Xarelto

Xarelto

rivaroxaban

Manufacturer:

Bayer HealthCare Pharma

Distributor:

DKSH
Full Prescribing Info
Contents
Rivaroxaban.
Action
ATC Code: B01AX06.
Pharmacology: Mechanism of Action: Rivaroxaban is a highly selective direct factor Xa (FXa) inhibitor with oral bioavailability. Activation of factor X to FXa via the intrinsic and extrinsic pathway plays a central role in the cascade of blood coagulation.
Pharmacodynamic Effects: Dose-dependent inhibition of FXa activity was observed in humans. Prothrombin time (PT) is influenced by rivaroxaban in a dose-dependent way with a close correlation to plasma concentrations (r value=0.98) if Neoplastin is used for the assay. Other reagents would provide different results. The readout for PT is to be done in seconds, because the International Normalized Ratio (INR) is only calibrated and validated for coumarins and cannot be used for any other anticoagulant. In patients undergoing major orthopedic surgery, the 5/95 percentiles for PT (Neoplastin) 2-4 hrs after tablet intake (ie, at the time of maximum effect) ranged from 13-25 sec.
The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dose dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban. Anti-FXa activity is also influenced by rivaroxaban; however, no standard for calibration is available.
There is no need for monitoring of coagulation parameters during treatment with rivaroxaban.
Clinical Efficacy and Safety: Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopedic surgery of the lower limbs.
The rivaroxaban clinical program was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE ie, proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopedic surgery of the lower limbs. Over 9500 patients (7050 in total hip replacement surgery, 2531 in total knee replacement surgery) were studied in controlled randomized double-blind phase III clinical studies, known as the RECORD-program.
Rivaroxaban 10 mg once daily started not earlier than 6 hrs postoperatively was compared with enoxaparin 40 mg once daily started 12 hrs preoperatively.
In all three Phase III studies rivaroxaban significantly reduced the rate of total VTE (any venographically detected or symptomatic DVT, non-fatal PE or death) and major VTE (proximal DVT, non-fatal PE or VTE-related death), the prespecified primary and major secondary efficacy endpoints. Furthermore in all 3 studies, the rate of symptomatic VTE (symptomatic DVT, non-fatal PE, VTE-related death) was lower in rivaroxaban-treated patients compared to patients treated with enoxaparin.
The main safety endpoint, major bleeding, showed comparable rates for patients treated with rivaroxaban 10 mg compared to enoxaparin 40 mg. (See table.)

Click on icon to see table/diagram/image

The analysis of the pooled results of the phase III trials corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Special Patient Populations: Ethnic Differeces, Elderly/Gender, Different Weight Categories, Hepatic Impairment, Renal Impairment: See Pharmacokinetics.
Pharmacokinetics: Absorption and Bioavailability: The absolute bioavailability of rivaroxaban is high (80-100%) for the 10-mg dose. Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2-4 hrs after tablet intake.
Intake with food does not affect rivaroxaban AUC or Cmax at the 10-mg dose. Rivaroxaban 10-mg dose can be taken with or without food (see Dosage & Administration).
Variability in rivaroxaban pharmacokinetics is moderate with interindividual variability (CV%) ranging from 30-40%, apart from the day of surgery and the following day when variability in exposure is high (70%).
Distribution: Plasma protein-binding in humans is high at approximately 92-95%, with serum albumin being the main binding component. The volume of distribution is moderate with Vss being approximately 50 L.
Metabolism and Elimination: Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with ½ then eliminated renally and the other ½ eliminated via the fecal route. The other 1/3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion.
Rivaroxaban is metabolized via CYP3A4, CYP2J2 and CYP-independent mechanisms. Oxidative degradation of the morpholinone moiety and hydrolysis of the amide bonds are the major sites of biotransformation. Based on in vitro investigations, rivaroxaban is a substrate of the transporter proteins P-glycoprotein (P-gp) and breast cancer resistance protein (Bcrp).
Unchanged rivaroxaban is the most important compound in human plasma with no major or active circulating metabolites being present. With a systemic clearance of about 10 L/hr, rivaroxaban can be classified as a low-clearance drug. Elimination of rivaroxaban from plasma occurred with terminal half-lives of 5-9 hrs in young individuals, and with terminal half-lives of 11-13 hrs in the elderly.
Gender/Elderly (>65 years): Elderly patients exhibited higher plasma concentrations than younger patients with mean AUC values being approximately 1.5-fold higher, mainly due to reduced (apparent) total and renal clearance (see Dosage & Administration).
