Last update 16 Dec 2024
Warfarin Sodium
Last update 16 Dec 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Warfarin sodium (USP), Coumadin, Jantoven + [4] |
Target |
Mechanism VKOR inhibitors(Vitamin K epOxide reductase complex subunit 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (08 Jun 1954), |
Regulation- |
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Structure
Molecular FormulaC19H16NaO4 |
InChIKeyFSSPYKRRYDTFQZ-UHFFFAOYSA-N |
CAS Registry129-06-6 |
Related
88
Clinical Trials associated with Warfarin Sodium一项在健康受试者中评价TG103注射液对缬沙坦胶囊、华法林钠片、阿托伐他汀钙片和地高辛片的药代动力学影响的I期临床试验
[Translation] A Phase I clinical trial evaluating the effect of TG103 injection on the pharmacokinetics of valsartan capsules, warfarin sodium tablets, atorvastatin calcium tablets, and digoxin tablets in healthy subjects
主要目的：
队列1：在中国健康受试者中评价TG103注射液对缬沙坦胶囊和华法林钠片的药代动力学（Pharmacokinetics，PK）影响。
队列2：在中国健康受试者中评价TG103注射液对阿托伐他汀钙片和地高辛片的PK影响。
次要目的：
队列1：在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性；评价TG103注射液对华法林钠片药效动力学（Pharmacodynamics，PD）的影响；TG103注射液、缬沙坦胶囊和华法林钠片的安全性和耐受性；初步探索中国健康受试者中TG103注射液对QTc间期的影响。
队列2：在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性；评价TG103注射液、阿托伐他汀钙片和地高辛片的安全性和耐受性。
[Translation]
Primary objectives:
Cohort 1: To evaluate the effect of TG103 injection on the pharmacokinetics (PK) of valsartan capsules and warfarin sodium tablets in healthy Chinese subjects.
Cohort 2: To evaluate the effect of TG103 injection on the PK of atorvastatin calcium tablets and digoxin tablets in healthy Chinese subjects.
Secondary objectives:
Cohort 1: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the effect of TG103 injection on the pharmacodynamics (PD) of warfarin sodium tablets; the safety and tolerability of TG103 injection, valsartan capsules and warfarin sodium tablets; to preliminarily explore the effect of TG103 injection on the QTc interval in healthy Chinese subjects.
Cohort 2: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the safety and tolerability of TG103 injection, atorvastatin calcium tablets and digoxin tablets.
Start Date10 Oct 2024 |
Sponsor / Collaborator |
Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported with a Left Ventricular Assist Device
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.
This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.
This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.
Start Date02 Oct 2024 |
Sponsor / Collaborator  Columbia University [+1] |
The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with Non-Valvular Atrial Fibrillation/ Venous Thromboembolism and End-Stage Kidney Disease on Dialysis
This is a retrospective study of End-Stage Kidney Disease (ESKD) patients on dialysis receiving apixaban or warfarin at Tawam Hospital [a tertiary care hospital in Al Ain, UAE]. The study aims to assess the appropriateness of prescribing apixaban and warfarin in this population and evaluate their safety and effectiveness.
Start Date01 Jan 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with Warfarin Sodium
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100 Translational Medicine associated with Warfarin Sodium
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100 Patents (Medical) associated with Warfarin Sodium
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1,734
Literatures (Medical) associated with Warfarin Sodium01 Nov 2024·Annales de cardiologie et d'angeiologie
Article
Author: Belabed, M R ; Berdague, P ; Hoara, M C ; Georger, F ; Simorre, B
Libman-Sacks endocarditis is a rare cardiac manifestation of anti-phospholipid syndromes, in which non-infectious thrombotic vegetations are found on the heart valves. Most patients are asymptomatic whereas the risk of thromboembolism is considerable. Diagnostic work-up is based on questioning and clinical examination data looking for extracardiac signs, biological data and also on imaging, and, above all, echocardiography. We report the case of a 47-year-old female patient with no known history who is admitted to hospital with paresthesia of the right hemi-body associated with dysarthria. Cerebral CT scan confirms a paraventricular ischemic stroke. The etiological work-up for stroke is negative except the transesophageal echocardiogram which reveals mitral valve vegetations. Further investigations lead to the diagnosis of Libman-Sacks endocarditis. Treatment with Coumadin is started, with a target INR of between 2 and 3, as recommended. The clinical course was favourable, with stable lesions on transoesophageal echocardiography carried out later.
