FDA Approves XARELTO® (rivaroxaban) to Treat Deep Vein Thrombosis and
Pulmonary Embolism, and to Reduce the Risk of Recurrent Events
XARELTO® Has the Broadest Indication Profile of Any New Oral Anticoagulant
RARITAN, N.J., Nov. 2, 2012
RARITAN, N.J., Nov. 2, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc.
(Janssen) today announced the U.S. Food and Drug Administration (FDA) has
approved XARELTO^® (rivaroxaban), an oral anticoagulant, for the treatment of
deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the
risk of recurrence of DVT and PE following initial treatment.
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XARELTO^® is the first and only oral anticoagulant approved to treat DVT and
PE without the need for injections orroutine blood monitoring, and was
approved for these three new indications on a priority review timeline (6
months). Today's approvals distinguish XARELTO^® as having the broadest
profile of any of the new oral anticoagulants in the U.S. market today or
coming to market in the foreseeable future.
"XARELTO^® provides a single-drug treatment option from the moment of
diagnosis through the completion of therapy, and in the initial treatment
phase, it can cut a patient's risk of major bleeding by nearly half," said
Jack E. Ansell*, M.D., MACP, Professor of Medicine at New York University
School of Medicine and Chairman of the Department of Medicine at Lenox Hill
Hospital in New York. "Venous blood clots are associated with a high risk of
serious complications^1, so the approval of XARELTO^® will immediately impact
how we treat these patients and may set a new standard of care."
DVT is a condition in which blood clots form in one of the large, deep veins,
usually in the legs. PE is a serious condition that most commonly occurs when
part or all of a DVT dislodges and travels to the lung, via the heart, where
it can partially or completely block a branch of the pulmonary artery. When PE
occurs with large clots, multiple clots, or when the patient already has
pre-existing heart or lung disease, the event may be fatal. Each year up to
900,000 Americans experience a DVT or PE, resulting in up to 300,000 deaths.^2
"Today's FDA approvals of XARELTO^® offer physicians an effective, safe and
convenient medication for treating patients with a DVT or PE, while reducing
their risk of recurrent events," said Larry E. Fields, M.D., Senior Director,
Clinical Development, Medical Affairs at Janssen. "We are pleased the FDA has
broadened the indications for XARELTO^® to include these new uses. These are
in addition to its previously approved indications, which include reducing the
risk of stroke in patients with nonvalvular atrial fibrillation, and reducing
the risk of DVTs and PEs associated with hip or knee replacement surgery."
XARELTO^® is approved to treat patients with DVT or PE at a dose of 15 mg
twice daily for three weeks, followed by 20 mg once daily for the remaining
treatment period.XARELTO^® also is approved to reduce the risk of recurrence
of DVT and PE at a dose of 20 mg once daily following an initial six months of
treatment for acute venous thromboembolism.
The approvals of XARELTO^® for these three new uses were based on data from
the global EINSTEIN program, which included two Phase 3 studies evaluating the
safety and efficacy of XARELTO^® in the treatment of patients with acute
symptomatic DVT or PE and the prevention of recurrent, symptomatic DVT and PE.
A third Phase 3 study evaluated the safety and efficacy of XARELTO^® in the
long-term prevention of recurrent symptomatic DVT and PE. In total, these
Phase 3 studies included more than 9,400 patients, making it the largest DVT
and PE treatment-related Phase 3 clinical trial program ever conducted.
XARELTO^® is broadly reimbursed for more than 90% of commercial and Medicare
health plan members, with the majority covered at the lowest branded co-pay.
To date, more than 2.5 million patients have received XARELTO^® worldwide and
more than 760,000 prescriptions have been written for XARELTO^® in the U.S.
Janssen Pharmaceuticals, Inc. holds U.S. marketing rights for XARELTO^®, and
is supported by the Bayer HealthCare U.S. sales force in designated hospital
About XARELTO^® (rivaroxaban)
Unlike other oral anticoagulants available in the U.S., only XARELTO^® works
by blocking the blood clotting Factor Xa. XARELTO^® does not require routine
blood monitoring, and is approved for six distinct uses:
1.To reduce the risk of blood clots in the legs and lungs of people who have
just had knee replacement surgery.
2.To reduce the risk of blood clots in the legs and lungs of people who have
just had hip replacement surgery.
3.To reduce the risk of both hemorrhagic and thrombotic strokes as well as
other blood clots in people with atrial fibrillation not caused by a heart
valve problem. There is limited information on how XARELTO^® compares to a
medicine called warfarin in reducing the risk of stroke when the effects
of warfarin are well-controlled.
4.To treat people with pulmonary embolism (PE).
5.To treat people with deep vein thrombosis (DVT).
6.To reduce the risk of recurrence of DVT or PE following an initial six
months of treatment for acute venous thromboembolism.
The extensive program of clinical trials evaluating rivaroxaban makes the
compound the most studied oral, Factor Xa inhibitor in the world today. By the
time of its completion, more than 75,000 patients will have participated in
the rivaroxaban clinical development program. There are two additional
indications currently submitted and under review at the FDA.
Janssen Research & Development, LLC, and Bayer HealthCare together are
The XARELTO^® CarePath™ Support Program is a resource designed for health care
providers, patients and caregivers. Visit goxarelto.com or call
1-888-XARELTOto learn more about the XARELTO^® CarePath™ resources focused on
access, education and adherence.
