Fenofibrate: Uses, Dosage, Side Effects, and Precautions

What Is Fenofibrate?

Fenofibrate helps manage your cholesterol and triglyceride levels. It works by lowering the "bad" LDL (low-density lipoprotein) cholesterol while boosting your "good" HDL (high-density lipoprotein) cholesterol. This medication belongs to the fibrate family. It shows good results when combined with a good diet and physical activity.

The FDA (the Food and Drug Administration) gave it the green light back on December 31st, 1993, to help treat high triglycerides and abnormal blood fats when paired with a low-fat diet.

What Is the Dosage and Strength of Fenofibrate?

It comes in tablet and capsule form. You will take it by mouth.

Tablets:

You can get these in 40 mg (milligrams), 48 mg, 54 mg, 120 mg, 145 mg, and 160 mg options.

Capsules:

Your choices include 30 mg, 43 mg, 50 mg, 67 mg, 90 mg, 130 mg, 134 mg, 150 mg, and 200 mg.

Delayed-Release Capsules:

These come in 45 mg and 135 mg.

For Patients:

How Does Fenofibrate Work?

Fenofibrate is a medication that helps bring down your high triglycerides and cholesterol. How does it work? When you take this medication, it activates something called PPARα (peroxisome proliferator-activated receptor) in your body.

Once activated, it gets your genes working to break down fat particles (triglycerides) more efficiently. At the same time, it gets your liver to produce more of the good stuff, which is HDL (high-density lipoprotein) cholesterol, and slows down the production of VLDL (very low-density lipoprotein).

What Are the Uses of Fenofibrate?

• If you are dealing with too much fat in your blood (that is, hypertriglyceridemia), high cholesterol levels (primary hypercholesterolemia), or mixed-up fat and cholesterol levels (mixed dyslipidemia), Fenofibrate can help get things back on track.
• You will need to pair Fenofibrate with a low-fat diet and some lifestyle changes to bring down your bad cholesterol (LDL (low-density lipoprotein) kind).
• If you have gout, your doctor might also add Fenofibrate to your treatment plan to help manage those high uric acid levels that come with it.

What Are the Warnings and Precautions of Fenofibrate?

Warnings:

• If you are taking Fenofibrate, you need to know it can trigger severe allergic reactions like anaphylaxis and angioedema.
• If you are already dealing with gallbladder problems, then Fenofibrate is off the table for you. It pushes more cholesterol into your bile, which ups your chances of developing gallstones and gallbladder inflammation.
• When your kidneys are not filtering properly, Fenofibrate becomes risky business. Your body cannot clear it out like it should, so the drug builds up and can cause serious problems, including muscle breakdown (rhabdomyolysis) and dangerously high potassium levels.
• If you already have muscle problems (myopathy), adding Fenofibrate to the mix could make things much worse. Best to avoid it altogether.

Precautions:

• Fenofibrate can dramatically lower your HDL cholesterol within just two weeks. Your doctor will want to keep a close eye on this, especially in those first few months.
• If you are taking Fenofibrate long-term, it may decrease your white blood cell count, which can lead to issues with clotting (thrombocytopenia) and the ability to fight infections (agranulocytosis).
• Fenofibrate increases your risk of muscle damage, especially if you are older, have diabetes, kidney issues, or an underactive thyroid. These conditions make you more vulnerable to serious muscle toxicity.

How Is Fenofibrate Given?

• Fenofibrate comes in tablets and capsules that you will take by mouth. You will typically take it just once a day.
• You can take Fenofibrate with or without food, whatever works best for you.
• When you are taking Fenofibrate tablets, make sure you swallow them whole. Don't crush or chew them; they are designed to work best when taken as is.
• Try to take your medication at roughly the same time each day. This helps keep things consistent.
• Your doctor will probably start you on a middle-of-the-road dose. They might adjust it up or down based on your lab results.

What Should the Patient Tell the Doctor Before Starting Fenofibrate?

• Before you take Fenofibrate tablets or capsules, you will want to carefully review the ingredient list. If you are allergic to the medication itself or any other ingredients, make sure to tell your doctor right away.
• Your doctor needs to know your medical history, especially if you are currently dealing with any health issues. Things like heart disease, muscle pain, or if you have had problems with your gallbladder, kidneys, or liver in the past, all of this matters for your treatment plan.
• If you are taking statins, you should not combine them with Fenofibrate, because this combo can mess with how your body processes the medication and increase your risk of muscle problems. Your doctor will probably want to check your kidney function and creatinine levels before you start using both medicines together.
• If you are pregnant or thinking about becoming pregnant, this is definitely something to discuss with your doctor.
• If you are breastfeeding, let your doctor know about that, too.
• If you are an older adult, you might have age-related kidney issues or other health conditions that could affect how your body handles this medication.
• Fenofibrate is not approved for anyone under 18, so it is not an option for kids or teenagers.

What Are the Side Effects of Fenofibrate?

Common Side Effects:

• Nausea and vomiting.
• Runny nose and stuffy nose.
• Sneezing.
• Headache.
• Indigestion.
• Abdominal pain.

Serious Side Effects:

• Stomach pain spreads to your back and your shoulder.
• Loss of appetite.
• Fever and chills.
• Weakness.
• Sore throat.
• Chest pain.
• Swelling in your arms and legs.
• Mouth sores.
• Unusual bleeding.
• Trouble breathing.
• Rash.
• Trouble swallowing.

What Are the Dietary Restrictions to be Considered While Taking Fenofibrate?

