United States - English - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - rivaroxaban 10 mg - xarelto is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in adult patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in adult patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an a

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - rivaroxaban 10 mg - xarelto is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in adult patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in adult patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an a

United States - English - NLM (National Library of Medicine)

a-s medication solutions - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - xarelto is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in adult patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in adult patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for vte and not at high risk of bleeding [see warnings and precautions (5.2) and clinical studies (14.5)] . xarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. xarelto, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with pad, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic pad. xarelto is indicated for the treatment of venous thromboembolism (vte) and the reduction in the risk of recurrent vte in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. xarelto is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the fontan procedure. xarelto is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.2)] - severe hypersensitivity reaction to xarelto (e.g., anaphylactic reactions) [see adverse reactions (6.2)] risk summary the limited available data on xarelto in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. use xarelto with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. the anticoagulant effect of xarelto cannot be reliably monitored with standard laboratory testing. consider the benefits and risks of xarelto for the mother and possible risks to the fetus when prescribing xarelto to a pregnant woman [see warnings and precautions (5.2, 5.7)] . adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia. maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. fetal/neonatal adverse reactions based on the pharmacologic activity of factor xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see warnings and precautions (5.7)]. the risk of bleeding should be balanced with the risk of thrombotic events when considering the use of xarelto in this setting. data human data there are no adequate or well-controlled studies of xarelto in pregnant women, and dosing for pregnant women has not been established. post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage. in an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. animal data rivaroxaban crosses the placenta in animals. rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis. this dose corresponds to about 4 times the human exposure of unbound drug, based on auc comparisons at the highest recommended human dose of 20 mg/day. fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. this dose corresponds to about 14 times the human exposure of unbound drug. in rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day). risk summary rivaroxaban has been detected in human milk. there are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. rivaroxaban and/or its metabolites were present in the milk of rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xarelto and any potential adverse effects on the breastfed infant from xarelto or from the underlying maternal condition (see data) . data animal data following a single oral administration of 3 mg/kg of radioactive [ 14 c]-rivaroxaban to lactating rats between day 8 to 10 postpartum, the concentration of total radioactivity was determined in milk samples collected up to 32 hours post-dose. the estimated amount of radioactivity excreted with milk within 32 hours after administration was 2.1% of the maternal dose. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including xarelto should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of xarelto have been established in pediatric patients from birth to less than 18 years for the treatment of vte and the reduction in risk of recurrent vte. use of xarelto is supported in these age groups by evidence from adequate and well-controlled studies of xarelto in adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, open-label, active-controlled randomized study in 500 pediatric patients from birth to less than 18 years of age. xarelto was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14.8)] . the safety and effectiveness of xarelto have been established for use in pediatric patients aged 2 years and older with congenital heart disease who have undergone the fontan procedure. use of xarelto is supported in these age groups by evidence from adequate and well-controlled studies of xarelto in adults with additional data from a multicenter, prospective, open-label, active controlled study in 112 pediatric patients to evaluate the single- and multiple-dose pharmacokinetic properties of xarelto and the safety and efficacy of xarelto when used for thromboprophylaxis for 12 months in children with single ventricle physiology who had the fontan procedure [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14.9)] . clinical studies that evaluated safety, efficacy, pharmacokinetic and pharmacodynamic data support the use of xarelto 10 mg, 15 mg, and 20 mg tablets in pediatric patients. for the xarelto 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. therefore, xarelto 2.5 mg tablets are not recommended for use in pediatric patients. although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents. of the total number of adult patients in clinical trials for the approved indications of xarelto (n=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. 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. both thrombotic and bleeding event rates were higher in these older patients [see clinical pharmacology (12.3) and clinical studies (14)] . in pharmacokinetic studies, compared to healthy adult subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in adult subjects with renal impairment. increases in pharmacodynamic effects were also observed [see clinical pharmacology (12.3)] . nonvalvular atrial fibrillation patients with chronic kidney disease not on dialysis in the rocket af trial, patients with crcl 30 to 50 ml/min were administered xarelto 15 mg once daily resulting in serum concentrations of rivaroxaban and clinical outcomes similar to those in patients with better renal function administered xarelto 20 mg once daily. patients with crcl <30 ml/min were not studied, but administration of xarelto 15 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment [see clinical pharmacology (12.3)] . patients with end-stage renal disease on dialysis clinical efficacy and safety studies with xarelto did not enroll patients with end-stage renal disease (esrd) on dialysis. in patients with esrd maintained on intermittent hemodialysis, administration of xarelto 15 mg once daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in the rocket af study [see clinical pharmacology (12.2, 12.3)] . it is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with esrd on dialysis as was seen in rocket af. treatment of dvt and/or pe and reduction in the risk of recurrence of dvt and/or pe in the einstein trials, patients with crcl values <30 ml/min at screening were excluded from the studies, but administration of xarelto is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (crcl 