Icosapent Ethyl (icosapent ethyl)

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Icosapent ethyl is administered orally twice daily with food. In clinical studies, icosapent ethyl was administered with or following a meal; food effect studies have not been performed.

Icosapent ethyl capsules should be swallowed whole and should not be broken, crushed, dissolved, or chewed.

Cytochrome P-450 (CYP) isoenzymes play a minor role in the metabolism of eicosapentaenoic acid (EPA).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

*Known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Atrial fibrillation
• Increased risk of bleeding

• Disease of liver

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.

More Frequent

• Atrial fibrillation
• Gout

Less Frequent

• Hemorrhage

Rare or Very Rare

• Atrial flutter

More Frequent

• Musculoskeletal pain
• Pain in oropharynx
• Peripheral edema

Less Frequent

• Arthralgia

Rare or Very Rare

• Acute abdominal pain
• Diarrhea
• Pain

No enhanced messaging available.

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

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.