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SANDOZ EDOXABAN is a brand name for Edoxaban, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Edoxaban (edoxaban tablets) is indicated for: • Prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate. • Treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and…
Verbatim from this product's HC label. Tap a section to expand.
, and 14 CLINICAL TRIALS). , recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see 10 CLINICAL PHARMACOLOGY - Hepatic Insufficiency) • 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, rivaroxaban except under circumstances of switching therapy to or from Sandoz Edoxaban.
• Pregnancy (See 7 WARNING AND PRECAUTIONS - Special Populations, Pregnant Women) • Nursing Women (See 7 WARNING AND PRECAUTIONS - Special Populations, Breast-feeding) • Hypersensitivity to edoxaban or to any ingredients of the formulation.
For a complete listing of ingredients see
1 Adverse Reaction Overview SPAF In the pivotal double-blind randomized ENGAGE AF-TIMI 48 study, a total of 21,026 subjects with documented atrial fibrillation (AF) received at least one dose of edoxaban tablets 60 mg (N=7012), edoxaban tablets 30 mg (N=7002), or warfarin (N=7012).
The duration of edoxaban tablets exposure was ≥360 days for 11,479 subjects and ≥720 days for 10,075 subjects. 5 years. 2%) of the subjects treated with edoxaban tablets 60 mg (30 mg dose-reduced) experienced adverse reactions. 0% of the subjects in the edoxaban tablets 60 mg, and the warfarin treatment groups, respectively.
Treatment of VTE and Prevention of Recurrent DVT and PE In the pivotal double-blind randomized HOKUSAI-VTE study, subjects with acute, symptomatic DVT involving the popliteal, femoral or iliac veins, or PE requiring anticoagulant therapy were treated with edoxaban tablets (N=4118) or warfarin (N=4122) after a heparin-based initial treatment of ≥5 days.
These 8240 subjects comprised the safety population. 8 months in both groups. 3%) of subjects. 3%) of the subjects treated with edoxaban tablets 60 mg (30 mg dose-reduced) experienced adverse reactions. 4% in the warfarin group. Bleeding in Patients with VTE in the Hokusai VTE Cancer Study In the Hokusai VTE Cancer, randomized, open-label, non-inferiority study, evaluating the efficacy and safety of edoxaban 60 mg once daily after at least 5 days of low molecular weight heparin (LMWH) versus Sandoz Edoxaban (edoxaban) Product Monograph Page 16 of 54 dalteparin (200 IU/kg day 1-30; 150 IU/kg day 31 to the end of treatment) in 1050 patients with acute VTE and predominantly advanced cancer (see 10 CLINICAL PHARMACOLOGY).
The median duration of edoxaban tablets exposure was 211 days (range, 2 to 423). The safety outcome was major bleeding that occurred during or within three days of stopping study treatment. 66)]. 0361 Abbreviations: HR = hazard ratio, CI = confidence interval, CRNM = clinically relevant non-major Note: The HR, 2-sided CI and p-value for pairwise comparisons versus dalteparin are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.
Table 5, 4 DOSAGE AND ADMINISTRATION, and 14 CLINICAL TRIALS). , recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see 10 CLINICAL PHARMACOLOGY - Hepatic Insufficiency) • 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, rivaroxaban except under circumstances of switching therapy to or from Sandoz Edoxaban.
• Pregnancy (See 7 WARNING AND PRECAUTIONS - Special Populations, Pregnant Women) • Nursing Women (See 7 WARNING AND PRECAUTIONS - Special Populations, Breast-feeding) • Hypersensitivity to edoxaban or to any ingredients of the formulation.
For a complete listing of ingredients see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations As for any non-vitamin K antagonist oral anticoagulant (NOAC) drug, before initiating Sandoz Edoxaban, ensure that the patient understands and is prepared to accept adherence to NOAC therapy, as directed.
Sandoz Edoxaban should be taken regularly, as prescribed, to ensure optimal effectiveness. All temporary discontinuations should be avoided, unless medically indicated. Determine estimated creatinine clearance (eCrCl) in all patients before instituting Sandoz Edoxaban, and monitor renal function during Sandoz Edoxaban treatment, as clinically appropriate.
Determination of renal function by eCrCL should occur at least once per year, and especially during circumstances when renal function may be expected to be compromised, ie, acute myocardial infarction (AMI), acute decompensated heart failure (AHF), increased use of diuretics, dehydration, hypovolemia, etc.
, recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see 10 CLINICAL PHARMACOLOGY - Hepatic Insufficiency) • 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, rivaroxaban except under circumstances of switching therapy to or from Sandoz Edoxaban.
• Pregnancy (See 7 WARNING AND PRECAUTIONS - Special Populations, Pregnant Women) • Nursing Women (See 7 WARNING AND PRECAUTIONS - Special Populations, Breast-feeding) • Hypersensitivity to edoxaban or to any ingredients of the formulation.
For a complete listing of ingredients see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Sandoz Edoxaban (edoxaban) Product Monograph Page 5 of 54
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4% (3/125) in the dalteparin group. 3% (13/399) in the dalteparin group. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Bleeding Events The most notable adverse reactions reported with edoxaban tablets were related to bleeding.
7 % in the HOKUSAI-VTE study. Bleeding can occur at any site and may be severe, life-threatening, and even fatal (see 7 WARNINGS AND PRECAUTIONS). Known complications secondary to severe bleeding, such as acute renal injury due to hypoperfusion, have been reported.
0%) was the most common bleeding-related adverse reaction in HOKUSAI-VTE study only. Since the patient populations treated with edoxaban tablets for different indications are not interchangeable, a summary description of major and total bleeding is provided by indication and pivotal trial below.
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Clinically relevant deterioration of renal function may require dosage adjustment or discontinuation of Sandoz Edoxaban (see below, Renal Impairment). The method used to estimate renal function (CrCL in mL/min) during the clinical development of edoxaban tablets was the Cockcroft-Gault method.
2 Recommended Dose and Dosage Adjustment SPAF The usual recommended dose of Sandoz Edoxaban is 60 mg once daily. Treatment of VTE and Prevention of Recurrent DVT and PE The recommended dose of Sandoz Edoxaban is 60 mg once daily following initial use of a parenteral anticoagulant for 5-10 days.
The duration of therapy should be individualized after careful assessment of the treatment benefit against the risk of bleeding. , surgery, trauma, immobilisation), while extended duration should be based on permanent risk factors or idiopathic DVT or PE.
Dose reductions for SPAF and VTE The recommended dose of Sandoz Edoxaban is 30 mg once daily in patients with one or more of the following clinical factors: Sandoz Edoxaban (edoxaban) Product Monograph Page 6 of 54 • Moderate renal impairment (creatinine clearance (CrCL) 30- 50 mL/min or severe renal impairment (CrCL 15-29 mL/min) • Low body weight ≤ 60 kg (132 lbs) • Concomitant use of P-gp inhibitors except amiodarone and verapamil Table 1 – Summary Dosing in SPAF and VTE (DVT and PE) Summary Guide for Dosing SPAF: Recommended dose 60 mg once daily VTE: Recommended dose 60 mg once daily (following initial use of heparin) Renal Impairment: Moderate (CrCL 30 - 50 mL/min) or Severe (CrCL 15 - 29 mL/min) Low Body Weight: ≤ 60 kg P-gp Inhibitors except amiodarone and verapamil 30 mg once daily Renal impairment There are limited data in patients with end stage renal impairment (CrCl < 15 mL/min) or on dialysis as these patients were excluded from pivotal Phase III trials.
Therefore, Sandoz Edoxaban is not recommended in these patients (see 7 WARNINGS AND PRECAUTIONS - Renal). Table 2 – Summary Posology in Renal Impairment for SPAF and VTE Renal Impairment Status Creatinine Clearance (CrCL) mL/min Sandoz Edoxaban Dose Once Daily Mild >50-80 60 mg Moderate 30-50 30 mg Severe 15-29 30 mg End Stage Renal Disease or on Dialysis* <15 Not recommended (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
*Hemodialysis does not significantly contribute to edoxaban clearance. Hepatic impairment In patients with mild to moderate hepatic impairment the recommended dose of Sandoz Edoxaban is 60 mg once daily (see 10 CLINICAL PHARMACOLOGY).
Edoxaban tablets has not been studied in patients with severe hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Therefore, its use in these patients is not recommended. Sandoz Edoxaban is contraindicated in patients with hepatic disease associated with intrinsic coagulation abnormalities (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Sandoz Edoxaban (edoxaban) Product Monograph Page 7 of 54 Patients undergoing cardioversion Sandoz Edoxaban can be initiated or continued in patients who may require cardioversion. For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Sandoz Edoxaban […]