Drugs List

Therapeutic Indications

Uses

Mixed hyperlipidaemia in patients with CV risk: adjunctive treatment
Mixed hyperlipidaemia when statin is contraindicated or not tolerated
Severe hypertriglyceridaemia with or without low HDL cholesterol

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

Severe hypertriglyceridaemia with or without low HDL cholesterol
Mixed hyperlipidaemia when a statin is contraindicated or not tolerated
Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Contraindications

Children under 4 years
Creatine kinase levels over 5 times upper limit of normal
Photoallergic or phototoxic reactions to fibrates
Photosensitivity to ketoprofen
Biliary cirrhosis
Breastfeeding
Galactosaemia
Gallbladder disease
Myopathy
Pancreatitis - unless due to severe hypertriglyceridaemia
Pregnancy
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment

Precautions and Warnings

Children aged 4 to 18 years
Family history of hereditary muscular disorders
High alcohol intake
Hypoalbuminaemia
Major surgery
Patients over 70 years
Severe infection
Severe trauma
Glucose-galactose malabsorption syndrome
Hereditary muscular disorder
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
History of non-traumatic rhabdomyolysis
History of renal impairment
Hypothyroidism
Lactose intolerance
Renal impairment - eGFR 30 to 59 ml/minute/1.73 m squared

Exclude/correct secondary causes of dyslipidaemia prior to treatment
Not all available products are licensed for all age groups
Some formulations contain lactose
Some products may contain soya or soya derivative
Evaluate nature of hyperlipidaemia in patients using oestrogens
Monitor hepatic function
Monitor patients at risk of muscle toxicity
Monitor serum creatinine
Monitor serum transaminases every 3 months during first 12 months of use
Review if an adequate response not obtained within 3 months
Discontinue if hepatitis develops
Discontinue if myopathy is suspected
Suspend treatment if serum creatinine > 50% upper limit of normal
Discontinue if ALT level exceeds 3 times the upper limit of normal
Discontinue if AST level exceeds 3 times the upper limit of normal
Discontinue if CPK rises to > or equal to 5x upper limit of normal range
Discontinue if eGFR falls below 30ml/minute/1.73 m squared
Dietary restrictions should be maintained

Pancreatitis has been reported in patients taking fenofibrate. This may be as a result of a direct drug effect, obstruction of the common bile duct or a failure of efficacy in patients with severe hypertriglyceridaemia.

Pregnancy and Lactation

Pregnancy

Fenofibrate is contraindicated during pregnancy.

Although there is insufficient data in humans, animal studies have not demonstrated any teratogenic effects but have demonstrated embryotoxicity and therefore fenofibrate should not be taken during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Fenofibrate is contraindicated during breastfeeding.

There is no data available on the excretion of fenofibrate or its metabolites into breast milk. Lactating mothers should be advised not to breastfeed their child during treatment especially due to the infant's need for cholesterol and the carcinogenicity observed in rats treated with this product. An alternative drug is preferred, especially while nursing a newborn or pre-term infant. The relative low molecular weight (about 319) of the active metabolite suggest that it is excreted into the breast milk (Briggs, 2015). Schaefer (2015) suggests that there is no disadvantage to the mother if treatment is stopped during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Cholelithiasis
Decrease in haemoglobin
Deep vein thrombosis (DVT)
Diarrhoea
Erythema
Fatigue
Flatulence
Gallstones
Gastric discomfort
Gastro-intestinal symptoms
Headache
Hepatitis
Hypersensitivity reactions
Increase in serum transaminases
Interstitial pneumopathies
Jaundice
Leucopenia
Leukocytes decreased
Muscle cramps
Muscle spasm
Muscle toxicity
Muscle weakness
Myalgia
Myositis
Nausea
Pancreatitis
Peripheral neuropathy
Photosensitivity
Pruritus
Pulmonary embolism
Rash
Rhabdomyolysis
Serum creatinine increased
Serum urea increased
Sexual asthenia
Skin nodules
Stevens-Johnson syndrome
Thromboembolism
Toxic epidermal necrolysis
Urticaria
Vertigo
Vesiculation
Vomiting
Weakness
White blood cell count decreased

Presentation

Oral formulations of fenofibrate.

