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• A specific antidote for rivaroxaban is not available. Because • Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism
of high plasma protein binding, rivaroxaban is not expected (PE), and Reduction in the Risk of Recurrence of DVT and of PE:
to be dialyzable. Avoid the use of XARELTO® in patients with CrCl <30 mL/min
due to an expected increase inrivaroxaban exposure and
• Concomitant use of other drugs that impair hemostasis increases
pharmacodynamic effects in this patient population.
the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors,
other antithrombotic agents, fibrinolytic therapy, and NSAIDs. • Prophylaxis of Deep Vein Thrombosis Following Hip or Knee
Replacement Surgery: Avoid the use of XARELTO® in patients
Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia
with CrCl <30 mL/min due to an expected increase in rivaroxaban
(spinal/epidural anesthesia) or spinal puncture is employed, patients
exposure and pharmacodynamic effects in this patient population.
treated with anticoagulant agents for prevention of thromboembolic
Observe closely and promptly evaluate any signs or symptoms
complications are at risk of developing an epidural or spinal
of blood loss in patients with CrCl 30 to 50 mL/min. Patients who
hematoma, which can result in long-term or permanent paralysis. To
develop acute renal failure while on XARELTO® should discontinue
reduce the potential risk of bleeding associated with the concurrent
the treatment.
use of rivaroxaban and epidural or spinal anesthesia/analgesia or
spinal puncture, consider the pharmacokinetic profile of rivaroxaban. Use in Patients With Hepatic Impairment: No clinical data are
Placement or removal of an epidural catheter or lumbar puncture is available for patients with severe hepatic impairment. Avoid use
best performed when the anticoagulant effect of rivaroxaban is low; of XARELTO® in patients with moderate (Child-Pugh B) and severe
however, the exact timing to reach a sufficiently low anticoagulant (Child-Pugh C) hepatic impairment or with any hepatic disease
effect in each patient is not known. An epidural catheter should not associated with coagulopathy, since drug exposure and bleeding risk
be removed earlier than 18 hours after the last administration of may be increased.
038573-150812
due to increased bleeding risk, unless benefit outweighs risk. ADVERSE REACTIONS IN CLINICAL STUDIES
Promptly evaluate any signs or symptoms of blood loss if patients he most common adverse reactions with XARELTO® were
T
are treated concomitantly with aspirin, other platelet aggregation bleeding complications.
inhibitors, or NSAIDs.
ARELTO® should not be used in patients with CrCl 15 to <80 mL/min
X Please see accompanying full Prescribing Information, including Boxed
who are receiving concomitant combined P-gp and moderate WARNINGS or visit www.XareltoHCP.com/PI.
CYP3A4 inhibitors (eg, diltiazem, verapamil, dronedarone, and
erythromycin) unless the potential benefit justifies the potential risk.
1. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-
1297. 2. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
3. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the Rocket AF Investigators. Rivaroxaban versus
warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891. 4. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3
Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
5. Kakkar AK, Brenner B, Dahl OE, et al; for the 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.
6. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip
arthroplasty. N Engl J Med. 2008;358(26):2765-2775. 7. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and
pharmacodynamics of rivaroxaban – an oral, direct Factor Xa inhibitor – in patients undergoing major orthopaedic surgery. Clin Pharmacokinet.
2008;47(3):203-216.