120 mg (Fenofibrate): Uses, Dosage, Side Effects ... - RxList

The initial dose is 50 to 150 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat ... Fenofibrate GenericName:fenofibrateBrandName:Fenofibrate40mg/120mg DrugClass:FibricAcidAgents MedicalEditor: JohnP.Cunha,DO,FACOEP LastupdatedonRxList:10/7/2021 home drugsa-zlist sideeffectsdrugcenterfenofibrate40mg/120mg(fenofibrate)drug RelatedDrugs Repatha HealthResources Cholesterol(LoweringYourCholesterol) RelatedSupplements Alfalfa Artichoke Avocado Barley Beta-Sitosterol BlackPsyllium BlondPsyllium Calcium CodLiverOil EnglishWalnut FishOil Flaxseed GammaOryzanol Glucomannan GreenTea GuarGum InositolNicotinate Inulin Jiaogulan MacadamiaNut Magnesium Mesoglycan Oats Olive Pantethine Pectin RedYeast RiceBran Safflower Sitostanol Soy SoybeanOil SweetOrange XanthanGum Yogurt Fenofibrate40mg/120mgUserReviews PROFESSIONAL CONSUMER SIDEEFFECTS DrugDescription Indications Dosage SideEffects DrugInteractions Warnings&Precautions Overdosage&Contraindications ClinicalPharmacology MedicationGuide DrugDescription WhatisFenofibrateandhowisitused?Fenofibrateisaprescriptionmedicineusedtotreatthesymptomsofhighcholesterolandtriglycerides(fattyacids)intheblood.Fenofibratemaybeusedaloneorwithothermedications.FenofibratebelongstoaclassofdrugscalledFibricAcidAgents.ItisnotknownifFenofibrateissafeandeffectiveinchildren.WhatarethepossiblesideeffectsofFenofibrate?Fenofibratemaycauseserioussideeffectsincluding:sharpstomachpainspreadingtoyourbackorshoulderblade,lossofappetite,stomachpainjustaftereatingameal,yellowingoftheskinoreyes(jaundice),fever,chills,weakness,sorethroat,mouthsores,unusualbruisingorbleeding,chestpain,suddencough,wheezing,rapidbreathing,coughingupblood,andswelling,warmthorrednessinanarmorlegGetmedicalhelprightaway,ifyouhaveanyofthesymptomslistedabove.ThemostcommonsideeffectsofFenofibrateinclude:runnynose,sneezing,andabnormallaboratorytestsTellthedoctorifyouhaveanysideeffectthatbothersyouorthatdoesnotgoaway.ThesearenotallthepossiblesideeffectsofFenofibrate.Formoreinformation,askyourdoctororpharmacist.Callyourdoctorformedicaladviceaboutsideeffects.YoumayreportsideeffectstoFDAat1-800-FDA-1088.DESCRIPTIONFenofibrateCapsulesUSParealipidregulatingagentavailableashardgelatincapsulesfororaladministration.Eachhardgelatincapsulecontains50or150mgoffenofibrateUSP.Thechemicalnameforfenofibrateis2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoicacid,1-methylethylesterwiththefollowingstructuralformula:TheempiricalformulaisC20H21O4C1andthemolecularweightis360.83;fenofibrateisinsolubleinwater.Themeltingpointis79-82°C.Fenofibrateisawhitesolidwhichisstableunderordinaryconditions.FenofibrateCapsulesUSPmeetUSPDissolutionTest2.InactiveIngredients:EachhardgelatincapsulecontainsGelucire44/14(lauroylmacrogolglyceridetype1500),polyethyleneglycol20,000,polyethyleneglycol8000,hydroxypropylcellulose,sodiumstarchglycolate,gelatin,titaniumdioxide,shellac,propyleneglycol,mayalsocontainblackironoxide,FD&CBlue#1,FD&CBlue#2,FD&CRed#40,D&CYellow#10. Indications INDICATIONS PrimaryHypercholesterolemiaOrMixedDyslipidemia Fenofibratecapsulesareindicatedasadjunctivetherapy todiettoreduceelevatedlow-densitylipoproteincholesterol(LDL-C),total cholesterol(total-c),Triglycerides(TG)andapolopoproteinB(ApoB),andto increasehigh-densitylipoproteincholesterol(HDL-C)inadultpatientswith primaryhypercholesterolemiaormixeddyslipidemia. SevereHypertriglyceridemia Fenofibratecapsulesarealsoindicatedasadjunctive therapytodietfortreatmentofadultpatientswithsevere hypertriglyceridemia.Improvingglycemiccontrolindiabeticpatientsshowing fastingchylomicronemiawillusuallyobviatetheneedforpharmacologic intervention. Markedlyelevatedlevelsofserumtriglycerides(e.g. >2,000mg/dL)mayincreasetheriskofdevelopingpancreatitis.Theeffect offenofibratetherapyonreducingthisriskhasnotbeenadequatelystudied. ImportantLimitationsOfUse Fenofibrateatadoseequivalentto150mgwasnotshown toreducecoronaryheartdiseasemorbidityandmortalityin2large,randomized controlledtrialsofpatientswithtype2diabetesmellitus[seeWARNINGS ANDPRECAUTIONS]. SLIDESHOW HowtoLowerYourCholesterol&SaveYourHeart SeeSlideshow Dosage DOSAGEANDADMINISTRATION GeneralConsiderations Sectionsorsubsectionsomittedfromthefullprescribing informationarenotlisted. Fenofibratecapsulesshouldbegivenwithmealsthereby optimizingtheabsorptionofthemedication. Patientsshouldbeadvisedtoswallowfenofibrate capsuleswhole.Donotopen,crush,dissolveorchewcapsules. Patientsshouldbeplacedonanappropriate