Gemfibrozil (Lexi-Drugs)

Pronunciation

(jem FI broe zil)

Brand Names: US

Lopid

Brand Names: Canada

APO-Gemfibrozil; DOM-Gemfibrozil; Gemfibrozil-600 [DSC]; MYLAN-Gemfibrozil [DSC]; PHL-Gemfibrozil [DSC]; PMS-Gemfibrozil; TEVA-Gemfibrozil

Pharmacologic Category

Antilipemic Agent, Fibric Acid

Dosing: Adult

Hyperlipidemia/hypertriglyceridemia: Oral: 600 mg twice daily 30 minutes before breakfast and dinner. Note: Discontinue if lipid response is inadequate after 3 months of therapy.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Manufacturer’s labeling:

Mild-to-moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; deterioration of renal function has been reported in patients with baseline serum creatinine >2 mg/dL

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use is contraindicated

Alternate recommendations (Aronoff 2007):

GFR >50 mL/minute: No dosage adjustment necessary.

GFR 10 to 50 mL/minute: Administer 75% of dose.

GFR <10 mL/minute: Administer 50% of dose.

Intermittent hemodialysis: Supplemental dose not necessary.

Peritoneal dialysis: Administer 50% of dose as supplement for dialysis.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use is contraindicated.

Use: Labeled Indications

Treatment of hypertriglyceridemia in Fredrickson types IV and V hyperlipidemia for patients who are at greater risk for pancreatitis and who have not responded to dietary intervention; to reduce the risk of CHD development in Fredrickson type IIb patients without a history or symptoms of existing CHD who have not responded to dietary and other interventions (including pharmacologic treatment) and who have decreased HDL, increased LDL, and increased triglycerides

Clinical Practice Guidelines

Dyslipidemia:

AACE/ACE, “Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease,” April 2017

ACC, “2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk,” October 2017

ACC/AHA, “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” November 2013

AHA/ACC, “Guideline on the Management of Blood Cholesterol,” November 2018

Canadian Cardiovascular Society, “2012 Update of the Canadian Cardiovascular Society Guidelines for the Diagnosis and Treatment of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult, 2012

NLA, “National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia” Part 1: April 2015Part 2: December 2015

Administration: Oral

Administer 30 minutes prior to breakfast and dinner.

Dietary Considerations

Before initiation of therapy, patients should be placed on a standard cholesterol-lowering diet for 3 to 6 months and the diet should be continued during drug therapy. Administer 30 minutes prior to breakfast and dinner

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F). Protect from light and moisture.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, abdominal pain, or diarrhea. Have patient report immediately to prescriber signs of gallstones (pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; jaundice; or fever with chills), signs of infection, muscle pain, muscle weakness, urinary retention, change in amount of urine passed, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to gemfibrozil or any component of the formulation; hepatic or severe renal dysfunction; primary biliary cirrhosis; preexisting gallbladder disease; concurrent use with dasabuvir, repaglinide, selexipag, or simvastatin.

Canadian labeling: Additional contraindications (not in the US labeling): Renal dysfunction; concurrent use with cerivastatin; pregnancy; breastfeeding.

Documentation of allergenic cross-reactivity for fibrates is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Cholelithiasis: May increase risk of cholelithiasis; discontinue if gallstones are found upon gallbladder studies.

• Elevated transaminases: Elevations in serum transaminases may be seen with use; periodic monitoring recommended.

• Hematologic effects: May cause mild decreases in hemoglobin, hematocrit, and WBC upon initiation which usually stabilizes with long-term therapy. Anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have rarely been reported. Periodic monitoring recommended during the first year of therapy.

• Malignancy: Possible increased risk of malignancy.

• Myopathy/rhabdomyolysis: Has been associated with rare myositis or rhabdomyolysis; patients should be monitored closely. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine.