01 Oct 2024·Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
Iatrogenic pseudoaneurysm of the middle meningeal artery during embolization of bilateral chronic subdural hematomas
Article
Author: Gemmete, Joseph J. ; Chaudhary, Neeraj ; Khan, Adam A. ; Wilseck, Zachary M.
Summary/Abstract Middle meningeal artery embolization has become an important treatment option for chronic subdural hematomas. While the treatment is safe, we present a unique case of development of an iatrogenic middle meningeal artery pseudoaneurysm during endovascular embolization with use of a dual-lumen balloon catheter used for injection of a liquid embolic agent. A 62-year-old man on Coumadin for portal vein thrombosis presented to the hospital with headache and supratherapeutic INR. Imaging revealed bilateral acute on chronic subdural hematomas. Given his medical comorbidities he underwent endovascular middle meningeal artery embolization. During the embolization, angiography revealed a pseudoaneurysm of the middle meningeal artery related to use of a dual-lumen balloon catheter. This pseudoaneurysm was successfully treated with ethylene vinyl alcohol embolization. Intracranial pseudoaneurysm related to balloon catheter use is a rare cause of iatrogenic pseudoaneurysm and could lead to life-threatening intracranial bleeding. Therefore, recognition and timely treatment are important.
27 Sep 2024·Cureus Journal of Medical Science
A Benign Finding of Hemorrhagic Pancreatitis
Article
Author: Schmitt, Andrea ; Singh, Jaspreet ; Sodoma, Andrej M ; Pellegrini, James R ; Stone, Eric
Hemorrhagic pancreatitis is a rare cause of hypovolemic shock. It presents as silent bleeding, with signs of hypovolemic shock and abdominal pain eventually culminating in life-threatening bleeding. This case study delves into a case of hemorrhagic pancreatitis in a 49-year-old male. Notably, he has a history of recurrent lower extremity (LE) deep vein thrombosis (DVT) and atrial fibrillation (AF) on Coumadin. He came in with shortness of breath (SOB) and was admitted for acute hypoxic respiratory failure secondary to Influenza A. A few days into admission, the patient developed acute cardiogenic shock, septic shock, and acute respiratory distress syndrome (ARDS). The patient developed rectal bleeding with a decrease in hemoglobin and hematocrit. A computed tomography (CT) of the chest, abdomen, and pelvis (CAP) without (w/o) contrast was performed to find a source. It showed hemorrhagic pancreatitis in the head/tail region. The bleeding resolved on its own without interventions or blood transfusion. Hemorrhagic pancreatitis carries a high mortality rate. In this case, it had an insidious onset with self-resolution, a rare case. Physicians should make quick referrals for surgical resection in hopes of better outcomes.
7
News (Medical) associated with Warfarin Sodium08 Apr 2024
New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention
XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States
NEW BRUNSWICK, N.J., April 8, 2024 /PRNewswire/ -- Johnson & Johnson announced today a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery.1,2 These data were featured in an oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04).
"Despite advances in cardiovascular care, patients with nonvalvular AF continue to be at risk of potentially life-threatening cardiovascular events, especially older patients considered difficult to treat due to multiple factors, including age and co-morbidities," said C. Michael Gibson*, M.D., CEO, of the nonprofit Baim Institute and professor of Medicine, Harvard Medical School. "A significant challenge in managing nonvalvular AF in older individuals undergoing PCI is determining a treatment that balances the prevention of stroke with the risk for bleeding. Results from the PIONEER AF-PCI trial reinforce the need to continue to research this complex and fragile elderly patient population."
