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NRA-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.
Used for: NRA-RIVAROXABAN (rivaroxaban) film-coated tablet (10 mg, 15 mg, 20 mg) is indicated for the: • prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery. • treatment of venous thromboembolic events (deep vein thrombosis…
Verbatim from this product's HC label. Tap a section to expand.
). 3 Pediatrics). 4 Geriatrics and Renal Impairment, and 4 DOSAGE AND ADMINISTRATION – Renal Impairment and Geriatrics (>65 years of age). Safety and efficacy data are available (see 14 CLINICAL TRIALS). g, recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein (P-gp), such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir (see 7 WARNINGS AND PRECAUTIONS – Drug Interactions) Product Monograph – NRA-RIVAROXABAN Page 5 of 93 • Concomitant treatment with any other anticoagulant, including o unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter, o low molecular weight heparins (LMWH), such as enoxaparin and dalteparin, o heparin derivatives, such as fondaparinux, and o oral anticoagulants, such as warfarin, dabigatran, apixaban, edoxaban, except under circumstances of switching therapy to or from rivaroxaban.
2 Breast-feeding) • Hypersensitivity to rivaroxaban or to any ingredient in the formulation, (see
1 Adverse Reaction Overview Prevention of VTE after THR or TKR The safety of rivaroxaban 10 mg has been evaluated in three randomized, double- blind, active-control Phase III studies (RECORD 1, RECORD 2, and RECORD 3). In the Phase III studies, 4657 patients undergoing total hip replacement or total knee replacement surgery were randomized to rivaroxaban, with 4571 patients actually receiving rivaroxaban.
In RECORD 1 and 2, a total of 2209 and 1228 THR patients, respectively, were randomized to rivaroxaban 10 mg od. In RECORD 1, the treatment period for both groups was 35±4 days postoperatively. In RECORD 2, patients randomized to rivaroxaban were treated for 35 ±4 days postoperatively, and patients randomized to enoxaparin received placebo after day 12±2 until day 35±4 postoperatively.
In RECORD 3, a total of 1220 TKR patients were randomized to rivaroxaban 10 mg od, and both groups received study drug until day 12±2 postoperatively. Treatment of VTE and Prevention of Recurrent DVT and PE The safety of rivaroxaban has been evaluated in four Phase III trials with 6790 patients treated up to 21 Product Monograph – NRA-RIVAROXABAN Page 21 of 93 months.
Patients were exposed to 15 mg rivaroxaban twice daily for 3 weeks followed by: • 20 mg once daily (EINSTEIN DVT, EINSTEIN PE) or • 20 mg once daily after at least 6 months of treatment for DVT or PE (EINSTEIN Extension), or • 20 mg or 10 mg rivaroxaban once daily after at least 6 months of treatment for DVT or PE (EINSTEIN CHOICE).
The mean treatment duration was 194 days in EINSTEIN DVT, 183 days in EINSTEIN PE, 188 days in EINSTEIN Extension and 290 days in EINSTEIN CHOICE. 2% for ASA (EINSTEIN CHOICE). Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation (SPAF) In the pivotal double-blind ROCKET AF study, a total of 14,264 patients with atrial fibrillation at risk for stroke and systemic embolism were randomly assigned to treatment with either rivaroxaban (7,131) or warfarin (7,133) in 45 countries.
, Bleeding 06/2023 7 WARNINGS AND PRECAUTIONS, Drug Interactions 06/2023 7 WARNINGS AND PRECAUTIONS, Surgery / Procedural Interventions, Peri- Operative Spinal/Epidural Anesthesia, Lumbar Puncture 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed .
RECENT MAJOR LABEL CHANGES ..................................................................................................... 2 TABLE OF CONTENTS ........................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................................... 4 1 INDICATIONS .............................................................................................................................
1 Pediatrics ............................................................................................................................... 2 Geriatrics .............................................................................................................................
4 2 CONTRAINDICATIONS ............................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ...............................................................................................
1 Dosing Considerations ........................................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................................
4 Geriatrics .................................................................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Product Monograph – NRA-RIVAROXABAN Page 3 of 93 Data Clinical Trial Findings ..............................................................................................................
g, recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein (P-gp), such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir (see 7 WARNINGS AND PRECAUTIONS – Drug Interactions) Product Monograph – NRA-RIVAROXABAN Page 5 of 93 • Concomitant treatment with any other anticoagulant, including o unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter, o low molecular weight heparins (LMWH), such as enoxaparin and dalteparin, o heparin derivatives, such as fondaparinux, and o oral anticoagulants, such as warfarin, dabigatran, apixaban, edoxaban, except under circumstances of switching therapy to or from rivaroxaban.
2 Breast-feeding) • Hypersensitivity to rivaroxaban or to any ingredient in the formulation, (see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0. The safety population included patients who were randomized and took at least 1 dose of study medication. In total, 14,236 patients were included in the safety population, with 7,111 and 7,125 patients in rivaroxaban and warfarin groups, respectively.
The median time on treatment was 19 months and overall treatment duration was up to 41 months. 2% in the warfarin group. 5 mg bid in combination with ASA 100 mg od (9,152), rivaroxaban 5 mg bid alone (9,117) or ASA 100 mg od (9,126).
The intention-to-treat (ITT) analysis set includes all randomized subjects. The median duration of treatment for any of the antithrombotic study drugs was 615 days and was similar for all 3 treatment groups. 6% in the ASA 100 mg od arm.
Bleeding Due to the pharmacological mode of action, rivaroxaban is associated with an increased risk of occult or overt bleeding from any tissue and organ (see 7 WARNINGS AND PRECAUTIONS – Bleeding, and Drug Interactions). g, patients with uncontrolled severe arterial hypertension and/or on concomitant medication affecting hemostasis (see Table 3).
The signs, symptoms, and Product Monograph – NRA-RIVAROXABAN Page 22 of 93 severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anemia. Hemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnea, and unexplained shock.
In some cases as a consequence of anemia, symptoms of cardiac ischemia like chest pain or angina pectoris have been observed. Known complications secondary to severe bleeding such as compartment syndrome and renal failure due to hypoperfusion have been reported for rivaroxaban.
Therefore, the possibility of a hemorrhage should be considered in evaluating the medical condition in any anticoagulated patient. Major or severe bleeding may occur and, regardless of location, may lead to disabling, life- threatening or even fatal outcomes.
Since the adverse event profiles of the patient populations treated with rivaroxaban for different indications are not interchangeable, a summary description of major and total bleeding is provided by indication, in Table 4 for VTE prevention in patients undergoing elective THR or TKR surgery, in Table 5 for Treatment of VTE and prevention of recurrent DVT and PE, in Table 6 for stroke prevention in atrial fibrillation, and in Table 7 for prevention of stroke, myocardial infarction (MI), cardiovascular (CV) death, acute limb ischemia (ALI) and mortality in patients with CAD with or without PAD.
Table 4 - RECORD 1, 2, and 3 (VTE Prevention After THR or TKR) – Treatment-Emergent Bleeding Events (Safety Population with Central Adjudication) in Patients Randomized to Rivaroxaban (First Dose 6 to 8 […]
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