The drug Fenofibrate Canon (145 mg) from the manufacturer

Fenofibrate Canon (145 mg)

Before starting treatment with fenofibrate, appropriate treatment should be carried out to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, effects of drug therapy, alcoholism. In patients with hyperlipidemia taking estrogens or hormonal contraceptives containing estrogens, it is necessary to determine whether the hyperlipidemia is of a primary or secondary nature. In such cases, an increase in lipid concentrations may be caused by estrogen intake.

Liver function

When taking fenofibrate and other drugs that lower lipid concentrations, an increase in the activity of “liver” transaminases has been described in some patients. In most cases, this increase was temporary, minor and asymptomatic. It is recommended to monitor the activity of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) every 3 months during the first 12 months and periodically during further treatment. Patients whose activity of “liver” transaminases has increased during treatment require attention, and if the activity of ALT and AST increases by more than 3 times compared to the upper limit of normal, the drug is stopped. If symptoms of hepatitis appear (jaundice, itching), laboratory tests should be performed and, if the diagnosis of hepatitis is confirmed, fenofibrate should be discontinued.

Pancreatitis

Cases of pancreatitis have been described during treatment with fenofibrate. Possible causes of pancreatitis in these cases were: insufficient effectiveness of the drug in patients with severe hypertriglyceridemia, direct exposure to the drug, as well as secondary phenomena associated with the presence of stones or sediment formation in the bile ducts, accompanied by obstruction of the common bile duct.

Skeletal muscles

Muscle toxicity, with or without renal failure, including very rare cases of rhabdomyolysis, has been reported with fenofibrate and other lipid-lowering drugs. The incidence of such disorders increases in the case of hypoalbuminemia and a history of renal failure.

Toxic effects on muscle tissue can be suspected based on patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and cramps, and/or a marked increase in creatinine phosphokinase (CPK) activity (more than 5 times the upper limit of normal). In these cases, treatment with fenofibrate should be discontinued.

The risk of developing rhabdomyolysis may increase in patients with a predisposition to myopathy and/or rhabdomyolysis, including age over 70 years, a family history of hereditary muscle diseases, hypothyroidism, and alcohol abuse. Such patients should be prescribed the drug only if the expected benefit outweighs the possible risk of developing rhabdomyolysis.

When fenofibrate is taken concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious muscle toxicity is increased, especially if the patient has a history of muscle disease prior to treatment. In this regard, the joint prescription of fenofibrate and a statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of a history of muscle disease and under conditions of close monitoring aimed at identifying signs of the development of toxic effects on muscle tissue.

Kidney function

When fenofibrate was used as monotherapy or in combination with statins, a reversible increase in serum creatinine concentrations was observed in some patients. In clinical studies, an increase in creatinine of more than 30 μmol/L from the initial value was detected in 10% of patients receiving combination therapy with fenofibrate and simvastatin and in 4.4% of patients receiving simvastatin monotherapy. In 0.3% of patients during combination therapy, a clinically significant increase in serum creatinine concentration (more than 200 µmol/l) was observed. The increase in creatinine concentrations generally remained stable over time, with no evidence of further increases in serum creatinine concentrations with long-term therapy and with a tendency for creatinine concentrations to return to baseline values after discontinuation of treatment. The clinical significance of these changes has not been established.

It is recommended to determine creatinine concentrations in the first three months of therapy and periodically during further treatment. Particularly careful monitoring of renal function should be carried out in patients at risk of developing renal failure, namely in the elderly and patients with diabetes mellitus. If the creatinine concentration increases by more than 50% relative to the upper limit of normal, the drug should be discontinued.

Venous thromboembolism

In a clinical trial, a higher incidence of pulmonary embolism (PE) and deep vein thrombosis (DVT) was noted in the fenofibrate group compared with the placebo group. The proportion of patients with DVT was 1.3% (67/4895) in the fenofibrate group and 0.97% (48/4900) in the placebo group (p = 0.074). PE occurred in 53 (1.0%) patients in the fenofibrate group and in 32 (0.7%) patients in the placebo group (p = 0.022).