lipid-loweringdietbeforereceivingfenofibratecapsules,andshouldcontinue thisdietduringtreatmentwithfenofibratecapsules. Theinitialtreatmentfordyslipidemiaisdietarytherapy specificforthetypeoflipoproteinabnormality.Excessbodyweightandexcess alcoholicintakemaybeimportantfactorsinhypertriglyceridemiaandshouldbe addressedpriortoanydrugtherapy.Physicalexercisecanbeanimportant ancillarymeasure.Diseasescontributorytohyperlipidemia,suchas hypothyroidismordiabetesmellitusshouldbelookedforandadequately treated.Estrogentherapy,thiazidediureticsandbeta-blockers,aresometimesassociated withmassiverisesinplasmatriglycerides,especiallyinsubjectswith familialhypertriglyceridemia.Insuchcases,discontinuationofthespecific etiologicagentmayobviatetheneedforspecificdrugtherapyof hypertriglyceridemia. Periodicdeterminationofserumlipidsshouldbeobtained duringinitialtherapyinordertoestablishthelowesteffectivedoseof fenofibrate.Therapyshouldbewithdrawninpatientswhodonothaveanadequate responseaftertwomonthsoftreatmentwiththemaximumrecommendeddoseof150 mgperday. Considerationshouldbegiventoreducingthedosageof fenofibrateiflipidlevelsfallsignificantlybelowthetargetedrange. PrimaryHypercholesterolemiaOrMixedDyslipidemia Thedoseoffenofibratecapsulesis150mgoncedaily. SevereHypertriglyceridemia Theinitialdoseis50to150mgperday.Dosageshould beindividualizedaccordingtopatientresponse,andshouldbeadjustedif necessaryfollowingrepeatlipiddeterminationat4to8weekintervals. Themaximumdoseoffenofibratecapsulesis150mgonce daily. ImpairedRenalFunction Inpatientswithmild-to-moderaterenalimpairment, treatmentwithfenofibratecapsulesshouldbeinitiatedatadoseof50mgper day,andincreasedonlyafterevaluationoftheeffectsonrenalfunctionand lipidlevelsatthisdose.Theuseoffenofibrateshouldbeavoidedinpatients withsevererenalimpairment[seeUseinSpecificPopulationsandCLINICAL PHARMACOLOGY]. GeriatricPatients Doseselectionfortheelderlyshouldbemadeonthe basisofrenalfunction[seeUseinSpecificPopulationsandCLINICAL PHARMACOLOGY]. HOWSUPPLIED DosageFormsAndStrengths 50mg:Size3whiteopaquegelatincapsuleimprinted“G 246”and“50”inblackink. 150mg:Size1whiteopaquegelatincapsuleimprinted“G 248”and“150”ingreenink. StorageAndHandling FenofibrateCapsulesUSPareavailableintwostrengths: 50mg:Size3whiteopaque/whiteopaquegelatincapsule, imprintedinblackinkwith“50”betweenlinesonthebody,“G246”onthecap andcontainingawhitetoalmostwhitepaste,availableinbottlesof90(NDC 62559-460-90). 150mg:Size1whiteopaque/whiteopaquegelatincapsule, imprintedingreeninkwith“150”betweenlinesonthebody,“G248”onthecap andcontainingawhitetoalmostwhitepaste,availableinbottlesof90(NDC 62559-461-90). Storeat25°C;excursionspermittedat15°to30°C(59° to86°F)[seeUSPControlledRoomTemperature].Keepoutofthereachof children.Protectfrommoistureandlight. Manufacturedfor:ANIPharmaceuticals,Inc.,Baudette,MN 56623.Revised:Feb2016 SideEffects SIDEEFFECTS ClinicalTrialsExperience Becauseclinicaltrialsareconductedunderwidely varyingconditions,adversereactionratesobservedintheclinicaltrialsofa drugcannotbedirectlycomparedtoratesintheclinicaltrialsofanother drugandmaynotreflecttherateobservedinclinicalpractice. Adversereactionsreportedby2%ormoreofpatients treatedwithfenofibrate(andgreaterthanplacebo)duringthedouble-blind, placebo-controlledtrials,regardlessofcausality,arelistedinTable1 below.Adverseeventsledtodiscontinuationoftreatmentin5.0%ofpatients treatedwithfenofibrateandin3.0%treatedwithplacebo.Increasesinliver functiontestswerethemostfrequentevents,causingdiscontinuationof fenofibratetreatmentin1.6%ofpatientsindouble-blindtrials. Table1:AdverseReactionsReportedby2%orMoreof PatientsTreatedwithFenofibrateandGreaterthanPlaceboDuringthe Double-Blind,Placebo-ControlledTrials BODYSYSTEM AdverseEvent Fenofibrate* (N=439) Placebo (N=365) BODYASAWHOLE AbdominalPain 4.6% 4.4% BackPain 3.4% 2.5% Headache 3.2% 2.7% DIGESTIVE AbnormalLiverFunctionTests 7.5%** 1.4% Nausea 2.3% 1.9% Constipation 2.1% 1.4% METABOLICANDNUTRITIONALDISORDERS IncreasedALT 3.0% 1.6% CreatinePhosphokinaseIncreased 3.0% 1.4% IncreasedAST 3.4%** 0.5% RESPIRATORY RespiratoryDisorder 6.2% 5.5% Rhinitis 2.3% 1.1% *Dosageequivalentto150mgfenofibrate **Significantlydifferentfromplacebo PostmarketingExperience Thefollowingadversereactionshavebeenidentified duringpostapprovaluseoffenofibrate:myalgia,rhabdomyolysis,pancreatitis, acuterenalfailure,musclespasm,hepatitis,cirrhosis,anemia,arthralgia,decreases inhemoglobin,decreasesinhematocrit,whitebloodcelldecreases,asthenia, andseverelydepressedHDLcholesterollevels.Becausethesereactionsare