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 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 assay or in the in vivo mouse micronucleus assay. A chromosomal aberration assay in Chinese Hamster Ovary cells was positive for clastogenicity with and without metabolic activation.
Who Should Not Take This Medication
You shouldn’t take Vascepa if you have ever had a severe allergic reaction to Vascepa or any of its ingredients. Because the modified EPA has been obtained from oils derived from fish, Vascepa should be used with caution if you have an allergy to fish or shellfish. Vascepa has not been studied in people who have a fish or shellfish allergy.
Vascepa has also not been extensively studied in people with kidney or liver disease. If you have liver or renal disease or impairment, you should let your healthcare provider know. He or she will decide whether or not Vascepa is appropriate for you and monitor your condition while you are on the medication.
This product has also not been studied in pregnant or breastfeeding women. Therefore, Vascepa should be taken only if clearly needed.
New Vascepa Indication Expected To See Rapidly Expanded Use In 2020
Amarin reaffirmed its intention to promptly launch Vascepa in the United States for this new preventive care indication. Amarin said it was doubling the size of its sales force near the beginning of 2019 and said it is on track to double the size of its sales force again to a total of 800 sales representatives by the beginning of 2020.
You May Like: Is Corn Good For Cholesterol
If Your Triglyceride Levels Are Elevated Your Healthcare Provider May Decide To Try And Lower Your Levels By Changing Up Your Lifestyle This Includes Making Your Diet Healthier Losing Weight Or Addressing Medical Conditionssuch As Uncontrolled Diabetesthat Could Be Causing Your Triglyceride Levels To Be Too High If These Changes Dont Work Or If Your Triglycerides Are Extremely Elevated Your Healthcare Provider May Decide To Add Medication This Is When Medications Like Vascepa May Be Prescribed To You
Vascepa is a modified form of the omega-3 fatty acid, eicosapentaenoic acid , and is taken by people who have been diagnosed with severe hypertriglyceridemia, which consists of triglyceride levels greater than or equal to 500 mg/dL. If you have been prescribed this medication to take, you should also be following a diet to lower your triglyceride levels. Vascepa was approved for use in the United States by the Food and Drug Administration in July 2012.1
There have been a few studies that have examined the safety and effectiveness of Vascepa in lowering triglycerides. The pivotal study, the MARINE trial, compared the triglyceride-lowering ability of Vascepa to placebo in people with triglyceride levels between 500 and 2000 mg/dL over a 12 week period. Compared to placebo, triglyceride levels were lowered by roughly 33% in those taking 4 grams of Vascepa daily. Additionally, VLDL was lowered by 27.9%. LDL and HDL were slightly lowered, however, this reduction was not statistically significant. No significant differences in vital signs, blood sugar levels, and liver enzymes were noted in people taking Vascepa versus those taking a placebo.2
Side Effects Requiring Immediate Medical Attention
Along with its needed effects, icosapent may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking icosapent:
Less common
- swelling of the hands, ankles, feet, or lower legs
- unusual bleeding
Recommended Reading: How Long Does It Take Fish Oil To Lower Cholesterol
What Is The Price Of Vascepa
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.
Vascepa is available as the generic drug icosapent ethyl. Generics usually cost less than brand-name drugs. Talk with your doctor if youd like to know about taking generic icosapent ethyl.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. For a couple of options that may help you save on the cost of Vascepa, visit this site.
You can also check out this article to learn more about saving money on prescriptions.
Certain factors can affect whether Vascepa is a good treatment option for you. These may include having specific medical conditions or taking certain medications. Read on to find out more about these factors.
Vascepa For Lowering The Risk Of Certain Cardiovascular Problems
Vascepa is FDA-approved to lower the risk of certain cardiovascular problems in adults with high triglyceride levels and:
- diabetes and two or more additional risk factors for cardiovascular disease, such as high blood pressure, high cholesterol, or obesity
Triglycerides are a type of fat that flows through your blood. High triglyceride levels in your blood can contribute to the narrowing and hardening of your arteries. This may not cause any symptoms. However, it increases your risk of cardiovascular problems such as heart attack or stroke. A high triglyceride level is considered to be 150 mg/dL or more.
If you have cardiovascular disease, diabetes, or risk factors of cardiovascular disease, you likely have an increased risk of cardiovascular problems. High triglyceride levels may further increase your risk of these problems.
Vascepa helps lower your triglyceride levels. And it helps lower your risk of the following cardiovascular problems:
- unstable angina that needs treatment in a hospital
- coronary revascularization
To lower the risk of these cardiovascular problems, Vascepa is FDA-approved to be taken with statin medications. These drugs lower triglyceride and cholesterol levels. High cholesterol is another factor that increases your risk of cardiovascular problems. Examples of statin medications include atorvastatin and simvastatin . For additional information, see the Vascepa use with other treatments section below.
