What is icosapent?

Icosapent is used together with other medicines (such as statins) to reduce the risk of heart attack, stroke, and some types of heart problems that need hospitalization in adults.

Icosapent is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides.

It is not known whether icosapent will lower your risk of pancreatitis (inflammation of your pancreas).

Icosapent may also be used for purposes not listed in this medication guide.

Icosapent side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Icosapent may cause serious side effects. Call your doctor at once if you have:

• fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or
• serious bleeding.

Common side effects of icosapent may include:

• muscle or joint pain;
• constipation;
• swelling of the hands, legs, or feet.
• gout; or
• 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 .

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use icosapent if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease;
• diabetes;
• a thyroid disorder;
• problems with your pancreas;
• a bleeding or blood-clotting disorder; or
• if you are allergic to fish or shellfish.

It is not known whether icosapent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Icosapent can pass into breast milk, and may harm your baby. Tell your doctor if you are breastfeeding.

Icosapent is not approved for use by anyone younger than 18 years old.

How should I take icosapent?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You will need frequent blood tests.

Icosapent is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Icosapent dosing information

Usual Adult Dose for Hypertriglyceridemia:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

Usual Adult Dose for Cardiovascular Risk Reduction:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking icosapent?

Avoid eating foods that are high in fat or cholesterol. Icosapent will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

What other drugs will affect icosapent?

Tell your doctor about all your other medicines, especially:

• a blood thinner–warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect icosapent, including prescription and over-the-counter medicines, vitamins, and herbal products. 

What is Juxtapid?

Juxtapid is used along with diet changes (restriction of cholesterol and fat intake) and other treatments to reduce the amount of low-density lipoprotein (LDL) cholesterol (‘bad cholesterol’), total cholesterol, and other fatty substances in the blood in people that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally).

Juxtapid should not be used to decrease cholesterol levels in people who do not have HoFH.

Juxtapid belongs to a class of medications called cholesterol-lowering medications. Lomitapide works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

It is not known whether Juxtapid will lower your risk of heart problems.

Juxtapid is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Warnings

You should not use Juxtapid if you have severe liver disease or a history of abnormal liver function tests.

Do not use if you are pregnant. Birth control pills may be less effective if you vomit or have diarrhea. Ask your doctor about the best way to prevent pregnancy while you are taking Juxtapid.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can affect lomitapide, and some drugs should not be used at the same time.

Juxtapid can cause liver problems. Call your doctor at once if you have nausea, vomiting, upper stomach pain, tiredness, flu-like symptoms, dark urine, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Juxtapid if you are allergic to lomitapide, or if you:

• are pregnant;
• have moderate or severe liver disease, or active liver disease; or
• have abnormal liver function tests.

Some drugs should not be used with Juxtapid. Your treatment plan may change if you also use:

• aprepitant;
• conivaptan;
• crizotinib, imatinib;
• nefazodone;
• an antibiotic – ciprofloxacin, clarithromycin, erythromycin, telithromycin;
• antifungal medication – fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
• heart or blood pressure medicine – diltiazem, verapamil;
• hepatitis C medication – boceprevir or telaprevir; or
• HIV or AIDS medicine – atazanavir, darunavir when given with ritonavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

To make sure Juxtapid is safe for you, tell your doctor if you have ever had:

• liver problems, even if caused by taking certain medicines;
• kidney disease (or if you are on dialysis);
• bowel problems, or an intestinal disorder;
• hereditary galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption; or
• if you drink large amounts of alcohol.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using Juxtapid. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lomitapide on the baby.

Birth control pills may be less effective if you vomit or have diarrhea. Ask your doctor about the best way to prevent pregnancy while taking Juxtapid.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Juxtapid?

Take Juxtapid exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure Juxtapid is safe for you to take.

Take Juxtapid on an empty stomach, at least 2 hours after your evening meal.

Swallow the capsule whole and do not crush, chew, break, or dissolve it. Take this medicine with a full glass of water.

Your doctor may have you take vitamin E or essential fatty acid supplements while you are taking Juxtapid. Take only the type and amount of vitamins or supplements your doctor has prescribed.

Juxtapid is only part of a treatment program that may also include exercise and weight control. Follow your doctor’s dosing instructions very carefully.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 60 mg orally once a day (should be individualized, taking into account the goal of therapy and the response to treatment)
Maximum dose: 60 mg orally once a day.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 60 mg orally once a day (should be individualized, taking into account the goal of therapy and the response to treatment)
Maximum dose: 60 mg orally once a day

Comments:
-Dose should be escalated gradually based on response, safety, and tolerability. The dose may be escalated using the following incremental schedule: 5 mg orally once a day for a minimum of 2 weeks, then 10 mg, 20 mg, 40 mg, 60 mg orally once a day after a minimum of 4 weekly intervals between each dose increase.
-Juxtapid should be taken with a full glass of water on an empty stomach at least 2 hours after the evening meal.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. Talk to your doctor if you stop taking Juxtapid for more than a week.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Juxtapid?

Avoid eating foods high in fat or cholesterol, or Juxtapid will not be as effective and may cause nausea, vomiting, and stomach pain.