reportedvoluntarilyfromapopulationofuncertainsize,itisnotalways possibletoreliablyestimatetheirfrequencyorestablishacausalrelationship todrugexposure. QUESTION Whatischolesterol? SeeAnswer DrugInteractions DRUGINTERACTIONS CoumarinAnticoagulants Potentiationofcoumarin-typeanticoagulanteffecthas beenobservedwithprolongationofthePT/INR. Cautionshouldbeexercisedwhenfenofibrateisgivenin conjunctionwithcoumarinanticoagulants.Fenofibratemaypotentiatethe anticoagulanteffectoftheseagentsresultinginprolongationofthePT/INR. Topreventbleedingcomplications,frequentmonitoringofPT/INRanddose adjustmentoftheoralanticoagulantasrecommendeduntilthePT/INRhas stabilized[seeWARNINGSANDPRECAUTIONS]. Immunosuppressants Immunosuppressantagentssuchascyclosporineand tacrolimuscanimpairrenalfunctionandbecauserenalexcretionistheprimary eliminationrouteoffibratedrugsincludingfenofibratecapsules,thereisa riskthataninteractionwillleadtodeteriorationofrenalfunction.When immunosuppressantsandotherpotentiallynephrotoxicagentsareco-administered withfenofibratecapsules,thelowesteffectivedoseoffenofibratecapsules shouldbeemployedandrenalfunctionshouldbemonitored. Bile-AcidBindingResins Sincebile-acidbindingresinsmaybindotherdrugsgiven concurrently,patientsshouldtakefenofibrateatleast1hourbeforeor4to6 hoursafterabileacidbindingresintoavoidimpedingitsabsorption. Colchicine Casesofmyopathy,includingrhabdomyolysis,havebeen reportedwithfenofibratesco-administeredwithcolchicine,andcautionshould beexercisedwhenprescribingfenofibratewithcolchicine. Warnings&Precautions WARNINGS IncludedaspartofthePRECAUTIONSsection. PRECAUTIONS CoronaryHeartDiseaseMorbidityAndMortality Theeffectoffenofibrateoncoronaryheartdisease morbidityandmortalityandnon-cardiovascularmortalityhasnotbeen established. TheActiontoControlCardiovascularRiskinDiabetes Lipid(ACCORDLipid)trialwasarandomizedplacebo-controlledstudyof5518 patientswithtype2diabetesmellitusonbackgroundstatintherapytreated withfenofibrate.Themeandurationoffollow-upwas4.7years.Fenofibrate plusstatincombinationtherapyshowedanon-significant8%relativerisk reductionintheprimaryoutcomeofmajoradversecardiovascularevents(MACE), acompositeofnon-fatalmyocardialinfarction,non-fatalstroke,and cardiovasculardiseasedeath(hazardratio[HR]0.92,95%CI0.79-1.08) (p=0.32)ascomparedtostatinmonotherapy.Inagendersubgroupanalysis,the hazardratioforMACEinmenreceivingcombinationtherapyversusstatin monotherapywas0.82(95%CI0.69-0.99),andthehazardratioforMACEinwomen receivingcombinationtherapyversusstatinmonotherapywas1.38(95%CI0.98-1.94) (interactionp=0.01).Theclinicalsignificanceofthissubgroupfindingis unclear. TheFenofibrateInterventionandEventLoweringin Diabetes(FIELD)studywasa5-yearrandomized,placebo-controlledstudyof 9795patientswithtype2diabetesmellitustreatedwithfenofibrate.Fenofibrate demonstratedanon-significant11%relativereductionintheprimaryoutcomeof coronaryheartdiseaseevents(hazardratio[HR]0.89,95%CI0.75-1.05, p=0.16)andasignificant11%reductioninthesecondaryoutcomeoftotalcardiovascular diseaseevents(HR0.89[0.80-0.99],p=0.04).Therewasanon-significant11% (HR1.11[0.95,1.29],p=0.18)and19%(HR1.19[0.90,1.57],p=0.22)increase intotalandcoronaryheartdiseasemortality,respectively,withfenofibrate ascomparedtoplacebo.1 Becauseofchemical,pharmacological,andclinical similaritiesbetweenfenofibrate,clofibrate,andgemfibrozil,theadverse findingsin4largerandomized,placebo-controlledclinicalstudieswiththeseother fibratedrugsmayalsoapplytofenofibratecapsules. IntheCoronaryDrugProject,alargestudyofpost myocardialinfarctionpatientstreatedfor5yearswithclofibrate,therewas nodifferenceinmortalityseenbetweentheclofibrategroupandtheplacebogroup. Therewashowever,adifferenceintherateofcholelithiasisandcholecystitis requiringsurgerybetweenthetwogroups(3.0%vs.1.8%). InastudyconductedbytheWorldHealthOrganization (WHO),5000subjectswithoutknowncoronaryarterydiseaseweretreatedwithplacebo orclofibratefor5yearsandfollowedforanadditionaloneyear.Therewasa statisticallysignificant,higherage-adjustedall-causemortalityinthe clofibrategroupcomparedwiththeplacebogroup(5.70%vs.3.96%,p=<0.01). Excessmortalitywasduetoa33%increaseinnon-cardiovascularcauses, includingmalignancy,post-cholecystectomycomplications,andpancreatitis. Thisappearedtoconfirmthehigherriskofgallbladderdiseaseseenin clofibratetreatedpatientsstudiedintheCoronaryDrugProject. TheHelsinkiHeartStudywasalarge(n=4081)studyof middleagedmenwithoutahistoryofcoronaryarterydisease.Subjectsreceived