The PIONEER AF-PCI exploratory trial enrolled 2,124 patients with nonvalvular AF undergoing PCI, of whom 729 (34.3%) were elderly.1,3 Patients were randomized to either rivaroxaban- or warfarin-based antithrombotic regimens.1,3 The data analysis demonstrated a reduced rate of CSB among both elderly (≥75 years) and non-elderly (<75) patients with nonvalvular AF undergoing PCI treated with XARELTO® compared to warfarin.1 Elderly patients treated with XARELTO® had a lower rate of CSB at 12 months compared to those treated with warfarin (21.3% vs 31.4%; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88; P=0.005; number needed to treat [NNT]=10).1 The reduction in CSB was consistent among non-elderly patients treated with XARELTO® compared to warfarin (15.3% vs 24.6%; HR, 0.58; 95% CI, 0.45-0.75; P<0.001; NNT=11; interaction P=0.676).1
The analysis also showed XARELTO® treatment was associated with a lower risk of NACE or rehospitalization in both elderly (HR, 0.77; 95% CI, 0.62-0.96) and non-elderly patients (HR, 0.69; 95% CI, 0.58-0.82; interaction P=0.435), primarily driven by a lower risk of CSB.1 In addition, the rates of major bleeding were lower in patients treated with XARELTO® compared to warfarin in both elderly (3.7% vs 5.2%; HR, 0.71; 95% CI, 0.33-1.55) and non-elderly (1.1% vs 2.5%; HR, 0.45; 95% CI, 0.18-1.10) patients.1 Patients treated with XARELTO® also experienced lower rates of minor bleeding compared to warfarin in both elderly (1.4% vs 3.8%; HR, 0.36; 95% CI, 0.12-1.07) and non-elderly (1.0% vs 1.4%; HR, 0.67; 95% CI, 0.23-1.92) patients.1
"At Johnson & Johnson, we are committed to driving innovation that can improve outcomes for all patients," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Johnson & Johnson. "With this new exploratory analysis at ACC.24, we're pleased to bring the latest research to healthcare providers that adds to the growing body of clinical evidence in older adults."
About PIONEER AF-PCI
PIONEER AF-PCI was an international, multi-center, randomized, open-label clinical trial evaluating the safety of rivaroxaban compared to warfarin for the treatment of patients at least 18 years of age with paroxysmal, persistent, or permanent nonvalvular AF who had undergone PCI with stent placement. In the trial, 2,124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting received, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y12 inhibitor for 12 months (group 1), low-dose rivaroxaban (2.5 mg twice daily) plus DAPT for 1, 6, or 12 months (group 2), or standard therapy with a dose-adjusted vitamin K antagonist (once daily) plus DAPT for 1, 6, or 12 months (group 3).
The primary safety endpoint was the occurrence of clinically significant bleeding, a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction (TIMI) criteria or bleeding requiring medical attention during the treatment period (which was defined as the time from the first administration of a trial drug to 2 days after the trial drugs were discontinued, through 12 months of therapy). Secondary endpoints included the incidence of each component of the primary safety endpoint, as well as the following efficacy endpoints: the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke), each component of the major adverse cardiovascular event endpoint, and stent thrombosis.3
About 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
FDA approved dosing for patients with nonvalvular AF is 20 mg once daily with an evening meal in patients with CrCl >50 mL/min. For patients with moderate to severe renal impairment (CrCl ≤50 mL/min), the FDA approved dosing is 15 mg once daily with an evening meal.
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 the 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. Janssen and Bayer together are developing rivaroxaban.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed.
Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Pharmaceuticals, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
*Dr. C. Michael Gibson is author of the PIONEER AF-PCI analysis titled, "Effect of Rivaroxaban on Bleeding or Ischemic Event and Rehospitalization Among Elderly or Non-Elderly Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: Insights from the PIONEER AF-PCI Trial," and was provided payment for his participation in the study; he has not been compensated for contributing to this press release.
SOURCE Johnson & Johnson
Clinical ResultDrug ApprovalAHA
04 Apr 2024
Clinical and real-world evidence presentations highlight how the Company is transforming care for patients who are fighting some of the most common and devastating cardiovascular diseases
NEW BRUNSWICK, N.J., April 4, 2024 /PRNewswire/ -- Johnson & Johnson announced today that clinical and real-world evidence from its cardiovascular portfolio will be featured at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) taking place April 6-8, 2024, in Atlanta, Georgia. Eleven abstracts, including five oral presentations, will showcase data from Company-sponsored studies demonstrating therapeutic benefit of breakthrough medicines, such as XARELTO® (rivaroxaban), and interventional technologies, such as those from Abiomed® and Biosense Webster®, to help treat cardiovascular diseases, including atrial fibrillation (AF) and peripheral artery disease (PAD).
