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PMS-RIVAROXABAN is a brand name for Rivaroxaban, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Other situations requiring thrombolytic therapy). Patients with malignant disease may simultaneously be at higher risk of bleeding and thrombosis than patients without malignant disease. In patients with malignant disease who undergo antithrombotic treatment with rivaroxaban, risk of bleeding may increase, in particular in the gastrointestinal, genitourinary tract or respiratory system.
The individual benefit of antithrombotic treatment should be weighed against risk for bleeding in patients with active cancer dependent on tumor location, antineoplastic therapy and stage of disease. Cases of atraumatic splenic rupture in patients taking direct oral anticoagulants, including pms-RIVAROXABAN Page 21 of 122 Protected B / Protégé B rivaroxaban have been reported in the context of a hemorrhagic complication of anticoagulation.
Patients receiving rivaroxaban who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture. g, acute clinical hepatitis, chronic active hepatitis, liver cirrhosis) were excluded from clinical trials.
Therefore, pms-RIVAROXABAN is contraindicated in patients with hepatic disease (including Child-Pugh Class B and C) associated with coagulopathy and having clinically relevant bleeding risk. The limited data available for patients with mild hepatic impairment without coagulopathy indicate that there is no difference in pharmacodynamic response or pharmacokinetics as compared to healthy subjects.
No clinical data are available in children with hepatic impairment. Monitoring and Laboratory Tests The prothrombin time (PT), measured in seconds, is influenced by rivaroxaban in a dose- dependent way with a close correlation to plasma concentration if the Neoplastin® reagent is used.
In patients who are bleeding, measuring the PT using the Neoplastin® reagent may be useful to assist in determining an excess of anticoagulant activity (see 4 DOSAGE AND ADMINISTRATION – Considerations for INR Monitoring of VKA Activity during Concomitant pms- RIVAROXABAN Therapy).
2 Pharmacodynamics), the INR is not a valid measure to assess the anticoagulant activity of rivaroxaban. The INR is only calibrated and validated for VKA and should not be used for any other anticoagulant, including pms-RIVAROXABAN.
At recommended doses, pms-RIVAROXABAN affects the measurement of the aPTT and Heptest®. 2 Pharmacodynamics). 2 Pharmacodynamics). Anti-Factor-Xa activity is influenced by rivaroxaban in a dose-dependent fashion. If it is desired to test the pharmacodynamic effects of rivaroxaban during the switching period, tests of anti- pms-RIVAROXABAN Page 22 of 122 Protected B / Protégé B Factor-Xa activity can be used as they are not affected by warfarin.
2 Pharmacodynamics). Although there is no need for routine monitoring of anticoagulation effect of pms- RIVAROXABAN during clinical practice, in certain infrequent situations such as overdosage, acute bleeding, urgent surgery, in cases of suspected non-compliance, or in other unusual circumstances, assessment of the anticoagulant effect of rivaroxaban may be appropriate.
2 Pharmacodynamics). 6. 5 mg 10 mg, 15 mg and 20 mg Microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulphate. 5 mg), Iron Oxide Red (10 mg, 15 mg and 20 mg).
5” below on one side and nothing on the other side. pms-RIVAROXABAN (rivaroxaban) 10 mg Tablets: Light-red, round, coated tablets debossed with “RI” on top and “10” below on one side and nothing on the other side. pms-RIVAROXABAN (rivaroxaban) 15 mg Tablets: Red, round, coated tablets debossed with “RI” on top and “15” below on one side and nothing on the other side.
pms-RIVAROXABAN (rivaroxaban) 20 mg Tablets: Brown-red, round, coated tablets debossed with “RI” on top and “20” below on one side and nothing on the other side. 5 mg, 10 mg and 15 mg tablets are supplied in bottle of 100. pms-RIVAROXABAN (rivaroxaban) 20 mg tablets are supplied in bottle of 100, 250 and 500.
7. Warnings and Precautions General Premature discontinuation of any oral anticoagulant, including pms-RIVAROXABAN increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if pms-RIVAROXABAN is discontinued for a reason other than pathological bleeding or completion of a course of therapy.
Cardiovascular Patients with valvular disease pms-RIVAROXABAN is not indicated and is not recommended for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR). Results from a randomized controlled clinical study (GALILEO) showed that the rivaroxaban regimen failed to demonstrate clinical benefit compared with an antiplatelet strategy.
In the intention- to-treat analysis, all-cause mortality, thromboembolic and bleeding events occurred more frequently in patients randomized to the rivaroxaban regimen. A causal relationship between rivaroxaban and all-cause mortality could not be established.
). Should severe bleeding occur, treatment with pms-RIVAROXABAN must be discontinued and the source of bleeding investigated promptly. Close clinical surveillance (looking for signs of bleeding or anemia) is recommended throughout the treatment period, especially in the presence of multiple risk factors for bleeding (see Table 4 below).
Table 4 – Factors Which Increase Hemorrhagic Risk Factors increasing rivaroxaban plasma levels Severe renal impairment (CrCl < 30 mL/min) Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp Pharmacodynamic interactions NSAID Platelet aggregation inhibitors, including ASA, clopidogrel, prasugrel, ticagrelor Selective serotonin reuptake inhibitors (SSRI), and serotonin norepinephrine reuptake inhibitors (SNRIs) Diseases / procedures with special hemorrhagic risks Congenital or acquired coagulation disorders Thrombocytopenia or functional platelet defects Uncontrolled severe arterial hypertension Active ulcerative gastrointestinal disease Recent gastrointestinal bleeding Vascular retinopathy, such as hypertensive or diabetic Recent intracranial hemorrhage Intraspinal or intracerebral vascular abnormalities Recent brain, spinal or ophthalmological surgery Bronchiectasis or history of pulmonary bleeding Others Age > 75 years pms-RIVAROXABAN Page 20 of 122 Protected B / Protégé B Concomitant use of drugs affecting hemostasis increases the risk of bleeding.
