ICOSAPENT ETHYL

2 DOSAGE AND ADMINISTRATION Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. 1) Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment.

5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. 2) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules. 1 Prior to Initiation of Icosapent Ethyl Capsules Assess lipid levels before initiating therapy.

, diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment with icosapent ethyl capsules.

5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food. Advise patients to swallow icosapent ethyl capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules.

3)] Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. 1) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain.

1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Common adverse reactions (incidence ≥3% on icosapent ethyl and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Hypertriglyceridemia Trials In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with icosapent ethyl at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.

2 Postmarketing Experience Additional adverse reactions have been identified during post-approval use of icosapent ethyl capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Diarrhea Blood triglycerides increased Abdominal discomfort Pain in the extremities

5 WARNINGS AND PRECAUTIONS Atrial Fibrillation/Flutter: Icosapent ethyl was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.

1) Potential for Allergic Reactions in Patients with Fish Allergy: Icosapent ethyl capsules contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl capsules.

Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue icosapent ethyl and seek medical attention if any reactions occur. 2) Bleeding: Icosapent ethyl was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial.

The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. 1 Atrial Fibrillation/Flutter Icosapent ethyl is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization.

98)]. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. 2 Potential for Allergic Reactions in Patients with Fish Allergy Icosapent ethyl contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish.

It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to icosapent ethyl and advise them to discontinue icosapent ethyl and seek medical attention if any reactions occur.

, anaphylactic reaction) to icosapent ethyl or any of its components. , anaphylactic reaction) to icosapent ethyl or any of its components. (4)