Disease-related concerns:

• Renal impairment: Use with caution in patients with mild-to-moderate renal impairment; contraindicated in patients with severe impairment. Deterioration has been seen when used in patients with a serum creatinine >2 mg/dL.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Secondary causes of hyperlipidemia should be ruled out prior to therapy. Be careful in patient selection, this is not a first- or second-line choice; other agents may be more suitable. Discontinue if lipid response not seen.

Geriatric Considerations

Gemfibrozil is the drug of choice for the treatment of hypertriglyceridemia and hypoalphaproteinemia in the elderly; it is usually well tolerated; myositis may be more common in patients with poor renal function. The definition of and, therefore, when to treat hyperlipidemia in the elderly is a controversial issue. According to the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, there are no supporting data for the routine use of non-statin drugs in combination with a statin to further reduce atherosclerotic cardiovascular disease (ASCVD) events. Evidence for non-statins in statin-intolerant patients is also lacking (Stone 2013). It is the authors’ belief that pharmacologic treatment be reserved for those who are unable to obtain a desirable plasma cholesterol concentration by diet alone and for whom the benefits of treatment are believed to outweigh the potential adverse effects, drug interactions, and cost of treatment.

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Gemfibrozil crosses the placenta (Tsai 2004).

Triglyceride concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary intervention should be initiated. In women who develop very severe hypertriglyceridemia and are at risk for pancreatitis, use of gemfibrozil beginning in the second trimester is one intervention that may be considered (Avis 2009; Berglund 2012; Jacobson 2015; Wong 2015).

Breast-Feeding Considerations

It is not known if gemfibrozil is present in breast milk.

Lipids are a normal component of breast milk and the fatty acid component is required for normal infant neurologic development. Maternal diet, as well as other factors, may influence the fatty acid composition (Innis 2014). When treatment for very severe hypertriglyceridemia in breastfeeding women at risk for pancreatitis is needed, therapy with gemfibrozil may be considered (Jacobson 2015). When treatment is needed for other indications, agents other than gemfibrozil are preferred (Jacobson 2015; NICE 2008). Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%: Gastrointestinal: Dyspepsia (20%)

1% to 10%:

Cardiovascular: Atrial fibrillation (1%)

Central nervous system: Fatigue (4%), vertigo (2%)

Dermatologic: Eczema (2%), skin rash (2%)

Gastrointestinal: Abdominal pain (10%), nausea and vomiting (3%)

<1%, postmarketing and/or case reports (probable causation): Anemia, angioedema, arthralgia, blurred vision, bone marrow depression, cholecystitis, cholelithiasis, cholestatic jaundice, decreased libido, depression, dermatitis, dermatomyositis, dizziness, drowsiness, dysgeusia, eosinophilia, exfoliative dermatitis, headache, hypoesthesia, hypokalemia, impotence, increased creatine phosphokinase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases, laryngeal edema, leukopenia, limb pain, myalgia, myasthenia, myopathy, nephrotoxicity, paresthesia, peripheral neuritis, polymyositis, pruritus, Raynaud phenomenon, rhabdomyolysis, synovitis, urticaria

Reports where causal relationship has not been established: Alopecia, anaphylaxis, cataract, colitis, confusion, extrasystoles, hepatic neoplasm, intracranial hemorrhage, lupus-like syndrome, pancreatitis, peripheral vascular disease, positive ANA titer, reduced fertility (male), renal insufficiency, retinal edema, seizure, skin photosensitivity, syncope, thrombocytopenia, vasculitis, weight loss

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;Inhibits CYP2C8 (strong), OATP1B1/1B3 (SLCO1B1/1B3)

Drug Interactions 

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Risk C: Monitor therapy

Alitretinoin (Systemic): CYP2C8 Inhibitors (Strong) may increase the serum concentration of Alitretinoin (Systemic). Management: Consider reducing the alitretinoin dose to 10 mg when used together with strong CYP2C8 inhibitors. Monitor for increased alitretinoin effects/toxicities if combined with a strong CYP2C8 inhibitor. Risk D: Consider therapy modification