There were no clinically relevant differences in pharmacokinetics between male and female patients (see Dosage & Administration).
Different Weight Categories: Extremes in body weight (<50 kg vs >120 kg) had only a small influence on rivaroxaban plasma concentrations (<25%) (see Dosage & Administration).
Children (From Birth to 16 or 18 years Depending on Local Law): No data are available for this patient population (see Dosage & Administration).
Interethnic Differences: No clinically relevant interethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding pharmacokinetics and pharmacodynamics (see Dosage & Administration).
Hepatic Impairment: The effect of hepatic impairment on rivaroxaban pharmacokinetics has been studied in subjects categorized according to the Child-Pugh classification, a standard procedure in clinical development. The Child-Pugh classification's original purpose is to assess the prognosis of chronic liver disease, mainly cirrhosis. In patients for whom anticoagulation is intended, the critical aspect of liver impairment is the reduced synthesis of normal coagulation factors in the liver. Since this aspect is captured by only 1 of the 5 clinical/biochemical measurements composing the Child-Pugh classification system, the bleeding risk in patients may not clearly correlate with this classification scheme. The decision to treat patients with an anticoagulant should therefore be made independently of the Child-Pugh classification.
Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
Cirrhotic patients with mild hepatic impairment (classified as Child-Pugh A) exhibited only minor changes in rivaroxaban pharmacokinetics (1.2-fold increase in rivaroxaban AUC on average), nearly comparable to their matched healthy control group. No relevant difference in pharmacodynamic properties was observed between these groups.
In cirrhotic patients with moderate hepatic impairment (classified as Child-Pugh B), rivaroxaban mean AUC was significantly increased by 2.3-fold compared to healthy volunteers, due to significantly impaired drug clearance which indicates significant liver disease. Unbound AUC was increased 2.6-fold. There are no data in patients with severe hepatic impairment.
The inhibition of FXa activity was increased by a factor of 2.6 as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 2.1. Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper pharmacokinetics/pharmacodynamics (PK/PD) relationship between concentration and PT.
No data are available for Child-Pugh C patients (see Dosage & Administration and Contraindications).
Renal Impairment: There was an increase in rivaroxaban exposure being inversely correlated to the decrease in renal function, as assessed via creatinine clearance (CrCl) measurements.
In individuals with mild (CrCl 80 to 50 mL/min), moderate (CrCl <50 to 30 mL/min) or severe (CrCl <30 to 15 mL/min) renal impairment, rivaroxaban plasma concentrations (AUC) were 1.4-, 1.5- and 1.6-fold increased, respectively, as compared to healthy volunteers (see Dosage & Administration and Precautions).
Corresponding increases in pharmacodynamic effects were more pronounced (see Dosage & Administration and Precautions).
In individuals with mild, moderate or severe renal impairment, the overall inhibition of FXa activity was increased by a factor of 1.5, 1.9 and 2, respectively, as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4, respectively. There are no data in patients with CrCl <15 mL/min.
Use is not recommended in patients with CrCl <15 mL/min. Rivaroxaban is to be used with caution in patients with severe renal impairment CrCl 15-30 mL/min (see Dosage & Administration and Precautions).
Toxicology: Preclinical Safety Data: Except for effects related to an exaggerated pharmacological mode of action (bleedings), preclinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Indications/Uses
Prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery of the lower limbs. Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Treatment of deep vein thrombosis (DVT) and for prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Dosage/Direction for Use
Stroke Prevention in Atrial Fibrillation (SPAF): Recommended Dose: 20 mg once daily. For patients with CrCl <50 to 30 mL/min, the recommended dose is 15 mg once daily.
VTE Treatment: Recommended Dose: Initial Treatment of Acute DVT: 15 mg twice daily for the 1st 3 weeks followed by 20 mg once daily for the continued treatment and the prevention of recurrent DVT and PE.
VTE Prevention in Major Orthopedic Surgery: Recommended Dose: 10 mg taken once daily. Duration of Treatment: After major hip surgery: 5 weeks; major knee surgery: 2 weeks.
Rivaroxaban may be taken with or without food. The initial dose should be taken 6-10 hrs after surgery provided that hemostasis has been established. If a dose is missed, the patient should take rivaroxaban immediately and continue on the following day with the once-daily intake as before.
Special Populations: Elderly >65 years, Gender and Body Weight: No dose adjustment is required for these patient populations (see Pharmacokinetics under Actions).
Children (From Birth to 16 or 18 years Depending on Local Law): No clinical data available in children.
Patients with Impaired Liver Function: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases (see Pharmacokinetics under Actions).
