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| __NOTOC__
| | #REDIRECT [[Rivaroxaban#Warnings]] |
| {{Rivaroxaban}}
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| {{CMG}}; {{AE}} {{AZ}}
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| == Warnings and Precautions==
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| [[image:riva1.png|800px]] | | [[Category: Cardiovascular Drugs]] |
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| ===5.1 Increased Risk of Thrombotic Events after Premature Discontinuation===
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| 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 [see [[Rivaroxaban dosage and administration | Dosage and Administration]] and [[Rivaroxaban clinical studies | Clinical Studies]]].
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| ===5.2 Risk of Bleeding===
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| XARELTO increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of [[thrombotic]] events should be weighed against the risk of bleeding.
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| Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO in patients with active pathological [[hemorrhage]]. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.
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| Concomitant use of other drugs that impair [[hemostasis]] increases the risk of bleeding. These include [[aspirin]], [[P2Y12 platelet inhibitors]], other [[antithrombotic]] agents, [[fibrinolytic]] therapy, and [[non-steroidal anti-inflammatory drugs]] ([[NSAIDs]]) [see [[Rivaroxaban drug interactions | Drug Interactions]]].
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| Concomitant use of drugs that are combined P-gp and [[CYP3A4 inhibitors]] (e.g., [[ketoconazole]] and [[ritonavir]]) increases rivaroxaban exposure and may increase bleeding risk [see [[Rivaroxaban drug interactions | Drug Interactions]]]
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| ====Reversal of Anticoagulant Effect: ====
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| A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable [see [[Rivaroxaban clinical pharmacology |Clinical Pharmacology]]]. [[Protamine sulfate]] and [[vitamin K]] are not expected to affect the anticoagulant activity of rivaroxaban. Partial reversal of [[prothrombin]] time prolongation has been seen after administration of [[prothrombin]] complex concentrates (PCCs) in healthy volunteers. The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.
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| ===5.3 Spinal/Epidural Anesthesia or Puncture===
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| 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]] [see [[Rivaroxaban warnings and precautions|Boxed Warning]]].
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| 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.
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| ===5.4 Use in Patients with Renal Impairment===
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| ====Nonvalvular Atrial Fibrillation====
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| Avoid the use of XARELTO in patients with CrCl <15 mL/min since drug exposure is increased. Periodically assess renal function as clinically indicated (i.e., more frequently in situations in which renal function may decline) and adjust therapy accordingly. Discontinue XARELTO in patients who develop [[acute renal failure]] while on XARELTO [see [[Rivaroxaban use in specific populations | Use in Specific Populations (8.7)]]].
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| ====Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE====
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| 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[ [[Rivaroxaban use in specific populations | Use in Specific Populations (8.7)]]].
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| ====Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery====
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| 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 [see[[Rivaroxaban use in specific populations | Use in Specific Populations (8.7)]]].
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| ===5.5 Use in Patients with Hepatic Impairment===
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| No clinical data are available for patients with severe [[hepatic impairment]].
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| 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[[Rivaroxaban use in specific populations | Use in Specific Populations (8.8)]]].
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| ===5.6 Use with P-gp and Strong CYP3A4 Inhibitors or Inducers===
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| Avoid concomitant use of XARELTO with combined [[P-gp]] and strong [[CYP3A4]] inhibitors (e.g., [[ketoconazole]], [[itraconazole]], [[lopinavir]]/[[ritonavir]], ritonavir, [[indinavir]], and [[conivaptan]]) [see[[Rivaroxaban drug interactions | Drug Interactions (7.1)]]].
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| Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., [[carbamazepine]], [[phenytoin]], [[rifampin]], [[St. John's wort]]) [see [[Rivaroxaban drug interactions | Drug Interactions (7.2)]]].
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| ===5.7 Risk of Pregnancy-Related Hemorrhage===
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| 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 nor readily reversed. Promptly evaluate any signs or symptoms suggesting blood loss (e.g., a drop in [[hemoglobin]] and/or [[hematocrit]], [[hypotension]], or fetal distress).
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| ===5.8 Patients with Prosthetic Heart Valves===
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| 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.
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| ===5.9 Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy===
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| 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]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = XARELTO (RIVAROXABAN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] |url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]]
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