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BOXED WARNINGS:

 


WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA


A. PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS

Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

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, see Drug Interactions

  • A history of traumatic or repeated epidural or spinal punctures

  • A history of spinal deformity or spinal surgery

  • Optimal timing between the administration of XARELTO® and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

 

 

Affordability and Access

Resources, reimbursement information, and tools to help you and your patients get the most out of XARELTO®.

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Comprehensive Patient Support

The XARELTO® CarePathTM program offers extensive support for patients and caregivers

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Affordability and Access

 

 

Resources, access information, and tools to help you and your patients get the most out of XARELTO®.

We are dedicated to making XARELTO® affordable and accessible for all patients. With widespread inclusion of XARELTO® on hospital, managed care, and PBM formularies, >90% of commercial and Medicare patients are covered at the lowest branded co-pay.1 This site contains more specific information on the Affordability and Access of XARELTO®, the XARELTO® CarePathTM Support Program for Patients & Caregivers, benefits verification, prior authorization, and the Patient Assistance Program.

If your patients have questions about insurance coverage, XARELTO® CarePathTM can help explain their insurance benefits and provide counseling regarding eligibility for each patient affordability option. The program can also help with:

  • Rapid investigation and assessment of patient eligibility and coverage
  • Assistance with the prior authorization process for XARELTO®
  • Savings, information, and tools to help support patients on their journey
    with XARELTO®

For more information on the following programs, please call XARELTO® CarePath™ at 1-888-XARELTO (1-888-927-3586), Monday-Friday, 8:00 AM-8:00 PM ET and speak to a XARELTO® CarePath™ Site Coordinator.

Option 1: Patients With Commercial Insurance

Instant Savings

The XARELTO® CarePath™ Savings Card

Eligible patients pay $10 per month* for XARELTO®.

  • Subject to a $1200 maximum annual benefit, 12 months after activation, or 12 uses, whichever comes first.
  • Continuing support may also be available for eligible patients who have exhausted their 12 months in the program.

For eligibility requirements and restrictions, visit XARELTOCarePath.com or call 1-888-XARELTO (1-888-927-3586).
A XARELTO® CarePathTM Trial Offer may also be available
(see Option 2).

*The Savings Card is not available to patients enrolled in federally subsidized healthcare programs that cover prescription drugs, Medicare Part D, Medicaid, TRICARE, or other federal or state programs.

Option 2: Patients With Federally Funded Medicare, Medicaid, TRICARE, or Commercial Insurance

The XARELTO® CarePath™ Trial Offer

  • Eligible patients will receive a free 10-day supply of XARELTO®.
  • Subject to 1 use or 12 months from program start date, whichever comes first

For eligibility requirements and restrictions, call 1-888-XARELTO (1-888-927-3586).

Other Patient Assistance Resources

Patients With No Insurance

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is committed to providing access to uninsured individuals who lack the financial resources to pay for their medicines. If your patients need XARELTO® and are uninsured and unable to pay for their medicine, please contact a JJPAF program specialist at 1-800-652-6227 or visit the Foundation website at JJPAF.org to see if they might qualify for assistance.

If a patient does not have coverage for XARELTO®, a comprehensive list of additional programs is available at JanssenPrescriptionAssistance.com/XARELTO.

Resources

 

XARELTO® CarePath™ Support Program

XARELTO® CarePath™ Support Program

A comprehensive support program focused on access, education, and adherence tools to help patients start and stay on therapy.

 

XARELTO® Patient Affordability Chart

XARELTO® Patient Affordability Chart

Download this resource to help patients to explore all of their affordability options for XARELTO®, including the XARELTO® CarePathTM Savings Card, 10-day trial offer, and more.

 

Business Associate Agreement (BAA)

Business Associate Agreement (BAA)

Sign and submit this BAA to allow Janssen to provide high levels of service and to ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

 

Benefits Investigation Form

Benefit Investigation Form (BIF)

Submit a BIF for each patient who you would like to complete an assessment of eligibility and coverage for XARELTO®. You can also use this form to request assistance with the prior authorization process for XARELTO®.

 

Physician Portal

Physician Portal

Use this Provider Portal to submit benefit investigation requests electronically and review the status of your XARELTO® CarePathTM patients online.