Grapefruit may interact with lomitapide and cause side effects. Avoid consuming grapefruit products.

Do not drink more than 1 alcoholic drink per day. Drinking alcohol may increase your risk of liver damage.

Juxtapid side effects

Get emergency medical help if you have signs of an allergic reaction to Juxtapid: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking Juxtapid and tell your doctor if you have:

• severe diarrhea;
• a light-headed feeling, like you might pass out;
• decreased urination; or
• tiredness.

Call your doctor at once if you have signs of liver problems, such as:

• nausea, vomiting, upper stomach pain;
• loss of appetite;
• swelling around your midsection;
• flu-like symptoms, tiredness;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Common Juxtapid side effects may include:

• stomach cramps;
• nausea, vomiting;
• indigestion; or
• diarrhea.

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.

What is Nexletol?

Nexletol (bempedoic acid) is an oral pill for high cholesterol that may be used to reduce the risk of heart attacks and other heart problems in adults with heart disease or at high risk OR lower LDL (“bad”) cholesterol levels in adults with high cholesterol.

Nexletol works by blocking an enzyme in your liver called ACL. This enzyme helps make cholesterol, so blocking it helps lower your cholesterol levels.

Nexletol was first FDA-approved on February 21, 2020. It is only available as the brand Nexletol, there is no bempedoic acid generic.

What is Nexletol used for?

Nexletol is an oral prescription medicine used:

• to lower the risk of heart attack and heart procedures like stent placement or bypass surgery, in
  adults who are unable to take recommended statin treatment (a cholesterol-lowering medicine), or
  are not taking a statin, who:
  • have known heart disease, or
  • are at high risk for heart disease but without known heart disease.
• along with diet and other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH).

It is not known if Nexletol is safe and effective in children.

Nexletol side effects

The most common side effects of Nexletol are:

• symptoms of the common cold, flu, or flu-like symptoms
• back pain
• stomach pain
• high uric acid levels
• increased liver enzymes
• muscle spasms
• pain in the shoulder, legs, or arms
• anemia
• bronchitis.

There’s no evidence that Nexletol affects your weight. Any weight changes are likely due to diet and exercise, not the medication. It is important to follow a healthy diet while taking Nexletol to manage your cholesterol or reduce your risk of a major heart event.

Serious side effects and warnings

Serious hypersensitivity reactions have occurred with Nexletol, including angioedema (swelling of the face and airways), wheezing, rash, and urticaria (hives). Do not take Nexletol if you are allergic to it or any of its inactive ingredients.

Nexletol may cause the following serious side effects.

Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of starting treatment and continue throughout. Your healthcare provider will monitor your blood uric acid levels while you are taking Nexletol. High levels of blood uric acid may lead to gout. Call your healthcare provider if you have the following symptoms of hyperuricemia and gout:

• severe foot pain especially in the toe joint
• warm joints
• swelling
• tender joints
• joint redness.

Gout may happen more in people who have had gout before but can also happen in people who have never had it before.

Tendon rupture or injury. Tendon problems can happen in people who take Nexletol. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include pain, swelling, tears, and inflammation of tendons including the arm, shoulder, and back of the ankle (Achilles).

• Tendon rupture can happen while you are taking Nexletol. Tendon ruptures can happen within days or months of starting Nexletol.
• The risk of getting tendon problems while you take Nexletol is higher if you:
  • are over 60 years of age
  • are taking antibiotics (fluoroquinolones)
  • have had tendon problems
  • are taking steroids (corticosteroids)
  • have renal failure.
• Stop taking Nexletol immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or put weight on the affected area
• If you suspect a tendon rupture, do not take Nexletol until this has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common areas of pain and swelling are the rotator cuff (the shoulder), the biceps tendon (upper arm), and the Achilles tendon at the back of the ankle. This can happen with other tendons.
• Talk to your healthcare provider about the risk of tendon rupture with the continued use of Nexletol. You may need a different lipid-lowering medicine to treat your cholesterol levels.

May cause harm to an unborn baby. Breastfeeding is not recommended.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Nexletol. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

Before taking Nexletol

It is not known if Nexletol is safe and effective in:

• people with severe liver problems
• severe kidney problems including people with end-stage kidney disease who are on dialysis
• children under 18 years of age.

Do not take Nexletol if you are allergic to bempedoic acid or any of the inactive ingredients in Nexletol (see Nexletol ingredients below for a list of ingredients). Stop taking Nexletol and call your healthcare provider or go to the nearest hospital emergency room right away if you have any signs or symptoms of an allergic reaction including:

• swelling of your face, lips, mouth, or tongue
• trouble breathing
• wheezing
• skin rashes, redness, or swelling
• severe itching
• dizziness or fainting
• fast heartbeat or pounding in your chest.

Before you start taking Nexletol, tell your healthcare provider about all your medical conditions, including if you:

• have or had gout.
• have or had tendon problems
• have severe kidney problems.
• have severe liver problems
• are pregnant, think you might be pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Nexletol may cause harm to your unborn baby. You and your healthcare provider will decide if you should take
it while you are pregnant. If you become pregnant during Nexletol treatment, tell your healthcare provider right away and call Esperion at 1-833-377-7633 to share information about the health of you and your baby.