30 to <50 ml/min) [see clinical pharmacology (12.3)]. observe closely and promptly evaluate any signs or symptoms of blood loss in patients with crcl 15 to <30 ml/min. avoid the use of xarelto in patients with crcl <15 ml/min. prophylaxis of dvt following hip or knee replacement surgery the combined analysis of the record 1–3 clinical efficacy studies did not show an increase in bleeding risk for patients with crcl 30 to 50 ml/min and reported a possible increase in total venous thromboemboli in this population. in the record 1–3 trials, patients with crcl values <30 ml/min at screening were excluded from the studies, but administration of xarelto 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (crcl 30 to <50 ml/min) [see clinical pharmacology (12.3)]. observe closely and promptly evaluate any signs or symptoms of blood loss in patients with crcl 15 to <30 ml/min. avoid the use of xarelto in patients with crcl <15 ml/min. prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding patients with crcl values <30 ml/min at screening were excluded from the magellan study. in patients with crcl <30 ml/min a dose of xarelto 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (crcl 30 to <50 ml/min) [see clinical pharmacology (12.3)] . observe closely and promptly evaluate any signs or symptoms of blood loss in patients with crcl 15 to <30 ml/min. avoid use of xarelto in patients with crcl <15 ml/min. reduction of risk of major cardiovascular events in patients with cad and reduction of risk of major thrombotic vascular events in patients with pad, including patients after recent lower extremity revascularization due to symptomatic pad patients with chronic kidney disease not on dialysis patients with a crcl <15 ml/min at screening were excluded from compass and voyager, and limited data are available for patients with a crcl of 15 to 30 ml/min. in patients with crcl <30 ml/min, a dose of 2.5 mg xarelto twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (crcl 30 to <50 ml/min) [see clinical pharmacology (12.3)] , whose efficacy and safety outcomes were similar to those with preserved renal function. patients with end-stage renal disease on dialysis no clinical outcome data is available for the use of xarelto with aspirin in patients with esrd on dialysis since these patients were not enrolled in compass or voyager. in patients with esrd maintained on intermittent hemodialysis, administration of xarelto 2.5 mg twice daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in moderate renal impaired patients in the compass study [see clinical pharmacology (12.2, 12.3)] . it is not known whether these concentrations will lead to similar cv risk reduction and bleeding risk in patients with esrd on dialysis as was seen in compass. pediatric use no dosage adjustment is required in patients 1 year of age or older with mild renal impairment (egfr 50 to ≤ 80 ml/min/1.73 m 2 ). there are limited clinical data in pediatric patients 1 year or older with moderate or severe renal impairment (egfr <50 ml/min/1.73 m 2 ); therefore, avoid the use of xarelto in these patients. there are no clinical data in pediatric patients younger than 1 year with serum creatinine results above 97.5 th percentile; therefore, avoid the use of xarelto in these patients [see dosage and administration (2.2)] . in a pharmacokinetic study, compared to healthy adult subjects with normal liver function, auc increases of 127% were observed in adult subjects with moderate hepatic impairment (child-pugh b). the safety or pk of xarelto in patients with severe hepatic impairment (child-pugh c) has not been evaluated [see clinical pharmacology (12.3)] . 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. no clinical data are available in pediatric patients with hepatic impairment. this instructions for use contains information on how to give a dose of xarelto oral suspension. read this instructions for use before giving xarelto and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your doctor about your child's medical condition or treatment. important information: - xarelto suspension is for oral use only. - give xarelto to your child exactly as prescribed by your doctor. the adult caregiver should give the dose. if you have questions, contact your doctor or pharmacist for more information on giving a dose. - only use the oral dosing syringe provided with xarelto oral suspension. contact your doctor or pharmacist if the oral dosing syringe is missing, lost or damaged. storage information store xarelto oral suspension at room temperature between 68°f to 77°f (20°c to 25°c). do not freeze. store the bottle upright with the oral dosing syringes in the original carton. keep xarelto and all medicines out of reach of children. xarelto oral dosing syringe: xarelto bottle check "discard after" date on the xarelto bottle. if "discard after" date has passed, do not use and call your doctor or pharmacist. wash hands. wash your hands well with soap and warm water. shake bottle slowly for 10 seconds before each use. check xarelto oral suspension. if there are lumps or granules at the bottom of the bottle, shake the bottle slowly again for 10 seconds . find your dose line. you can use either side of the syringe to set your dose. if using ml side of syringe: top of the plunger should line up with the prescribed ml. if using color side of syringe: top of the plunger should line up with the prescribed ml dose line at the bottom of the color band. if your dose is more than 5 ml. you will need to use the same syringe more than one time. repeat steps 4 and 5 to complete your dose. ask your pharmacist if you are not sure. push plunger all the way in to remove air. insert oral dosing syringe into bottle adaptor. twist off the cap from the bottle. do not remove the bottle adaptor from the bottle. insert the syringe tip into the bottle adaptor. fill oral dosing syringe. turn the bottle upside down, as shown. pull the plunger to fill the oral dosing syringe slightly past your prescribed dose line to help remove any air bubbles. caution: make sure you have enough medicine for a full dose. do not take a partial dose. tap syringe to move air bubbles to the top. doing this helps set the correct dose. adjust to your prescribed dose. if using ml side of syringe: push plunger to align with the prescribed dose line. if using color side of syringe: push plunger to align with the prescribed ml dose line at the bottom of the color band. remove oral dosing syringe. place the bottle on a flat surface. remove the oral dosing syringe from the bottle. give the dose. place the oral dosing syringe gently into the child's mouth with the tip of the syringe pointing toward the cheek and slowly press the plunger. this allows the child to swallow naturally. make sure the child swallows the full dose. if your child vomits or spits out the medicine repeatedly, contact your child's doctor right away. close xarelto bottle and rinse oral dosing syringe. rinse the oral dosing syringe with tap water and let it air dry. disposing xarelto bottle and syringe - throw the xarelto bottle away in your household trash. - throw away any used oral dosing syringe with the opening of a new xarelto bottle. - do not pour xarelto suspension down the drain (for example: sink, toilet, shower or tub). - do not recycle the bottle. manufactured for: janssen pharmaceuticals, inc. titusville, nj 08560 licensed from: bayer healthcare ag 51368 leverkusen, germany for patent information: www.janssenpatents.com © 2021 janssen pharmaceutical companies this instructions for use has been approved by the u.s. food and drug administration. issued: 02/2023

