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.
Published Studies Related to Xarelto (Rivaroxaban)
Relationship between time in therapeutic range and comparative treatment effect
of rivaroxaban and warfarin: results from the ROCKET AF trial. 
CONCLUSIONS: The treatment effect of rivaroxaban compared with warfarin for the
Outcomes of temporary interruption of rivaroxaban compared with warfarin in
patients with nonvalvular atrial fibrillation: results from the rivaroxaban once
daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for
prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). 
CONCLUSIONS: TI of oral anticoagulation is common and is associated with
Efficacy and safety of rivaroxaban compared with warfarin in patients with
peripheral artery disease and non-valvular atrial fibrillation: insights from
ROCKET AF. 
CONCLUSION: Patients with PAD in ROCKET AF did not have a statistically
Rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial
fibrillation in relation to the CHADS2 score: a subgroup analysis of the J-ROCKET
AF trial. 
CONCLUSION: This subanalysis indicated that the safety and efficacy of
Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with
nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF. 
compared with warfarin in Japanese patients with AF... CONCLUSION: Analysis of the NCB supports that rivaroxaban therapy provides
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.
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis [Completed]
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug
enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may
change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy
participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per
minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on
maintenance hemodialysis (a method used to remove waste material from the blood when the
kidneys are unable to do so).
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.
Switching Study From Warfarin to Rivaroxaban [Completed]
The study objective is to investigate the pharmacodynamics (effects of a drug product) when
switching the treatment from warfarin to rivaroxaban.
84 young, healthy subjects will participate; they will be treated following a randomized,
parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind
(Treatments A and B) design.
The first two groups (A, B) will receive warfarin for approximately one week to adjust their
blood coagulation values to a specific level, i. e. to maintain an INR (international
normalized ratio) of 2. 0 - 3. 0. This range is commonly used for long-term anticoagulant
The first group (A) will receive rivaroxaban for four days, the second group (B) will take
placebo. On the last day, all subjects in groups A and B will receive vitamin K to
neutralize the effects of warfarin. The third group (C) will not undergo prior treatment
with warfarin but will receive rivaroxaban for four days.
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden) [Recruiting]
This prospective cohort study will provide information about:
Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first
time compared to patients who are prescribed standard of care for the first time.
The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and
the occurrence of non-infective liver disease.
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: 2015-08-10