 

Doc Center App

DocCenter by XARELTO®

Want Prescribing Information, resources, videos, and patient education materials right at your fingertips? Download the DocCenter app today.

 

For more information about patient benefits coverage, please visit JanssenPrescriptionAssistance.com/XARELTO.

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Important Safety Information

WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

A. PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS


Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

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, see Drug Interactions

  • A history of traumatic or repeated epidural or spinal punctures

  • A history of spinal deformity or spinal surgery

  • Optimal timing between the administration of XARELTO® and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS

  • Active pathological bleeding

  • Severe hypersensitivity reaction to XARELTO® (eg, anaphylactic reactions)

WARNINGS AND PRECAUTIONS

  • Increased Risk of Thrombotic Events After Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO®, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO® to warfarin in clinical trials in atrial fibrillation patients. If XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

  • Risk of Bleeding: XARELTO® increases the risk of bleeding and can cause serious or fatal bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO® in patients with active pathological hemorrhage.

    • A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable.

    • Concomitant use of other drugs affecting hemostasis increases the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, and NSAIDs.

  • Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO®. The next XARELTO® dose is not to be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, the administration of XARELTO® is to be delayed for 24 hours. Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), or bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

  • Use in Patients With Renal Impairment:

    • Nonvalvular Atrial Fibrillation: Avoid the use of XARELTO® in patients with creatinine clearance (CrCl) <15 mL/min, since drug exposure is increased. Discontinue XARELTO® in patients who develop acute renal failure while on XARELTO®.

    • Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population.

    • Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 30 to 50 mL/min. Patients who develop acute renal failure while on XARELTO® should discontinue the treatment.

  • Use in Patients With Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment. Avoid use of XARELTO® in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy, since drug exposure and bleeding risk may be increased.

  • Use With P-gp and Strong CYP3A4 Inhibitors or Inducers: Avoid concomitant use of XARELTO® with combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan). Avoid concomitant use of XARELTO® with drugs that are P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort).

  • Risk of Pregnancy-Related Hemorrhage: In pregnant women, XARELTO® should be used only if the potential benefit justifies the potential risk to the mother and fetus. XARELTO® dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO® cannot be monitored with standard laboratory testing and is not readily reversed. Promptly evaluate any signs or symptoms suggesting blood loss (eg, a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).

  • Patients With Prosthetic Heart Valves: The safety and efficacy of XARELTO® have not been studied in patients with prosthetic heart valves. Therefore, use of XARELTO® is not recommended in these patients.

  • Acute PE in Hemodynamically Unstable Patients/Patients Who Require Thrombolysis or Pulmonary Embolectomy: Initiation of XARELTO® is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

DRUG INTERACTIONS

  • Avoid concomitant use of XARELTO® with other anticoagulants due to increased bleeding risk, unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.

  • XARELTO® should not be used in patients with CrCl 15 to 80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors unless the potential benefit justifies the potential risk.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C: XARELTO® should be used during pregnancy only if the potential benefit justifies the potential risk to mother and fetus. There are no adequate or well-controlled studies of XARELTO® in pregnant women, and dosing for pregnant women has not been established. Use XARELTO® with caution in pregnant patients because of the potential for pregnancy-related hemorrhage and/or emergent delivery with an anticoagulant that is not readily reversible. The anticoagulant effect of XARELTO® cannot be reliably monitored with standard laboratory testing.

  • Labor and Delivery: Safety and effectiveness of XARELTO® during labor and delivery have not been studied in clinical trials.

  • Nursing Mothers: It is not known if rivaroxaban is excreted in human milk.

  • Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

  • Females of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.

OVERDOSAGE

  • Discontinue XARELTO® and initiate appropriate therapy if bleeding complications associated with overdosage occur. A specific antidote for rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of XARELTO® overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable.

ADVERSE REACTIONS IN CLINICAL STUDIES

  • The most common adverse reactions with XARELTO® were bleeding complications.

011416-140307
Please see full Prescribing Information, including Boxed WARNINGS.

Reference:

  1. Data on file. Janssen Pharmaceuticals, Inc. Data as of 1/6/14.