eitherplaceboorgemfibrozilfor5years,witha3.5yearopenextension afterward.Totalmortalitywasnumericallyhigherinthegemfibrozil randomizationgroupbutdidnotachievestatisticalsignificance(p=0.19,95% confidenceintervalforrelativeriskG:P=0.91-1.64).Althoughcancerdeaths trendedhigherinthegemfibrozilgroup(p=0.11),cancers(excludingbasalcell carcinoma)werediagnosedwithequalfrequencyinbothstudygroups.Duetothe limitedsizeofthestudy,therelativeriskofdeathfromanycausewasnot showntobedifferentthanthatseeninthe9yearfollow-updatafromtheWHO study(RR=1.29). AsecondarypreventioncomponentoftheHelsinkiHeart Studyenrolledmiddle-agedmenexcludedfromtheprimarypreventionstudy becauseofknownorsuspectedcoronaryheartdisease.Subjectsreceived gemfibrozilorplacebofor5years.Althoughcardiacdeathstrendedhigherin thegemfibrozilgroup,thiswasnotstatisticallysignificant(hazardratio 2.2,95%confidenceinterval:0.94-5.05). SkeletalMuscle Fibratesincreasetheriskformyopathyandhavebeen associatedwithrhabdomyolysis.Theriskforseriousmuscletoxicityappearsto beincreasedinelderlypatientsandinpatientswithdiabetes,renalinsufficiency, orhypothyroidism. Datafromobservationalstudiesindicatethattherisk forrhabdomyolysisisincreasedwhenfibrates,inparticulargemfibrozil,are co-administeredwithanHMG-CoAreductaseinhibitor(statin).Thecombination shouldbeavoidedunlessthebenefitoffurtheralterationsinlipidlevelsis likelytooutweightheincreasedriskofthisdrugcombination[seeCLINICAL PHARMACOLOGY]. Myopathyshouldbeconsideredinanypatientwithdiffuse myalgias,muscletendernessorweakness,and/ormarkedelevationsofcreatine phosphokinase(CPK)levels. Patientsshouldbeadvisedtoreportpromptlyunexplained musclepain,tendernessorweakness,particularlyifaccompaniedbymalaiseor fever.Creatinephosphokinase(CPK)levelsshouldbeassessedinpatients reportingthesesymptoms,andfenofibratetherapyshouldbediscontinuedifmarkedly elevatedCPKlevelsoccurormyopathyisdiagnosed. Casesofmyopathy,includingrhabdomyolysis,havebeen reportedwithfenofibratesco-administeredwithcolchicine,andcautionshould beexercisedwhenprescribingfenofibratewithcolchicine[seeDRUG INTERACTIONS]. LiverFunction Fenofibrateatdosesequivalentto100mgto150mg fenofibrateperdayhasbeenassociatedwithincreasesinserumtransaminases [AST(SGOT)orALT(SGPT)].Inapooledanalysisof10placebocontrolledtrials offenofibrate,increasesto>3timestheupperlimitofnormalofALT occurredin5.3%ofpatientstakingfenofibrateversus1.1%ofpatientstreated withplacebo.Theincidenceofincreasesintransaminasesobservedwith fenofibratetherapymaybedoserelated.Whentransaminasedeterminationswere followedeitherafterdiscontinuationoftreatmentorduringcontinued treatment,areturntonormallimitswasusuallyobserved. Chronicactivehepatocellularandcholestatichepatitis associatedwithfenofibratetherapyhavebeenreportedafterexposuresofweeks toseveralyears.Inextremelyrarecases,cirrhosishasbeenreportedin associationwithchronicactivehepatitis. Baselineandregularmonitoringoflivertests,including ALTshouldbeperformedforthedurationoftherapywithfenofibrate,and therapydiscontinuedifenzymelevelspersistabovethreetimesthenormallimit. SerumCreatinine Elevationsinserumcreatininehavebeenreportedin patientsonfenofibrate.Theseelevationstendtoreturntobaselinefollowing discontinuationoffenofibrate.Theclinicalsignificanceoftheseobservations isunknown.Monitorrenalfunctioninpatientswithrenalimpairmenttaking fenofibrate.Renalmonitoringshouldalsobeconsideredforpatientstaking fenofibrateandareatriskforrenalinsufficiency,suchastheelderlyand patientswithdiabetes. Cholelithiasis Fenofibrate,likeclofibrateandgemfibrozil,may increasecholesterolexcretionintothebile,leadingtocholelithiasis.If cholelithiasisissuspected,gallbladderstudiesareindicated.Fenofibrate therapyshouldbediscontinuedifgallstonesarefound. CoumarinAnticoagulants Cautionshouldbeexercisedwhenfenofibrateisgivenin conjunctionwithcoumarinanticoagulants.Fenofibratemaypotentiatethe anticoagulanteffectsoftheseagentsresultinginprolongationoftheProthrombin Time/InternationalNormalizedRatio(PT/INR).Topreventbleeding complications,frequentmonitoringofPT/INRanddoseadjustmentofthe anticoagulantarerecommendeduntilPT/INRhasstabilized[seeDRUG INTERACTIONS]. Pancreatitis Pancreatitishasbeenreportedinpatientstaking fenofibrate,gemfibrozil,andclofibrate.Thisoccurrencemayrepresenta failureofefficacyinpatientswithseverehypertriglyceridemia,adirectdrug effect,orasecondaryphenomenonmediatedthroughbiliarytractstoneor sludgeformationwithobstructionofthecommonbileduct. HematologicChanges