Vascepa is a prescription drug of omega-3 fatty acids derived from fish oil, with the main active ingredient being high-purity ethyl ester of eicosapentaenoic acid (EPA).

1、 Drug name

Vascepa (Icosapentaethyl)

2、 Indications

1. Used as an adjuvant therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients who have received maximum tolerated dose statin therapy.

2. Applicable patients should meet the following requirements: elevated triglyceride (TG) level (≥ 150mg/dL), confirmed cardiovascular disease or diabetes, and accompanied by 2 or more other cardiovascular disease risk factors.

3. As a dietary aid, it is used to reduce TG levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL).

4. Note: The impact of this product on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined.

3、 Specifications and characteristics

1. This product is a soft capsule.

2. 1 gram: Amber color, long oval shape, printed with the words "VASCEPA".

4、 Main components

Active ingredient: IcosapentEthyl.

5、 Usage and dosage

1. Dosage: The recommended daily total dose is 4 grams.

2. Usage:

(1) Take twice a day with meals.

(2) Optional plan: Take 2 capsules of 1 gram each time.

(3) Usage: Swallow the whole capsule, do not break, crush, dissolve or chew the capsule.

(4) Preparation before starting: before starting treatment, the blood lipid level should be evaluated, and other causes of hypertriglyceridemia (such as diabetes, hypothyroidism, drugs, etc.) should be identified and managed. Patients should adhere to appropriate nutritional intake and physical activity before and during treatment.

6、 Dose adjustment

No special dosage adjustment plan was mentioned. Medication should be taken according to medical advice.

7、 Medication precautions

1. Timing of administration: It must be taken with meals or after meals.

2. Leakage treatment: If one dose is missed, it should be replenished as soon as possible. But if it is close to the next dose, skip the missed dose and take the next dose at the regular time. Do not double the dosage during the next medication.

3. Vomiting treatment: Not yet clear, it is recommended to consult a doctor or pharmacist.

4. Other: During the use of this product, one should continue to follow the doctor's recommended diet and exercise plan that is low in saturated fat and cholesterol. Regular monitoring of blood lipid levels may be necessary during treatment.

8、 Medication for special populations

1. Pregnant women: The existing data is insufficient to assess the relevant risks, and it is necessary to weigh the pros and cons before use.

2. Breastfeeding women: The active ingredients of this product may be excreted in breast milk, and their effects on infants are unknown. The benefits and potential risks of breastfeeding should be considered.

3. Children: Safety and efficacy have not yet been established.

4. Elderly patients (≥ 65 years old): In clinical studies, there was no overall difference in safety and efficacy compared to younger patients.

5. Patients with liver dysfunction: During treatment, regular monitoring of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be conducted.

6. Patients with renal insufficiency: No relevant research has been conducted yet.

9、 Adverse reactions

1. Serious adverse reactions:

(1) Atrial fibrillation/atrial flutter: Increased risk of hospitalization, especially in patients with a history of atrial fibrillation.

(2) Bleeding: The risk of bleeding increases, especially when combined with antithrombotic drugs such as aspirin, clopidogrel, and warfarin.

(3) Allergic reactions: Patients who are allergic to fish/shellfish may be at risk.

2. Common adverse reactions:

(1) In cardiovascular outcome trials (incidence ≥ 3% and higher than placebo ≥ 1%): musculoskeletal pain, peripheral edema, constipation, gout, atrial fibrillation.

(2) In the hypertriglyceridemia test (incidence rate higher than placebo ≥ 1%): joint pain, oropharyngeal pain.

(3) Post market monitoring: diarrhea, elevated blood triglycerides, abdominal discomfort, limb pain.

10、 Contraindications

Patients with known hypersensitivity reactions (such as allergic reactions) to this product or any of its ingredients are prohibited from using it.

11、 Drug interactions

1. Anticoagulants and antiplatelet drugs: may increase the risk of bleeding. Close monitoring of bleeding signs is necessary when used together.

2. Interaction studies with specific drugs: Clinical studies have shown that when this product (4 grams per day) is used in combination with omeprazole, Rogoglitazone, warfarin, or atorvastatin, there is no significant change in the pharmacokinetics or anticoagulant efficacy (for warfarin) of these drugs. However, it is still recommended to exercise caution when combining any medication.

12、 Storage method

1. Stored at 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing for short-term fluctuations between 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Keep out of reach of children.

3. Do not use expired drugs.

13、 Manufacturer

AmarinPharma,Inc.

Icosapent ethylinformation