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MAR-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: MAR-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.
). MAR-RIVAROXABAN (rivaroxaban) film-coated tablet (20 mg) is indicated for the: • treatment of venous thromboembolic events (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment (see 4 DOSAGE AND ADMINISTRATION).
Acute Pulmonary Embolus in hemodynamically unstable patients, or in those requiring thrombolysis or pulmonary embolectomy For the treatment of VTE, MAR-RIVAROXABAN is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolus who are hemodynamically unstable, or who may receive thrombolysis or pulmonary embolectomy, since the safety and efficacy of rivaroxaban have not been established in these clinical situations (see 4 DOSAGE AND ADMINISTRATION).
1 Pediatrics Pediatrics (< 18 years of age): In children less than 18 years of age, the safety and efficacy of rivaroxaban have not been established for indications other than treatment of venous thromboembolic events (VTE) and prevention of VTE recurrence.
Therefore, MAR- RIVAROXABAN is not recommended for use in children below 18 years of age for indications other than the treatment of VTE and prevention of VTE recurrence. 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) • 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 MAR-RIVAROXABAN (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 MAR-RIVAROXABAN (Rivaroxaban Tablets) Page 23 of 107 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 rivaroxaban10 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 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.
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) • 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 MAR-RIVAROXABAN (rivaroxaban) or to any ingredient in the formulation, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 1 Dosing Considerations As for any non-vitamin K antagonist oral anticoagulant (NOAC) drug, before initiating MAR- RIVAROXABAN (rivaroxaban), ensure that the patient understands and is prepared to accept adherence to NOAC therapy, as directed.
Determine estimated creatinine clearance (eCrCl) in all patients before instituting MAR- RIVAROXABAN (rivaroxaban), and monitor renal function during MAR-RIVAROXABAN treatment, as clinically appropriate. e, acute myocardial infarction (AMI), acute decompensated heart failure (AHF), MAR-RIVAROXABAN (Rivaroxaban Tablets) Page 6 of 107 increased use of diuretics, dehydration, hypovolemia, etc.
Clinically relevant deterioration of renal function may require dosage adjustment or discontinuation of MAR-RIVAROXABAN (see below, Renal Impairment). 85 serum creatinine (mcmol/L) 72 x serum creatinine (mg/100 mL) Switching from Parenteral Anticoagulants to MAR-RIVAROXABAN MAR-RIVAROXABAN can be started when the infusion of full-dose intravenous heparin is stopped or 0 to 2 hours before the next scheduled injection of full-dose subcutaneous low- molecular-weight heparin (LMWH) or fondaparinux.
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) • 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 MAR-RIVAROXABAN (rivaroxaban) or to any ingredient in the formulation, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
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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 MAR-RIVAROXABAN (Rivaroxaban Tablets) Page 24 of 107 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 4). The signs, symptoms, and 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 5 for VTE prevention in patients undergoing elective THR or TKR surgery, in Table 6 for Treatment of VTE and prevention of recurrent DVT and PE, in Table 7 for stroke prevention in atrial fibrillation, and in Table 8 for prevention of stroke, myocardial infarction (MI), cardiovascular (CV) death, acute limb ischemia (ALI) and mortality in patients with CAD with or without PAD or prevention of atherothrombotic events in patients with symptomatic PAD at […]
In patients receiving prophylactic heparin, LMWH or fondaparinux, MAR-RIVAROXABAN can be started 6 or more hours after the last prophylactic dose. Switching from MAR-RIVAROXABAN to Parenteral Anticoagulants Discontinue MAR-RIVAROXABAN and give the first dose of parenteral anticoagulant at the time that the next MAR-RIVAROXABAN dose was scheduled to be taken.
Switching from Vitamin K Antagonists (VKA) to MAR-RIVAROXABAN To switch from a VKA to MAR-RIVAROXABAN, stop the VKA and determine the INR. 5, start MAR-RIVAROXABAN at the usual dose. 5 (see Considerations for INR Monitoring of VKA Activity during Concomitant MAR-RIVAROXABAN Therapy).
Switching from MAR-RIVAROXABAN to a VKA As with any short-acting anticoagulant, there is a potential for inadequate anticoagulation when transitioning from MAR-RIVAROXABAN to a VKA. It is important to maintain an adequate level of anticoagulation when transitioning patients from one anticoagulant to another.
0. For the first 2 days of the conversion period, the VKA can be given in the usual starting doses without INR testing (see Considerations for INR Monitoring of VKA Activity during Concomitant MAR- RIVAROXABAN Therapy). Children who switch from MAR-RIVAROXABAN to VKA need to continue MAR-RIVAROXABAN for 48 hours after the first dose of VKA.
Thereafter, while on concomitant therapy, the INR should be tested just prior to the next dose of MAR- RIVAROXABAN, as appropriate. 0. Once MAR-RIVAROXABAN is discontinued, INR testing may be done at least 24 hours after the last dose of MAR-RIVAROXABAN and should then reliably reflect the anticoagulant effect of the VKA.
Considerations for INR Monitoring of VKA Activity during Concomitant MAR- RIVAROXABAN Therapy In general, after starting VKA therapy, the initial anticoagulant effect is not readily apparent for at MAR-RIVAROXABAN (Rivaroxaban Tablets) Page 7 of 107 least 2 days, while the full therapeutic effect is achieved in 5-7 days.
Consequently, INR monitoring in the first 2 days after starting a VKA is rarely necessary. Likewise, the INR may remain increased for a number of days after stopping VKA therapy. 2 Pharmacodynamics), the INR is not a valid measure to assess the anticoagulant activity of MAR-RIVAROXABAN.
The INR is only calibrated and […]