COMMITTED TO PATIENT SAFETY ...
XARELTO ® establishing real-world outcomes
IMPORTANT SAFETY INFORMATION ( cont ’ d ) WARNINGS AND PRECAUTIONS ( cont ’ d )
Spinal / Epidural Anesthesia or Puncture ( cont ’ d ): 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 : 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 of 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 , 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 ( eg , diltiazem , verapamil , dronedarone , and erythromycin ) 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 .
Please see Important Safety Information on preceding and following page . Please see Brief Summary of full Prescribing Information , including Boxed WARNINGS , on preceding pages , or visit www . XareltoHCP . com / PI .