"Cardiovascular disease remains the leading cause of death for adults worldwide and millions more may be at risk of stroke and other life-threatening cardiovascular conditions as the population ages.1 As a global leader in healthcare, we are determined to improve these statistics and empower those living with cardiovascular disease to lead fuller, healthier lives," said Katie Devine, President, US General Medicines, Canada and Puerto Rico, Johnson & Johnson Innovative Medicine. "At ACC.24, we look forward to sharing the latest research and innovation from our broad portfolio, including XARELTO®, to equip clinicians and researchers with knowledge and insights that can help transform cardiovascular care for all."
Improving the outlook for people with cardiovascular disease
Johnson & Johnson is committed to elevating the standard of care in cardiovascular diseases and unlocking the potential of medicines and solutions of tomorrow. Several data presentations at ACC.24 demonstrate how the Company is improving outcomes for people living with cardiovascular disease, including older adults and other patient populations often considered hard to treat. These include:
Data from the PIONEER AF-PCI Phase 3 clinical trial evaluating the safety and efficacy of rivaroxaban for reducing the rate of bleeding among elderly and non-elderly patients with nonvalvular AF undergoing percutaneous coronary intervention (Abstract #906-04).
Data from the Real-World Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation Using Novel Contact Force Technologies (REAL AF) Registry study evaluating the impact of scar burden on ablation strategy (Abstract #916-10).
Data about Impella® heart pumps will be featured in more than 50 presentations, abstracts and posters, including the Danish-German Cardiogenic Shock Trial (DanGer), which is a Late Breaking Clinical Trial (Abstract #406-14).
"Our advancements have changed how cardiovascular diseases are diagnosed and treated and have had a meaningful impact on the lives of millions of patients and families. The data we're presenting at ACC.24 demonstrate how we're continuing to deliver on our commitment," said Tim Schmid, Executive Vice President and Worldwide Chairman, Johnson & Johnson MedTech. "We are intent on elevating the standard of care in cardiovascular diseases and, with our partners, are leading research in areas like nonvalvular AF, stroke, and acute coronary syndrome. The real-world and clinical evidence presented at ACC.24 will provide cardiology teams with critical information to help deliver improved care for their patients."
The list of Company-sponsored abstracts follows:
About 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 the 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. Janssen and Bayer together are developing rivaroxaban.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at or at . Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Pharmaceuticals, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
© Johnson & Johnson, Inc. 2024. All rights reserved.
1 World Health Organization. Cardiovascular diseases (CVDs). 2021. Accessed February 15, 2024. Available at: (cvds).
SOURCE Johnson & Johnson
Phase 3Drug Approval
14 Nov 2023
Data presentations at AHA 2023 Meeting reinforce treatment with XARELTO® plus aspirin consistently reduces major cardiovascular events (MACE) as well as major adverse limb events (MALE) in complex patients with PAD
Janssen continues commitment to supporting PAD patients with ongoing research to help understand this undertreated and underdiagnosed disease1
TITUSVILLE, N.J., Nov. 14, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Results were presented at the American Heart Association's (AHA) 2023 Scientific Sessions, hosted in Philadelphia, Pennsylvania, November 11-13, 2023.
"These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO® plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as 'fragile' are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments," said Marc P. Bonaca*, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. "We hope the ongoing wealth of data coming from VOYAGER PAD presented at AHA offers clinicians the information they need to support shared decision-making in prescribing XARELTO® plus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex."
Impact of XARELTO® plus Aspirin on Total Vascular Events in Fragile Patients with PAD
Fragile patients with PAD can be at a heightened risk for MALE, defined as a composite of acute limb ischemia (ALI) and major amputation. In this analysis, fragile patients are defined as age greater than 75 years, or weight less than 50 kg or baseline eGFR less than 50 mL/min/1.732. XARELTO® plus aspirin (2.5 mg twice daily plus aspirin 100 mg once daily) was shown to be effective in reducing the occurrence of MALE in both fragile and non-fragile patients, compared to placebo (aspirin alone). In fragile patients treated with XARELTO® plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo. In non-fragile patients, 7.9% of patients treated with XARELTO® plus aspirin experienced a MALE compared to 9.7% of patients treated with placebo.
