|By PR Newswire||
|November 2, 2012 05:37 PM EDT||
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.
To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/58325-xarelto-rivaroxaban-deep-vein-thrombosis-dvt-pulmonary-embolism-pe-fda
XARELTO® is the first and only oral anticoagulant approved to treat DVT and PE without the need for injections or routine 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 complications1, 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 accounts.
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:
- To reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery.
- To reduce the risk of blood clots in the legs and lungs of people who have just had hip replacement surgery.
- 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.
- To treat people with pulmonary embolism (PE).
- To treat people with deep vein thrombosis (DVT).
- 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 developing rivaroxaban.
The XARELTO® CarePath™ Support Program is a resource designed for health care providers, patients and caregivers. Visit goxarelto.com or call 1-888-XARELTO to 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®?
- For 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.
- XARELTO® 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:
- Aspirin or aspirin-containing products
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin®, Jantoven®)
- Any medicine that contains heparin
- Clopidogrel (Plavix®)
- 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 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 that 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 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 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 tingling, numbness, or muscles weakness, especially in your legs and feet.
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:
- 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®.
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor if you:
- Have ever had bleeding problems
- Have liver or kidney problems
- Have any other medical condition
- 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 while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.
- Are 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:
- Ketoconazole (Nizoral®)
- Itraconazole (Onmel™, Sporanox®)
- Ritonavir (Norvir®)
- Lopinavir/ritonavir (Kaletra®)
- Indinavir (Crixivan®)
- Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)
- Phenytoin (Dilantin-125®, Dilantin®)
- Phenobarbital (Solfoton™)
- Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
- St. 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.
- Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking with your doctor first.
- Your doctor may change your dose if needed,
For people who have:
- Atrial 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.
- Blood clots in the veins of your legs or lungs:
- To 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.
- Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food.
- Your 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.
- Do 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 any doses.
- If 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.
- If 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 XARELTO®?"
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical 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).
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 Pharmaceuticals, Inc.
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.
1 Heit JA. The epidemiology of venous thromboembolism in the community: implications for prevention and management. J Thromb Thrombolysis. 2006;21:23-29.
2 Roger VL, Go AS, Lloyd DM, et al. Heart disease and stroke statistics- 2012 Update: A report from the American Heart Association. Circulation. 2012;25(1):e12-e230.
SOURCE Janssen Pharmaceuticals
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
May. 31, 2016 09:15 PM EDT Reads: 1,016
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
May. 31, 2016 09:00 PM EDT Reads: 2,082
18th Cloud Expo, taking place June 7-9, 2016, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some...
May. 31, 2016 09:00 PM EDT Reads: 3,334
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
May. 31, 2016 08:30 PM EDT Reads: 1,246
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...
May. 31, 2016 08:00 PM EDT Reads: 2,509
SYS-CON Events announced today that IBM Cloud Data Services has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. IBM Cloud Data Services offers a portfolio of integrated, best-of-breed cloud data services for developers focused on mobile computing and analytics use cases.
May. 31, 2016 07:15 PM EDT Reads: 1,805
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
May. 31, 2016 07:15 PM EDT Reads: 1,911
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, will discuss the importance of WebRTC and how it enables companies to fo...
May. 31, 2016 04:45 PM EDT Reads: 2,666
"What we see what happens when you have a completely networked society and the potential to now drive the value creation and the collaboration and the ecosystems that are possible when you start to be able to connect people and industries together in ways that have never been possible before," explained Esmeralda Swartz, VP of Marketing Enterprise & Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
May. 31, 2016 04:45 PM EDT Reads: 1,917
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 31, 2016 02:30 PM EDT Reads: 1,508
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 31, 2016 02:00 PM EDT Reads: 3,155
Customer experience has become a competitive differentiator for companies, and it’s imperative that brands seamlessly connect the customer journey across all platforms. With the continued explosion of IoT, join us for a look at how to build a winning digital foundation in the connected era – today and in the future. In his session at @ThingsExpo, Chris Nguyen, Group Product Marketing Manager at Adobe, will discuss how to successfully leverage mobile, rapidly deploy content, capture real-time d...
May. 31, 2016 01:45 PM EDT Reads: 1,811
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
May. 31, 2016 12:30 PM EDT Reads: 1,431
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
May. 31, 2016 12:00 PM EDT Reads: 1,520
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
May. 31, 2016 12:00 PM EDT Reads: 2,641
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 31, 2016 11:45 AM EDT Reads: 2,145
SYS-CON Events announced today that MobiDev will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobile software company with over 200 develope...
May. 31, 2016 10:15 AM EDT Reads: 2,951
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 31, 2016 09:00 AM EDT Reads: 2,462
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 31, 2016 08:45 AM EDT Reads: 2,435
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
May. 31, 2016 08:00 AM EDT Reads: 2,376