Drugs List

Therapeutic Indications

Uses

Mixed hyperlipidaemia in patients with CV risk: adjunctive treatment
Mixed hyperlipidaemia when statin is contraindicated or not tolerated
Severe hypertriglyceridaemia with or without low HDL cholesterol

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

Severe hypertriglyceridaemia with or without low HDL cholesterol
Mixed hyperlipidaemia when a statin is contraindicated or not tolerated
Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Dosage

Adults

Children

Patients with Renal Impairment

Additional Dosage Information

Contraindications

Children under 4 years
Creatine kinase levels over 5 times upper limit of normal
Photoallergic or phototoxic reactions to fibrates
Photosensitivity to ketoprofen
Biliary cirrhosis
Breastfeeding
Galactosaemia
Gallbladder disease
Myopathy
Pancreatitis - unless due to severe hypertriglyceridaemia
Pregnancy
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment

Precautions and Warnings

Children aged 4 to 18 years
Family history of hereditary muscular disorders
High alcohol intake
Hypoalbuminaemia
Major surgery
Patients over 70 years
Severe infection
Severe trauma
Glucose-galactose malabsorption syndrome
Hereditary muscular disorder
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
History of non-traumatic rhabdomyolysis
History of renal impairment
Hypothyroidism
Lactose intolerance
Renal impairment - eGFR 30 to 59 ml/minute/1.73 m squared

Exclude/correct secondary causes of dyslipidaemia prior to treatment
Not all available products are licensed for all age groups
Some formulations contain lactose
Some products may contain soya or soya derivative
Evaluate nature of hyperlipidaemia in patients using oestrogens
Monitor hepatic function
Monitor patients at risk of muscle toxicity
Monitor serum creatinine
Monitor serum transaminases every 3 months during first 12 months of use
Review if an adequate response not obtained within 3 months
Discontinue if hepatitis develops
Discontinue if myopathy is suspected
Suspend treatment if serum creatinine > 50% upper limit of normal
Discontinue if ALT level exceeds 3 times the upper limit of normal
Discontinue if AST level exceeds 3 times the upper limit of normal
Discontinue if CPK rises to > or equal to 5x upper limit of normal range
Discontinue if eGFR falls below 30ml/minute/1.73 m squared
Dietary restrictions should be maintained

Pancreatitis has been reported in patients taking fenofibrate. This may be as a result of a direct drug effect, obstruction of the common bile duct or a failure of efficacy in patients with severe hypertriglyceridaemia.

Pregnancy and Lactation

Pregnancy

Fenofibrate is contraindicated during pregnancy.

Although there is insufficient data in humans, animal studies have not demonstrated any teratogenic effects but have demonstrated embryotoxicity and therefore fenofibrate should not be taken during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Fenofibrate is contraindicated during breastfeeding.

There is no data available on the excretion of fenofibrate or its metabolites into breast milk. Lactating mothers should be advised not to breastfeed their child during treatment especially due to the infant's need for cholesterol and the carcinogenicity observed in rats treated with this product. An alternative drug is preferred, especially while nursing a newborn or pre-term infant. The relative low molecular weight (about 319) of the active metabolite suggest that it is excreted into the breast milk (Briggs, 2015). Schaefer (2015) suggests that there is no disadvantage to the mother if treatment is stopped during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Cholelithiasis
Decrease in haemoglobin
Deep vein thrombosis (DVT)
Diarrhoea
Erythema
Fatigue
Flatulence
Gallstones
Gastric discomfort
Gastro-intestinal symptoms
Headache
Hepatitis
Hypersensitivity reactions
Increase in serum transaminases
Interstitial pneumopathies
Jaundice
Leucopenia
Leukocytes decreased
Muscle cramps
Muscle spasm
Muscle toxicity
Muscle weakness
Myalgia
Myositis
Nausea
Pancreatitis
Peripheral neuropathy
Photosensitivity
Pruritus
Pulmonary embolism
Rash
Rhabdomyolysis
Serum creatinine increased
Serum urea increased
Sexual asthenia
Skin nodules
Stevens-Johnson syndrome
Thromboembolism
Toxic epidermal necrolysis
Urticaria
Vertigo
Vesiculation
Vomiting
Weakness
White blood cell count decreased

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summaries of Product Characteristics: Fenofibrate 67mg capsules. Actavis UK Ltd. Revised January 2017.
Summaries of Product Characteristics: Fenofibrate 200mg capsules. Actavis UK Ltd. Revised April 2016.

Summary of Product Characteristics: Fenofibrate 267mg capsules. Zentiva. Revised September 2017.

Summaries of Product Characteristics: Lipantil Micro 67mg. Mylan Products Ltd. Revised February 2017.
Summaries of Product Characteristics: Lipantil Micro 200mg. Mylan Products Ltd. Revised February 2017.
Summaries of Product Characteristics: Lipantil Micro 267mg. Mylan Products Ltd. Revised February 2017.

Summary of Product Characteristics: Supralip 160mg. Mylan Products Ltd. Revised February 2017.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 03 January 2018.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Fenofibrate. Last revised: 06 December 2013.
Last accessed: 03 January 2018.