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity. No clinical data are available for patients with severe hepatic impairment (see Contraindications and Pharmacokinetics under Actions).
Patients with Impaired Renal Function: No dose adjustment is required if rivaroxaban is administered in patients with mild or moderate renal impairment (see Pharmacokinetics under Actions).
Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma levels are significantly increased in this patient population. Therefore, rivaroxaban must be used with caution in these patients. Use of rivaroxaban is not recommended in patients with CrCl <15 mL/min (see Precautions and Pharmacokinetics under Actions).
Ethnic Differences: No dose adjustment is required based on ethnic differences (see Pharmacokinetics under Actions).
Overdosage
Overdose following administration of rivaroxaban may lead to hemorrhagic complications due to its pharmacodynamic properties.
A specific antidote antagonizing the pharmacoceutical effect of rivaroxaban is not available.
The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered. Administration of activated charcoal up to 8 hrs after overdose may reduce the absorption of rivaroxaban.
Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable.
Should bleeding occur, management of the hemorrhage may include the following steps: Delay of next rivaroxaban administration or discontinuation of treatment as appropriate. Rivaroxaban has a half-life of approximately 5-13 hrs (see Pharmacokinetics under Actions); appropriate symptomatic treatment eg, mechanical compression (eg, for severe epistaxis), surgical interventions, fluid replacement and hemodynamic support, blood product or component transfusion should be considered.
If bleeding cannot be controlled by the previously mentioned measures, administration of one of the following procoagulants may be considered: Activated prothrombin complex concentrate (APCC); prothrombin complex concentrate (PCC); recombinant factor VIIa (rF VIIa).
However, there is currently no experience with the use of these products in individuals receiving rivaroxaban.
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. There is no scientific rationale for benefit or experience with systemic hemostatics (eg, desmopressin, aprotinin, tranexamic acid, aminocaproic acid) in individuals receiving rivaroxaban.
Contraindications
Patients with hypersensitivity to rivaroxaban or any of the excipients of Xarelto (see Description); clinically significant active bleeding (eg, intracranial and gastrointestinal bleeding); hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
Use in Pregnancy: No human data are available on the use of rivaroxaban in pregnant women.
In rats and rabbits, rivaroxaban showed pronounced maternal toxicity with placental changes related to its pharmacological mode of action (eg, hemorrhagic complications). No primary teratogenic potential was identified. Data from animals showed a pronounced maternal toxicity of rivaroxaban related to its pharmacological mode of action (eg, hemorrhagic complications) leading to reproductive toxicity (see Toxicology under Actions). Due to the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, rivaroxaban is contraindicated in pregnancy (see Toxicology under Actions).
Women of Childbearing Potential: Rivaroxaban should be used in women of childbearing potential only with effective contraception.
Use in Lactation: No human data on the use of rivaroxaban in nursing mothers are available. In rats, rivaroxaban is secreted into breast milk. Therefore, rivaroxaban may only be administered after breastfeeding is discontinued (see Toxicology under Actions).
Special Precautions
Concomitant Medication: Rivaroxaban is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (eg, ketoconazole) or HIV protease inhibitors (eg, ritonavir). These drugs are strong inhibitors of both CYP3A4 and P-gp. Therefore, these drugs may increase rivaroxaban plasma concentrations to a clinically relevant degree which may lead to an increased bleeding risk. (See Interactions.)
Renal Impairment: Rivaroxaban is to be used with caution in patients with moderate renal impairment (CrCl 30-49 mL/min) receiving co-medications leading to increased rivaroxaban plasma concentrations (see Interactions).
In patients with severe renal impairment, rivaroxaban plasma levels may be significantly elevated which may lead to an increased bleeding risk.
Due to limited clinical data, rivaroxaban should be used with caution in patients with CrCl <30 to 15 mL/min.
No clinical data are available for patients with severe renal impairment (CrCl <15 mL/min). Therefore, use of rivaroxaban is not recommended in these patients. (See Pharmacology and Pharmacokinetics under Actions and Dosage & Administration.)
Patients with severe renal impairment or increased bleeding risk and patients receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors are to be carefully monitored for signs of bleeding complications after initiation of treatment. This may be done by regular physical examination of the patients, close observation of the surgical wound drainage and periodic measurements of hemoglobin.
Hip Fracture Surgery: Rivaroxaban has not been studied in clinial trials in patients undergoing hip fracture surgery.
Bleeding Risk: Rivaroxaban like other antithrombotics should be used with caution in patients with an increased bleeding risk eg, congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, active ulcerative gastrointestinal disease, recent gastrointestinal ulcerations, vascular retinopathy, recent intracranial or intracerebral hemorrhage, intraspinal or intracerebral vascular abnormalities, shortly after brain, spinal or ophthalmological surgery.