Breastfeeding

It is not known if Nexletol passes into your breast milk. You and your healthcare provider should decide if you will take Nexletol or breastfeed. You should not do both.

How should I take Nexletol?

Take Nexletol exactly as your healthcare provider tells you to take it. Check with your healthcare provider or pharmacist if you are not sure.

• Take 1 Nexletol 180 mg tablet by mouth each day. Each tablet contains 180mg of bempedoic acid.
• You may take it with or without food.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and just go back to your regular dosing schedule. Do not take two doses at once.

What happens if I overdose?

If you take too much Nexletol, call your poison control center or go to the nearest hospital emergency room right away.

What other drugs will affect Nexletol?

Nexletol may affect the way other medicines work, and other medicines may affect how Nexletol works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you take simvastatin or pravastatin (other cholesterol-lowering medicines). Taking statins with Nexletol may increase your risk of developing muscle pain or weakness (myopathy).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What is Olezarsen?

Olezarsen (Tryngolza) is used to treat adults with familial chylomicronemia syndrome (FCS) to help reduce triglyceride levels alongside dietary changes. It is administered subcutaneously once a month using a single-dose auto-injector.

Olezarsen gained FDA approval on December 19, 2024 and is made by Ionis Pharmaceuticals Inc. under the brand name Tryngolza. There is no generic.

How does olezarsen work?

Olezarsen works by targeting and lowering the amount of apoC-III, a protein found in the blood that plays a crucial role in triglyceride metabolism.

• The liver naturally produces apoC-III to help break down triglycerides, but Olezarsen interferes with this process by destroying the messenger RNA (mRNA) that contains instructions for making the protein.
• When the medication successfully reduces apoC-III levels in the blood, it enhances the body’s natural ability to clear out certain types of fats, including triglycerides and very low-density lipoproteins (VLDL), from the bloodstream.

Olezarsen belongs to the drug class called APOC-III-directed antisense oligonucleotides (ASO).

Olezarsen side effects

Common side effects of olezarsen include injection site reactions like redness and pain, lower platelet counts (which may affect blood clotting), and joint pain and stiffness.

It is not known if this medicine is safe and effective in children.

Serious side effects and warnings

Olezarsen may cause an allergic reaction that could be serious. Allergic reactions can include redness of the skin, red itchy bumps (hives), swelling of the face, chills or trouble breathing. Stop taking olezarsen and call your healthcare provider or get emergency help right away if you have any of these symptoms.

These are not all the possible side effects of olezarsen. Tell your healthcare provider if you have any side effect that bothers you or

Before taking

Do not use this medicine if you have had a serious allergic reaction to olezarsen, Tryngolza, or any of the inactive ingredients in the injection (see the ingredient list below).

Before using olezarsen, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if olezarsen can harm your unborn baby. Tell your healthcare provider if you become pregnant while using this medicine.

Breastfeeding

It is not known if olezarsen passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

How do I use olezarsen?

Read the detailed Instructions for Use that come with the Tryngolza (olezarsen) Package Insert for your single-dose autoinjector.

Your healthcare provider will show you and/or your caregiver how to inject this medicine the first time.

• Olezarsen is injected under your skin (subcutaneous use) in your stomach area (abdomen) or the front of your upper legs (thighs). Only a healthcare provider or caregiver may give you an injection in the back of your upper arm.
• Olezarsen should be injected 1 time each month.

Stay on your low-fat diet (less than 20 grams of fat each day) while using olezarsen.

Dietary restrictions with olezarsen

Olezarsen requires patients to follow a strict low-fat diet, limited to just 20 grams of fat per day. This requires medical supervision and often consultation with a dietitian.

Common foods and their fat content:

• One tablespoon olive oil (14g fat)
• One medium avocado (21g fat – exceeds daily limit)
• One ounce almonds (14g fat)
• One tablespoon butter (12g fat)
• Two eggs (10g fat)
• Three ounces skinless chicken breast (3g fat)
• One cheese slice (6g fat).

A sample daily meal plan staying within the 20g limit:

• 1-2 teaspoons cooking oil (5-10g fat)
• One skinless chicken breast (3g fat)
• One egg (5g fat)
• Small amounts of other foods for remaining fat allowance.

Olezarsen dosage

The recommended dosage of olezarsen for FCS is 80 mg administered subcutaneously (under the skin) once monthly.

What happens if I miss a dose?

If you miss a dose of olezarsen, take the missed dose as soon as possible. Then inject olezarsen 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your dosing schedule, ask your healthcare provider.

What other medicines can affect olezarsen?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I store olezarsen?

Store the olezarsen autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.

• Olezarsen can also be stored at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton for up to 6 weeks.
• Do not let this medicine reach temperatures above 86°F (30°C).
• Throw away the autoinjector if kept at room temperature longer than 6 weeks.
• Do not freeze.
• Do not expose the olezarsen autoinjector to heat.
• Protect from light.

Keep the autoinjector in the carton until ready to use.

• Do not store the autoinjector with the clear cap removed.