VASCEPA

AbsorptionAfter oral administration, VASCEPA is de-esterified during the absorption process and the active metabolite EPA is absorbed in the small intestine and enters the systemic circulation mainly via the thoracic duct lymphatic system. Peak plasma concentrations of EPA were reached approximately 5 hours following oral doses of VASCEPA. VASCEPA was administered with or following a meal in all clinical studies; no food effect studies were performed. Take VASCEPA with or following a meal. Dist...

14.1 Prevention of Cardiovascular Events REDUCE-IT (NCT01492361) was a multinational, double-blind, randomized, placebo-controlled, event-driven trial in 8,179 (4,089 VASCEPA, 4,090 placebo) statin-treated adult patients enrolled with LDL-C >40 mg/dL and ≤100 mg/dL and elevated TG levels (90% of enrolled patients had TG ≥ 150 mg/dL and <500 mg/dL) and either established cardiovascular disease (71%) or diabetes and other risk factors for cardiovascular disease (29%). Patients with established cardiovascular disease were defined as being at least 45 years of age and having a documented history o...

The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions ( 5.1 )] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions ( 5.2 )] Bleeding [see Warnings and Precautions ( 5.3 )] Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and at...

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. ( 4 )

Atrial Fibrillation/Flutter: VASCEPA 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. ( 5.1 ) Potential for Allergic Reactions in Patients with Fish Allergy: VASCEPA contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fis...

7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding. ( 7 ) 7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with o...