Mildtomoderatedecreasesinhemoglobin,hematocrit,and whitebloodcelldecreaseshavebeenobservedinpatientsfollowinginitiation offenofibratetherapy.However,theselevelsstabilizeduringlongterm administration.Thrombocytopeniaandagranulocytosishavebeenreportedin individualstreatedwithfenofibrate.Periodicmonitoringofredandwhite bloodcellcountsisrecommendedduringthefirst12monthsoffenofibrate administration. HypersensitivityReactions Acutehypersensitivityreactionsincludingsevereskin rashessuchasSteven-Johnsonsyndromeandtoxicepidermalnecrolysisrequiring patienthospitalizationandtreatmentwithsteroidshavebeenreportedin individualstreatedwithfenofibrate.Urticariawasseenin1.1vs.0%andrash in1.4vs.0.8%offenofibrateandplacebopatientsrespectivelyincontrolled trials. VenothromboembolicDisease IntheFIELDtrial,pulmonaryembolus(PE)anddeepvein thrombosis(DVT)wereobservedathigherratesinthefenofibratethanthe placebo-treatedgroup.Of9,795patientsenrolledinFIELD,4,900inthe placebogroupand4,895inthefenofibrategroup.ForDVT,therewere48events (1%)intheplacebogroupand67(1%)inthefenofibrategroup(p=0.074);and forPE,therewere32(0.7%)eventsintheplacebogroupand53(1%)inthe fenofibrategroup(p=0.022). IntheCoronaryDrugProject,ahigherproportionofthe clofibrategroupexperienceddefiniteorsuspectedfatalornonfatalpulmonary embolismorthrombophlebitisthantheplacebogroup(5.2%vs.3.3%at5years; p<0.01). ParadoxicalDecreasesInHDLCholesterolLevels Therehavebeenpostmarketingandclinicaltrialreports ofseveredecreasesinHDLcholesterollevels(aslowas2mg/dL)occurringin diabeticandnon-diabeticpatientsinitiatedonfibratetherapy.Thedecrease inHDL-CismirroredbyadecreaseinapolipoproteinA1.Thisdecreasehasbeen reportedtooccurwithin2weekstoyearsafterinitiationoffibratetherapy. TheHDL-Clevelsremaindepresseduntilfibratetherapyhasbeenwithdrawn;the responsetowithdrawaloffibratetherapyisrapidandsustained.Theclinical significanceofthisdecreaseinHDL-Cisunknown.ItisrecommendedthatHDL-C levelsbecheckedwithinthefirstfewmonthsafterinitiationoffibrate therapy.IfaseverelydepressedHDL-Clevelisdetected,fibratetherapy shouldbewithdrawn,andtheHDL-Clevelmonitoreduntilithasreturnedto baseline,andfibratetherapyshouldnotbere-initiated. NonclinicalToxicology Carcinogenesis,Mutagenesis,ImpairmentOfFertility Carcinogenesis Twodietarycarcinogenicitystudieshavebeenconducted inratswithfenofibrate.Inthefirst24-monthstudy,Wistarratsweredosed withfenofibrateat10,45and200mg/kg/day,approximately0.3,1,and6times themaximumrecommendedhumandose(MRHD),basedonbodysurfaceare comparisons(mg/m²).Atadoseof200mg/kg/day(at6timesMRHD),the incidenceoflivercarcinomawassignificantlyincreasedinbothsexes.A statisticallysignificantincreaseinpancreaticcarcinomaswasobservedin malesat1and6timestheMRHD;anincreaseinpancreaticadenomasandbenign testicularinterstitialcelltumorswasobservedinmalesat6timestheMRHD. Inasecond24-monthstudyinadifferentstrainofrats(Sprague-Dawley), dosesof10and60mg/kg/day(0.3and2timestheMRHD)producedsignificant increasesintheincidenceofpancreaticacinaradenomasinbothsexesand increasesintesticularinterstitialcelltumorsinmalesat2timestheMRHD. A117-weekcarcinogenicitystudywasconductedinrats comparingthreedrugs:fenofibrate10and60mg/kg/day(0.3and2timesthe MRHD),clofibrate(400mg/kg;2timesthehumandose),andgemfibrozil(250 mg/kg;2timesthehumandose,basedonmg/m²surfacearea).Fenofibrate increasedpancreaticacinaradenomasinbothsexes.Clofibrateincreased hepatocellularcarcinomasinmalesandhepaticneoplasticnodulesinfemales. Gemfibrozilincreasedhepaticneoplasticnodulesinmalesandfemales,while allthreedrugsincreasedtesticularinterstitialcelltumorsinmales. Ina21-monthstudyinCF-1mice,fenofibrate10,45and 200mg/kg/day(approximately0.2,1,and3timestheMRHDonthebasisofmg/m² surfacearea)significantlyincreasedthelivercarcinomasinbothsexesat3 timestheMRHD.Inasecond18monthstudyat10,60and200mg/kg/day, fenofibratesignificantlyincreasedthelivercarcinomasinmalemiceandliver adenomasinfemalemiceat3timestheMRHD. Electronmicroscopystudieshavedemonstratedperoxisomal proliferationfollowingfenofibrateadministrationtotherat.Anadequate studytotestforperoxisomeproliferationinhumanshasnotbeendone,but changesinperoxisomemorphologyandnumbershavebeenobservedinhumansafter treatmentwithothermembersofthefibrateclasswhenliverbiopsieswere comparedbeforeandaftertreatmentinthesameindividual. Mutagenesis Fenofibratehasbeendemonstratedtobedevoidof mutagenicpotentialinthefollowingtests:Ames,mouselymphoma,chromosomal aberrationandunscheduledDNAsynthesisinprimaryrathepatocytes. ImpairmentOfFertility