You will get the most out of your Fenofibrate if you take it with food, as it absorbs much better that way. If you are taking Fenofibrate, do not take cholesterol-heavy foods like fried dishes and red meat. Take lighter foods, such as low-fat milk, fresh vegetables, and egg whites. Use heart-healthy oils like corn, soybean, or sunflower oil.

Missed Dose:

If you fail to take your medicine, do not worry, just skip that dose completely. When it is time for your next scheduled dose, take it like normal. Whatever you do, don't try to catch up by taking two doses at once. That is not safe and won't help you get back on track any faster. Just pick up where you left off with your regular schedule, and you will be fine.

Overdose:

It is important that you stick to the exact amount of Fenofibrate your doctor tells you to take. Taking more than you are supposed to can actually cause adverse effects, so please do not do that. If you think you have taken more Fenofibrate than you should have, give your doctor a call right away.

What Are the Storage and Disposal Requirements of Fenofibrate?

Storage:

You will want to keep your Fenofibrate at room temperature, somewhere between 59 and 70 degrees Fahrenheit. Find a cool, dry spot that is away from any moisture. Make sure you keep the medication in its original packaging or container, and always close that lid tightly when you are done. Keep this medication well out of reach of your kids and pets.

Disposal:

When it is time to dispose of your used Fenofibrate tablets or capsules, check with your local pharmacy about medicine take-back programs in your area. They will have all the details you need.

For Doctors:

What Are the Pharmacological Actions of Fenofibrate?

Fenofibrate is a lipid-regulating agent. The chemical name for Fenofibrate is propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate.

Pharmacodynamics

When you take Fenofibrate, it quickly transforms into its active form called fenofibric acid. It acts as a prodrug. It targets something called PPAR (peroxisome proliferator-activated receptor)-alpha receptors to help manage your cholesterol and fat levels. Your triglycerides could drop by 30 to 60%, your LDL cholesterol goes down, and your HDL cholesterol goes up. It boosts an enzyme called lipoprotein lipase, helps your body burn fatty acids more efficiently, and puts the brakes on VLDL (very low-density lipoprotein) production.

Components:

Active Ingredients:

• The active ingredient is Fenofibric acid.

Inactive Ingredients:

• Lactose monohydrate.
• Colloidal silicon dioxide
• Sodium lauryl sulfate.
• Lactose monohydrate.
• Silicified microcrystalline cellulose.
• Crospovidone.
• Magnesium stearate.

Pharmacokinetics

Distribution:

Once you have been taking Fenofibrate regularly, your plasma levels stabilize and double compared to a single dose. You will reach these steady levels quickly, too, within about nine hours. Almost all of the drug (99%) binds to proteins in your blood, which helps it reach its target sites in your body.

Metabolism:

Your body starts working on Fenofibrate quickly. Special enzymes called esterases rapidly break it down into fenofibric acid. From there, your body attaches glucuronic acid to it (a process called conjugation) so it can be eliminated through your urine. A tiny bit is processed differently at the carbonyl moiety, forming a benzhydryl metabolite, which is then conjugated and removed.

Excretion:

Your body is efficient at eliminating Fenofibrate. About 60% of what you take is excreted in your urine as metabolites (mainly fenofibric acid and its glucuronide). Another 25% exits through your feces. Between these two routes, your body clears most of the medication without any issues.

Elimination:

100% of Fenofibrate elimination happens through hepatic metabolism. The drug has a half-life of about 20 hours, which means it takes that long for half of it to leave your system. This relatively long half-life is why you typically only need to take it once a day.

What Are the Drug Interactions of Fenofibrate?

The drug interactions of Fenofibrate are described below:

• Blood Thinners (Coumarin Anticoagulants):

If you are taking Fenofibrate with blood thinners like Warfarin, you will need to watch out. This combo can make your blood take longer to clot, which shows up in your PT (prothrombin time) and INR (international normalized ratio) tests. Your doctor will likely lower your dose to keep these numbers in check and prevent any bleeding issues.

• Immunosuppressants:

When you mix medications like Cyclosporine or Tacrolimus with Fenofibrate, they can affect how well your kidneys work. You might see your creatinine levels rise, which isn't great for kidney health. That is why you will need a lower dose of Fenofibrate and regular kidney function check-ups.

• Bile Acid Binding Resins:

Timing is everything with this one. Make sure you take your Fenofibrate at least an hour before your bile acid resin, or wait 4 to 6 hours after. This spacing helps your body absorb the medication properly.

• Colchicine:

If you are on Colchicine, you will want to be extra careful when adding Fenofibrate. This combination can increase your risk of muscle problems, so your doctor will need to monitor you closely if they prescribe both together.

How Does Fenofibrate Work for Different Populations?

• Pregnancy:

If you are planning to have a baby or are already pregnant, you need to know that Fenofibrate could potentially harm your developing baby. We don't have adequate data yet, but what we do know suggests there might be risks of birth defects.

• Breastfeeding:

It is unknown if Fenofibrate passes into breast milk. Because of this uncertainty, you will need to make a choice: either stop breastfeeding or stop taking the medication. Your doctor will help you weigh the pros and cons based on what is best for you and your baby.

• If You Are Older:

There is no need to change your dose. Research on people between 77 and 87 years old shows that your body handles the drug just like younger adults do. While you won't need a different dose, your doctor will want to monitor you carefully, especially your kidney function.

• If You Have Metabolic Syndrome:

If you have obesity, high blood pressure, or insulin resistance, you are probably dealing with high triglycerides and low HDL cholesterol, too. Fenofibrate works well for people like you.