XARELTO® (rivaroxaban) Information for Healthcare Professionals

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NVAF: Reducing stroke risk
Chronic CAD/PAD: Reducing the risk of major CV events
DVT/PE: Initial Treatment
DVT/PE: Extended Treatment
DVT Prophylaxis: After hip/knee replacement surgery
VTE Prophylaxis: Acutely ill medical patients

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Clinical Trial
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- COMPASS study design
Efficacy Profile
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- Chronic CAD/PAD major CV events
Safety Profile
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- Chronic PAD subgroup safety profile
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APPROVED in acutely ill medical patients^◇

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Patients with thrombotic disease are complex.^1-6 Helping protect them against thrombosis doesn’t have to be.

Patients with thrombotic disease are complex. Helping protect them against thrombosis doesn’t have to be.

Chronic CAD/PADReducing the risk of major CV events

VTE ProphylaxisAcutely ill medical patients^◇

DVT ProphylaxisAfter hip/knee replacement surgery

^◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.
CAD = coronary artery disease; CV = cardiovascular; DVT = deep vein thrombosis; NVAF = nonvalvular atrial fibrillation; PAD = peripheral artery disease; PE = pulmonary embolism; VTE = venous thromboembolism.

Intentionally developed to help protect against thrombotic events, providing unique versatility across the broadest range of patients in its class

Largest clinical development program of its class with more than 20 RCTs and 116,000-plus patients^7-26
Dosing regimens optimized for each therapeutic indication
Proven efficacy and safety profile across the most indications – NVAF, chronic CAD/PAD, DVT/PE initial and extended treatment, VTE prophylaxis in acutely ill medical patients and after hip/knee replacement surgery

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 in patients with active pathological hemorrhage.
- An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable.
- Concomitant use of other drugs that impair hemostasis increases risk of bleeding. These include aspirin, P2Y₁₂ platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, NSAIDs, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).
- Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding: Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of XARELTO^® for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage; active cancer (ie, undergoing acute, in-hospital cancer treatment); active gastroduodenal ulcer or history of bleeding in the three months prior to treatment; or dual antiplatelet therapy. XARELTO^® is not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding.

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 concurrent use of XARELTO^® and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO^®. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of XARELTO^® is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. An indwelling epidural or intrathecal catheter should not be removed before at least 2 half-lives have elapsed (ie, 18 hours in young patients aged 20 to 45 years and 26 hours in elderly patients aged 60 to 76 years), after the last administration of XARELTO^®. The next dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO^® for 24 hours. Monitor frequently to detect 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 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: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation in patients who develop acute renal failure while on XARELTO^®. Clinical efficacy and safety studies with XARELTO^® did not enroll patients with CrCl <30 mL/min or end-stage renal disease (ESRD) on dialysis.
- Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO^® in these patients. Discontinue XARELTO^® in patients who develop acute renal failure while on treatment.
- Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO^® in these patients. Discontinue XARELTO^® in patients who develop acute renal failure while on treatment.
- Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding: In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO^® in these patients. Discontinue XARELTO^® in patients who develop acute renal failure while on treatment.
- Reduction of Risk of Major Cardiovascular Events in Patients with Chronic CAD or PAD: For patients with CrCl <15 mL/min, no data are available, and limited data are available for patients with a CrCl of 15 to 30 mL/min. In patients with CrCl <30 mL/min, a dose of 2.5 mg XARELTO^® twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (CrCl 30 to <50 mL/min), whose efficacy and safety outcomes were similar to those with preserved renal function. Clinical efficacy and safety studies with XARELTO^® did not enroll patients with end-stage renal disease (ESRD) on dialysis.

Use in Patients with Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment. Avoid use 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 CYP3A Inhibitors or Inducers: Avoid concomitant use of XARELTO^® with known combined P-gp and strong CYP3A inhibitors or inducers.
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. Promptly evaluate signs or symptoms suggesting blood loss (eg, a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).
Patients with Prosthetic Heart Valves: Use of XARELTO^® is not recommended in patients who have had transcatheter aortic valve replacement (TAVR), based on the results of the GALILEO study, which reported higher rates of death and bleeding in patients randomized to XARELTO^® compared to those randomized to an antiplatelet regimen. Safety and efficacy of XARELTO^® have not been studied in patients with other prosthetic heart valves or other valve procedures. Use of XARELTO^® is not recommended in patients with prosthetic heart valves.
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.
Increased Risk of Thrombosis in Patients with Antiphospholipid Syndrome: Direct-acting oral anticoagulants (DOACs), including XARELTO^®, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

DRUG INTERACTIONS

Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase risk of bleeding.
Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase risk of thromboembolic events.
XARELTO^® should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (eg, erythromycin) unless the potential benefit justifies the potential risk.
Coadministration of enoxaparin, warfarin, aspirin, clopidogrel, and chronic NSAID use may increase risk of bleeding.
Avoid concurrent use of XARELTO^® with other anticoagulants due to increased bleeding risk, unless benefit outweighs risk. Promptly evaluate signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.

USE IN SPECIFIC POPULATIONS

Pregnancy: The limited available data on XARELTO^® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO^® with caution in pregnant patients because of the potential for pregnancy-related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO^® cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of XARELTO^® for the mother and possible risks to the fetus when prescribing to a pregnant woman.
- Fetal/Neonatal adverse reactions: Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.
- Labor or delivery: The risk of bleeding should be balanced with the risk of thrombotic events when considering use in this setting.
- There are no adequate or well-controlled studies of XARELTO^® in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
Lactation: Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for XARELTO^® and any potential adverse effects on the breastfed infant from XARELTO^® or from the underlying maternal condition.
Females and Males of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants, including XARELTO^®, should be assessed in females of reproductive potential and those with abnormal uterine bleeding.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

OVERDOSAGE

Overdose of XARELTO^® may lead to hemorrhage. Discontinue XARELTO^® and initiate appropriate therapy if bleeding complications associated with overdosage occur. An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

ADVERSE REACTIONS IN CLINICAL STUDIES

Most common adverse reactions with XARELTO^® were bleeding complications.