Infertilitystudiesratsweregivenoraldietarydoses offenofibrate,malesreceived61dayspriortomatingandfemales15days priortomatingthroughweaningwhichresultedinnoadverseeffecton fertilityatdosesupto300mg/kg/day(approximately10timestheMRHD,basedon mg/m²surfaceareacomparisons). UseInSpecificPopulations Pregnancy PregnancyCategoryC Safetyinpregnantwomenhasnotbeenestablished.There arenoadequateandwellcontrolledstudiesoffenofibrateinpregnantwomen. Fenofibrateshouldbeusedduringpregnancyonlyifthepotentialbenefit justifiesthepotentialrisktothefetus. Infemaleratsgivenoraldietarydosesof15,75,and 300mg/kg/dayoffenofibratefrom15dayspriortomatingthroughweaning, maternaltoxicitywasobservedat0.3timesthemaximumrecommendedhumandose (MRHD),basedonbodysurfaceareacomparisons;mg/m². Inpregnantratsgivenoraldietarydosesof14,127,and 361mg/kg/dayfromgestationday6-15duringtheperiodoforganogenesis, adversedevelopmentalfindingswerenotobservedat14mg/kg/day(lessthan1 timestheMRHD,basedonbodysurfaceareacomparisons;mg/m²).Athigher multiplesofhumandosesevidenceofmaternaltoxicitywasobserved. Inpregnantrabbitsgivenoralgavagedosesof15,150, and300mg/kg/dayfromgestationday6-18duringtheperiodoforganogenesis andallowedtodeliver,abortedlitterswereobservedat150mg/kg/day(10 timestheMRHD,basedonbodysurfaceareacomparisons;mg/m²).No developmentalfindingswereobservedat15mg/kg/day(atlessthan1timesthe MRHD,basedonbodysurfaceareacomparisons;mg/m²). Inpregnantratsgivenoraldietarydosesof15,75,and 300mg/kg/dayfromgestationday15throughlactationday21(weaning), maternaltoxicitywasobservedatlessthan1timestheMRHD,basedonbody surfaceareacomparisons;mg/m². NursingMothers Fenofibrateshouldnotbeusedinnursingmothers.A decisionshouldbemadewhethertodiscontinuenursingortodiscontinuethe drug,takingintoaccounttheimportanceofthedrugtothemother. PediatricUse Safetyandeffectivenesshavenotbeenestablishedin pediatricpatients. GeriatricUse Fenofibrateissubstantiallyexcretedbythekidney,and theriskofadversereactionstothisdrugmaybegreaterinpatientswith impairedrenalfunction.Sinceelderlypatientshaveahigherincidenceof renalimpairment,thedoseselectionfortheelderlyshouldbemadeonthe basisofrenalfunction[seeDOSAGEANDADMINISTRATIONandCLINICAL PHARMACOLOGY].Fenofibrateexposureisnotinfluencedbyage.Elderly patientswithnormalrenalfunctionshouldrequirenodosemodifications. Considermonitoringrenalfunctioninelderlypatientstakingfenofibrate. RenalImpairment Theuseoffenofibrateshouldbeavoidedinpatientswho havesevererenalimpairment[seeCONTRAINDICATIONS].Dosereductionis requiredinpatientswithmildtomoderaterenalimpairment[seeDOSAGEAND ADMINISTRATIONandCLINICALPHARMACOLOGY].Monitoringrenalfunction inpatientswithrenalimpairmentisrecommended. HepaticImpairment Theuseoffenofibratehasnotbeenevaluatedinpatients withhepaticimpairment[seeCONTRAINDICATIONSandCLINICAL PHARMACOLOGY]. Overdosage&Contraindications OVERDOSE Thereisnospecifictreatmentforoverdosewith fenofibrate.Generalsupportivecareofthepatientisindicated,including monitoringofvitalsignsandobservationofclinicalstatus,shouldan overdoseoccur.Ifindicated,eliminationofunabsorbeddrugshouldbeachieved byemesisorgastriclavage.Theusualprecautionsshouldbeobservedto maintaintheairway.Becausefenofibrateishighlyboundtoplasmaproteins, hemodialysisshouldnotbeconsidered. CONTRAINDICATIONS Fenofibratecapsulesarecontraindicatedin: patientswithsevererenalimpairment,includingthose receivingdialysis[seeCLINICALPHARMACOLOGY]. patientswithactiveliverdisease,includingthosewith primarybiliarycirrhosisandunexplainedpersistentliverfunction abnormalities[seeWARNINGSANDPRECAUTIONS]. patientswithpreexistinggallbladderdisease[seeWARNINGS ANDPRECAUTIONS]. patientswithknownhypersensitivitytofenofibrateor fenofibricacid[seeWARNINGSANDPRECAUTIONS]. nursingmothers[seeUseinSpecificPopulations]. ClinicalPharmacology CLINICALPHARMACOLOGY MechanismOfAction Theactivemetaboliteoffenofibrateisfenofibricacid. Thepharmacologicaleffectsoffenofibricacidinbothanimalsandhumanshave beenextensivelystudiedthroughoraladministrationoffenofibrate. Thelipid-modifyingeffectsoffenofibricacidseenin clinicalpracticehavebeenexplainedinvivointransgenicmiceandinvitroin humanhepatocyteculturesbytheactivationofperoxisomeproliferatoractivated receptorα(PPARα).Throughthismechanism,fenofibrateincreases lipolysisandeliminationoftriglyceride-richparticlesfromplasmaby activatinglipoproteinlipaseandreducingproductionofapoproteinC-III(an inhibitoroflipoproteinlipaseactivity).Theresultingdecreasein