Fenofibrate

Fenofibrate is a lipid-lowering agent and belongs to the substance class of fibrates.

Significance: In contrast to statins, fibrates have only a minor effect on the LDL-C value, which plays a decisive role in cardiovascular risk, and have not been shown to improve prognosis.

Fibrates are therefore only used in very few indications, predominantly in cases of elevated triglyceride levels, and are used less frequently than satins and other lipid-lowering drugs. In addition, fibrates are very difficult to combine with other lipid-lowering drugs such as statins due to their complex WW profile, which further limits their applicability.

Anticoagulants: the effect of oral anticoagulants may be enhanced by fenofibrate and cause an increased risk of bleeding (close monitoring of INR and dose reduction of anticoagulants at the start of therapy).

Ciclosporin: considerable, reversible impairment of renal function possible with concomitant use of fibrate-containing medicinal products and ciclosporin. Monitor renal function carefully and discontinue fenofibrate if necessary.

Statins: Risk of severe myopathy with rhabdomyolysis is increased when statins are combined with fibrates. This combination should be avoided.

Glitazones: some cases of reversible paradoxical HDL cholesterol lowering have been observed with concomitant use of fenofibrate and glitazone; HDL cholesterol should be monitored; if HDL cholesterol falls, it is recommended to discontinue one of the two therapies.

Fenofibrate and the active metabolite fenofibric acid are weak inhibitors of CYP2C19 and CYP2A6 and moderate inhibitors of CYP2C9 at therapeutic concentrations.

Patients taking other drugs with a narrow therapeutic range that are metabolized via CYP2C19, CYP2A6 and especially CYP2C9 in addition to fenofibrate should be carefully monitored. If necessary, the dosage of these drugs should be adjusted.

However, the WW profile is complex and WW must therefore be clarified separately in each individual case!

• Liver failure (including biliary cirrhosis and unexplained persistent liver function abnormality)
• known gallbladder disease
• severe renal insufficiency (eGFR < 30 ml/min/ 1.73 m2)
• chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
• known photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen
• hypersensitivity to the active substance or one of the other ingredients

Use with caution in case of mild renal impairment; dose adjustment and close monitoring necessary.

Avoid combination with statins! Contraindications exist in some cases!

Note: due to the risk of hypersensitivity reactions, do not use if you are allergic to peanuts, peanut oil, soy lecithin (3-sn-phosphatidylcholine) or related substances.

Medicinal product contains lactose, therefore do not take in case of rare hereditary galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption.

Medicinal product contains sucrose, therefore do not take this medicinal product if you have rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.

For further information, see specialist information!