Care should be taken if patients are treated concomitantly with drugs affecting hemostasis such as non- steroidal anti- inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA), platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRI), and serotonin norepinephrine reuptake inhibitors (SNRIs) (see also 9 DRUG INTERACTIONS).
5 mg and ASA should only receive chronic concomitant treatment with NSAIDS, if the benefit outweighs the bleeding risk. In patients with atrial fibrillation and having a condition that warrants single or dual antiplatelet therapy, a careful assessment of the potential benefits against the potential risks should be made before combining this therapy with pms-RIVAROXABAN.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Accordingly, measuring PT using the Neoplastin reagent, or Factor-Xa assay using rivaroxaban- specific calibrators and controls, may be useful to inform clinical decisions in these circumstances. Perioperative Considerations As with any anticoagulant, patients on pms-RIVAROXABAN who undergo surgery or invasive procedures are at increased risk for bleeding.
In these circumstances, temporary discontinuation of pms-RIVAROXABAN may be required. If a patient concomitantly receiving platelet aggregation inhibitors is to undergo elective surgery and anti-platelet effect is not desired, platelet aggregation inhibitors should be discontinued as directed by the manufacturer’s prescribing information.
Limited clinical data are available for patients undergoing fracture-related surgery of the lower limbs. These patients were from a subgroup which was not pre-specified for enrollment in an international, non-interventional (no exclusion criteria), open label cohort study designed to compare the incidence of symptomatic thromboembolic events in patients undergoing elective hip or knee surgery while not randomly assigned to treatment with rivaroxaban or any local standard-of-care pharmacological therapy.
Pre-Operative Phase If an invasive procedure or surgical intervention is required, pms-RIVAROXABAN 10 mg, 15 mg and 20 mg should be stopped at least 24 hours before the intervention, if possible, due to increased risk of bleeding, and based on clinical judgment of the physician.
5 mg should be stopped at least 12 hours before the intervention. If a patient is to undergo elective surgery and anti-platelet effect is not desired, platelet aggregation inhibitors should be discontinued as per current treatment guidelines.
If the procedure cannot be delayed, the increased risk of bleeding should be assessed against the urgency of the intervention. Although there are limited data, in patients at higher risk of bleeding or in major surgery where complete hemostasis may be required, consider […]
Safety and efficacy of rivaroxaban have not been studied in patients with other prosthetic heart pms-RIVAROXABAN Page 18 of 122 Protected B / Protégé B valves or other valve procedures, or those with hemodynamically significant rheumatic heart disease, especially mitral stenosis.
There are no data to support that rivaroxaban provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of pms-RIVAROXABAN is not recommended in this setting.
Of note, in the pivotal Phase III ROCKET AF trial that evaluated rivaroxaban in the prevention of stroke in atrial fibrillation, 14% of patients had other valvular disease including aortic stenosis, aortic regurgitation, and/or mitral regurgitation.
Patients with a history of mitral valve repair were also not excluded from the study. Mitral valve repair rates are not known in ROCKET AF, since information on mitral valve repair status was not specifically collected in this study.
Patients with antiphospholipid syndrome pms-RIVAROXABAN is not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. In particular for patients who are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with rivaroxaban is associated with an increased rate of recurrent thrombotic events compared with vitamin K antagonists.
Patients with nonvalvular atrial fibrillation who undergo PCI (Percutaneous Coronary Intervention) with stent placement Clinical data are available from an open label interventional study with the primary objective to assess safety in patients with nonvalvular atrial fibrillation who undergo PCI with stent placement.
2 Pharmacodynamics, Patients with nonvalvular atrial fibrillation who undergo PCI with stent placement). Patients with hemorrhagic or lacunar stroke CAD / PAD patients with a history of previous hemorrhagic or lacunar stroke were not studied.
5 mg twice daily in combination with ASA should be avoided in these patients. Patients with ischemic, non-lacunar stroke CAD / PAD patients who have experienced an ischemic, non-lacunar stroke within the previous month were not studied.
3 Pharmacokinetics). Gastrointestinal pms-RIVAROXABAN tablets contain lactose. g, the Lapp lactase deficiency or glucose-galactose malabsorption) should not take pms-RIVAROXABAN. 4 Drug- Drug Interactions). 4 Drug-Drug Interactions). Bleeding pms-RIVAROXABAN, like other anticoagulants, should be used with caution in patients with an increased bleeding risk.
Bleeding can occur at […]
5 mg BID has not been studied in combination with, or as replacement of dual antiplatelet therapy (DAPT) for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).
The combination has also not been studied for the prevention of atherothrombotic events in patients with symptomatic PAD at demonstrated high risk of major adverse limb events (MALE) or major adverse cardiovascular and cerebrovascular events (MACCE).
5 mg BID is not indicated in patients with unstable atherosclerotic disease when DAPT is indicated. Concomitant ASA use (almost exclusively at a dose of 100 mg or less) with either rivaroxaban or warfarin during the ROCKET-AF trial was identified as an independent risk factor for major bleeding (see also 9 DRUG INTERACTIONS).
The antiplatelet agents, prasugrel and ticagrelor, have not been studied with rivaroxaban, and are not recommended as concomitant therapy. The use of thrombolytics should generally be avoided during acute myocardial infarction (AMI) or acute stroke in patients treated with rivaroxaban, due to expected increased risk of major bleeding (see