VASCEPA Capsule (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Amarin Pharma Inc.
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1. Indications and Usage
VASCEPA (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring ...
2. Dosage and Administration
2.1 Prior to Initiation of VASCEPA Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage ...
3. Dosage Forms and Strengths
VASCEPA capsules are supplied as: 0.5 gram amber-colored, oval, soft-gelatin capsules imprinted with V500 1 gram amber-colored, oblong, soft-gelatin capsules imprinted with VASCEPA
4. Contraindications
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
5. Warnings and Precautions
5.1 Atrial Fibrillation/Flutter VASCEPA is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. In a double-blind, placebo-controlled trial of 8,179 statin-treated ...
6. Adverse Reactions
The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter <em>[see Warnings and Precautions (5.1)]</em> Potential for Allergic Reactions ...
6.1. 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 ...
6.2. Postmarketing Experience
Additional adverse reactions have been identified during post-approval use of VASCEPA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible ...
7. Drug Interactions
7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time ...
8.1. Pregnancy
Risk Summary The available data from published case reports and the pharmacovigilance database on the use of VASCEPA in pregnant women are insufficient to identify a drug-associated risk for major birth ...
8.2. Lactation
Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Of the total number of patients in well-controlled clinical studies of VASCEPA, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients ...
8.7. Hepatic Impairment
In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with VASCEPA.
11. Description
VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ...
12.1. Mechanism of Action
Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms ...
12.2. Pharmacodynamics
In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia and in the event-driven REDUCE-IT trial, VASCEPA 4 grams per day reduced median TG from baseline relative to placebo [see Clinical ...
12.3. Pharmacokinetics
Absorption After 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 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91 g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms. Hemangiomas and hemangiosarcomas ...
14. Clinical Studies
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 ...
16.1. How Supplied
VASCEPA (icosapent ethyl) capsules are supplied as Strength Quantity Description NDC 0.5 gram capsules Bottles of 240 amber-colored soft-gelatin capsules imprinted with V500 52937-003-40 1 gram capsules ...
16.2. Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling before starting VASCEPA (Patient Information). Inform patients that VASCEPA may increase their risk for atrial fibrillation or atrial flutter ...