Amodiaquine: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Amodiaquine. Risk X: Avoid combination

Apalutamide: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Apalutamide. Risk C: Monitor therapy

Asunaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Asunaprevir. Risk X: Avoid combination

AtorvaSTATin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of AtorvaSTATin. Gemfibrozil may increase the serum concentration of AtorvaSTATin. Risk X: Avoid combination

Bexarotene (Systemic): Gemfibrozil may increase the serum concentration of Bexarotene (Systemic). Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Exceptions: Colesevelam. Risk D: Consider therapy modification

Chenodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Chenodiol. Management: Monitor clinical response to chenodiol closely when used together with any fibric acid derivative. Risk C: Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of Fibric Acid Derivatives. Risk X: Avoid combination

Colchicine: Fibric Acid Derivatives may enhance the myopathic (rhabdomyolysis) effect of Colchicine. Risk C: Monitor therapy

CycloSPORINE (Systemic): May enhance the nephrotoxic effect of Fibric Acid Derivatives. Fibric Acid Derivatives may decrease the serum concentration of CycloSPORINE (Systemic). Management: Careful consideration of the risks and benefits should be undertaken prior to use of this combination; extra monitoring of renal function and cyclosporine concentrations will likely be required. Adjustment of cyclosporine dose may be necessary. Risk D: Consider therapy modification

CYP2C8 Substrates (High risk with Inhibitors): CYP2C8 Inhibitors (Strong) may decrease the metabolism of CYP2C8 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

Dabrafenib: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Dabrafenib. Risk X: Avoid combination

Dasabuvir: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Dasabuvir. Risk X: Avoid combination

Desloratadine: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Desloratadine. Risk C: Monitor therapy

Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix. Risk X: Avoid combination

Eluxadoline: Gemfibrozil may increase the serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with gemfibrozil and monitor patients for increased eluxadoline effects/toxicities. Risk D: Consider therapy modification

Enzalutamide: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Enzalutamide. Management: Avoid concurrent use of strong CYP2C8 inhibitors and enzalutamide if possible. If the combination must be used, reduce enzalutamide to 80 mg once daily. Risk D: Consider therapy modification

Ezetimibe: Gemfibrozil may enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Gemfibrozil may increase the serum concentration of Ezetimibe. Risk X: Avoid combination

Fluvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Fluvastatin. Risk X: Avoid combination

Grazoprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Grazoprevir. Risk X: Avoid combination

Imatinib: Gemfibrozil may decrease serum concentrations of the active metabolite(s) of Imatinib. Specifically N-desmethylimatinib concentrations may be decreased. Gemfibrozil may decrease the serum concentration of Imatinib. Risk C: Monitor therapy

Lovastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Lovastatin. Gemfibrozil may increase the serum concentration of Lovastatin. More specifically, gemfibrozil may increase the serum concentrations of lovastatin acid (active form of parent drug). Risk X: Avoid combination

Montelukast: Gemfibrozil may increase the serum concentration of Montelukast. Risk C: Monitor therapy

OATP1B1/1B3 (SLCO1B1/1B3) Substrates: Gemfibrozil may increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. See separate drug interaction monographs for agents listed as exceptions. Exceptions: AtorvaSTATin; Eluxadoline; Ezetimibe; Fluvastatin; Pitavastatin; Pravastatin; Repaglinide; Rosuvastatin; Simvastatin.Risk C: Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir. Specifically, the serum concentrations of dasabuvir may increase significantly. Risk X: Avoid combination

Pioglitazone: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Pioglitazone. Management: Limit pioglitazone adult maximum dose to 15 mg/day when used in combination with any strong CYP2C8 inhibitor. Risk D: Consider therapy modification

Pitavastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Pitavastatin. Gemfibrozil may increase the serum concentration of Pitavastatin. Risk X: Avoid combination

Pravastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Pravastatin. Gemfibrozil may increase the serum concentration of Pravastatin. Risk X: Avoid combination

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Risk C: Monitor therapy

Repaglinide: Gemfibrozil may increase the serum concentration of Repaglinide. The addition of itraconazole may augment the effect of gemfibrozil on repaglinide. Risk X: Avoid combination

Revefenacin: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentrations of the active metabolite(s) of Revefenacin. Risk X: Avoid combination

Rosuvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Gemfibrozil may increase the serum concentration of Rosuvastatin. Management: If possible, avoid concomitant use of rosuvastatin with gemfibrozil. If concomitant can not be avoided, limit rosuvastatin to 10 mg/day (US recommendation) or 20 mg/day (Canadian recommendation). Monitor for signs/symptoms of rhabdomyolysis. Risk X: Avoid combination

Selexipag: CYP2C8 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Selexipag. CYP2C8 Inhibitors (Strong) may increase the serum concentration of Selexipag. Risk X: Avoid combination

Simvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Gemfibrozil may increase the serum concentration of Simvastatin. Concentrations of the active simvastatin acid metabolite may also be increased by gemfibrozil. Risk X: Avoid combination

Sulfonylureas: Fibric Acid Derivatives may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Thiazolidinediones: Gemfibrozil may decrease the metabolism of Thiazolidinediones. Management: Limit pioglitazone maximum adult dose to 15 mg/day, and consider dose reduction of rosiglitazone, when used in combination with gemfibrozil. Risk D: Consider therapy modification

Treprostinil: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Treprostinil. Management: Reduce the initial treprostinil extended release tablet dose to 0.125 mg twice daily, titrating by 0.125 mg twice daily every 3 to 4 days. No preemptive dose adjustment is recommended for other treprostinil products. Risk D: Consider therapy modification

Ursodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Ursodiol. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Fibric Acid Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Voxilaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Voxilaprevir. Risk X: Avoid combination

Food Interactions

When given after meals, the AUC of gemfibrozil is decreased. Management: Administer 30 minutes prior to breakfast and dinner.

Monitoring Parameters

Serum cholesterol, LFTs periodically, CBC periodically (first year)

Advanced Practitioners Physical Assessment/Monitoring

Assess serum cholesterol and LFTs and monitor as clinically indicated. Monitor for gastrointestinal disturbances periodically during therapy. Check patient’s problem list against contraindications. If myopathy is suspected or diagnosed, discontinue therapy. If inadequate response to therapy in 3 months, discontinue. Caution when on concomitant anticoagulants. Monitor PT/INR closely.

Nursing Physical Assessment/Monitoring

Assess serum cholesterol and LFTs. Monitor for signs of myopathy (muscular pain, weakness, fatigue). If myopathy is suspected or diagnosed, discontinue therapy. If inadequate response to therapy in 3 months, discontinue. Caution when on concomitant anticoagulants. Monitor PT/INR closely.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Lopid: 600 mg [scored]

Generic: 600 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 300 mg

Tablet, Oral:

Generic: 600 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C10AB04
Generic Available (US)

Yes

Pricing: US

Tablets (Gemfibrozil Oral)

600 mg (per each): $0.14 – $2.32

Tablets (Lopid Oral)

600 mg (per each): $8.07

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

The exact mechanism of action of gemfibrozil is unknown, however, several theories exist regarding the VLDL effect; it can inhibit lipolysis and decrease subsequent hepatic fatty acid uptake as well as inhibit hepatic secretion of VLDL; together these actions decrease serum VLDL levels; increases HDL-cholesterol; the mechanism behind HDL elevation is currently unknown

Pharmacodynamics/Kinetics

Onset of action: May require several days

Absorption: Well absorbed

Protein binding: 99%

Metabolism: Hepatic via oxidation to two inactive metabolites; undergoes enterohepatic recycling

Half-life elimination: 1.5 hours

Time to peak, serum: 1 to 2 hours

Excretion: Urine (~70% primarily as conjugated drug); feces (6%)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

Anemia has been reported in <1% of patients.

