Compared to healthy subjects with normal creatinine clearance, rivaroxaban exposure increased in subjects with renal impairment.Animal reproduction studies showed no increased risk of structural malformations, but increased post-implantation pregnancy loss occurred in rabbits.This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.Avoid the 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.It is not known if Xarelto is safe and effective in children.Other information about Xarelto The European Commission granted a marketing authorisation valid throughout the European Union for Xarelto on 30 September 2008.
When Xarelto is used to prevent venous thromboembolism in patients undergoing hip- or knee-replacement surgery, the recommended dose is 10 mg once daily.Table 9 displays the overall results for the primary composite endpoint and its components for EINSTEIN DVT and EINSTEIN PE studies.
Reduction in the Risk of Recurrence of Deep Vein Thrombosis and of Pulmonary Embolism.
Some of your other medicines may affect the way Xarelto works.For the prevention of atherothrombotic events in patients who have had acute coronary syndrome, Xarelto was compared with placebo (a dummy treatment) in one main study involving over 15,000 patients who had recently had an acute coronary syndrome.If you are taking the higher dosages (15 or 20 mg daily), you must take it with food.
Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy.Patients undergoing hip- or knee-replacement surgery and patients with atrial fibrillation, DVT, pulmonary embolism or who have had acute coronary syndrome are at a risk of blood clots forming or re-occuring and moving to another part of the body.Before you start taking Xarelto (rivaroxaban), keep in mind that while it can normally be taken with or without food, in high doses it may be better taken with food.Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery.
Keep a list of them to show your doctor and pharmacist when you get a new medicine.If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence.
Unchanged rivaroxaban was the predominant moiety in plasma with no major or active circulating metabolites.The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.Status: Authorised Authorisation Date: 2008-09-30 Therapeutic Area: Arthroplasty, Replacement.Do not stop taking Xarelto without talking to the doctor who prescribes it for you.
In two drug interaction studies where clopidogrel (300 mg loading dose followed by 75 mg daily maintenance dose) and Xarelto (15 mg single dose) were coadministered in healthy subjects, an increase in bleeding time to 45 minutes was observed in approximately 45% and 30% of subjects in these studies, respectively.Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding.After knee-replacement surgery, 10% of the patients receiving Xarelto had blood clots or died (79 out of 824), compared with 19% of the patients receiving enoxaparin (166 out of 878).Patients randomized to warfarin had a mean percentage of time in the INR target range of 2.0 to 3.0 of 55%, lower during the first few months of the study.In a study with 44 healthy subjects, both mean AUC and C max values for 20 mg rivaroxaban administered orally as a crushed tablet mixed in applesauce were comparable to that after the whole tablet.Figure 4 is a plot of the time from randomization to the occurrence of the first primary endpoint event in the two treatment arms.
Since rivaroxaban absorption is dependent on the site of drug release, avoid administration of Xarelto distal to the stomach which can result in reduced absorption and thereby, reduced drug exposure.This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.