Fenofibrate

Registered South African indications:

• Hypertriglyceridaemia
• Hypercholesterolemia

Contraindications

• Breastfeeding
• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment
• Hepatic impairment 
• Gallbladder disease
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
• Previous phototoxic reaction due to treatment with fibrates or ketoprofen

Cautions

• Pregnancy
• Risk factors for myopathy and/or rhabdomyolysis
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• Galactose intolerance

Forms avail. in SA and covered in this monograph: cap

Severe hypertriglyceridaemia
Mixed hyperlipidaemia 
Primary hypercholesterolemia
Dysbetalipoproteinaemia
Familial combined hyperlipidaemia

• Oral (cap): 200mg, dly

Take with food

Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate and should continue on this diet during treatment

If an adequate response has not been achieved  within 3 months discontinue drug

Not established for use in children below 18 years

Pregnancy 

• Caution
• There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown
• Therefore, fenofibrate should only be used during pregnancy after a careful benefit/risk assessment

Breastfeeding

• Contraindicated
• It is unknown whether fenofibrate and/or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Therefore fenofibrate should not be used during breastfeeding

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Contraindicated 

Elderly

• No dose adjustment is recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Thromboembolism 

Gastrointestinal Disorders

• Pancreatitis

Hepatobiliary Disorders

• Elevated serum transaminases
• Cholelithiasis
• Hepatitis

Genitourinary Disorders

• Sexual dysfunction

Musculoskeletal Disorders

• Muscle disorder

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Decreased haemoglobin
• Decreased white blood cell count

• Coumarin anticoagulants
• HMG CoA reductase inhibitors
• Fibrates
• Ciclosporin
• Glitazones
• CYP2C19 substrates
• CYP2A6 substrates
• CYP2C9 substrates

• Hepatic function

Specific cases may require

• Renal function

Fenofibrate is a fibric acid derivative whose lipid modifying effects are through activation of Peroxisome Proliferator Activated Receptor type alpha  (PPARα). This increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. The resulting fall in triglycerides produces an alteration in the size and composition of low density lipoprotein from small, dense particles, to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly.

Capsule 200mg 

• Lipanthyl (Abbott Laboratories)