Index Terms

Cl-719

FDA Approval Date
December 21, 1981
References

Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007.

Avis HJ, Hutten BA, Twickler MT, et al. Pregnancy in women suffering from familial hypercholesterolemia: a harmful period for both mother and newborn? Curr Opin Lipidol. 2009;20(6):484-490. doi: 10.1097/MOL.0b013e3283319127.[PubMed 19741526]

Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, 2012; 97(9):2969-2989. doi: 10.1210/jc.2011-3213.[PubMed 22962670]

Bermingham RP, Whitsitt TB, Smart ML, et al, “Rhabdomyolysis in a Patient Receiving the Combination of Cerivastatin and Gemfibrozil,” Am J Health Syst Pharm, 2000, 57:461-4.[PubMed 10711527]

Duell PB, Connor WE, and Illingworth DR, “Rhabdomyolysis After Taking Atorvastatin With Gemfibrozil,” Am J Cardiol, 1998, 81:368-9.[PubMed 9468088]

Frick MH, Heinonen OP, Huttunen JK, et al, “Efficacy of Gemfibrozil in Dyslipidaemic Subjects With Suspected Heart Disease. An Ancillary Study in the Helsinki Heart Study Frame Population,” Ann Med, 1993, 25(1):41-5.[PubMed 8435186]

Innis SM. Impact of maternal diet on human milk composition and neurological development of infants. Am J Clin Nutr. 2014;99(3):734S-741S. doi: 10.3945/ajcn.113.072595.[PubMed 24500153]

Jacobson TA, Maki KC, Orringer CE, et al; NLA Expert Panel. National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 2 [published correction appears in J Clin Lipidol. 2016;10(1):211]. J Clin Lipidol. 2015;9(6)(suppl):S1-S122. doi: 10.1016/j.jacl.2015.09.002.[PubMed 26699442]

Lopid (gemfibrozil) [prescribing information]. New York, NY: Parke-Davis; received April 26, 2018.

Mahley RW and Bersot TP, “Drug Therapy for Hypercholesterolemia and Dyslipidemia,” Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 10th ed, Hardman JE and Limbird LE, eds, New York, NY: McGraw-Hill, 2001, 993-5.

McPherson R, Frohlich J, Fodor G, et al, “Canadian Cardiovascular Society Position Statement–Recommendations for the Diagnosis and Treatment of Dyslipidemia and Prevention of Cardiovascular Disease,” [published correction appears in Can J Cardiol. 2006, 22(12):1077]. Can J Cardiol. 2006;22(11):913-927.[PubMed 16971976]

National Institute for Health and Care Excellence (2008) Clinical guidelines and evidence review for familial hypercholesterolaemia: the identification and management of adults and children with familial hypercholesterolaemia. London: NICE. (Clinical Guideline 71). https://www.nice.org.uk/guidance/CG71

Pierce LR, Wysowski DK, and Gross TP, “Myopathy and Rhabdomyolysis Associated With Lovastatin/Gemfibrozil Combination Therapy,” JAMA, 1990, 264(1):71-5.[PubMed 2355431]

Rubins HB, Robbins SJ, Collins D, et al, “Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men With Low Levels of High-Density Lipoprotein Cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group,” N Engl J Med, 1999, 341(6):410-8.[PubMed 10438259]

Stone NJ, Robinson J, Lichtenstein AH, et al, 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online ahead of print November 12, 2013].Circulation. 2013; doi: 10.1161/01.cir.0000437738.63853.7a.[PubMed 24222016]

Tal A, Rajeshawari M, and Isley W, “Rhabdomyolysis Associated With Simvastatin/Gemfibrozil Therapy,” South Med J, 1997, 90(5):546-7.[PubMed 9160078]

Teva-Gemfibrozil [product monograph]. Toronto, Canada: Teva Canada Limited; June 2015.

