Before treatment drug fenofibrate Canon should conduct an appropriate treatment to eliminate the cause of secondary hypercholesterolaemia, e.g., in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, Dysproteinemia, obstructive liver disease, the effects of drug therapy, alcoholism.
The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in serum. In the absence of a therapeutic effect after several months of therapy (as a rule,after 3 months) should consider the feasibility of concomitant or alternative therapy.
In patients with hyperlipidemia, taking estrogens or hormonal contraceptives containing estrogens, it is necessary to find out whether hyperlipidemia has a primary or secondary nature. In such cases, the increase in lipid levels can be caused by the use of estrogens.
Liver function: when taking fenofibrate and other drugs that reduce lipid concentrations, some patients described an increase in the activity of "liver" transaminases. In most cases, this increase was temporary, minor and asymptomatic. During the first 12 months of treatment, it is recommended to monitor the activity of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)) every 3 months. Patients who have increased concentrations of transaminases against the background of treatment, require attention, and in the case of increased concentrations of ALT and ACT more than 3 times compared with the upper limit of normal reception of the drug is stopped.
Pancreatitis: cases of development of pancreatitis during the treatment with fenofibrate have been described.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 the formation of sediment in the gallbladder, accompanied by obstruction of the common bile duct.
Muscles: when taking fenofibrate and other drugs that reduce lipid concentrations, there are cases of toxic effects on muscle tissue, including very rare cases of rhabdomyolysis. The frequency of such a disorder is increased in the case of hypoalbuminemia and renal insufficiency in the anamnesis. The possibility of this complication increases in cases of hypoalbuminemia and renal failure.
Toxic effects on muscle tissue can be suspected on the basis of patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and convulsions and / or a pronounced increase in creatinine phosphokinase (CK) activity (more than 5 times the upper limit of normal). In these cases, treatment with fenofibrate should be discontinued.
The risk of rhabdomyolysis may increase in patients with a predisposition to myopathy and / or rhabdomyolysis, including age over 70 years, a history of hereditary muscle diseases, renal dysfunction, hypothyroidism, alcohol abuse. Such patients should be prescribed a drug only if the expected benefit exceeds the possible risk of rhabdomyolysis. When taking Fenofibrate Canon simultaneously with inhibitors of HMG-CoA reductase or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient suffered from muscle disease before starting treatment. In this regard, the joint administration of the drug Fenofibrate Canon and statin is allowed only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of a history of muscle disease and under close monitoring aimed at revealing signs of the development of toxic effects on muscle tissue.
Renal function: When using Fenofibrate Canon as a monotherapy or in combination with statins, a reversible increase in serum creatinine concentration was noted in patients.The increase in creatinine concentration was generally stable for a time without signs of a further increase in serum creatinine concentration with prolonged therapy, with a tendency to return to baseline values after treatment withdrawal. The clinical significance of these observations is not established. In patients with renal insufficiency, it is recommended that kidney function be monitored when taking Fenofibrate Canon. Control of renal function should be performed in patients at risk of developing renal failure, namely, elderly patients and patients with diabetes mellitus. Treatment should be reversed if the concentration of creatinine> 50% of the upper limit of the norm is increased. It is recommended to determine the concentration of creatinine during the first 3 months after the start of treatment, and also periodically after its termination.