Paradoxical reduction in HDL cholesterol

In clinical studies and post-marketing use, cases of marked reductions in HDL cholesterol levels (less than 2 mg/dL [0.052 mmol/L]) after initiation of fibrate therapy have been described in patients with and without diabetes mellitus. The decrease in HDL cholesterol was accompanied by a decrease in apolipoprotein AI. This reduction usually developed between 2 weeks and 1 year after initiation of fibrates. HDL cholesterol levels remained low as long as fibrate therapy was continued. After discontinuation of fibrate therapy, a rapid and sustained response (increase in HDL cholesterol) was observed.

The clinical significance of this reduction in HDL cholesterol has not been established. It is recommended to monitor HDL cholesterol levels during the first few months after initiating fibrate therapy. If there is a significant decrease in HDL cholesterol levels, the drug should be discontinued and monitoring of HDL cholesterol levels should continue until it returns to initial values. Fibrates should not be re-prescribed in such patients.

Impact on the ability to drive vehicles and other mechanisms

The drug Fenofibrate Canon does not affect or has a minimal effect on the ability to drive a vehicle and operate machinery (risk of developing dizziness).

Tricor

Before starting treatment with Trikor 145 mg, appropriate treatment should be carried out to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver diseases, consequences of drug therapy, alcoholism.

In patients with hyperlipidemia taking estrogens or hormonal contraceptives containing estrogens, it is necessary to determine whether the hyperlipidemia is of a primary or secondary nature. In such cases, an increase in lipid concentrations may be caused by estrogen intake.

Effect on cardiovascular morbidity and mortality

The ACCORD clinical randomized placebo-controlled trial was conducted in 5518 patients with type 2 diabetes mellitus who received fenofibrate in addition to simvastatin therapy. The fenofibrate plus simvastatin group demonstrated a statistically nonsignificant 8% reduction in the relative risk of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death, compared with simvastatin alone (hazard ratio 0.92, 95% CI 0.79-1.08, P

=0.32;
absolute risk reduction: 0.74%). A subgroup analysis of patients with dyslipidemia (triglycerides (TG) ≥ 2.3 mmol/L and high-density lipoprotein (HDL) cholesterol ≤ 0.88 mmol/L) demonstrated a statistically significant 31% reduction in the relative risk of major cardiovascular events in fenofibrate plus simvastatin group compared with simvastatin monotherapy group (hazard ratio 0.69, 95% CI 0.49-0.97, P
= 0.03; absolute risk reduction: 4.95%).
Another subgroup analysis revealed a statistically significant difference between sexes ( P
=0.01), indicating a possible benefit of combination therapy in men (
P
=0.037) but a potentially higher risk in women
( P
= 0.069) compared with simvastatin monotherapy.

The 5-year randomized, placebo-controlled FIELD trial was conducted in 9795 patients with type 2 diabetes treated with fenofibrate. Fenofibrate demonstrated a non-significant 11% reduction in the primary cardiovascular outcome (hazard ratio 0.89, 95% CI 0.75-1.05, P=0.

16) and a statistically significant 11% reduction in the secondary outcome of general cardiovascular diseases (risk ratio 0.89% (0.80-0.99), P = 0.04).
There was a nonsignificant increase in all-cause mortality of 11% (hazard ratio 1.11, 95% CI 0.95–1.29, P
=0.18) and a nonsignificant increase in mortality from coronary heart disease of 19% (hazard ratio 1.19, P = 0.18). 95% CI 0.90-1.57,
P
=0.22) with fenofibrate versus placebo.

Liver function

When taking the drug Traykor and other drugs that reduce lipid concentrations, some patients have described an increase in the activity of “liver” transaminases. In most cases, this increase was temporary, minor and asymptomatic. It is recommended to monitor the activity of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) every 3 months during the first 12 months and periodically during further treatment. Patients whose activity of “liver” transaminases has increased during treatment require attention, and if the activity of ALT and AST increases by more than 3 times compared to the upper limit of normal, the drug is stopped. If symptoms of hepatitis appear (jaundice, itching), laboratory tests should be performed and, if the diagnosis of hepatitis is confirmed, the drug Traykor should be discontinued.