Tsai EC, Brown JA, Veldee MY, Anderson GJ, Chait A, Brunzell JD. Potential of essential fatty acid deficiency with extremely low fat diet in lipoprotein lipase deficiency during pregnancy: A case report. BMC Pregnancy Childbirth. 2004;4(1):27. doi: 10.1186/1471-2393-4-27.[PubMed 15610556]

Wong B, Ooi TC, Keely E. Severe gestational hypertriglyceridemia: A practical approach for clinicians. Obstet Med. 2015;8(4):158-167. doi: 10.1177/1753495X15594082.[PubMed 27512474]

Brand Names: International

Antalip (CY, LB); Ausgem (AU); Brezimed (VN); Brozil (LK, MY, SG); Cell (PY); Clearol (TW); Detrichol (ID); Elmogan (HK, HR); Fetinor (ID); Fibropid (EG); G.F.B.-600 (TH); Gedum (AR); Gem-S (TW); Gemd (SG, TW); Gemfi (DE); Gemfibril (TH); Gemfil (BD); Gemnpid (TW); Gevilon (AT, BG, CH, CZ, DE, HR, HU, IS, PL); Goprozil (EG); Gozid (TH); Hidil (SG, TH); Hipolixan (CU, PY); Innogem (HU); Ipolipid (AE, BF, BH, BJ, CI, CY, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, OM, RU, SA, SC, SD, SG, SL, SN, SY, TN, TR, TZ, UG, VN, YE, ZM, ZW); Lesdown (TH); Lifibron (ID); Lipazil (NZ); Lipicap (TH); Lipigem (BD, PH); Lipison (HK, SG); Lipistorol (HK); Lipitrop (ID); Lipizile (PH); Lipofor (JO, SG); Lipolo (TH); Lipres (ID); Lipur (FR); Loceride (PH); Lopid (AE, AR, BB, BE, BH, BR, CL, CO, CR, CY, DK, DO, EC, EG, ES, FI, GB, GR, GT, HK, HN, ID, IE, IL, IQ, IR, IT, JO, KR, KW, LB, LU, LY, MX, NI, NL, OM, PA, PE, PH, PK, PT, QA, SA, SE, SV, SY, TH, TR, TW, UY, VE, YE, ZA); Lopid OD (PH); Low-Lip (AE, BH, CY, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Lozil (BR); Manobrozil (TH); Mersikol (ID); Minilip (HU); Normolip (IN); Polyxit (TH); Qualipid (HK); Reducel (PH); Regulip (AE, BH, CY, IL, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Ronox (TH); Synbrozil (HK); Tgil (BD); Trialmin (ES); Triglizil (CO); Weijiangzhi (CN)

Gemfibrozil (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(jem FI broe zil)

Brand Names: US

Lopid

What is this drug used for?
  • It is used to lower bad cholesterol and raise good cholesterol (HDL).
  • It is used to lower triglycerides.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to gemfibrozil or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Dasabuvir, repaglinide, selexipag, or a statin such as simvastatin.
  • If you have any of these health problems: Gallbladder disease, kidney disease, liver disease, or primary biliary cirrhosis.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • Talk with your doctor before you drink alcohol.
  • Do not take colestipol or cholestyramine within 2 hours of this drug.
  • Follow the diet and workout plan that your doctor told you about.
  • Muscle aches or weakness has happened with this drug. Rarely, a very bad muscle problem with or without very bad kidney problems has also happened with this drug. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
  • Muscle pain or weakness.
  • Not able to pass urine or change in how much urine is passed.
  • Feeling very tired or weak.
  • Low white blood cell counts have happened with this drug. This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Belly pain or heartburn.
  • Diarrhea.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take 30 minutes before breakfast and dinner.
  • To gain the most benefit, do not miss doses.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.