Important Safety Information
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO^®?
oFor people taking XARELTO^® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) 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.
oXARELTO^® can cause bleeding, which can be serious, and rarely may lead to
death. This is because XARELTO^® is a blood thinner medicine that reduces
blood clotting. While you take 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 take other
medicines that increase your risk of bleeding, including:
oAspirin or aspirin-containing products
oNon-steroidal anti-inflammatory drugs (NSAIDs)
oWarfarin sodium (Coumadin^®, Jantoven^®)
oAny medicine that contains heparin
oOther 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 develop any of these
signs or symptoms of bleeding:
oUnexpected bleeding or bleeding that lasts a long time such as:
oNosebleeds that happen often
oUnusual bleeding from gums
oMenstrual bleeding that is heavier than normal, or vaginal bleeding
oBleeding that is severe or that you cannot control
oRed, pink, or brown urine
oBright red or black stools (looks like tar)
oCough up blood or blood clots
oVomit blood or your vomit looks like "coffee grounds"
oHeadaches, feeling dizzy or weak
oPain, 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 than 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
oa thin tube called an epidural catheter is placed in your back to give you
oyou take NSAIDs or a medicine to prevent blood from clotting
oyou have a history of difficult or repeated epidural or spinal punctures
oyou have a history of problems with your spine or have had surgery on your
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 tingling, numbness, or muscles
weakness, especially in your legs and feet.
WHO SHOULD NOT TAKE XARELTO^®?
Do not take XARELTO^® if you:
oCurrently have certain types of abnormal bleeding.Talk to your doctor
before taking XARELTO^® if you currently have unusual bleeding.
oAre allergic to rivaroxaban or any of the ingredients of XARELTO^®.
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO^®?
Before taking XARELTO^®, tell your doctor if you:
oHave ever had bleeding problems
oHave liver or kidney problems
oHave any other medical condition
oAre 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
while taking XARELTO^®.If you take XARELTO^® during pregnancy, tell your
doctor right away if you have bleeding or symptoms of blood loss.
oAre breastfeeding or plan to breastfeed. It is not known if XARELTO^®
passes into your breast milk.You and your doctor should decide if you
will take XARELTO^® or breastfeed.
Tell all of your doctors and dentists that you 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 take, including prescription and
nonprescription medicines, vitamins, and herbal supplements. Some of your
other medicines may affect the way XARELTO^® works. Certain medicines may
increase your risk of bleeding.
Especially tell your doctor if you take:
oItraconazole (Onmel™, Sporanox^®)
oCarbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol^®-XR, Teril™,
oPhenytoin (Dilantin-125^®, Dilantin^®)
oRifampin (Rifater^®, Rifamate^®, Rimactane^®, Rifadin^®)
oSt. John's wort (Hypericum perforatum)
Ask your doctor if you are not sure if your medicine is one listed above. Know
the medicines you take. Keep a list of them to show your doctor and pharmacist
when you get a new medicine.
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.
oYour doctor will decide how long you should take XARELTO^®. Do not stop
taking XARELTO^® without talking with your doctor first.
oYour doctor may change your dose if needed,
For people who have:
oAtrial Fibrillation: Take XARELTO^® 1 time a day with your evening
meal. Stopping XARELTO^® may increase your risk of having a stroke or
forming blood clots in other parts of your body.
oBlood clots in the veins of your legs or lungs:
oTo treat blood clots, take XARELTO^® once or twice a day according
to your doctor's instructions.XARELTO^® is usually taken with
food.Take XARELTO^® at the same time each day.
oHip or knee replacement surgery: Take XARELTO^® 1 time a day with or
oYour doctor may stop XARELTO^® for a short time before any surgery,
medical or dental procedure. Your doctor will tell you when to start
taking XARELTO^® again after your surgery or procedure.
oDo not run out of XARELTO^®. Refill your prescription for XARELTO^® before
you run out. When leaving the hospital following a hip or knee
replacement, be sure that you have XARELTO^® available to avoid missing
oIf you miss a dose of XARELTO^®, take it as soon as you remember on the
same day and continue with your next regularly scheduled dose.
oIf you take too much XARELTO^®, go to the nearest hospital emergency room
or call your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO^®?
XARELTO^® can cause bleeding, which can be serious, and rarely may lead to
death. Please see "What is the most important information I should know about
Tell your doctor if you have any side effect that bothers you or that does not
Call your doctor formedical advice about side effects. You are also
encouraged to report side effects to the FDA: visit
http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side
effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full prescribing information, including Boxed Warnings
and the Medication Guide.
Trademarks are those of their respective owners.
*Dr. Ansell was not associated with the EINSTEIN clinical trials and was not
compensated for any media work. He has been a paid consultant to Janssen
About Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson,
Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the
major unmet medical needs of our time. Driven by our commitment to patients,
healthcare professionals, and caregivers, we strive to develop sustainable and
integrated healthcare solutions by working in partnership with all
stakeholders on the basis of trust and transparency. Our daily work is guided
by meeting goals of excellence in quality, innovation, safety, and efficacy in
order to advance patient care.
Our company provides medicines for an array of health concerns in several
therapeutic areas. Other innovative therapies that Janssen Pharmaceuticals,
Inc. offers include ACIPHEX^® (rabeprazole sodium), DORIBAX^® (doripenem for
injection), ELMIRON^® (pentosan polysulfate sodium), NUCYNTA^® (tapentadol)
and NUCYNTA^® ER (tapentadol extended-release tablets). The full prescribing
information for NUCYNTA^® and NUCYNTA^® ER, including boxed warnings, are
available here and here.
For more information on Janssen Pharmaceuticals, Inc., visit us at
www.janssenpharmaceuticalsinc.comor follow us on Twitter at
www.twitter.com/JanssenUSand on YouTube at www.Youtube.com/JanssenUS.
^1Heit JA. The epidemiology of venous thromboembolism in the community:
implications for prevention and management. J Thromb Thrombolysis.
^2Roger VL, Go AS, Lloyd DM, et al. Heart disease and stroke statistics- 2012
Update: A report from the American Heart Association. Circulation.
SOURCE Janssen Pharmaceuticals
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