Care should be taken if patients are treated concomitantly with drugs affecting hemostasis eg, nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors or other antithrombotics (see Interactions).
Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site.
Neuraxial (Epidural/Spinal) Anesthesia: When neuraxial (epidural/spinal) anesthesia or spinal puncture is performed, patients treated with antithrombotics for prevention of thromboembolic complications are at risk for development of an epidural or spinal hematoma which may result in long-term paralysis.
The risk of these events is even further increased by use of indwelling epidural catheters or the concomitant use of drugs affecting hemostasis. The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Patients should be frequently monitored for signs and symptoms of neurological impairment (eg, numbness or weakness of the legs, bowel or bladder dysfunction). If neurological deficits are noted, urgent diagnosis and treatment is necessary.
The physician should consider the potential benefit versus the risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
An epidural catheter should not be withdrawn earlier than 18 hrs after the last administration of rivaroxaban.
Rivaroxaban should be administered at earliest 6 hrs after the removal of the catheter.
If traumatic puncture occurs, the administration of rivaroxaban should be delayed for 24 hrs.
Women of Childbearing Potential: See Use in pregnancy under Contraindications.
Use In Pregnancy & Lactation
Use in Pregnancy: No human data are available on the use of rivaroxaban in pregnant women.
In rats and rabbits, rivaroxaban showed pronounced maternal toxicity with placental changes related to its pharmacological mode of action (eg, hemorrhagic complications). No primary teratogenic potential was identified. Data from animals showed a pronounced maternal toxicity of rivaroxaban related to its pharmacological mode of action (eg, hemorrhagic complications) leading to reproductive toxicity (see Toxicology under Actions). Due to the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, rivaroxaban is contraindicated in pregnancy (see Toxicology under Actions).
Women of Childbearing Potential: Rivaroxaban should be used in women of childbearing potential only with effective contraception.
Use in Lactation: No human data on the use of rivaroxaban in nursing mothers are available. In rats, rivaroxaban is secreted into breast milk. Therefore, rivaroxaban may only be administered after breastfeeding is discontinued (see Toxicology under Actions).
Adverse Reactions
The safety of rivaroxaban 10 mg has been evaluated in three Phase III studies including 4571 patients exposed to rivaroxaban undergoing major orthopedic surgery of the lower limbs (total hip replacement or total knee replacement) treated up to 39 days. The adverse reactions are presented within each frequency grouping and system organ classes; the adverse reactions should be interpreted within the surgical setting. Frequencies are defined as: Common: ≥1% to <10% (≥1/100 to <1/10); uncommon: ≥0.1% to <1% (≥1/1000 to <1/100); rare: ≥0.01% to <0.1% (≥1/10,000 to <1/1000); very rare: <0.01% (<1/10,000).
Due to the pharmacological mode of action, rivaroxaban may be associated with an increased risk of occult or overt bleeding from any tissue and organ which may result in posthemorrhagic anemia. The signs, symptoms and severity (including possible fatal outcome) will vary according to the location and degree or extent of the bleeding. The risk of bleedings may be increased in certain patient groups eg, patients with uncontrolled severe arterial hypertension and/or on concomitant medications affecting hemostasis (see Precautions). Hemorrhagic complications may present as weakness, asthenia, paleness, dizziness, headache or unexplained swelling. Therefore, the possibility of a hemorrhage should be considered in evaluating the condition in any anticoagulated patient.
Adverse reactions as reported by the investigators in the three Phase III studies are listed as follows by system organ class (in MedDRA) and frequency.
All Treatment-Emergent Adverse Drug Reactions Reported in Patients in Studies 11354, 11357, 11356: Blood and the Lymphatic System Disorders: Common: Anemia (including respective laboratory parameters). Uncommon: Thrombocythemia (including increased platelet count).
Cardiac Disorders: Uncommon: Tachycardia.
Gastrointestinal Disorders: Common: Nausea. Uncommon: Constipation, diarrhea, abdominal and gastrointestinal pain (including upper abdominal pain, stomach discomfort), dyspepsia (including epigastric discomfort), dry mouth, vomiting.
General Disorders and Administration Site Conditions: Uncommon: Localized edema, peripheral edema, feeling unwell (including fatigue, asthenia), fever.
Hepatobiliary Disorders: Rare: Abnormal hepatic function.
Immune System Disorders: Rare: Allergic dermatitis.
Injury, Poisoning and Procedural Complications: Uncommon: Wound secretion.