XARELTO® plus aspirin also reduced the occurrence of total vascular events in fragile patients over time, with an absolute rate of 82.1 events per 100 patients at three years compared to 99.3 events per 100 patients in those treated with placebo at three years. A similar benefit was also seen in non-fragile patients, with a rate of 70.4 events per 100 patients at three years in those treated with XARELTO® plus aspirin compared to 81.6 events per 100 patients in those treated with placebo at three years. Importantly, thrombolysis in myocardial infarction (TIMI) major bleeding was consistent in both the fragile and non-fragile treatment groups. XARELTO® plus aspirin demonstrated a consistent, numerical increase in TIMI major bleeding for both the fragile (HR 1.66; 95% CI 0.87-3.19) and the non-fragile (HR 1.37; 95% CI 0.83-2.24, p-interaction 0.65) patients.
Role of XARELTO® Plus Aspirin on Myocardial Infarction in Patients with PAD with and without Concomitant CAD Following Lower Extremity Revascularization (LER)
Following LER, patients with PAD are four times more likely to experience acute limb ischemia, or a rapid decrease in lower limb blood flow, which is often associated with long hospitalizations and high incidences of amputation, disability, and death unless appropriate treatment is given.2 Patients with PAD are also at a heightened risk of MACE, defined as myocardial infarction (MI), ischemic stroke, or cardiovascular death. In this analysis, 14.1% of patients with PAD and CAD treated with XARELTO® plus aspirin experienced a MACE versus 17.6% of patients treated with placebo (aspirin alone). In patients with PAD only, 11% of patients treated with XARELTO® plus aspirin experienced a MACE versus 9.8% of patients treated with placebo. Overall, XARELTO® plus aspirin showed a consistent benefit in reducing MACE in patients with and without CAD.
In this analysis, patients with CAD (HR 2.23; CI 1.10-4.53) and patients without CAD (HR 1.15; CI 0.72-1.84) had higher rates of TIMI major bleeding with XARELTO® plus aspirin compared to placebo plus aspirin. The rates of intracerebral hemorrhage (ICH) and fatal bleeding were similar across both patient groups. Overall, the safety of XARELTO® plus aspirin in patients with PAD was consistent regardless of CAD with no significant interactions.
"At Janssen, we work tirelessly to bring the latest research and clinical practice insights to healthcare providers and their patients to help improve cardiovascular care for all," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Janssen Scientific Affairs, LLC. "These new findings continue to support the use of XARELTO® with its positive benefit-risk profile in many types of patients, including those who are high-risk and considered harder to treat."
In August 2021, the U.S. Food and Drug Administration (FDA) approved an expanded PAD indication for XARELTO® (2.5 mg twice daily plus aspirin 75 - 100 mg once daily) to include patients following a recent LER due to symptomatic PAD. XARELTO® acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation.
About VOYAGER PAD
The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized in a 1:1 ratio and received either the XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) (n=3,286) or aspirin alone (100 mg once daily) (n=3,278). Patients were stratified by revascularization procedure type (endovascular vs. surgical) and use of clopidogrel, which was administered at the treating physician's discretion. Patients were followed for a median of 28 months.
The VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® plus aspirin was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular events (composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or cardiovascular death) by 15 percent in patients with symptomatic PAD after lower-extremity revascularization. The benefit of adding XARELTO® to aspirin was apparent early, was consistent among major subgroups and continued to accrue over time. There was no significant increase in thrombolysis in myocardial infarction (TIMI) major bleeding observed in patients treated with the XARELTO® plus aspirin compared to aspirin alone (Kaplan-Meier estimate at three years 2.65% vs. 1.87%, respectively).
About 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 the 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. Janssen and Bayer together are developing rivaroxaban.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension and Retina.
Learn more at . Follow us at @JNJInnovMed and @JanssenUS Janssen Scientific Affairs, LLC, is a Johnson & Johnson company.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Scientific Affairs, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References
Afzal N, Sohn S, Scott CG, Liu H, Kullo IJ, Arruda-Olson AM. Surveillance of Peripheral Arterial Disease Cases Using Natural Language Processing of Clinical Notes. AMIA Jt Summits Transl Sci Proc. 2017;2017:28-36. Accessed October 20, 2023. .
Beckman, JA, Schneider PA, Conte MS. Advances in revascularization for peripheral artery disease: revascularization in PAD. Circ Res. 2021;128.12: 1885-1912. Accessed October 27, 2023.
