VASCEPA

1 Dosing Considerations  VASCEPA is to be administered together with statin treatment.  Patients should not take other omega-3 fatty acid products while they are taking VASCEPA without first consulting their attending physician.  Pregnancy should be ruled out prior to administration.

 Fish and/or shellfish hypersensitivity should be ruled out prior to administration.  Prior to initiation of VASCEPA: o Assess lipid levels before initiating therapy. , diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate.

VASCEPA Product Monograph Page 5 of 24 o Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA. 2 Recommended Dose and Dosage Adjustment  The dose of VASCEPA is 4 grams per day, taken as two 1 g capsules twice a day with food.

 Discontinue if anaphylactic/hypersensitivity reactions occur.  Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS). 4 Administration Patients should be advised to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.

5 Missed Dose If a dose is missed, patients should take it as soon as they remember. However, if they miss one day of VASCEPA, they should not double the dose when they take their next dose.

1 Adverse Drug Reaction Overview The safety of VASCEPA was evaluated in 8,179 patients in the REDUCE-IT cardiovascular outcomes trial, with 4,089 randomized to VASCEPA and 4,090 patients randomized to placebo. 9 years. The overall adverse event rates were similar in patients treated with VASCEPA (82%), compared to placebo (81%), while the incidence of serious adverse events was the same in patients treated with VASCEPA (31%) and placebo (31%).

The rate of adverse events leading to discontinuation of study drug was also the same in patients treated with VASCEPA (8%) and placebo (8%). The most serious adverse reactions associated with VASCEPA were bleeding events (see Bleeding) and atrial fibrillation/flutter (see Cardiovascular).

3%). 2 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials 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 is useful for identifying drug-related adverse events and for approximating rates. Adverse Reactions in the REDUCE-IT trial VASCEPA Product Monograph Page 9 of 24 In this double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 4,089 patients were randomized to VASCEPA, and 4,090 to placebo (see 14 CLINICAL TRIALS).

The median age of enrolled patients was 64 years (range: 44 to 92 years), and 46% were 65 years of age or older. 2% identified as Hispanic ethnicity. 3 years; with 87% of patients for ≥12 months, 77% for ≥24 months, 65% for ≥36 months, 54% for ≥48 months, and 29% for ≥60 months.

004). 008). 006). 06). 15). 3 Less Common Clinical Trial Adverse Reactions The following less common adverse reactions at <5% in the VASCEPA group and at least 1% greater than in the placebo group are presented below. 4 Post-Market Adverse Reactions The following adverse reactions have been identified from global post-marketing use of VASCEPA.

, Cardiovascular 04/2022 7 WARNINGS AND PRECAUTIONS, Immune System 04/2022 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 ...........................................................................................................

4 2 CONTRAINDICATIONS ........................................................................................... 4 4 DOSAGE AND ADMINISTRATION ......................................................................... 5 5 OVERDOSAGE .........................................................................................................

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 5 7 WARNINGS AND PRECAUTIONS.......................................................................... 1 Pregnant Women .............................................................................................

2 Breast-feeding ................................................................................................. 3 Pediatrics ........................................................................................................

4 Geriatrics ........................................................................................................ 8 8 ADVERSE REACTIONS........................................................................................... 4 Post-Market Adverse Reactions..........................................................................

10 9 DRUG INTERACTIONS.......................................................................................... 2 Drug Interaction Overview ................................................................................. 3 Drug-Behavioural Interactions ...........................................................................

, anaphylactic reaction) to VASCEPA or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.