Vascepa

Drug overview for VASCEPA (icosapent ethyl):

Generic name: ICOSAPENT ETHYL (eye-KOE-sa-pent ETH-il)
Drug class: Antihyperlipidemic-eicosapentaenoic acid (EPA) derivatives
Therapeutic class: Cardiovascular Therapy Agents

Icosapent ethyl, an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA), is an antilipemic agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

VASCEPA 1 GM CAPSULE
VASCEPA 0.5 GM CAPSULE

The following indications for VASCEPA (icosapent ethyl) have been approved by the FDA:

Indications:
Hypertriglyceridemia

Professional Synonyms:
Abnormally increased triglycerides in the blood
Elevated triglyceride level
Increased triglyceride levels

Dosing information for VASCEPA
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VASCEPA 1 GM CAPSULE	Maintenance	Adults take 2 capsules (2 gram) by oral route 2 times per day with food swallowing whole. Do not chew, open, dissolve and/or crush.
VASCEPA 0.5 GM CAPSULE	Maintenance	Adults take 4 capsules (2 gram) by oral route 2 times per day with food swallowing whole. Do not chew, open, dissolve and/or crush.

Generic dosing information for ICOSAPENT ETHYL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ICOSAPENT ETHYL 1 GRAM CAPSULE	Maintenance	Adults take 2 capsules (2 gram) by oral route 2 times per day with food swallowing whole. Do not chew, open, dissolve and/or crush.
ICOSAPENT ETHYL 0.5 GM CAPSULE	Maintenance	Adults take 4 capsules (2 gram) by oral route 2 times per day with food swallowing whole. Do not chew, open, dissolve and/or crush.
ICOSAPENT ETHYL 500 MG CAPSULE	Maintenance	Adults take 4 capsules (2 gram) by oral route 2 times per day with food swallowing whole. Do not chew, open, dissolve and/or crush.

The following drug interaction information is available for VASCEPA (icosapent ethyl):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 0 severe interactions.

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Icosapent Ethyl/Anticoagulant;Antiplatelet;Thrombolytic SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: In vitro data suggests that fish oils can competitively inhibit cyclooxygenase which decreases synthesis of thromboxane A1 leading to a decrease in platelet aggregation.(1) CLINICAL EFFECTS: Concurrent use of anticoagulant, antiplatelet, or thrombolytic agents increase bleeding risks. PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: If concurrent therapy is deemed medically necessary, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory tests (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: Specific studies with icosapent ethyl and affects on bleeding risk have not been conducted. Concurrent use of anticoagulant, antiplatelet, or thrombolytic agents may increase bleeding risks by impairing platelet function and prolonging bleeding time.(1) Several case reports have shown increased bleeding time and an increased risk of adverse effects from concurrent therapy.(2,3,4) A randomized placebo controlled study of 40 people taking omega-3 fatty acids and oral anticoagulants showed a significant prolongation in bleeding time.(5)	ACD SOLUTION A, ACD-A, ACETYL SALICYLIC ACID, ACTIVASE, AGGRASTAT, ANISINDIONE, ANTICOAGULANT SODIUM CITRATE, ARGATROBAN, ARGATROBAN-0.9% NACL, ARIXTRA, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BIVALIRUDIN, BRILINTA, BUTALBITAL-ASPIRIN-CAFFEINE, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CATHFLO ACTIVASE, CILOSTAZOL, CITRATE PHOS 2X DEXTROSE(CP2D), CITRATE PHOSPHATE DEXTROSE, CLOPIDOGREL, CLOPIDOGREL BISULFATE, CRRT TRISODIUM CITRATE, DABIGATRAN ETEXILATE, DEFITELIO, DICUMAROL, DIPYRIDAMOLE, DURLAZA, EFFIENT, ELIQUIS, ELMIRON, ENOXAPARIN SODIUM, ENOXILUV, EPTIFIBATIDE, FONDAPARINUX SODIUM, FRAGMIN, HEPARIN LOCK, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W, JANTOVEN, KENGREAL, LMD 10% WITH 0.9% SOD CHLORIDE, LMD 10% WITH 5% DEXTROSE, LOVENOX, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, PENTOSAN POLYSULFATE SODIUM, PHENINDIONE, PLAVIX, PRADAXA, PRASUGREL HCL, RIVAROXABAN, SAVAYSA, SODIUM CITRATE, TICAGRELOR, TIROFIBAN HCL, TNKASE, TRICITRASOL, TRISODIUM CITRATE CRRT, WARFARIN SODIUM, XARELTO, YOSPRALA, ZONTIVITY

Drug Interaction

Drug Names

Icosapent Ethyl/Anticoagulant;Antiplatelet;Thrombolytic

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: In vitro data suggests that fish oils can competitively inhibit cyclooxygenase which decreases synthesis of thromboxane A1 leading to a decrease in platelet aggregation.(1)

CLINICAL EFFECTS: Concurrent use of anticoagulant, antiplatelet, or thrombolytic agents increase bleeding risks.

PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs).

PATIENT MANAGEMENT: If concurrent therapy is deemed medically necessary, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory tests (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding.

Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug.

DISCUSSION: Specific studies with icosapent ethyl and affects on bleeding risk have not been conducted. Concurrent use of anticoagulant, antiplatelet, or thrombolytic agents may increase bleeding risks by impairing platelet function and prolonging bleeding time.(1) Several case reports have shown increased bleeding time and an increased risk of adverse effects from concurrent therapy.(2,3,4) A randomized placebo controlled study of 40 people taking omega-3 fatty acids and oral anticoagulants showed a significant prolongation in bleeding time.(5)

ACD SOLUTION A, ACD-A, ACETYL SALICYLIC ACID, ACTIVASE, AGGRASTAT, ANISINDIONE, ANTICOAGULANT SODIUM CITRATE, ARGATROBAN, ARGATROBAN-0.9% NACL, ARIXTRA, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BIVALIRUDIN, BRILINTA, BUTALBITAL-ASPIRIN-CAFFEINE, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CATHFLO ACTIVASE, CILOSTAZOL, CITRATE PHOS 2X DEXTROSE(CP2D), CITRATE PHOSPHATE DEXTROSE, CLOPIDOGREL, CLOPIDOGREL BISULFATE, CRRT TRISODIUM CITRATE, DABIGATRAN ETEXILATE, DEFITELIO, DICUMAROL, DIPYRIDAMOLE, DURLAZA, EFFIENT, ELIQUIS, ELMIRON, ENOXAPARIN SODIUM, ENOXILUV, EPTIFIBATIDE, FONDAPARINUX SODIUM, FRAGMIN, HEPARIN LOCK, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W, JANTOVEN, KENGREAL, LMD 10% WITH 0.9% SOD CHLORIDE, LMD 10% WITH 5% DEXTROSE, LOVENOX, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, PENTOSAN POLYSULFATE SODIUM, PHENINDIONE, PLAVIX, PRADAXA, PRASUGREL HCL, RIVAROXABAN, SAVAYSA, SODIUM CITRATE, TICAGRELOR, TIROFIBAN HCL, TNKASE, TRICITRASOL, TRISODIUM CITRATE CRRT, WARFARIN SODIUM, XARELTO, YOSPRALA, ZONTIVITY

Severe List
Atrial fibrillation
Increased risk of bleeding

Moderate List
Disease of liver

The following adverse reaction information is available for VASCEPA (icosapent ethyl):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in patients receiving icosapent ethyl and occurring more frequently than with placebo in hypertriglyceridemia trials include arthralgia and oropharyngeal pain. Adverse effects reported in >=3% of patients receiving icosapent ethyl and occurring more frequently than with placebo in the cardiovascular outcomes trial (REDUCE-IT) include musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
Atrial fibrillation Gout	Hemorrhage

Rare/Very Rare
Atrial flutter

There are 7 less severe adverse reactions.

More Frequent	Less Frequent
Musculoskeletal pain Pain in oropharynx Peripheral edema	Arthralgia

Rare/Very Rare
Acute abdominal pain Diarrhea Pain

The following precautions are available for VASCEPA (icosapent ethyl):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of icosapent ethyl have not been established in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Available data are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes with the use of icosapent ethyl in pregnant women. In animal reproduction studies in pregnant rats, minor developmental findings were observed following oral administration of icosapent ethyl during organogenesis at exposures equivalent to that in humans at a dosage of 4 g daily. No clinically relevant adverse developmental effects were observed when icosapent ethyl was administered orally to pregnant rabbits at exposures 5 times the human exposure at the maximum dosage of 4 g daily.

Omega-3 fatty acids, including EPA, have been detected in human milk. Higher levels of omega-3 fatty acids have been observed in the milk of lactating women receiving omega-3 fatty acid supplementation. There are no data on the effects of omega-3 fatty acid ethyl esters on the breast-fed infant or on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for icosapent ethyl and any potential adverse effects on the breast-fed child from icosapent ethyl or from the underlying maternal condition.

In clinical studies of icosapent ethyl, approximately 45% of patients were >=65 years of age. No overall differences in safety or efficacy were observed between geriatric and younger adults, and other reported clinical experience has not revealed age-related differences in response.

Hypertriglyceridemia
E78.1	Pure hyperglyceridemia
E78.2	Mixed hyperlipidemia