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Gemfibrozil

Class
Hypolipidemic agents
Subclass
PPARα agonists
Substance name
Gemfibrozil
Brand names
Lopid®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Familial combined hyperlipidemia
•
600 mg PO BID
Taken 30 minutes before meals.
Familial hypertriglyceridemia
•
600 mg PO BID
Taken 30 minutes before meals.
Mixed hyperlipidemia
•
600 mg PO BID
Taken 30 minutes before meals.
Other off-label uses
•
Treatment of hypertriglyceridemia, after liver transplantation
Indications for use
Labeled indications
Adults
•
Treatment of familial combined hyperlipidemia
•
Treatment of familial hypertriglyceridemia
•
Treatment of mixed hyperlipidemia
Off-label indications
Adults
•
Treatment of hypertriglyceridemia, after liver transplantation
Safety risks
Contraindications
Hypersensitivity to gemfibrozil or its components
Gallbladder disease
Hepatic impairment
•
Do not use gemfibrozil in patients with hepatic impairment, including primary biliary cirrhosis.
Concomitant use of dasabuvir
Concomitant use of repaglinide
Concomitant use of selexipag
Concomitant use of simvastatin
Warnings and precautions
Anemia, decreased WBC count, decreased platelet count
•
Maintain a high level of suspicion, as gemfibrozil has been associated with an increased risk for these adverse events. Monitor blood counts in the first 12 months of treatment.
Bleeding
•
Use caution in patients taking warfarin. Reduce warfarin dose and monitor prothrombin levels.
Carcinogenesis
•
Maintain a high level of suspicion, as an increased incidence of cancer (excluding basal cell carcinoma) has been reported in patients receiving gemfibrozil.
Cardiovascular mortality
•
Maintain a high level of suspicion, as gemfibrozil has been associated with increased non-coronary heart disease-related mortality.
Gallstones
•
Maintain a high level of suspicion, as gemfibrozil has been associated with an increased risk of developing gallstones. Discontinue if gallstones develop.
Increased liver enzymes
•
Maintain a high level of suspicion, as gemfibrozil has been associated with an increased risk of elevated liver enzymes. Monitor liver enzymes periodically.
Myositis
•
Maintain a high level of suspicion, as gemfibrozil has been associated with an increased risk of developing myositis. Discontinue if myositis develops.
Rhabdomyolysis
•
Use caution in elderly patients and in patients with renal dysfunction or taking colchicine.
Seizure
•
Use caution in patients taking enzalutamide. Reduce enzalutamide dose.
Specific populations
Renal impairment
CrCl ≥ 60 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 30-60 mL/min
•
Reduce dose. Titrate with caution.
CrCl < 30 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
Avoid use as much as possible. Maximal dose of 600 mg. Maximal frequency of daily. Titrate with caution.
Hepatic impairment
Any severity
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Do not treat physiological hyperlipidemia of pregnancy.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Dyspepsia
Common 1-10%
•
Acute appendicitis, gallstones, abdominal pain, constipation, diarrhea, dizziness, vertigo, fatigue, headache, nausea, skin rash, vomiting
Uncommon < 1%
•
Atrial fibrillation
Unknown frequency
•
Acute cholecystitis, angioedema, basal cell carcinoma, myositis, ↓ WBC count, ↓ platelet count, ↑ blood eosinophil count, ↑ liver enzymes, ↑ serum TBIL, jaundice, laryngeal edema, neuritis, raynaud's phenomenon, arthralgia, blurred vision, ↓ libido, depression, erectile dysfunction, itching, myalgia, paresthesia, rhabdomyolysis, synovitis, urticaria, anemia
Interactions
Drug(s)
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