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AG-APIXABAN is a brand name for Apixaban, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................... 3 CONTRAINDICATIONS ................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................... 4 ADVERSE REACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
5 mg twice daily has been evaluated in one Phase II and three Phase III studies (ADVANCE 1, 2 and 3) including 5,924 patients exposed to apixaban after undergoing major orthopedic surgery of the lower limbs (elective hip replacement or elective knee replacement) and treated for up to 38 days.
5 mg twice daily. The duration of apixaban exposure was ≥ 12 months for 9,375 patients, and ≥ 24 months for 3,369 patients in the two studies. 5 weeks. In AVERROES, 2,798 patients were exposed to apixaban, and 2,780 to ASA, over a mean duration of approximately 59 weeks in both treatment groups.
3% for ASA in the AVERROES study. 5 mg twice daily. The mean duration of exposure to apixaban 10 mg twice daily followed by 5 mg twice daily was 154 days and to enoxaparin/warfarin was 152 days in the AMPLIFY study. 5 mg or 5 mg apixaban was approximately 330 days and to placebo was 312 days in the AMPLIFY-EXT study.
Bleeding Bleeding is the most relevant adverse reaction of AG-Apixaban. Bleeding of any type was observed in approximately 12% of patients treated with apixaban short-term following hip replacement surgery and about 6% following knee replacement surgery.
In long-term treatment in patients having atrial fibrillation, bleeding of any type of severity occurred at a rate of 18% per year for patients exposed to apixaban in the ARISTOTLE trial, and 11% per year in the AVERROES trial. Major or severe bleeding may occur and, regardless of location, may lead to disabling, life - threatening or even fatal outcomes.
PrAG-Apixaban (Apixaban Tablets) Page 12 of 84 Prevention of VTE following Elective Hip or Knee Replacement Surgery In all Phase III studies, bleeding was assessed beginning with the first dose of double-blind study drug. In studies that compared apixaban to the 40 mg once daily dose of enoxaparin, the first dose of either enoxaparin or injectable placebo was given 9 to 15 hours before surgery.
Bleeding during the treatment period for these studies includes events that occurred before the first dose of apixaban, which was given 12-24 hours after surgery. Bleeding during the post-surgery treatment period only included events occurring after the first dose of study drug after surgery.
Over half the occurrences of major bleeding in the apixaban group in these two studies occurred prior to the first dose of apixaban. For the study that compared apixaban with enoxaparin given every 12 hours, the first dose of both oral and injectable study drugs was 12 -24 hours after surgery.
, ritonavir (see WARNINGS AND PRECAUTIONS, Drug Interactions, and DRUG INTERACTIONS,Inhibitors of both CYP 3A4 and P-gp) • 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, rivaroxaban, except under circumstances of switching therapy to or from apixaban.
• Hypersensitivity to AG-Apixaban (apixaban) or to any ingredients of the formulation. For a complete listing of ingredients see DOSAGE FORMS, COMPOSITION AND PACKAGING. WARNINGS AND PRECAUTIONS PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING AG-Apixaban, INCREASES THE RISK OF THROMBOTIC EVENTS.
To reduce this risk, consider coverage with another anticoagulant if AG-Apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy. The following Warnings and Precautions are listed in alphabetical order.
Bleeding The possibility of a hemorrhage should be considered in evaluating the condition of any anticoagulated patient. As with all anticoagulants, AG-Apixaban (apixaban) should be used with caution in circumstances associated with an increased risk of bleeding.
Bleeding can occur at any site during therapy with AG-Apixaban. An unexplained fall in hemoglobin, hematocrit or blood pressure should lead to a search for a bleeding site. Patients should be advised of signs and symptoms of blood loss and to report them immediately or go to an emergency room.
Patients at high risk of bleeding should not be prescribed AG-Apixaban PrAG-Apixaban (Apixaban Tablets) Page 5 of 84 (see CONTRAINDICATIONS). Should severe bleeding occur, treatment with AG-Apixaban must be discontinued and the source of bleeding investigated promptly.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Apixaban in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
For this study, the treatment period and post-surgery treatment period are identical. Table 2 shows the bleeding results from the treatment period and the post-surgery treatment period. 8%) aAll bleeding criteria included surgical site bleeding.
b Includes bleeding events which occurred before the first dose of apixaban. PrAG-Apixaban (Apixaban Tablets) Page 13 of 84 Stroke Prevention in Patients with Atrial Fibrillation (SPAF) Bleeding events observed in patients with atrial fibrillation are presented below in Tables 3 and 4.
0001 Events for each endpoint were counted once per subject but subjects may have contributed events to more than one endpoint *Dataset includes events occurring on-treatment plus the following two days; Assessed by sequential testing strategy for superiority designed to control the overall type I error in […]
, looking for signs of bleeding or anemia) is recommended throughout the treatment period. g. , especially if other factors/conditions that generally increase the risk of hemorrhage are also present. (see Table 1 below). Table 1 – Factors Which Increase Hemorrhagic Risk Factors increasing apixaban plasma levels Severe renal impairment (eCrCl < 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 Recent intracranial hemorrhage Intraspinal or intracerebral vascular abnormalities Recent brain, spinal or ophthalmological surgery Bronchiectasis or history of pulmonary bleeding Others Age > 75 years Concomitant use of AG-Apixaban with 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 (NSAID), acetylsalicylic acid (ASA), platelet aggregation inhibitors, selective serotonin reuptake inhibitors (SSRI), or serotonin norepinephrine reuptake inhibitors (SNRIs) (see also DRUG INTERACTIONS).
Concomitant use of ASA or dual antiplatelet therapy with either AG-Apixaban or warfarin increases the risk of major bleeding in patients with atrial fibrillation. Other platelet aggregation inhibitors such as prasugrel and ticagrelor, have not been studied with apixaban in any patient population, and are not recommended as concomitant therapy (see DRUG INTERACTIONS).
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 PrAG-Apixaban (Apixaban Tablets) Page 6 of 84 before combining this therapy with AG-Apixaban.
In high-risk patients following acute coronary thrombosis, apixaban 5 mg bid, as an adjunct to standard anti-platelet treatment, has led to significantly increased bleeding (see ACTION AND CLINICAL PHARMACOLOGY, Post-acute coronary syndrome patients).
The use of thrombolytics should generally be avoided during acute myocardial infarction (AMI) or acute stroke in patients treated with apixaban, due to expected increased risk of major bleeding. Cardiovascular Patients with Valvular Disease Safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves or those with hemodynamically significant rheumatic heart disease, especially mitral stenosis.
5 mg twice daily provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of […]