Drug Detail:Fenofibrate (Fenofibrate [ fen-oh-fye-brate ])
Drug Class: Fibric acid derivatives
1. How it works
- Fenofibrate may be used for the treatment of high cholesterol.
- Fenofibrate activates an enzyme called lipoprotein lipase which increases the breakdown of lipids and the elimination of triglyceride-rich particles from the blood.
- Fenofibrate belongs to the class of medicines called fibrates.
2. Upsides
- May be used to treat high cholesterol (dyslipidemia) in adults with primary hypercholesterolemia or mixed dyslipidemia.
- Can be a good alternative for people who can't tolerate statins.
- Should be used in addition to a healthy diet.
- Also used to lower the risk of pancreatitis in adults with very high triglyceride levels (more than 2000 mg/dL).
- Fenofibrate is more effective than statins at increasing HDL cholesterol levels, similar to atorvastatin and rosuvastatin at reducing triglyceride levels, but less effective than statins at lowering LDL cholesterol levels.
- Available as oral tablets in two strengths, 54mg, and 160mg.
- Generic fenofibrate is available.
3. Downsides
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Abdominal pain, a headache, backache, nausea, constipation, nasal congestion, or a runny nose.
- Fenofibrate has been associated with myopathy (dysfunction of muscle fibers) and rhabdomyolysis (muscle cell destruction). The risk is increased in seniors and in people with diabetes, kidney disease, hypothyroidism, and also in those taking statins or colchicine. Tablets may need to be discontinued if serious muscle problems occur.
- Has not been shown to reduce the risk of death from heart disease in patients with type 2 diabetes.
- Dosage may need to be reduced in people with mild-to-moderate kidney disease (the recommended initial dose is 54 mg/day). Not recommended for people with severe kidney disease.
- May cause an increase in liver enzymes. Liver enzymes need to be periodically monitored and fenofibrate should be discontinued if liver enzymes reach three times the upper limit of normal.
- In some people, fenofibrate may severely depress HDL cholesterol levels. HDL levels should be checked within the first few weeks of fenofibrate therapy and the drug discontinued if HDL cholesterol levels have dropped significantly.
- Has not been shown to reduce coronary heart disease morbidity and mortality in people with type 2 diabetes mellitus.
- May not be suitable for some people including those with gallbladder disease, liver disease, severe kidney disease, and in women who are pregnant or breastfeeding.
- May interact with some drugs including warfarin (may prolong bleeding times), sulfonylureas, statins, colchicine, bile acid-binding resins, and immunosuppressants.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
4. Tips
- Can be given with or without food.
- Use in addition to an appropriate lipid-lowering diet and regular exercise. Reducing body weight and alcohol consumption will also help lower cholesterol and triglyceride levels.
- Report promptly any unexplained muscle tenderness, weakness, or pain, especially if other symptoms (such as fever or feeling unwell) are also present.
- Seek urgent medical attention if you develop symptoms of an allergic reaction (such as difficulty breathing, swelling, or a rash) or yellowing of the skin or eyes while taking fenofibrate.
- Diseases such as hypothyroidism (low thyroid levels) and diabetes contribute to dyslipidemia, so it is important these must be treated as well. In addition, some medications (for example, estrogen, bendroflumethiazide, and atenolol) may increase triglyceride levels.
- Monitoring of cholesterol/triglyceride levels every four to eight weeks is important to establish the effectiveness of fenofibrate therapy. Your doctor should consider discontinuing therapy if you have not had an adequate response after two months of treatment.
- Tell your doctor if you are pregnant or intend to become pregnant because it is not known if fenofibrate has any effects on the developing baby. Do not breastfeed if you are being treated with fenofibrate.
5. Response and effectiveness
- Fenofibrate is quickly absorbed and converted into its active ingredient fenofibric acid once inside the body. Takes about a week for levels to stabilize. May take several weeks before effects on cholesterol and triglycerides levels are apparent.
- Fenofibrate lowers total cholesterol by 9 to 13%, VLDL cholesterol by 44 to 49%, triglycerides by 46 to 54%, and apolipoprotein B (Apo B). Fenofibrate also increases HDL cholesterol by 19-22%.
- Cholesterol and triglyceride levels should be monitored every four to eight weeks.
- Dosage should be individualized according to the response.
- People with markedly elevated levels of serum triglycerides (> 2000 mg/dL) have a higher risk of developing pancreatitis. It is not known if fenofibrate treatment reduces this risk.
6. Interactions
Medicines that interact with fenofibrate may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with fenofibrate. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.
Common medications that may interact with fenofibrate include:
- acyclovir
- aminoglycosides, such as gentamicin or neomycin
- beta-blockers, such as atenolol or sotalol
- black cohosh
- colchicine
- cancer medications, such as cisplatin or pemetrexed
- cholestyramine
- cyclosporine
- diabetes medications, such as insulin, glimepiride, glipizide, or glyburide
- diuretics, such as HCTZ or chlorthalidone
- ezetimibe
- leflunomide
- other lipid-lowering drugs such as atorvastatin or simvastatin
- raltegravir
- red yeast rice
- ursodiol
- warfarin.
Alcohol may make fenofibrate treatment less effective.
Note that this list is not all-inclusive and includes only common medications that may interact with fenofibrate. You should refer to the prescribing information for fenofibrate for a complete list of interactions.