, heart attack and stroke in adults
   with coronary artery disease (a condition where the blood supply to the heart
   is reduced or blocked)
 * reduce the risk of a sudden decrease in blood flow to the legs, major
   amputation, serious heart problems or stroke in adults with peripheral artery
   disease (a condition where the blood flow to the legs is reduced) and
   includes adults who have recently had a procedure to improve blood flow to
   the legs

XARELTO® is used in children to:

 * treat blood clots or reduce the risk of blood clots from happening again in
   children from birth to less than 18 years, after receiving at least 5 days of
   treatment with injectable or intravenous medicines used to treat blood clots
 * help prevent blood clots in children 2 years and older with congenital heart
   disease after the Fontan procedure

XARELTO® was not studied and is not recommended in children less than 6 months
of age who:

 * were less than 37 weeks of growth (gestation) at birth
 * had less than 10 days of oral feeding, or
 * had a body weight of less than 5.7 pounds (2.6 kg)

IMPORTANT SAFETY INFORMATION

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 (an irregular heart beat) that is not caused by a heart valve
   problem (nonvalvular) 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 be at 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:
   * Nosebleeds that happen often
   * Unusual bleeding from 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

 

 * 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)
 * or 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.

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 of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions,
including if you or your child:

 * Have 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. See “What is the most
     important information I should know about XARELTO®?” for signs and symptoms
     of bleeding.
 * Are breastfeeding or plan to breastfeed. XARELTO® may 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. See “What is the
most important information I should know about XARELTO®?”

HOW SHOULD I TAKE XARELTO®?

 * 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, XARELTO® may be taken 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 to 100 mg once daily 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 on how to properly give a dose of
   XARELTO® oral suspension to your child.
 * Do not switch between the XARELTO® oral suspension or tablet without first
   talking to your doctor.
 * If your child vomits or spits up:
   * right after or within 30 minutes of taking the oral suspension, give a new
     full dose.
   * more than 30 minutes after taking the oral suspension, do not give the dose
     again. Give the next dose at the regularly scheduled time.
   * if vomiting or spitting up persists, contact your child’s doctor right
     away.
 * If your child misses a dose:
   * If your child is taking XARELTO® 1 time a day, give the dose as soon as you
     remember on the same day. If this is not possible, skip this dose and give
     the next dose at the regularly scheduled time.
   * If your child is taking XARELTO® 2 times a day, give the missed morning
     dose as soon as you remember. You may give the missed morning dose together
     with the evening dose. However, a missed evening dose can only be taken in
     the same evening.
   * If your child is taking XARELTO® 3 times a day, skip the missed dose and
     give the next dose at the regularly scheduled time.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

XARELTO® may cause serious side effects:

 * See “What is the most important information I should know about XARELTO®?”

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. You may also report side effects to Janssen
Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please read full Prescribing Information, including Boxed Warnings, and
Medication Guide for XARELTO®.

Trademarks are those of their respective owners.

cp-53637v8

 
Expand +

WHAT IS XARELTO® (rivaroxaban)?

XARELTO® is a prescription medicine used to:

 * reduce the risk of stroke and blood clots in adults who have a medical
   condition called atrial fibrillation that is not caused by a heart valve
   problem. With atrial fibrillation, part of the heart does not beat the way it
   should. This can lead to the formation of blood clots, which can travel to
   the brain, causing a stroke, or to other parts of the body
 * treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or
   lungs (pulmonary embolism or PE)
 * reduce the risk of blood clots from happening again in adults who continue to
   be at risk for DVT or PE after receiving treatment for blood clots for at
   least 6 months
 * help prevent a blood clot in the legs and lungs of adults who have just had
   hip or knee replacement surgery
 * help prevent blood clots in certain adults hospitalized for an acute illness
   and after discharge, who are at risk of getting blood clots because of the
   loss of or decreased ability to move around (mobility) and other risks for
   getting blood clots, and who do not have a high risk of bleeding

XARELTO® is used with low dose aspirin to:

 * reduce the risk of serious heart problems, heart attack and stroke in adults
   with coronary artery disease (a condition where the blood supply to the heart
   is reduced or blocked)
 * reduce the risk of a sudden decrease in blood flow to the legs, major
   amputation, serious heart problems or stroke in adults with peripheral artery
   disease (a condition where the blood flow to the legs is reduced) and
   includes adults who have recently had a procedure to improve blood flow to
   the legs

XARELTO® is used in children to:

 * treat blood clots or reduce the risk of blood clots from happening again in
   children from birth to less than 18 years, after receiving at least 5 days of
   treatment with injectable or intravenous medicines used to treat blood clots
 * help prevent blood clots in children 2 years and older with congenital heart
   disease after the Fontan procedure

XARELTO® was not studied and is not recommended in children less than 6 months
of age who:

 * were less than 37 weeks of growth (gestation) at birth
 * had less than 10 days of oral feeding, or
 * had a body weight of less than 5.7 pounds (2.6 kg)

IMPORTANT SAFETY INFORMATION

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 (an irregular heart beat) that is not caused by a heart valve
   problem (nonvalvular) 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 be at 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:
   * Nosebleeds that happen often
   * Unusual bleeding from 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

 

 * 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)
 * or 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.

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 of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions,
including if you or your child:

 * Have 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. See “What is the most
     important information I should know about XARELTO®?” for signs and symptoms
     of bleeding.
 * Are breastfeeding or plan to breastfeed. XARELTO® may 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. See “What is the
most important information I should know about XARELTO®?”

HOW SHOULD I TAKE XARELTO®?

 * 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, XARELTO® may be taken 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 to 100 mg once daily 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 on how to properly give a dose of
   XARELTO® oral suspension to your child.
 * Do not switch between the XARELTO® oral suspension or tablet without first
   talking to your doctor.
 * If your child vomits or spits up:
   * right after or within 30 minutes of taking the oral suspension, give a new
     full dose.
   * more than 30 minutes after taking the oral suspension, do not give the dose
     again. Give the next dose at the regularly scheduled time.
   * if vomiting or spitting up persists, contact your child’s doctor right
     away.
 * If your child misses a dose:
   * If your child is taking XARELTO® 1 time a day, give the dose as soon as you
     remember on the same day. If this is not possible, skip this dose and give
     the next dose at the regularly scheduled time.
   * If your child is taking XARELTO® 2 times a day, give the missed morning
     dose as soon as you remember. You may give the missed morning dose together
     with the evening dose. However, a missed evening dose can only be taken in
     the same evening.
   * If your child is taking XARELTO® 3 times a day, skip the missed dose and
     give the next dose at the regularly scheduled time.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

XARELTO® may cause serious side effects:

 * See “What is the most important information I should know about XARELTO®?”

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. You may also report side effects to Janssen
Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please read full Prescribing Information, including Boxed Warnings, and
Medication Guide for XARELTO®.

Trademarks are those of their respective owners.

cp-53637v8

 

© Janssen Pharmaceuticals, Inc. 2024.

This site is published by Janssen Pharmaceuticals, Inc., which is solely
responsible for its contents. The material on this site is intended only as
informational or as an educational aid and it is not intended to be taken as
medical advice. The ultimate responsibility for patient care resides with a
healthcare professional.

This information is intended for the use of patients and caregivers in the
United States and Puerto Rico only. Laws, regulatory requirements, and medical
practices for pharmaceutical products vary from country to country. The
Prescribing Information included here may not be appropriate for use outside the
United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Last updated 03/24

Last updated 08/24

cp-368026v4

cp-368026v5

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