Pancreatitis

Cases of the development of pancreatitis have been described during treatment with Traykor. Possible causes of pancreatitis in these cases were: insufficient effectiveness of the drug in patients with severe hypertriglyceridemia, direct effects of the drug, as well as secondary phenomena associated with the presence of stones or sedimentation in the bile ducts, accompanied by obstruction of the common bile duct.

Muscles

When taking Trikor and other drugs that reduce lipid concentrations, cases of toxic effects on muscle tissue, with or without renal dysfunction, including very rare cases of rhabdomyolysis, have been described. The incidence of this disorder increases in the case of hypoalbuminemia and a history of impaired renal function.

When taking Trikor 145 mg concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient had a muscle disease before starting treatment. In this regard, the joint prescription of Trikor 145 mg and a statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of a history of muscle disease and under conditions of close monitoring aimed at identifying signs of the development of toxic effects on muscle tissue.

Renal function

If the creatinine concentration increases by more than 50% above the upper limit of normal, treatment should be suspended. It is recommended to determine creatinine concentrations in the first 3 months and periodically during further treatment.

Hematological disorders

After initiation of fenofibrate therapy, patients experienced a mild to moderate decrease in hemoglobin levels, a decrease in hematocrit, and a decrease in white blood cell count. However, with long-term use of the drug, the values of these indicators stabilize. Thrombocytopenia and agranulocytosis have been reported in individual patients receiving fenofibrate. During the first twelve months from the start of therapy with Traykor, periodic monitoring of the level of red blood cells and white blood cells is recommended.

Hypersensitivity reactions

Immediate hypersensitivity

Cases of anaphylaxis and angioedema have been reported during post-marketing use of fenofibrate. In some cases, such reactions were life-threatening for the patient and required emergency treatment. If signs or symptoms of immediate hypersensitivity are observed, consult a doctor immediately and stop using fenofibrate.

Delayed hypersensitivity

During post-marketing use of fenofibrate, cases of serious adverse skin reactions to the drug have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic manifestations (DRESS syndrome). Such reactions developed over a period of time ranging from several days to several weeks from the start of fenofibrate therapy. Cases of DRESS syndrome have been accompanied by skin reactions such as rash or exfoliative dermatitis, and a combination of eosinophilia and fever involving the renal, hepatic or respiratory systems. If serious adverse skin reactions to the drug are suspected, fenofibrate should be discontinued and specific treatment should be initiated.

Thromboembolic complications

In the FIELD study, patients receiving fenofibrate had a comparatively higher incidence of pulmonary embolism and deep vein thrombosis than patients receiving placebo. Of the 9795 patients enrolled in the FIELD trial, 4900 patients were randomized to placebo and 4985 patients were randomized to fenofibrate. In the group of patients receiving placebo, 48 cases (1.0%) of deep vein thrombosis were reported, and in the group of patients receiving fenofibrate, 67 such cases (1.4%) were recorded; R

=0.074.
In the placebo group, 32 cases (0.7%) of pulmonary embolism were reported; in the group of patients receiving fenofibrate - 53 cases (1.0%); P
=0.022.

Paradoxical reduction in HDL cholesterol

In clinical studies and post-marketing use, cases of marked reductions in HDL cholesterol levels (less than 2 mg/dL) after initiation of fibrate therapy in patients with and without diabetes have been described. The decrease in HDL cholesterol was accompanied by a decrease in apolipoprotein A1. This reduction usually developed between 2 weeks and several years after initiation of fibrates. HDL cholesterol levels remained low as long as fibrate therapy was continued. A rapid and sustained response was observed after discontinuation of fibrate therapy.

The clinical significance of this reduction in HDL cholesterol has not been established. It is recommended to monitor HDL cholesterol levels during the first few months after initiating fibrate therapy. If there is a significant decrease in HDL cholesterol levels, the drug should be discontinued and HDL cholesterol levels should continue to be monitored until they return to baseline values. Fibrates should not be re-prescribed in such patients.

