fenofibrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
fenofibrate: clinical details
Prescribing considerations
- Confirm and address secondary causes of dyslipidaemia, including uncontrolled diabetes, hypothyroidism, alcohol excess, obstructive liver disease and contributory medicines.
- Continue dietary and non-pharmacological measures and assess response using serum lipid values.
- Assess renal function, liver status, gallbladder and pancreatitis history, and factors predisposing to myopathy.
- Reserve concurrent statin treatment for appropriately selected high-risk patients and monitor for muscle toxicity.
Contraindications and cautions
- Severe renal impairment.
- Hepatic insufficiency, including biliary cirrhosis or unexplained persistent liver-function abnormalities.
- Known gallbladder disease.
- Chronic or acute pancreatitis, except acute pancreatitis caused by severe hypertriglyceridaemia.
- Previous photoallergic or phototoxic reaction to a fibrate or ketoprofen.
- Hypersensitivity to fenofibrate or formulation excipients; Supralip is also contraindicated with peanut, arachis-oil or soya allergy.
Monitoring
- Lipid profile to assess response.
- Liver transaminases before and during therapy; investigate symptoms suggesting hepatitis.
- Renal function at baseline, early after initiation and periodically thereafter.
- Creatine kinase when muscle toxicity is suspected; stop and assess promptly for significant muscle symptoms.
- INR with an oral anticoagulant.
- HDL cholesterol with a glitazone.
Clinical pharmacology
Fenofibrate is rapidly hydrolysed to active fenofibric acid. PPAR-alpha activation promotes lipoprotein-lipase activity and clearance of triglyceride-rich particles. Fenofibric acid is highly protein-bound and eliminated mainly in urine as fenofibric acid and its glucuronide conjugate.
Formulation and product differences
- Bioavailability differs between formulations, so milligram strengths should not automatically be regarded as interchangeable.
- The selected tablets and capsules are swallowed whole during a meal.
- Supralip tablets contain lactose and soybean lecithin. The selected capsules contain lactose, and their shell includes sunset yellow, which may cause allergic reactions.
fenofibrate preparations and strengths
Capsule
Route: Oral
Strengths: 200 mg, 267 mg
Tablet
Route: Oral
Strengths: 160 mg
fenofibrate interactions
Important interactions include treatments that increase bleeding, muscle toxicity or kidney impairment.
Warfarin and other oral anticoagulants
Fenofibrate can enhance anticoagulation and increase bleeding risk, requiring closer INR monitoring and possible anticoagulant adjustment.
Statins
Combined use increases muscle-toxicity risk and requires careful selection and monitoring for muscle symptoms.
Other fibrates
Combining fibrates increases the risk of serious muscle toxicity.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.