What is Fenofibrate?
Fenofibrate (Fenofibrato) is a drug used for the treatment of hyperlipoproteinemia and hypertriglyceridemia. The product ingredient is Fenofibric acid.
The brand names of Fenofibrate in the United States are: Tricor, Lofibra, Lipofen, Antara.
Mechanism of action (MOA) of Fenofibrate
It fundamentally reduces the levels of lipoproteins rich in triglycerides (reduction of 40-50%), such as VLDL, by increasing their catabolism due to an increase in the extrahepatic activity of lipoprotein lipase, and reducing the synthesis of VLDL at the hepatic level.
It also lowers cholesterol levels (20-25%) and slightly raises cholesterol-HDL levels.
Therapeutic Indications, Uses and Benefits of Fenofibrate
- Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
- Mixed hyperlipidemia when statins are contraindicated or not tolerated.
- Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Dosage of Fenofibrate
Oral:
Adults: 145 mg/day or 160 mg/day or 200 mg/day. Prolonged-release capsules: 250 mg/day.
Patients taking 200 mg of micronized this medicine may change to 160 or 145 without needing a dose adjustment.
Mode of administration
Oral use:
– Capsules: Administer with one of the main meals.
– Tablets: Administer at any time of day, with or without food.
Contraindications of Fenofibrate
- Hypersensitivity.
- Liver failure (including biliary cirrhosis and an abnormality of liver function).
- Renal failure.
- Children (< 18 years).
- Known photosensitivity or phototoxicity reactions during treatment with fibrates or ketoprofen.
- Gallbladder disease (gallstones).
- Acute or chronic pancreatitis (except acute pancreatitis due to severe hypertriglyceridemia).
- Pregnancy.
- Lactation.
Warnings and Precautions with Fenofibrate
Quarterly control during the first year of serum transaminases, interrupt if GPT > 100 UI.
If symptoms indicating muscle toxicity appear such as diffuse myalgia, myositis, cramps, weakness risk of: pancreatitis, muscle toxicity (increases with concomitant use with other fibrates or HMG-CoA reductase inhibitors), rhabdomyolysis (increases in myopathies and/or rhabdomyolysis, > 70 years, personal or family history of inherited disorders, renal failure, hypoalbuminemia, hypothyroidism, alcoholics).
Transaminase control every 3 months, during the first year and hemogram (first year of treatment).
Before starting treatment, treat secondary hypercholesterolemias caused by uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, hepatic obstructive disorder, pharmacological treatment, alcoholism.
Liver failure
Contraindicated.
Renal Insufficiency
Contraindicated. Stop if creatinine levels are > 50% LSN. It is recommended to monitor creatinine levels during the first 3 months of treatment increases the incidence of muscle toxicity.
Interactions
- Power effect of: oral anticoagulants.
- Caution with cyclosporine: monitor renal function.
- Do not associate with: perhexiline maleate and MAOI, hepatotoxic substances.
Pregnancy
No data are available on the use of fenofibrate in pregnant women. Contraindicated.
Breastfeeding
In the absence of information on the transition from fenofibrate to breast milk, prescription during lactation is not recommended.
Adverse reactions and side effects of Fenofibrate
Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhea, flatulence) of moderate intensity.
Rash, itching, hives, photosensitivity reactions; elevations of transaminases.
⭐⭐⭐⭐⭐ VIDEO OF FENOFIBRATE/TRICOR (DRUG)
Source: The content of this active ingredient has been written taking into account the clinical and molecular information of all medicines authorised and marketed in the United States under the Unique Ingredient Identifier (UNII) by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).
In order to know in detail the information authorized by the FDA for each drug, you should consult the corresponding medication guide authorized by the FDA.
Resources:
UNII: U202363UOS
ChemIDplus
DrugPortal
PubChem CID: 3339
NCI Thesaurus: C29047