Investigations: Common: Increased GGT, increase in transaminases (including increased ALT and AST). Uncommon: Increased lipase, amylase, blood bilirubin, LDH, alkaline phosphatase. Rare: Increased conjugated bilirubin (with or without concomitant increase of ALT).
Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Pain in extremity.
Nervous System Disorders: Uncommon: Dizziness, headache, syncope (including loss of consciousness).
Renal and Urinary Disorders: Uncommon: Renal impairment (including increased blood creatinine and blood urea).
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus (including rare cases of generalized pruritus), rash, urticaria (including rare cases of generalized urticaria), contusion.
Vascular Disorders: Common: Postprocedural hemorrhage (including postoperative anemia and wound hemorrhage). Uncommon: Hypotension (including decreased blood pressure, procedural hypotension), hemorrhage (including hematoma and rare cases of muscle hemorrhage), gastrointestinal tract hemorrhage (including gingival bleeding, rectal hemorrhage, hematemesis), hematuria (including presence of blood in urine), genital tract hemorrhage (including menorrhagia), nose bleed.
In other clinical studies with rivaroxaban, single cases of adrenal hemorrhage, conjunctival hemorrhage and fatal gastrointestinal ulcer hemorrhage were reported; jaundice and hypersensitivity were rare; hemoptysis was uncommon. Intracranial bleeding (especially in patients with arterial hypertension and/or on concomitant antihemostatic agents) which in single cases may be potentially life threatening have been reported.
Drug Interactions
Pharmacokinetic Interactions: Rivaroxaban is cleared mainly via cytochrome P-450 mediated (CYP3A4, CYP2J2) hepatic metabolism and renal excretion of the unchanged drug, involving the P-gp/Bcrp transporter systems.
CYP Inhibition or Induction: Rivaroxaban does not inhibit or induce CYP3A4 or any other major CYP isoforms.
Effects on Rivaroxaban: The concomitant use of rivaroxaban with strong CYP3A4 and P-gp inhibitors may lead to both reduced hepatic and renal clearance and thus significantly increased systemic exposure.
Co-administration of rivaroxaban with the azole-antimycotic ketoconazole (400 mg once daily), a strong CYP3A4 and P-gp inhibitor, led to a 2.6-fold increase in mean rivaroxaban steady-state AUC and a 1.7-fold increase in mean rivaroxaban Cmax with significant increases in its pharmacodynamic effects.
Co-administration of rivaroxaban with the HIV protease inhibitor ritonavir (600 mg twice daily), a strong CYP3A4 and P-gp inhibitor, led to a 2.5-fold increase in mean rivaroxaban AUC and a 1.6-fold increase in mean rivaroxaban Cmax with significant increases in its pharmacodynamic effects.
Therefore, rivaroxaban is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics or HIV-protease inhibitors (see Precautions).
Clarithromycin (500 mg twice daily), considered as strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5-fold increase in mean rivaroxaban AUC and a 1.4-fold increase in Cmax. This increase which is close to the magnitude of the normal variability of AUC and Cmax, is considered as clinically not relevant.
Erythromycin (500 mg thrice daily), which inhibits CYP3A4 and P-gp moderately, led to a 1.3-fold increase in mean rivaroxaban AUC and Cmax. This increase is within the magnitude of the normal variability of AUC and Cmax and is considered as clinically not relevant.
Co-administration of rivaroxaban with the strong CYP3A4 and P-gp inducer rifampicin led to an approximately 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects. The concomitant use of rivaroxaban with other strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbitone or St. John's wort) may also lead to a decreased rivaroxaban plasma concentration. The decrease in rivaroxaban plasma concentrations is considered as clinically not relevant.
Pharmacodynamic Interactions: After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose), an additive effect on anti-FXa activity was observed without any additional effects on clotting tests (PT, aPTT). Enoxaparin did not affect the pharmacokinetics of rivaroxaban (see Precautions).
Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction but a relevant increase in bleeding times was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels (see Precautions).
No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban and naproxen 500 mg. Nevertheless, there may be individuals with more pronounced pharmacodynamic response (see Precautions).
Food and Dairy Products: Rivaroxaban 10 mg can be taken with or without food (see Pharmacokinetics under Actions).
Laboratory Parameters: Clotting parameter tests (PT, aPTT, Hep Test) are affected as expected by the mode of action of rivaroxaban.
Incompatibilities: None known.
Storage
Do not store above 30°C.
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
FC tab 10 mg x 1 x 10's. 15 mg x 2 x 14's, 3 x 10's. 20 mg x 2 x 14's, 3 x 10's.
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