Bezafibrate

Bezafibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

• Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
• Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

In dialysis patients the use of bezafibrate is contraindicated.

In patients with renal insufficiency the dose should be adjusted according to serum creatinine levels or creatinine clearance as shown in the following table.

The response to therapy is normally rapid, although a progressive improvement may occur over a number of weeks. Treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months.

Severe renal failure (serum creatinine >530 μmol/l; creatinine clearance <15ml/min) and patients undergoing dialysis.

Combination therapy of bezafibrate with HMG CoA reductase inhibitors (statins) in patients with predisposing factors for myopathy.

Bezafibrate should be used with caution in combination with HMG CoA reductase inhibitors as the combination of HMG CoA inhibitors and fibrates has been shown to increase the incidence and severity of myopathy. Patients should be informed of symptoms and monitored for signs of myopathy and increased CPK activity and combination therapy discontinued if signs of myopathy develop. Combination therapy should not be used in patients with predisposing factors for myopathy.

There is insufficient information on the excretion of bezafibrate or its metabolites in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bezafibrate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

There are limited data from the use of bezafibrate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The potential risk for humans is unknown. Bezafibrate is not recommended during pregnancy and in women of childbearing potential not using contraception.

Significant hepatic disease (other than fatty infiltration of the liver associated with raised triglycerides values).

Gall bladder disease with or without cholelithiasis.

Bezafibrate alters the composition of bile. There have been isolated reports of the development of gallstones.

As bezafibrate could cause cholelithiasis appropriate diagnostic procedures should be performed if cholelithic signs or symptoms occur.