Recommended Reading: What Causes Increased Ldl Cholesterol
What Are The Side Effects Of Vascepa
Get emergency medical help if you have signs of an allergic reaction: hives difficult breathing swelling of your face, lips, tongue, or throat.
- fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed or
- serious bleeding.
Common side effects may include:
- muscle or joint pain
- swelling of the hands, legs, or feet.
- chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Vascepas Limitation Of Use
The manufacturer of Vascepa has noted a limitation to this drugs use. This is a situation in which Vascepa may not be recommended.
Having a severely high triglyceride level, which Vascepa treats, is known to increase your risk of pancreatitis. However, its not known what effect, if any, Vascepa has on the risk of pancreatitis.
Recommended Reading: Does Mct Oil Raise Cholesterol
Indications And Usage For Vascepa
Vascepa® is indicated:
- as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and
- established cardiovascular disease or
- diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
Limitations of Use:
The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Dr Roach: Very High Triglycerides May Need A Step Up From Otc Fish Oil
Dear Dr. Roach: I recently saw an ad on TV for Vascepa. It seems to be a drug for lowering triglycerides. I did some additional research and found that it also works as an anti-inflammatory. My triglycerides on my last bloodwork were 160. Would this drug be of benefit for me? Some say its merely fish oil, which I have taken for several years. I wonder if its just a higher octane of fish oil, so to speak.
B.
Dear B.: Before taking a medication, it should be very clear what the goals of the medication are. This is true whether the medicine is prescription, over-the-counter, vitamin or other supplement.
In the case of people with high triglycerides, the goal of omega-3 fish oil is preventive. For people with VERY high triglycerides , reducing triglycerides reduces the incidence of inflammation of the pancreas. That is not a concern for you in your case, the goal is to reduce the likelihood of having a heart attack or stroke.
Vascepa is a highly purified omega-3 fish oil ester. It was shown in a study to reduce risk of the combination of cardiac death, heart attack and stroke in people with elevated triglyceride levels AND a history of coronary artery disease OR diabetes and an additional risk factor such as high blood pressure, evidence of blood inflammation or peripheral artery disease. In this group of high-risk subjects, Vascepa reduced the risk of developing one of the endpoints from 22% to 17%. All subjects in the study were also taking a statin.
M.H.
You May Like: How To Increase Hdl Cholesterol With Diet
How Long Does It Take To Work
Vascepa starts working soon after you start taking it. However, youre unlikely to notice it working. It may take a few weeks before your triglyceride levels and risk of cardiovascular problems start to reduce. Your doctor will order blood tests from time to time to check if the medication is working for you.
Here are answers to some frequently asked questions about Vascepa.
Is weight loss a side effect of Vascepa?
No, weight loss is not known to be a side effect of Vascepa. Weight loss wasnt reported in the drugs clinical trials.
Vascepa is taken to lower blood triglyceride levels.* Triglycerides are a type of fat that flows through your blood. However, this type of fat doesnt affect body weight. And lowered levels of triglycerides wont lead to weight loss.
However, during Vascepa treatment, your doctor will advise you follow a diet thats healthy for you. They will also recommend increasing exercise. This can help lower your triglyceride levels and lead to weight loss. Losing weight can benefit people who have high triglyceride levels and an increased risk of cardiovascular problems.
* For additional information on the approved uses of Vascepa, see the Vascepa uses section above.
Vascepa: Questions For Your Doctor
If you have questions about Vascepa, talk with your doctor. They can help advise you on whether Vascepa could be a good treatment option for you.
Heres a list of questions you may want to ask your doctor:
- If I take a fish oil supplement, should I stop taking it if my doctor prescribes Vascepa?
- Do other medications I take increase my risk of side effects with Vascepa?
- How will I know if Vascepa is working for me?
Your doctor may also tell you about other treatment options for your condition. You may find this article helpful in learning about alternative drugs for heart conditions. You can view this article for a list of cholesterol treatments. Also, check out our selection of videos on heart health.
Disclaimer: Healthgrades has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Also Check: Does High Cholesterol Cause Mood Swings
Is Hair Loss A Side Effect Of Vascepa
No, Vascepa isnt known to cause hair loss. This side effect wasnt reported in studies of Vascepa. But hair loss can be a side effect of certain other medications you may take with Vascepa, such as statins and fibrates.
