Fenofibrate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Severe hypertriglyceridaemia Standard micronised formulation: Initial: 67 mg tid or 200 mg once daily. May reduce to 67 mg bid, or increase to 67 mg 4 times daily, or 267 mg once daily according to response. Non-micronised formulation: Initial: 200-300 mg daily given in divided doses, then may be adjusted to 200-400 mg daily according to response. Improved bioavailability formulation: 40-160 mg once daily. Mixed hyperlipidaemia In patients at high CV risk in addition to a statin, or when a statin is contraindicated or not tolerated: Standard micronised formulation: Initial: 67 mg tid or 200 mg once daily. May reduce to 67 mg bid or increase to 67 mg 4 times daily or 267 mg once daily according to response. Non-micronised formulation: Initial: 200-300 mg daily given in divided doses, then may be adjusted to 200-400 mg daily according to response. Improved bioavailability formulation: 40-160 mg once daily.
Dosage Details
Oral
Severe hypertriglyceridaemia
Adult: Standard micronised formulation: Initially, 67 mg tid or 200 mg once daily. May reduce to 67 mg bid, or increase to 67 mg 4 times daily, or 267 mg once daily according to response. Non-micronised formulation: Initially, 200-300 mg daily given in divided doses, then may be adjusted to 200-400 mg daily according to response. Improved bioavailability formulation: 40-160 mg once daily.

Oral
Mixed hyperlipidaemia
Adult: In patients at high CV risk in addition to a statin, or when a statin is contraindicated or not tolerated: Standard micronised formulation: Initially, 67 mg tid or 200 mg once daily. May reduce to 67 mg bid or increase to 67 mg 4 times daily or 267 mg once daily according to response. Non-micronised formulation: Initially, 200-300 mg daily given in divided doses, then may be adjusted to 200-400 mg daily according to response. Improved bioavailability formulation: 40-160 mg once daily.
Renal Impairment
GFR 30-59 mL/min/1.73 m2: Micronised formulation: 67 mg once daily. GFR <30 mL/min/1.73 m2: Contraindicated.
Hepatic Impairment
Contraindicated.
Administration
Should be taken with food.
Contraindications
Active liver disease including primary biliary cirrhosis, unexplained persistent liver function abnormality, severe renal impairment (GFR <30 mL/min/1.73 m2), pre-existing gallbladder disease, pancreatitis (with the exception of acute pancreatitis due to severe hypertriglyceridaemia, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen). Lactation.
Special Precautions
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis (diabetes mellitus, personal or familial history of hereditary muscular disorders, hypoalbuminaemia, hypothyroidism, high alcohol intake, concomitant use with HMG-CoA reductase inhibitors), risk factors for venous thromboembolism. Mild to moderate renal impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Cholelithiasis, agranulocytosis, thrombocytopenia, hypersensitivity, myopathy, rhabdomyolysis, pancreatitis, venous thromboembolism, elevated level of serum transaminase.
Blood and lymphatic system disorders: Decreased haemoglobin and leukocytes.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, flatulence.
Investigations: Increased serum creatinine, urea.
Musculoskeletal and connective tissue disorders: Diffuse myalgia, myopathy, muscular cramps and weakness.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis, rhinitis.
Skin and subcutaneous tissue disorders: Rash, pruritus. urticaria, alopecia, photosensitivity.
MonitoringParameters
Monitor blood counts, lipid profile, LFT during therapy and periodically thereafter.
Drug Interactions
May increase risk of ciclosporin-induced nephrotoxicity. May increase risk of bleeding with oral anticoagulants (e.g. warfarin). Increased risk of myopathy and rhabdomyolysis with colchicine, HMG-CoA reductase inhibitors, and other fibrates. May enhance adverse effects of ezetimibe. May decrease absorption with bile acid sequestrants (except colesevelam).
Food Interaction
Increased rate of absorption with food.
Action
Description: Fenofibrate, a fibric acid derivative, reduces total plasma triglycerides by the activation of peroxisome proliferator-activated receptor-α (PPAR-α) and lipoprotein lipase, thereby leading to a reduced production of apoprotein CIII, and an increased synthesis of apoproteins AI and AII, and fatty acid transport protein. Thus, resulting to an increased VLDL catabolism, fatty acid oxidation, and elimination of atherogenic triglyceride-rich particles; as a result of a decrease in VLDL and LDL and an increase in HDL levels.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Increased absorption with food except when given as choline salt. Bioavailability: Approx 81% (fenofibric acid). Time to peak plasma concentration: 2-8 hours.
Distribution: Widely distributed to most tissues. Plasma protein binding: Approx 99% mainly to plasma albumin (fenofibric acid).
Metabolism: Rapidly metabolised in the tissue and plasma via esterases to its active metabolite, fenofibric acid, then undergoes hepatic or renal inactivation via glucuronidation.
Excretion: Mainly via urine (approx 60% as metabolite); faeces (25%). Elimination half-life: Approx 20 hours (fenofibric acid).
Chemical Structure

Chemical Structure Image
Fenofibrate

Source: National Center for Biotechnology Information. PubChem Database. Fenofibrate, CID=3339, https://pubchem.ncbi.nlm.nih.gov/compound/Fenofibrate (accessed on Jan. 20, 2020)

Storage
Store between 15-30°C. Protect from moisture.
ATC Classification
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
References
Anon. Fenofibrate and Derivatives. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/03/2019.

Buckingham R (ed). Fenofibrate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/03/2019.

Fenofibrate 200 mg Capsules (Teva UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 22/03/2019.

Fenofibrate Capsule (Torrent Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 22/03/2019.

Fenofibrate Micro 267 mg Capsules (Teva UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 22/03/2019.

Joint Formulary Committee. Fenofibrate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/03/2019.

Disclaimer: This information is independently developed by MIMS based on Fenofibrate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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