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Source: European Medicines Agency Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect.In the EINSTEIN Extension clinical study, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 1.8% for XARELTO vs. 0.2% for placebo treatment groups.For patients receiving 15 mg twice daily: The patient should take XARELTO immediately to ensure intake of 30 mg XARELTO per day.Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media.The following adverse reactions are also discussed in other sections of the labeling.In vitro studies indicate that rivaroxaban neither inhibits the major cytochrome P450 enzymes CYP1A2, 2C8, 2C9, 2C19, 2D6, 2J2, and 3A4 nor induces CYP1A2, 2B6, 2C19, or 3A4.If a dose is missed, advise the patient to take XARELTO as soon as possible on the same day and continue on the following day with their recommended daily dose regimen.Renal impairment: Avoid or adjust dose based on CrCl and Indication ( 8.7 ).

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The main measure of effectiveness was the number of patients who had either a DVT recurrence or pulmonary embolism.

Figure 8 is a plot of the time from randomization to the occurrence of the first primary efficacy endpoint event in the two treatment groups.If the same patient had several events, the patient may have been counted for several components.Figure 1 shows the risk of major bleeding events across major subgroups.These hematomas may result in long-term or permanent paralysis.

The steady-state volume of distribution in healthy subjects is approximately 50 L.An in vitro compatibility study indicated that there is no adsorption of rivaroxaban from a water suspension of a crushed XARELTO tablet to PVC or silicone nasogastric (NG) tubing.Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup, but was a criterion for the CHADS2 score).See the end of this leaflet for a complete list of ingredients in XARELTO.Do not give XARELTO to other people, even if they have the same condition.Consumer information about rivaroxaban (Xarelto), a drug prescribed to prevent or treat AFib, DVT, and pulmonary embolism.

In pharmacokinetic studies, compared to healthy subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in subjects with renal impairment.An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients.Other clinical trial experience: In an investigational study of acute medically ill patients being treated with XARELTO 10 mg tablets, cases of pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis were observed.

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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).Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation ( 2.4 ).Tymlos Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein).

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The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.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.Table 12: Summary of Key Efficacy Analysis Results for Patients Undergoing Total Knee Replacement Surgery - Modified Intent-to-Treat Population.XARELTO increases the risk of bleeding and can cause serious or fatal bleeding.Safety and effectiveness of XARELTO during labor and delivery have not been studied in clinical trials.These highlights do not include all the information needed to use XARELTO.Read this Medication Guide before you start taking XARELTO and each time you get a refill.For people taking XARELTO for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.

Blister package containing 100 tablets (10 blister cards containing 10 tablets each).Compared to healthy subjects with normal liver function, significant increases in rivaroxaban exposure were observed in subjects with moderate hepatic impairment (Child-Pugh B) (see Figure 2 ).These hematomas may result in long-term or permanent paralysis ( 5.2, 5.3, 6.2 ).This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.Neither naproxen nor aspirin affected the pharmacokinetics of rivaroxaban (see Figure 3 ).Reports of any side effect of XARELTO: 4971 Percentage of XARELTO patients where GLAUCOMA is a reported side effect: 0.0201%.There are no adequate or well-controlled studies of XARELTO in pregnant women, and dosing for pregnant women has not been established.There is no clear understanding of the impact of hepatic impairment beyond this degree on the coagulation cascade and its relationship to efficacy and safety.

If a dose of XARELTO is not taken at the scheduled time, administer the dose as soon as possible on the same day as follows.

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In a thorough QT study in healthy men and women aged 50 years and older, no QTc prolonging effects were observed for XARELTO (15 mg and 45 mg, single-dose).The mean age was 71 years and the mean CHADS 2 score was 3.5. The population was 60% male, 83% Caucasian, 13% Asian and 1.3% Black. There was a history of stroke, TIA, or non-CNS systemic embolism in 55% of patients, and 38% of patients had not taken a vitamin K antagonist (VKA) within 6 weeks at time of screening.In the nonvalvular atrial fibrillation efficacy study XARELTO was taken with the evening meal.During the 28 days following the end of the study, there were 22 strokes in the 4637 patients taking XARELTO vs. 6 in the 4691 patients taking warfarin.Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3 ).XARELTO patients were generally switched to warfarin without a period of coadministration of warfarin and XARELTO, so that they were not adequately anticoagulated after stopping XARELTO until attaining a therapeutic INR.

In hip-replacement surgery, the first study compared five weeks of Xarelto with five weeks of enoxaparin in around 4,500 patients, and the second study compared five weeks of Xarelto with two weeks of enoxaparin in around 2,500 patients.In all of the studies, the effectiveness was measured by looking at the number of patients who either had blood clots in the veins or in the lungs, or who died of any cause during the treatment period.By inhibiting FXa, rivaroxaban decreases thrombin generation. Overdose of Xarelto may lead to hemorrhage.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.Ask your doctor if you are not sure if your medicine is one listed above.

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Immune system disorders: hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema.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.Dosage and Administration information for Xarelto (Rivaroxaban).

Administration via nasogastric (NG) tube or gastric feeding tube: After confirming gastric placement of the tube, 10 mg, 15 mg or 20 mg XARELTO tablets may be crushed and suspended in 50 mL of water and administered via an NG tube or gastric feeding tube.After this initial treatment period, the recommended dose of XARELTO is 20 mg taken orally once daily with food, at approximately the same time each day.

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A total of 1196 patients were randomized and followed on study treatment for a mean of 190 days for both XARELTO and placebo treatment groups.Figure 3: Effect of Coadministered Drugs on the Pharmacokinetics of Rivaroxaban.No clinical data are available for patients with severe hepatic impairment.

The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.For the 20 mg dose in the fasted state, the absolute bioavailability is approximately 66%.Consider these risks when scheduling patients for spinal procedures.Efficacy Profile Proven efficacy profile across 6 indications.XARELTO 15 mg Filmtabletten 42 St Filmtabletten Bayer Vital GmbH GB Pharma 08461404 Apotheke Schweiz.Tell your doctor if you have any side effect that bothers you or that does not go away.

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In clinical trials the efficacy of XARELTO in the elderly (65 years or older) was similar to that seen in patients younger than 65 years.