*Dr. Marc Bonaca is the lead study author of the VOYAGER PAD analysis entitled "Impact of Low-dose Rivaroxaban plus Aspirin on Total Vascular Events in Fragile Patients with Peripheral Artery Disease: Insights from VOYAGER PAD" and "Impact of Low-dose Rivaroxaban plus Aspirin on Myocardial Infarction in Patients with Peripheral Artery Disease with and without Concomitant Coronary Artery Disease: Insights from VOYAGER PAD," and was provided payment for his participation in the study; he has not been compensated for contributing to this press release.
SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson
Clinical ResultPhase 3AHADrug Approval
100 Deals associated with Warfarin Sodium
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00564 | Warfarin Sodium |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Atrial Fibrillation | AU | 05 May 2016 | |
| Coronary Occlusion | AU | 05 May 2016 | |
| Venous Thrombosis | AU | 05 May 2016 | |
| Thromboembolism | US | 08 Jun 1954 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 2 | Phase 1 | US | 04 Jun 2010 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | 70 | Anticoagulation (including Coumadin and NOACs) | pvpqyxacnn(xbmmcopqdf) = njxfelvled qxwiqxzrbt (sttljyuqmw ) View more | Positive | 09 Apr 2019 | ||
No anticoagulation | pvpqyxacnn(xbmmcopqdf) = gxwvoouarv qxwiqxzrbt (sttljyuqmw ) View more | ||||||
Phase 3 | 213 | (PA21) | htqsntkukt(rulrmoxvti) = qgmnqllehy ggszurlepj (geimbzljro, vlfeuqzwoc - lvjutguhzu) View more | - | 09 Oct 2018 | ||
(Sevelamer Hydrochloride) | htqsntkukt(rulrmoxvti) = zzvvhptaos ggszurlepj (geimbzljro, kubxfqtity - elkupcdzvt) View more | ||||||
Phase 3 | 35 | snytgjmyeu(mgznnonevw) = ptmavrspwg xhxhiizqiv (xdfmzcovvx, ezwlqrrozf - mftdotrmgh) View more | - | 09 Oct 2018 | |||
Phase 3 | 161 | epjgohitdx(iojdauykjm) = melwzyknix ilpfwaztze (prpaxcquwj, isagmspamx - afpdbrpjas) View more | - | 09 Oct 2018 | |||
Phase 2 | 183 | (PA21 750 mg/Day) | lskuowzoif(etmqfgrwae) = jeofcnluje wadriyacza (psdtbtlouo, zoiebnqaao - unsxtxjgdv) View more | - | 23 Aug 2018 | ||
(PA21 1500 mg/Day) | lskuowzoif(etmqfgrwae) = lclzalqdzv wadriyacza (psdtbtlouo, rddbvwydcg - lbwihxlddn) View more | ||||||
Not Applicable | 104 | (Moderate Risk Continuing Warfarin) | zdimhjickw(evlksbqyyo) = jopacmhwqs hnacmihznj (zuugmidfam, hnwtkdhuag - cdshcxnpfw) View more | - | 31 Aug 2017 | ||
(Moderate Risk Holding Warfarin) | zdimhjickw(evlksbqyyo) = tfkwdkluyp hnacmihznj (zuugmidfam, vxmkdcgjup - mtutlmodpc) View more | ||||||
Phase 2 | 183 | rzvlekfgxr(diyksrawqg) = significantly greater hkfuoegvsn (pdeacsovea ) View more | Positive | 01 Jun 2017 | |||
Placebo | |||||||
Phase 4 | 59 | vnslekmgyt(aysjlgtpag) = svrxvwvfgq wfqpodzxqe (spddeyzagz, ujvsrrhuhz - qplonsqxew) View more | - | 22 Feb 2016 | |||
Not Applicable | - | 39 | (CYP2C9*1/*1 Genotype) | yrtcochxyf(sadwfxnmeo) = dajxgtaeya lnynhmodvh (ardskoqszr, gdhtujpvdk - kdciikstlk) View more | - | 18 Aug 2014 | |
(CYP2C9*1B/*1B Haplotype) | yrtcochxyf(sadwfxnmeo) = xvecmlzbay lnynhmodvh (ardskoqszr, wtkhuijnrw - ddbioxouih) View more | ||||||
Phase 3 | 1,584 | Off-warfarin | clvomjhlsp(pttycjaxri) = nequxllzta vzllvrojrk (rytabejgoq ) View more | - | 24 Jun 2014 | ||
On-warfarin | clvomjhlsp(pttycjaxri) = enoxjkkgki vzllvrojrk (rytabejgoq ) View more |
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