WARNINGS: (A) DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA
A. DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION
Discontinuing XARELTO places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following XARELTO discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation with XARELTO must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant [see Dosage and Administration, Warnings and Precautions, and Clinical Studies].
B. SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
a history of traumatic or repeated epidural or spinal punctures
a history of spinal deformity or spinal surgery
[see Warnings and Precautions (5.2, 5.3) and Adverse Reactions].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions].
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions].
Rivaroxaban, a factor Xa inhibitor, is the active ingredient in XARELTO Tablets.
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
XARELTO (rivaroxaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies].
Prophylaxis of Deep Vein Thrombosis
XARELTO (rivaroxaban) is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery.
Media Articles Related to Xarelto (Rivaroxaban)
Xarelto's Approval Expanded
Source: MedicineNet Deep Vein Thrombosis Specialty [2012.11.06]
Title: Xarelto's Approval Expanded
Category: Health News
Created: 11/5/2012 12:35:00 PM
Last Editorial Review: 11/6/2012 12:00:00 AM
FDA Rejects New Use for Blood Thinner Xarelto
Source: MedicineNet Total Knee Replacement Specialty [2012.06.25]
Title: FDA Rejects New Use for Blood Thinner Xarelto
Category: Health News
Created: 6/23/2012 11:00:00 AM
Last Editorial Review: 6/25/2012 12:00:00 AM
Published Studies Related to Xarelto (Rivaroxaban)
Oral rivaroxaban after symptomatic venous thromboembolism: the continued
treatment study (EINSTEIN-extension study). 
Over recent years, research on anticoagulant drugs has been guided by the
requirement for convenient administration and a wide therapeutic window to allow
fixed dosing without the need for coagulation monitoring. Rivaroxaban is the
first of a new class of anticoagulant drugs, the direct, selective inhibitors of
Rationale and design of the Anti-Xa therapy to lower cardiovascular events in
addition to standard therapy in subjects with acute coronary
syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a
randomized, double-blind, placebo-controlled study to evaluate the efficacy and
safety of rivaroxaban in subjects with acute coronary syndrome. 
BACKGROUND: Although therapy with aspirin or aspirin plus a thienopyridine
reduces the incidence of long-term adverse cardiovascular events among patients
with acute coronary syndrome (ACS), there remains a significant residual risk of
cardiovascular death, recurrent myocardial infarction (MI), and stroke...
Rivaroxaban versus enoxaparin for thromboprophylaxis after total hip or knee
arthroplasty: a meta-analysis of randomized controlled trials. 
hip or knee arthroplasty... CONCLUSIONS: Rivaroxaban was more effective than the recommended dose of
Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS
ACS-TIMI 46): a randomised, double-blind, phase II trial. 
and aimed to select the most favourable dose and dosing regimen... INTERPRETATION: The use of an oral factor Xa inhibitor in patients stabilised
A dose-ranging study evaluating once-daily oral administration of the factor Xa
inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep
vein thrombosis: the Einstein-DVT Dose-Ranging Study. 
We performed a randomized dose-ranging study, double-blind for rivaroxaban doses
and open-label for the comparator (low-molecular-weight heparin followed by
vitamin K antagonists) to assess the optimal dose of rivaroxaban for the
treatment of deep vein thrombosis...
Clinical Trials Related to Xarelto (Rivaroxaban)
Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia [Recruiting]
Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with
heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some
patients develop an allergic reaction to heparin, a condition called heparin-induced
thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was
designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and
death. The objective of this 200 patient study is to determine if a new blood thinner called
rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not
require blood testing, and had a low risk of bleeding when it was used to treat blood clots
in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT,
there will be two very important benefits. For patients with HIT, the benefit will be having
a safe, and easy-to-use drug to protect them from developing further life or
limb-threatening blood clots. For the Canadian health care system, the benefit will be
having a drug that is much less expensive than the drugs currently used to treat HIT.
Xarelto [SPAF] Post-marketing Surveillance in Japan [Recruiting]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Xarelto for SPAF.
The objective of this study is to assess safety and effectiveness of Xarelto using in real
A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational
period. An annual follow-up survey will be conducted for 5 years at the longest after
standard observational period.
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease [Not yet recruiting]
The primary purpose of this study is to evaluate whether treatment with rivaroxaban and
aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks,
stroke or cardiovascular death in patients with coronary or peripheral artery disease.
Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan [Recruiting]
The objective of this study is to understand if Rivaroxaban can improve treatment
satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real
A total of 725 patients are to be enrolled and followed for a 6 months. period. QOL survey
will be conducted at month 0, 3, 6 using ACTS/TSQM.
This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a
local prospective and observational study of patients who have received Xarelto for SPAF.
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion [Recruiting]
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo
cardioversion (procedure to restore normal heart rhythm). The study will compare patients
assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist
(VKA). The study will measure common medical outcomes for this type of patient such as
bleeding and stroke.
Reports of Suspected Xarelto (Rivaroxaban) Side Effects
Pulmonary Embolism (440),
Deep Vein Thrombosis (310),
Gastrointestinal Haemorrhage (194),
Cerebrovascular Accident (112),
Haemoglobin Decreased (111),
Oedema Peripheral (105),
Haemorrhage Intracranial (94), more >>
Page last updated: 2013-02-10