Please read full Prescribing Information, including Boxed WARNINGS for XARELTO^®.

cp-62551v7

INDICATIONS

XARELTO^® (rivaroxaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

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.

XARELTO^® is indicated for the treatment of deep vein thrombosis (DVT). XARELTO^® is indicated for the treatment of pulmonary embolism (PE). XARELTO^® is indicated for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

XARELTO^® is indicated for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

XARELTO^® is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE-related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE, and not at high risk of bleeding.

XARELTO^® is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular [CV] death, myocardial infarction [MI], and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

References: 1. January CT, Wann LS, Alpert JS, et al; for the ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):2017-2104. doi:10.1161/CIR.0000000000000040 2. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12):e686-e725. doi:10.1161/CIR.0000000000000470 3. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012;126(25):e354-e471. doi:10.1161/CIR.0b013e318277d6a0 4. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2):e195S-e226S. doi:10.1378/chest. 11-2296 5. Ortel TL, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv. 2020;4(19):4693-4738. doi:10.1182/bloodadvances.2020001830 6. Falck-Yttr, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2)Suppl:e278S-e325S. doi:10.1378/chest. 11-2404 7. Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775. doi:10.1056/NEJMoa0800374 8. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510. doi:10.1056/NEJMoa1007903 9. Mega JL, Braunwald E, Wiviott SD, et al. N Engl J Med. 2012;366:9-19. doi:10.1056/NEJMoa1112277 10. Patel MR, Mahaffey KW, Garg J, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891. doi:10.1056/NEJMoa1009638 11. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297. doi:10.1056/NEJMoa1113572 12. Cohen AT, Spiro TE, Büller HR, et al; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368(6):513-523. doi:10.1056/NEJMoa1111096 13. Cappato R, Ezekowitz MD, Klein AL, et al. Eur Heart J. 2014;35(47):3346-3355. doi:10.1093/eurheartj/ehu367 14. Cappato R, Marchlinski FE, Hohnloser SH, et al. Eur Heart J. 2015;36(28):1805-1811. doi:10.1093/eurheartj/ehv177 15. Gibson CM, Mehran R, Bode C, et al. N Engl J Med. 2016;375(25):2423-2434. doi:10.1056/NEJMoa1611594 16. Eikelboom JW, Connolly SJ, Bosch J, et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-1330. doi:10.1056/NEJMoa1709118 17. Weitz JI, Lensing AWA, Prins MH, et al; EINSTEIN CHOICE Investigators. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376(13):1211-1222. doi:10.1056/NEJMoa1700518 18. Ohman EM, Roe MT, Steg G, et al. Lancet. 2017; 389(10081):1799-1808. doi:10.1016/S0140-6736(17)30751-1 19. Peacock WF, Coleman CI, Diercks DB, et al. Emergency department discharge of pulmonary embolus patients. Acad Emerg Med. 2018;25(9):995-1003. doi:10.1111/acem.13451 20. Hart RG, Sharma HM, Mundl H, et al. N Engl J Med. 2018;378(23):2191-2201. doi:10.1056/NEJMoa1802686 21. Spyropoulos AC, Ageno W, Albers GW, et al; MARINER Investigators. N Engl J Med. 2018;379:1118-1127. doi:10.1056/NEJMoa1805090 22. Zannad F, Anker SD, Byra WM, et al. N Engl J Med. 2018;379:1332-1342. doi:10.1056/NEJMoa1808848 23. Dangas GD, Tijssen JGP, Wöhrle J, et al. N Engl J Med. 2020;382:120-129. doi:10.1056/NEJMoa1911425 24. Spyropoulos AC, Lipardi C, Xu J, et al. Improved benefit risk profile of rivaroxaban in a subpopulation of the MAGELLAN study. Clin Appl Thromb Hemost. 2019;25:1076029619886022. doi:10.1177/1076029619886022 25. Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39. doi:10.1016/S0140-6736(08)60880-6 26. Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786. doi:10.1056/NEJMoa076016

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NVAF: Reducing stroke risk

Chronic CAD/PAD: Reducing the risk of major CV events

DVT/PE: Initial treatment

VTE Prophylaxis: Acutely ill medical

DVT/PE: Extended treatment

DVT Prophylaxis: After hip/knee replacement surgery

Close

NVAFReducing stroke risk

Chronic CAD/PADReducing the risk of major CV events

VTE ProphylaxisAcutely ill medical patients^◇

DVT/PEInitial treatment

DVT/PEExtended treatment

DVT ProphylaxisAfter hip/knee replacement surgery

IMPORTANT SAFETY INFORMATION

INDICATIONS

NVAF: Reducing stroke risk

Chronic CAD/PAD: Reducing the risk of major CV events

DVT/PE: Initial treatment

VTE Prophylaxis: Acutely ill medical

DVT/PE: Extended treatment

DVT Prophylaxis: After hip/knee replacement surgery

Close

NVAFReducing stroke risk

Chronic CAD/PADReducing the risk of major CV events

VTE ProphylaxisAcutely ill medical patients◇

DVT/PEInitial treatment

DVT/PEExtended treatment

DVT ProphylaxisAfter hip/knee replacement surgery

VTE ProphylaxisAcutely ill medical patients^◇