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - xarelto is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in adult patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in adult patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an a

United States - English - NLM (National Library of Medicine)

avera mckennan hospital - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - rivaroxaban 15 mg

United States - English - NLM (National Library of Medicine)

a-s medication solutions - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboemb

United States - English - NLM (National Library of Medicine)

a-s medication solutions - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in patients undergoing knee or hip replacement surgery. xarelto is indicated for the prophylaxis of venous thromboembolism (vte) and vte related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboemb

United States - English - NLM (National Library of Medicine)

a-s medication solutions - rivaroxaban (unii: 9ndf7jz4m3) (rivaroxaban - unii:9ndf7jz4m3) - xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. there are limited data on the relative effectiveness of xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see clinical studies (14.1)]. xarelto is indicated for the treatment of deep vein thrombosis (dvt). xarelto is indicated for the treatment of pulmonary embolism (pe). xarelto is indicated for the reduction in the risk of recurrence of dvt and/or pe in patients at continued risk for recurrent dvt and/or pe after completion of initial treatment lasting at least 6 months. xarelto is indicated for the prophylaxis of dvt, which may lead to pe in patients undergoing knee or hip replacement surgery. xarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (cv) death, myocardial infarction (mi) and stroke) in patients with chronic coronary artery disease (cad) or periph

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 2.5 mg - antithrombotic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 10 mg - antithrombotic agents