Fenofibrate 14-Jun-2017
lDRUG ACTIONFibrates act by decreasing serum
triglycerides; they have variable effect on LDL-cholesterol.
lINDICATIONS AND DOSE
Hyperlipidaemias including familial
hypercholesterolaemia (administered on expert advice)
▶BY MOUTH USING CAPSULES
▶Child 4–14 years:One 67 mg (micronised) capsule per
20 kg body-weight daily, maximum four 67 mg capsules
daily, or max. three 67 mg capsules daily with
concomitant statin
▶Child 15–17 years:Initially 3 capsules daily, then
increased if necessary to 4 capsules daily, max. 3
capsules daily with concomitant statin, dose relates to
67 mg (micronised) capsules
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶Manufacturer advises max. dose 200 mg daily with
concurrent use of a statin—no specific
recommendation made for children.lUNLICENSED USE 200 mg and 267 mg capsules not licensed
in children. Tablets not licensed in children.
lCONTRA-INDICATIONSGall bladder disease.pancreatitis
(unless due to severe hypertriglyceridaemia).
photosensitivity to ketoprofen
lCAUTIONSCorrect hypothyroidism before initiating
treatment
lINTERACTIONS→Appendix 1 :fibrates
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.diarrhoea.
flatulence.nausea.vomiting
▶UncommonCholelithiasis.embolism and thrombosis.
headache.muscle complaints.myopathy.pancreatitis.
sexual dysfunction.skin reactions
▶Rare or very rareAlopecia.hepatic disorders.
photosensitivity reaction
▶Frequency not knownFatigue.interstitial lung disease.
rhabdomyolysis (increased risk in renal impairment).
severe cutaneous adverse reactions (SCARs)
lPREGNANCYAvoid—embryotoxicity inanimalstudies.
lBREAST FEEDINGManufacturers advise avoid—no
information available.
lHEPATIC IMPAIRMENTAvoid.
lRENAL IMPAIRMENTManufacturer advises use with
caution in mild-to-moderate impairment; avoid if
estimated glomerularfiltration rate less than
30 mL/minute/ 1. 73 m^2.
MyotoxicitySpecial care needed in patients with renal
disease, as progressive increases in serum creatinine
concentration or failure to follow dosage guidelines may
result in myotoxicity (rhabdomyolysis); discontinue if
myotoxicity suspected or creatine kinase concentration
increases significantly.
Dose adjustmentsManufacturer advises max. 67 mg daily if
estimated glomerularfiltration rate
30 – 59 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTSManufacturer advises
monitor hepatic transaminases every 3 months during the
first 12 months of treatment and periodically thereafter—
discontinue treatment if levels increase to more than
3 times the upper limit of normal; monitor serum
creatinine levels during thefirst 3 months of treatment
and periodically thereafter—interrupt treatment if
creatinine level is 50 % above the upper limit of normal.
lPRESCRIBING AND DISPENSING INFORMATIONFibrates are
mainly used in those whose serum-triglyceride
concentration is greater than 10 mmol/litre or in those
who cannot tolerate a statin (specialist use).
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Capsule
CAUTIONARY AND ADVISORY LABELS 21
▶Fenofibrate (Non-proprietary)
Fenofibrate micronised 67 mgFenofibrate micronised 67 mg
capsules| 90 capsuleP£ 23. 30 DT = £ 22. 64
Fenofibrate micronised 200 mgFenofibrate micronised 200 mg
capsules| 28 capsuleP£ 21. 75 DT = £ 3. 65
Fenofibrate micronised 267 mgFenofibrate micronised 267 mg
capsules| 28 capsuleP£ 21. 75 DT = £ 5. 32
▶Lipantil Micro(Mylan)
Fenofibrate micronised 67 mgLipantil Micro 67 capsules|
90 capsuleP£ 23. 30 DT = £ 22. 64
Fenofibrate micronised 200 mgLipantil Micro 200 capsules|
28 capsuleP£ 14. 23 DT = £ 3. 65
Fenofibrate micronised 267 mgLipantil Micro 267 capsules|
28 capsuleP£ 21. 75 DT = £ 5. 32LIPID MODIFYING DRUGS›STATINS
Statins f
lDRUG ACTIONStatins competitively inhibit 3 -hydroxy-
3 -methylglutaryl coenzyme A (HMG CoA) reductase, an
enzyme involved in cholesterol synthesis, especially in the
liver.
lCAUTIONSHigh alcohol intake.history of liver disease.
hypothyroidism.patients at increased risk of muscle
toxicity, including myopathy or rhabdomyolysis (e.g. those
with a personal or family history of muscular disorders,
previous history of muscular toxicity and a high alcohol
intake)
CAUTIONS, FURTHER INFORMATION
▶Muscle effectsMuscle toxicity can occur with all statins,
however the likelihood increases with higher doses and in
certain patients (see below). Statins should be used with
caution in patients at increased risk of muscle toxicity,
including those with a personal or family history of
muscular disorders, previous history of muscular toxicity,
a high alcohol intake, renal impairment or
hypothyroidism.
In patients at increased risk of muscle effects, a statin
should not usually be started if the baseline creatine
kinase concentration is more than 5 times the upper limit
of normal (some patients may present with an extremely
elevated baseline creatine kinase concentration, for
example because of a physical occupation or rigorous
exercise—specialist advice should be sought regarding
consideration of statin therapy in these patients).
▶HypothyroidismHypothyroidism should be managed
adequately before starting treatment with a statin.
lSIDE-EFFECTS
▶Common or very commonAsthenia.constipation.
diarrhoea.dizziness.flatulence.gastrointestinal
discomfort.headache.myalgia.nausea.sleep disorders.
thrombocytopenia
▶UncommonAlopecia.hepatic disorders.memory loss.
pancreatitis.paraesthesia.sexual dysfunction.skin
reactions.vomiting
▶Rare or very rareMyopathy.peripheral neuropathy.
tendinopathy
▶Frequency not knownDepression.diabetes mellitus (in
those at risk).interstitial lung disease
SIDE-EFFECTS, FURTHER INFORMATION
Muscle effectsThe risk of myopathy, myositis, and
rhabdomyolysis associated with statin use is rare.
Although myalgia has been reported commonly in patients
receiving statins, muscle toxicity truly attributable to
statin use is rare. When a statin is suspected to be the
cause of myopathy, and creatine kinase concentration is
markedly elevated or if muscular symptoms are severe,BNFC 2018 – 2019 Hyperlipidaemia 131
Cardiovascular system2