Fenofibrate

Oral
Severe hypertriglyceridaemia
Adult: As an adjunct to diet and other non-pharmacological treatment: Dose is individualised according to the patient's response. Standard micronised formulation: Initially, 200 mg once daily; may increase if necessary to 267 mg once daily. Max: 200 mg once daily (with concomitant statin therapy); 267 mg once daily (if not on concomitant statin therapy). Alternatively, 67 mg up to 200 mg once daily may be given. Micronised formulations with improved bioavailability are also available in doses of 160 mg once daily. Non-micronised formulation: Initially, 54 mg up to 160 mg once daily. Nanoparticle formulation: 145 mg once daily. Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Renal impairment: eGFR <30 mL/min/1.73 m²: Contraindicated. eGFR 30-59 mL/min/1.73 m²: Max: 67 mg once daily (micronised formulation); 100 mg once daily (non-micronised formulation). Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Hepatic impairment: Contraindicated.

Oral
Mixed hyperlipidaemia
Adult: In patients at high CV risk in addition to a statin, or when a statin is contraindicated or not tolerated: As an adjunct to diet and other non-pharmacological treatment: Dose is individualised according to the patient's response. Standard micronised formulation: Initially, 200 mg once daily; may increase if necessary to 267 mg once daily. Max: 200 mg once daily (with concomitant statin therapy); 267 mg once daily (if not on concomitant statin therapy). Micronised formulations with improved bioavailability are also available in doses of 160 mg once daily. Non-micronised formulation: 160 mg once daily. Nanoparticle formulation: 145 mg once daily. Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Renal impairment: eGFR <30 mL/min/1.73 m²: Contraindicated. eGFR 30-59 mL/min/1.73 m²: Max: 67 mg once daily (micronised formulation); 100 mg once daily (non-micronised formulation). Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Hepatic impairment: Contraindicated.

Oral
Primary hypercholesterolaemia
Adult: In patients at high CV risk in addition to a statin, or when a statin is contraindicated or not tolerated: As an adjunct to diet and other non-pharmacological treatment: Dose is individualised according to the patient's response. Standard micronised formulation: Initially, 200 mg once daily; may increase if necessary to 267 mg once daily. Max: 200 mg once daily (with concomitant statin therapy); 267 mg once daily (if not on concomitant statin therapy). Micronised formulations with improved bioavailability are also available in doses of 160 mg once daily. Non-micronised formulation: 160 mg once daily. Nanoparticle formulation: 145 mg once daily. Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Renal impairment: eGFR <30 mL/min/1.73 m²: Contraindicated. eGFR 30-59 mL/min/1.73 m²: Max: 67 mg once daily (micronised formulation); 100 mg once daily (non-micronised formulation). Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Hepatic impairment: Contraindicated.

Should be taken with food.

Hypersensitivity. Active liver disease, including primary biliary cirrhosis, unexplained persistent liver function abnormality; known gallbladder disease, chronic or acute pancreatitis (except acute pancreatitis due to severe hypertriglyceridaemia), known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen. Severe renal impairment or ESRD, including those receiving haemodialysis. Lactation.

Patients with pre-disposing factors for myopathy and/or rhabdomyolysis (e.g. diabetes mellitus, personal or familial history of hereditary muscular disorders, hypoalbuminaemia, hypothyroidism, high alcohol intake, concomitant use with HMG-CoA reductase inhibitors or colchicine), risk factors for venous thromboembolism. Mild to moderate renal impairment. Elderly. Pregnancy. Monitoring Parameters Monitor blood counts (during 1st year of therapy), lipid profile (periodically), LFT (baseline and periodically thereafter); renal function (in patients with renal impairment or with risk for developing renal impairment). Monitor for signs and symptoms of myopathy.

Significant: Cholelithiasis, severe decrease in HDL cholesterol; agranulocytosis, thrombocytopenia, delayed hypersensitivity reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms), myositis, myopathy, rhabdomyolysis, pancreatitis, photosensitivity, DVT, pulmonary embolism, increased level of serum creatinine, ALT, AST. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, flatulence, constipation. General disorders and administration site conditions: Fatigue. Hepatobiliary disorders: Jaundice, cholangitis, cholecystitis, biliary colic. Investigations: Increased blood homocysteine level. Musculoskeletal and connective tissue disorders: Myalgia, muscular spasms and weakness, arthralgia. Nervous system disorders: Headache. Reproductive system and breast disorders: Sexual dysfunction. Respiratory, thoracic and mediastinal disorders: Interstitial lung disease. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Potentially Fatal: Serious drug-induced liver injury; acute hypersensitivity reactions (e.g. angioedema, anaphylaxis).

May increase the risk of bleeding with oral anticoagulants (e.g. warfarin). May increase the risk of nephrotoxicity with ciclosporin and tacrolimus. Increased risk of myopathy and rhabdomyolysis with colchicine, HMG-CoA reductase inhibitors, and other fibrates. Increased risk of reversible paradoxical reduction of HDL-cholesterol with glitazones. May decrease absorption with bile acid sequestrants.

Increased rate of absorption with food.

Fenofibrate, a fibric acid derivative, elicits its lipid-modifying effect by activating the peroxisome proliferator-activated receptor-α (PPAR-α) which induces the synthesis of apoproteins A-I and A-II. It also increases VLDL catabolism, fatty acid oxidation, and elimination of atherogenic triglyceride-rich particles by activating lipoprotein lipase and reducing the production of apoprotein CIII (an inhibitor of lipoprotein lipase).
Absorption: Readily absorbed from the gastrointestinal tract. Increased absorption with food. Bioavailability: Approx 81% (fenofibric acid). Time to peak plasma concentration: 2-8 hours.
Distribution: Widely distributed to most tissues. Plasma protein binding: Approx 99% (fenofibric acid).
Metabolism: Rapidly hydrolysed in the tissue and plasma by esterases to its active metabolite, fenofibric acid, then undergoes hepatic or renal inactivation via glucuronidation.
Excretion: Mainly via urine (approx 60% as metabolites); faeces (25%). Elimination half-life: Approx 20 hours (fenofibric acid).

Oral: Store between 15-30°C. Protect from light and moisture.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.