Reviews of Fenofibrate

This drug belongs to a new generation of fibrates , which are characterized by a high level of safety and a lower incidence of adverse reactions. All fibrates are used to lower triglyceride and increase HDL cholesterol . When taking this drug, there is a decrease in microvascular complications in diabetes mellitus - polyneuropathy , retinopathy , nephropathy . For more intensive treatment of atherosclerosis , it is recommended to take a statin + the drug Fenofibrate. However, with this combination the risk of muscle damage increases, so low doses of these drugs are used.

A large selection of fibrates allows you to find the drug at an affordable price and in any dosage form - tablets or capsules. They differ in the content of the active substance. For example, Lipantil - 200 mg, Trilipix - 45 mg, Exlip (long-acting drug) - 250 mg. Traykor is a third generation fenofibrate, in which the active substance is in micronized form (provides high efficiency, but in a lower dose) in the amount of 145 mg and 160 mg. Lipantil and Fenofibrate Canon have the same form of the active substance .

More often there are reviews from patients with diabetes who were prescribed these drugs. There is evidence of effectiveness in reducing triglycerides (based on the results of repeated tests), improvement in the condition of the lower extremities (pain, coldness disappeared) and no progression of fundus changes. Along with this, with long-term use, adverse reactions appeared: nausea, diarrhea , pain in the right hypochondrium, and in some cases, muscle pain.

“... I was prescribed diabetes mellitus and increased uric acid levels. The doctor said that this drug is for me and I need to take it for several years. Because of the side effects, I could only hold out for 7 months, and then I quit.”
“...My course of treatment for a year was successful. Now I really watch my diet and exercise. I think that with these measures it will be possible to keep cholesterol normal.”
“... I took it for six months, after which bilirubin increased and skin itching appeared. They canceled it right away."
“... I took contraceptive pills for many years. This is the only thing I associate with this increase in cholesterol levels. The doctor prescribed a diet and this drug. After 4 months everything returned to normal.”

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Lipid-lowering drug fibric acid . By activating alpha receptors , it enhances lipolysis of atherogenic lipoproteins . Helps reduce the level of VLDL and LDL and increase the HDL . Reduces the content of triglycerides and cholesterol (to a lesser extent - by 20-25%).

Given these effects, the use of Fenofibrate is indicated in patients with hypercholesterolemia combined with (or without) hypertriglyceridemia During treatment, tendon xanthomas cholesterol deposits ) are significantly reduced, elevated levels of fibrinogen and C-reactive protein , and uric acid (by 25%). In addition, the active substance reduces platelet and blood sugar levels in diabetes mellitus .

Pharmacokinetics

The drug in the form of a micronized active substance has higher bioavailability. Absorption is enhanced when taken with food. Cmax is determined after 4-5 hours. With constant long-term use, plasma concentrations remain stable. The main metabolite is fenofibric acid , which is determined in plasma. Strongly binds to albumin .

It is excreted by the kidneys and has a half-life of 20 hours. It is completely eliminated within a week. The drug does not accumulate even with long-term use.

Fenofibrate price, where to buy

You can buy Fenofibrate Canon in many pharmacies. The cost of 30 tablets of the drug ranges from 439-475 rubles.

Online pharmacies in RussiaRussia

ZdravCity

Fenofibrate Canon tablets p.p.o.
145 mg 30 pcs. JSC Kanonpharma Production RUB 395 order

Fenofibrate, instructions for use (Method and dosage)

Fenofibrate Canon is taken 145 mg once a day, which is the maximum daily dose. The tablet is swallowed whole during meals.

Fenofibrate tablets should be taken for a long time while following a cholesterol-lowering diet .

The effectiveness of treatment is assessed by blood lipid levels (usually after 3 months). , transaminase activity is monitored every 3 months. If an increase in levels of more than 3 times is noted, the drug is discontinued.

Treatment is also stopped if there is a toxic effect on the muscles and the level of creatinine phosphokinase by 5 times. Concomitant use with statins is acceptable for severe mixed dyslipidemia and an existing high risk of cardiovascular disease. In case of renal failure , elderly people and patients with diabetes mellitus, kidney function is monitored - determination of creatinine once every 2-3 months.