Real-World Data Presented at American Geriatrics Society Meeting Show Consistent Safety of XARELTO® in Elderly Patients

National Harbor, MD (May 15, 2015) — New data from an ongoing post-marketing study evaluating the safety of once-daily XARELTO^® (rivaroxaban) in patients with non-valvular atrial fibrillation (NVAF) were presented at the American Geriatrics Society 2015 Annual Scientific Meeting. The data show the rates of major bleeding and fatal outcomes in elderly patients treated in routine clinical practice generally are consistent with those reported in Phase 3 clinical trials, which show a correlation between increased age and bleeding.

“The data from this ongoing five-year observational study reaffirm the safety profile of XARELTO^®, including in elderly patients who are at a particularly increased risk for adverse events, like bleeding,” said study investigator W. Frank Peacock, M.D., FACEP, Associate Chair and Research Director, Emergency Medicine, Baylor College of Medicine, Houston, TX. “These real-world results are important as clinicians evaluate treatment options for high-risk non-valvular atrial fibrillation patients who are also at the greatest risk of having a stroke.”

Researchers reviewed data from nearly 10 million electronic healthcare records from the U.S. Department of Defense (DoD), via a collaboration with Health ResearchTx LLC (HRTX), to evaluate major bleeding rates in NVAF patients treated with XARELTO^® in the real-world setting. Of the 31,883 patients using XARELTO®, an incidence of major bleeding was observed at 2.85 per 100 person-years, with 74.1 percent of these events occurring in those 75 years of age and older. Gastrointestinal bleeding was the most common bleeding event in all age groups, followed by intracranial hemorrhage (ICH). The rate of ICH increased with age. Fatal outcomes as a result of major bleeding were low, and the mean age of those who died was 82.1 years. Comorbidities were more prevalent in the group experiencing major bleeding compared to those not experiencing major bleeding across all ages. Overall, the results were generally consistent with rates reported in the landmark ROCKET-AF clinical trial.

“Our post-marketing safety program demonstrates Janssen’s commitment to better understanding the safety of our medicine in all types of patients, particularly ones at high risk and with the greatest need,” said Paul Burton, M.D., Ph.D., Vice President, Medical Affairs, Janssen. “The program will include more than 74,000 patients and will continue to provide important real-world data across a variety of comorbidities that help doctors optimize care for people taking XARELTO^®.”

Janssen Pharmaceuticals, Inc. (Janssen) designed the post-marketing safety surveillance (PMSS) study, in conjunction with DoD and HRTX, and in agreement with the U.S. Food and Drug Administration (FDA), to proactively ascertain, analyze and report potential side effects of XARELTO^® use, including major bleeding events, associated risk factors and bleeding-related clinical outcomes in NVAF patients taking XARELTO^®.

Major bleeding cases for the study were ascertained using a validated Cunningham (2011) algorithm, which was generally consistent with, but not identical to, the definition of major bleeding used in clinical studies, because it relied on retrospectively-identified electronic medical records. While the results are not intended for any direct comparison, these data show rates and patterns of major bleeding were generally consistent with those reported in the previous large, randomized, FDA registration trial of XARELTO^®.

By the time of its completion, more than 275,000 patients will have participated in the XARELTO^® clinical development program, other completed and ongoing clinical trials, investigative registries, and non-interventional studies. As a part of this program, Janssen is conducting a number of post-marketing surveillance studies, through its ongoing development partnership with Bayer HealthCare, to further assess the benefit-risk profile of XARELTO^® in real-world settings. Results to date have shown the safety and efficacy observed since the medicine was approved are generally consistent with completed Phase 3 clinical trials. It is anticipated that by July 2015, this robust program of Phase 4 observational studies will include more than 74,000 patients across six approved indications.

About XARELTO® (rivaroxaban)

XARELTO^® works by blocking the blood clotting Factor Xa. XARELTO^® does not require routine blood monitoring. XARELTO^® has a broad indication profile and is approved for six indications that include:

1. To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO^® and warfarin compare in reducing the risk of stroke.
2. To treat patients with deep vein thrombosis (DVT).
3. To treat patients with pulmonary embolism (PE).
   
4. To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
   
5. To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
   
6. To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.

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 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 patients with artificial heart valves.

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

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 tell you how much XARELTO^®to take and when to take it.
  
• Your doctor may change your dose if needed.

If you take XARELTO^® for:

• Atrial Fibrillation: 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^® once or twice a day as prescribed by your doctor.
    
  • Take XARELTO^® with food at the same time each day.
    

  • If you miss a dose of XARELTO^®:

    • and take XARELTO^® 2 times a 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.
      
    • and 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.
  
• If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.
  
• Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO®without talking to your doctor first.
  
• 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 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®?

Please see “What is the most important information I should know about XARELTO®?” above.

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).

Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.

Janssen and Bayer HealthCare together are developing rivaroxaban.

For more information about XARELTO®, visit www.xarelto-us.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence.

About Janssen At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit JanssenPharmaceuticalsInc.com for more information.

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