icosapent ethyl (Vascepa)

US NDC LINE: 52937-001

Trade Name: Vascepa

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amarin Pharmaceuticals

Presentation: CAPSULE

Strength: 1000 mg/1

Storage and handling

ICOSAPENT ETHYL

  • No data
  • Assess lipid levels before initiating therapy. Identify other causes (e.g., 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 VASCEPA, which should continue during treatment with VASCEPA.
  • The daily dose of VASCEPA is 4 grams per day taken as either:
  • Patients should be advised to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.
  • VASCEPA (icosapent ethyl) is indicated:
  • Limitations of Use:
  • The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
  • VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated:
  • Limitations of Use:
  • No data
  • Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. ()
  • Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment. ()
  • The daily dose of VASCEPA is 4 grams per day taken as eithernttttttttttn
  • Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew VASCEPA. ()
  • VASCEPA capsules are supplied as:
  • Capsules: 0.5 gram and 1 gram ()
  • 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. ()
  • Atrial Fibrillation/Flutter:
  • Potential for Allergic Reactions in Patients with Fish Allergy:
  • Bleeding:
  • The following important adverse reactions are described below and elsewhere in the labeling:
  • Common adverse reactions in the cardiovascular outcomes trial (incidence u22653% and u22651% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation ()
  • Common adverse reactions in the hypertriglyceridemia trials (incidence u22651% more frequent than placebo): arthralgia and oropharyngeal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amarin Pharma, Inc. at 1-855-VASCEPA (1-855-827-2372) or contact the FDA at 1-800-FDA-1088 or n
  • Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding.
  • Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents:
  • 7
  • No data
  • 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 ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is CHO and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure:
  • VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water.
  • No data
  • 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 of the mesenteric lymph node, the site of drug absorption, were observed in females at clinically relevant exposures based on body surface area comparisons across species relative to the maximum clinical dose of 4 g/day. Overall incidence of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment.
  • In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell papilloma in the skin and subcutis of the tail was observed in high dose male mice. The papillomas were considered to develop secondary to chronic irritation of the proximal tail associated with fecal excretion of oil and therefore not clinically relevant. Drug-related neoplasms were not observed in female mice.
  • Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the mouse micronucleus assay. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation.
  • In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and 3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating through day 7 of gestation, increased anogenital distance in female pups and increased cervical ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose based on a body surface area comparison).
  • No data
  • VASCEPA (icosapent ethyl) capsules are supplied as
  • Store at 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0 C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • 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 .
  • Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to VASCEPA and advise them to discontinue VASCEPA and seek medical attention if any reactions occur .
  • Inform patients that VASCEPA may increase their risk for bleeding, especially if they are receiving other antithrombotic agents .
  • Advise patients to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA .
  • Instruct patients to take VASCEPA as prescribed. 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 it.
  • For more information about VASCEPA, go to or call 1-855-VASCEPA (1-855-827-2372).
  • AMARINn
  • VASCEPA (icosapent ethyl)
  • Distributed by:
  • Manufactured for:
  • VASCEPA is a registered trademark of the Amarin group of companies
  • u00a92019 Amarin Pharma, Inc. Bridgewater NJ 08807. u00a0All rights reserved
  • P00120M u00a0u00a0u00a012/2019
  • No data
  • NDC 52937-003-40
  • Vascepan- (icosapent ethyl) Capsules
  • 0.5 gram
  • 240 capsules
  • Rx only
  • NDC 52937-001-20
  • Vascepan- (icosapent ethyl)Capsules
  • 1 gram
  • 120 capsules
  • Rx only
  • RX only
  • NDC 52937-101-08
  • SAMPLE ONLY u2022 NOT FOR SALE
  • Vascepan- (icosapent ethyl)Capsules 1 gram
  • PATIENT SAMPLE PACK Contains 8 Capsules
  • Please see enclosed full Prescribing Information for more information on VASCEPA. n n
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GNH India is WHO GDP and ISO 9001 2015 Global Pharmaceutical Distributor/ Wholesaler/ Supplier/ Exporter/ Importer of icosapent ethyl (Vascepa) which is also known as Vascepa and manufactured by Amarin Pharmaceuticals. It is available in strength of 1000 mg/1 per ml.

icosapent ethyl (Vascepa) is supplied for Tenders/ Emergency imports/ Un-licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For clinical trials. Click to know price.

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