If you have hair loss while taking Vascepa, talk with your doctor. They can investigate the possible cause.
Vascepa Dosage For Severe Hypertriglyceridemia
Vascepa is also prescribed as an adjunct to a low-cholesterol, low-fat diet to people who have very high triglyceride levels, or severe hypertriglyceridemia, defined as more than 500 mg/dL . Very high triglyceride levels carry a significant risk of pancreatitis . Chemically-altered omega-3 fatty acids have been proven effective at reducing both triglyceride and LDL levels. Vascepa, an EPA ester, reduces triglycerides by about 1/3. EPA works by reducing the livers production of triglycerides, increasing the clearance of triglycerides from the blood, and increasing the activity of an enzyme that breaks down triglycerides and VLDL cholesterol.
-
Standard adult dosage for hypertriglyceridemia: 2 g taken twice per day
-
Maximum adult dosage for hypertriglyceridemia: 4 g per day
Recommended Reading: How Do Statin Drugs Work To Lower Cholesterol
Does Vascepa Cause Heart Palpitations
Vascepa may cause heart rhythm problems, such as atrial fibrillation . And heart palpitations can be a symptom of heart rhythm problems.
With palpitations, it may feel as though your heart is beating irregularly, pounding, racing, or skipping beats.
To learn more about Vascepa and heart rhythm problems, see Vascepas side effects explained in the Vascepa: Side effects section above. Talk with your doctor if youd like more information.
What If I Miss A Dose
If you miss a dose of Vascepa, take it as soon as possible. However, if its nearly time for your next scheduled dose, skip the missed dose and take your next dose as you typically would. Do not take two doses together to make up for a missed dose. And do not take extra doses to make up for missed doses. Doing so can increase your risk of side effects from Vascepa.
To help make sure that you dont miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Don’t Miss: Which Cholesterol Is The Good Cholesterol
Whats To Know About Vascepa Vs Statins
Vascepa is used to reduce certain cardiovascular risks in some people. Its also approved to lower triglyceride levels in some people. Statins can be used to lower triglycerides and other cholesterol levels, too. And similarly to Vascepa, statins are also used to reduce certain cardiovascular risks.
Statins work by lowering the amount of cholesterol thats made by your liver. Theyre commonly prescribed for lowering cholesterol levels, cardiovascular risks, or both. And theyre usually prescribed for people with:
- risk of cardiovascular disease
For lowering certain cardiovascular risks, your doctor will prescribe Vascepa in combination with a statin. Examples include atorvastatin or rosuvastatin .
To learn more about how Vascepa and statins compare, talk with your doctor or pharmacist.
What Are The Possible Side Effects Of Vascepavascepa May Cause Serious Side Effects Including:
- Heart rhythm problems . Heart rhythm problems which can be serious and cause hospitalization have happened in people who take VASCEPA, especially in people who have heart disease or diabetes with a risk factor for heart disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort or you faint.
- Possible allergic reactions if you are allergic to fish or shellfish. Stop taking VASCEPA and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction.
- Bleeding. Serious bleeding can happen in people who take VASCEPA. Your risk of bleeding may increase if you are also taking a blood thinner medicine.
- Muscle and joint pain
- Swelling of the hands, legs, or feet
Recommended Reading: What Is The Highest Recorded Cholesterol Level
Questions About Vascepas Dosage
Below are some common questions about Vascepas dosage.
- What if I miss a dose of Vascepa? If you miss a dose of Vascepa, take it as soon as you remember. But if youre close to your next dose, skip the dose entirely and take the next scheduled dose. If youre unsure when to take Vascepa, talk with your doctor or pharmacist. Do not double your dose if you forgot to take Vascepa.
- Will I need to use Vascepa long term? Yes, you may need to use Vascepa long term. High triglyceride levels can be a long lasting condition. And taking Vascepa long term can help manage triglyceride levels in your blood. If Vascepa is helping to lower your triglyceride levels and doesnt cause bothersome side effects, your doctor may recommend taking it long term. To find out how long youll need to take Vascepa, talk with your doctor.
- How long does Vascepa take to work? If youre taking Vascepa to lower your triglyceride levels, it may take a few weeks to work. In studies, researchers saw an improvement in triglyceride levels after 12 weeks. But it can take longer for Vascepa to lower your risk of heart problems.
Vascepa is a prescription medication used to help lower blood levels of triglycerides in adults with certain indications. An indication is a condition that a drug is used to treat.
Vascepa is used in adults with:
Vascepa works by decreasing the bodys production of very low-density lipoprotein triglycerides, a kind of fat produced by the liver. It also helps eliminate this fat from the body.