triglyceridesproducesanalterationinthesizeandcompositionofLDLfrom small,denseparticles(whicharethoughttobeatherogenicduetotheir susceptibilitytooxidation),tolargebuoyantparticles.Theselarger particleshaveagreateraffinityforcholesterolreceptorsandarecatabolized rapidly.ActivationofPPARαalsoinducesanincreaseinthesynthesisof apolipoproteinsAI,AIIandHDLcholesterol.Fenofibratealsoreducesserum uricacidlevelsinhyperuricemicandnormalindividualsbyincreasingthe urinaryexcretionofuricacid. Pharmacodynamics Elevatedlevelsoftotal-c,LDL-C,andapoBand decreasedlevelsofHDL-Canditstransportcomplex,ApoAIandApoAII,are riskfactorsforatherosclerosis.Epidemiologicinvestigationshaveestablished thatcardiovascularmorbidityandmortalityvarydirectlywiththelevelof total-c,LDL-C,andtriglycerides,andinverselywiththelevelofHDL-C.The independenteffectofraisingHDL-Corloweringtriglycerides(TG)ontherisk ofcardiovascularmorbidityandmortalityhasnotbeendetermined. Fenofibricacid,theactivemetaboliteoffenofibrate, producesreductionsintotalcholesterol,LDLcholesterol,apolipoproteinB, totaltriglyceridesandtriglyceriderichlipoprotein(VLDL)intreatedpatients. Inaddition,treatmentwithfenofibrateresultsinincreasesinhighdensity lipoprotein(HDL)andapolipoproteinsAIandAII. Pharmacokinetics Theextentandrateofabsorptionoffenofibricacid afteradministrationof150mgfenofibratecapsulesareequivalentunder low-fatandhigh-fatfedconditionsto160mgTriCor® tablets. Fenofibrateisapro-drugoftheactivechemicalmoiety fenofibricacid.Fenofibrateisconvertedbyesterhydrolysisinthebodyto fenofibricacidwhichistheactiveconstituentmeasurableinthecirculation. Inabioavailabilitystudywithfenofibratecapsules200mg,following single-doseadministration,theplasmaconcentration(AUC)fortheparent compoundfenofibratewasapproximately40μg/mLcomparedto204μg/mL forthemetabolite,fenofibricacid.Inthesamestudy,thehalflifewas observedtobe0.91hrsfortheparentcompoundversus16.76hrsforthe metabolite. Absorption Theabsolutebioavailabilityoffenofibratecannotbe determinedasthecompoundisvirtuallyinsolubleinaqueousmediasuitablefor injection.However,fenofibrateiswellabsorbedfromthegastrointestinal tract.Followingoraladministrationinhealthyvolunteers,approximately60% ofasingledoseofradiolabeledfenofibrateappearedinurine,primarilyas fenofibricacidanditsglucuronateconjugate,and25%wasexcretedinthe feces.Peakplasmalevelsoffenofibricacidoccurwithinapproximately5hours afteroraladministration. Theabsorptionoffenofibrateisincreasedwhen administeredwithfood.Withfenofibrate,theextentofabsorptionisincreased byapproximately58%and25%underhigh-fatfedandlow-fatfedconditionsascompared tofastingconditions,respectively. Inasingledoseandmultipledosebioavailabilitystudy withfenofibratecapsules200mg,theextentofabsorption(AUC)offenofibric acid,theprincipalmetaboliteoffenofibrate,was42%largeratsteadystate comparedtosingle-doseadministration.Therateofabsorption(Cmax)of fenofibricacidwas73%greateraftermultiple-dosethanaftersingle-dose administration. Theextentofabsorptionoffenofibratecapsulesinterms ofAUCvalueoffenofibricacidincreasedinalessthanproportionalmanner whiletherateofabsorptionintermsofCmaxvalueoffenofibricacidincreased proportionallyrelatedtodose. Distribution Uponmultipledosingoffenofibrate,fenofibricacid steadystateisachievedafter5days.Plasmaconcentrationsoffenofibricacid atsteadystateareslightlymorethandoublethosefollowingasingledose. Serumproteinbindingwasapproximately99%innormalandhyperlipidemic subjects. Metabolism Followingoraladministration,fenofibrateisrapidly hydrolyzedbyesterasestotheactivemetabolite,fenofibricacid;unchanged fenofibrateisdetectedatlowconcentrationsinplasmacomparedtofenofibric acidovermostofthesingledoseandmultipledosingperiods. Fenofibricacidisprimarilyconjugatedwithglucuronic acidandthenexcretedinurine.Asmallamountoffenofibricacidisreduced atthecarbonylmoietytoabenzhydrolmetabolitewhichis,inturn,conjugated withglucuronicacidandexcretedinurine. Invitroandinvivometabolismdataindicatethat neitherfenofibratenorfenofibricacidundergooxidativemetabolism(e.g., cytochromeP450)toasignificantextent. Elimination Afterabsorption,fenofibrateismainlyexcretedinthe urineintheformofmetabolites,primarilyfenofibricacidandfenofibricacid glucuronide.Afteradministrationofradiolabeledfenofibrate,approximately 60%ofthedoseappearedintheurineand25%wasexcretedinfeces. Fenofibricacidiseliminatedwithahalf-lifeof approximately20hoursallowingoncedailydosing. Geriatrics Inelderlyvolunteers77to87yearsofage,theapparent oralclearanceoffenofibricacidfollowingasingleoraldoseoffenofibrate