|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
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Oct. 24, 2016 07:30 PM EDT Reads: 3,188
SYS-CON Events announced today that Cloudbric, a leading website security provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Cloudbric is an elite full service website protection solution specifically designed for IT novices, entrepreneurs, and small and medium businesses. First launched in 2015, Cloudbric is based on the enterprise level Web Application Firewall by Penta Security Sys...
Oct. 24, 2016 07:15 PM EDT Reads: 1,149
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 24, 2016 07:15 PM EDT Reads: 1,042
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 24, 2016 06:15 PM EDT Reads: 4,739
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
Oct. 24, 2016 05:45 PM EDT Reads: 1,495
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Oct. 24, 2016 05:00 PM EDT Reads: 3,627
SYS-CON Events announced today that Coalfire will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Coalfire is the trusted leader in cybersecurity risk management and compliance services. Coalfire integrates advisory and technical assessments and recommendations to the corporate directors, executives, boards, and IT organizations for global brands and organizations in the technology, cloud, health...
Oct. 24, 2016 04:45 PM EDT Reads: 1,565
SYS-CON Events announced today that Transparent Cloud Computing (T-Cloud) Consortium will exhibit at the 19th International Cloud Expo®, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The Transparent Cloud Computing Consortium (T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data proces...
Oct. 24, 2016 04:30 PM EDT Reads: 1,365
The Internet of Things (IoT), in all its myriad manifestations, has great potential. Much of that potential comes from the evolving data management and analytic (DMA) technologies and processes that allow us to gain insight from all of the IoT data that can be generated and gathered. This potential may never be met as those data sets are tied to specific industry verticals and single markets, with no clear way to use IoT data and sensor analytics to fulfill the hype being given the IoT today.
Oct. 24, 2016 04:15 PM EDT Reads: 2,600
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
Oct. 24, 2016 04:15 PM EDT Reads: 2,766
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Oct. 24, 2016 04:00 PM EDT Reads: 3,722
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Oct. 24, 2016 02:15 PM EDT Reads: 3,953
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
Oct. 24, 2016 02:00 PM EDT Reads: 34,155
SYS-CON Events announced today that MathFreeOn will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. MathFreeOn is Software as a Service (SaaS) used in Engineering and Math education. Write scripts and solve math problems online. MathFreeOn provides online courses for beginners or amateurs who have difficulties in writing scripts. In accordance with various mathematical topics, there are more tha...
Oct. 24, 2016 01:00 PM EDT Reads: 1,012
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 24, 2016 01:00 PM EDT Reads: 860
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
Oct. 24, 2016 01:00 PM EDT Reads: 899
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 24, 2016 12:30 PM EDT Reads: 1,019
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Oct. 24, 2016 12:15 PM EDT Reads: 8,435
SYS-CON Events announced today that Niagara Networks will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Oct. 24, 2016 11:45 AM EDT Reads: 1,316
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and ...
Oct. 24, 2016 11:45 AM EDT Reads: 1,526