Dosing & Uses
Dosage Forms & Strengths
tablet
- 600mg
Hypertriglyceridemia, Hypercholesterolemia
600 mg PO q12hr
Administration: 30 min before morning and evening meals
Dosage Modifications
Renal impairment
- Mild to moderate: Use caution, if baseline serum creatine in patient is >2mg/dL; deterioration of renal function reported in such patients
- Severe: Contraindicated
Hepatic impairment
- Contraindicated
Dosing Considerations
Monitor: Serum lipoproteins
If after 3 months lipid response is indadequate, discontinue therapy
May be beneficial for prophylaxis of cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol.
Overdose management
- Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFT's, eye lens opacities
- Treatment is supportive
Neuronal Ceroid Lipofuscinoses (Orphan)
Orphan designation for treatment of neuronal ceroid lipofuscinoses
Sponsor
- Polaryx Therapeutics, Inc; 140 East Ridgewood Avenue, Suite 415, South Tower; Paramus, New Jersey 07652
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Dyspepsia (20%)
1-10%
Abdominal pain (10%)
Atrial fibrillation (1%)
Diarrhea (7%)
Fatigue (4%)
N/V (3%)
Eczema (2%)
Rash (2%)
Vertigo (2%)
Constipation (1%)
Headache (1%)
<1%
Myalgia
Rhabdomyolysis (especially with admin with statin)
Acute appendicitis
Cholelithiasis
Angioedema
Hypokalemia
Eosinophilia
Myopathy
Synovitis
Taste disturbance
Xerostomia
Flatulence
Rash
Warnings
Contraindications
Hypersensitivity
Severe liver/renal disease
Primary biliary cirrhosis
Preexisting gallbladder disease
Coadministration with repaglinide, simvastatin, selexipag, or dasabuvir
Cautions
If response inadequate after 3 months, discontinue gemfibrozil
Risk for myopathy/rhabdomyolysis increases with renal impairment
Risk for myopathy/rhabdomyolysis increases with concurrent HMG-CoA reductase inhibitors use (eg, atorvastatin, pravastatin)
If coadministered with anticoagulants, reduce anticoagulant dose and monitor prothrombin time until stabilized
Coadministration with bile acid resin binding agents decreases gemfibrozil AUC by 30%
May increase risk of malignancy
Rule out secondary causes of hyperlipidemia prior to initiating therapy; discontinue if lipid response not seen
Use with caution in patients taking warfarin; adjustments in warfarin may be required
Cases of cholelithiasis reported with gemfibrozil therapy; gemfibrozil may increase cholesterol excretion into bile; if cholelithiasis suspected, perform gallbladder studies; discontinue therapy if gallstones found
Coadministration with repaglinide shown to increase repaglinide plasma concentrations (8-fold increase); prolongs hypoglycemic effect; may result in severe hypoglycemia
Gemfibrozil inhibits CYP2C8 enzyme activity; may increase exposure of CYP2C8 substrates; consider dose reduction of CYP2C8 substrates when administered concomitantly
Gemfibrozil may increase exposure of OATP1B1 drug substrates when administered concomitantly; consider dose reduction of OATP1B1 substrates when administered concomitantly
Myopathy, including rhabdomyolysis, reported with chronic administration of colchicine at therapeutic doses; use caution, especially in the elderly and patients with renal dysfunction
Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia reported; periodic blood counts are recommended during first 12 months of therapy
Elevations in serum transaminases seen with use; periodic liver function studies recommended; therapy should be terminated if abnormalities persist
Worsening renal insufficiency upon addition of therapy in individuals with baseline plasma creatinine >2.0 mg/dL reported; in such patients, consider the use of alternative therapy against risks and benefits of a lower dose of metformin
Gemfibrozil may increase enzalutamide levels when administered concomitantly, which may increase risk of seizures; if coadministration necessary, reduce enzalutamide dose
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Drug has shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area); administration to female rats at 2 times human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate, an increase in stillborns, and a slight reduction in pup weight during lactation; there were also dose-related increased skeletal variations; anophthalmia occurred, but rarely
Administration of 0.6 and 2 times the human dose (based on surface area) of LOPID to female rats from gestation day 15 through weaning caused dose-related decreases in birth weight and suppressions of pup growth during lactation
Administration of 1 and 3 times the human dose (based on surface area) to female rabbits during organogenesis caused a dose-related decrease in litter size and, at high dose, an increased incidence of parietal bone variations
Lactation
It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for tumorigenicity shown for drug in animal studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account the importance of the drug to the mother
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inhibits peripheral lipolysis; decreases hepatic uptake of free fatty acids, which may in turn inhibit secretion of VLDL; may increase HDL-cholesterol (mechanism unknown)
Absorption
Peak serum time: 1-2 hr
Distribution
Protein bound: 99%
Metabolism
Enterohepatic circulation
Elimination
Half-life: 1.5 hr
Excretion: Urine (70%); feces (6%)
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.