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PRO-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 ......................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
As for any non-vitamin K antagonist oral anticoagulant (NOAC) drug, before initiating PRO- APIXABAN (apixaban), ensure that the patient understands and is prepared to accept adherence to NOAC therapy, as directed. PRO-APIXABAN (apixaban) can be taken with or without food.
PRO-APIXABAN should be taken regularly, as prescribed, to ensure optimal effectiveness. All temporary discontinuations should be avoided, unless medically indicated. For patients unable to swallow whole tablets, PRO-APIXABAN tablets may be crushed to a fine powder using a mortar and pestle or an adequate device designed for this purpose, suspended in water or mixed with applesauce.
The suggested procedures are shown in PART III, PROPER USE OF THIS MEDICATION - If you have trouble swallowing the tablet(s). The suspended crushed tablet(s) should be administered immediately after preparation (see ACTION AND CLINICAL PHARMACOLOGY – Pharmacokinetics) Determine estimated creatinine clearance (eCrCl) in all patients before instituting PRO- APIXABAN, and monitor renal function during PRO-APIXABAN treatment, as clinically appropriate.
, acute myocardial infarction (AMI), acute decompensated heart failure (AHF), increased use of diuretics, dehydration, hypovolemia, etc. Clinically relevant deterioration of renal function may require dosage adjustment or discontinuation of PRO-APIXABAN (see below, Renal Impairment).
5 mg twice daily. The initial dose should be taken 12 to 24 hours after surgery, and after hemostasis has been obtained. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. 23 serum creatinine (mcmol/L) or, PrPRO-APIXABAN (Apixaban Tablets) Page 26 of 80 In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.
Stroke Prevention in Patients with Atrial Fibrillation The recommended dose of PRO-APIXABAN is 5 mg taken orally twice daily. 5 mg/dL). These patients have been determined to be at higher risk of bleeding. Treatment of DVT and PE and Prevention of recurrent DVT and PE The recommended dose of PRO-APIXABAN for the treatment of acute DVT or PE is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.
The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk of bleeding. g. recent surgery, trauma, immobilisation) and extended duration should be based on permanent risk factors or idiopathic DVT or PE.
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 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. PrPRO-APIXABAN (Apixaban Tablets) Page 12 of 80 Major or severe bleeding may occur and, regardless of location, may lead to disabling, life- threatening or even fatal outcomes.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg taken orally twice daily. Special Populations Renal Impairment Prevention of VTE following Elective Hip or Knee Replacement Surgery Treatment of DVT and PE and Prevention of recurrent DVT and PE No dose adjustment is necessary in patients with mild or moderate renal impairment (eCrCl ≥ 30 mL/min) (see ACTION AND CLINICAL PHARMACOLOGY, Renal Impairment).
Limited clinical data in patients with severe renal impairment (eCrCl 15 to 29 mL/min) indicate that apixaban plasma concentrations are increased. Therefore, apixaban is to be used with caution in these patients because of potentially higher bleeding risk.
Because there is very limited clinical experience in patients with creatinine clearance < 15 mL/min, and there are no data in patients undergoing dialysis, apixaban is not recommended in these patients (see WARNINGS AND PRECAUTIONS, Renal Impairment, and ACTION AND CLINICAL PHARMACOLOGY, Renal Impairment).
PrPRO-APIXABAN (Apixaban Tablets) Page 27 of 80 A summarized dosing table is presented in Table 11 below. 5 mg bid† † Must be used with caution due to potentially higher bleeding risks. ‡After a minimum of 6 months of treatment for DVT or PE.
5 mg/dL). 5 mg twice daily. In patients with eCrCl 15 to 24 mL/min, no dosing recommendation can be made as clinical data are very limited. Because there are no data in […]
Bleeding during the treatment period for these studies includes events that occurred before the first dose of apixaban, which was given 12 to 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 to 24 hours after surgery.
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%) a All bleeding criteria included surgical site bleeding.
b Includes bleeding events which occurred before the first dose of apixaban. PrPRO-APIXABAN (Apixaban Tablets) Page 13 of 80 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 […]