was1.2L/h,whichcomparesto1.1L/hinyoungadults.Thisindicatesthatan equivalentdoseoffenofibratecanbeusedinelderlysubjectswithnormal renalfunction,withoutincreasingaccumulationofthedrugormetabolites[see DOSAGEANDADMINISTRATIONandUseinSpecificPopulations]. Pediatrics Pharmacokineticsoffenofibratehasnotbeenstudiedin pediatricpatients. Gender Nopharmacokineticdifferencebetweenmalesandfemales hasbeenobservedforfenofibrate. Race Theinfluenceofraceonthepharmacokineticsof fenofibratehasnotbeenstudied,howeverfenofibrateisnotmetabolizedby enzymesknownforexhibitinginter-ethnicvariability. RenalImpairment Thepharmacokineticsoffenofibricacidwasexaminedin patientswithmild,moderateandsevererenalimpairment.Patientswithmild (estimatedglomerularfiltrationrateeGFR60-89ml/min/1.73m²)tomoderate (eGFR30-59mL/min/1.73m²)renalimpairmenthadsimilarexposurebutanincrease inthehalf-lifeforfenofibricacidwasobservedascomparedtothatof healthysubjects.Patientswithsevererenalimpairment(eGFR<30 mL/min/1.73m²)showeda2.7-foldincreaseinexposureforfenofibricacidand increasedaccumulationoffenofibricacidduringchronicdosingcomparedto thatofhealthysubjects.Inpatientswithmildtomoderaterenalimpairment, treatmentwithfenofibrateshouldbeinitiatedatadoseof50mgperday,and increasedonlyafterevaluationoftheeffectsonrenalfunctionandlipid levelsatthisdose.Basedonthesefindings,theuseoffenofibrateshouldbe avoidedinpatientswhohavesevererenalimpairment. HepaticImpairment Nopharmacokineticstudieshavebeenconductedin patientshavinghepaticimpairment. Drug-DrugInteractions Invitrostudiesusinghumanlivermicrosomesindicate thatfenofibrateandfenofibricacidarenotinhibitorsofcytochromeP450 (CYP)isoformsCYP3A4,CYP2D6,CYP2E1,orCYP1A2.Theyareweakinhibitorsof CYP2C8,CYP2C19andCYP2A6,andmildtomoderateinhibitorsofCYP2C9at therapeuticconcentrations. Table2describestheeffectsofco-administereddrugson fenofibricacidsystemicexposure.Table3describestheeffectsoffenofibrate onco-administereddrugs. Table2:EffectsofCo-AdministeredDrugson FenofibricAcidSystemicExposurefromFenofibrateAdministration Co-AdministeredDrug DosageRegimenofCo-AdministeredDrug DosageRegimen ofFenofibrate ChangesinFenofibricAcid Exposure AUC Cmax Lipid-loweringagents Atorvastatin 20mgoncedailyfor10days Fenofibrate160mg1oncedailyfor10days ↓2% ↓4% Pravastatin 40mgasasingledose Fenofibrate3x67mg2asasingledose ↓1% ↓2% Fluvastatin 40mgasasingledose Fenofibrate160mg1asasingledose ↓2% ↓10% Anti-diabeticagents Glimepiride 1mgasasingledose Fenofibrate145mg1oncedailyfor10days ↑1% ↓1% Metformin 850mgthreetimesdailyfor10days Fenofibrate54mg1threetimesdailyfor10days ↓9% ↓6% Rosiglitazone 8mgoncedailyfor5days Fenofibrate145mg1oncedailyfor14days ↑10% T3% 1TriCor(fenofibrate)oraltablet 2TriCor(fenofibrate)oralmicronizedcapsule Table3:EffectsofFenofibrateonSystemicExposure ofCo-AdministeredDrugs DosageRegimenofFenofibrate DosageRegimenofCo-AdministeredDrug ChangeinCo-AdministeredDrugExposure Analyte AUC Cmax Lipid-loweringagents Fenofibrate160mg1oncedailyfor10days Atorvastatin,20mgoncedailyfor10days Atorvastatin ↓17% 0% Fenofibrate3x67mg2asasingledose Pravastatin,40mgasasingledose Pravastatin ↑13% ↑13% 3α-Hydroxyl-iso-pravastatin ↑26% ↑29% Fenofibrate160mg1asasingledose Fluvastatin,40mgasasingledose (+)-3R,5S-Fluvastatin ↑5% ↑16% Anti-diabeticagents Fenofibrate145mg1oncedailyfor10days Glimepiride,1mgasasingledose Glimepiride ↑35% ↑18% Fenofibrate54mg1threetimesdailyfor10days Metformin,850mgthreetimesdailyfor10days Metformin ↑3% ↑6% Fenofibrate145mg1oncedailyfor14days Rosiglitazone,8mgoncedailyfor5days Rosiglitazone ↑6% ↓1% 1TriCor(fenofibrate)oraltablet 2TriCor(fenofibrate)oralmicronizedcapsule ClinicalStudies Clinicaltrialshavenotbeenconductedwithfenofibrate capsules. PrimaryHypercholesterolemia(HeterozygousFamilialAndNonfamilial) AndMixedDyslipidemia Theeffectsoffenofibrateatadoseequivalentto150mg perdayoffenofibratewasassessedfromfourrandomized,placebo-controlled, double-blind,parallel-groupstudiesincludingpatientswiththefollowingmean baselinelipidvalues:total-c306.9mg/dL;LDL-C213.8mg/dL;HDL-C52.3 mg/dL;andtriglycerides191.0mg/dL.FenofibratetherapyloweredLDL-C, total-c,andtheLDL-C/HDL-Cratio.Fenofibratetherapyalsolowered triglyceridesandraisedHDL-C(seeTable4). Table4:MeanPercentChangeinLipidParametersat EndofTreatment+ TreatmentGroup Total-C LDL-C HDL-C TG PooledCohort Meanbaselinelipidvalues(n=646) 306.9mg/dL 213.8mg/dL 52.3mg/dL 191.0mg/dL* AllFEN(n=361) -18.7%* -20.6%* +11.0 %* -28.9%* Placebo(n=285) -0.4% -2.2% +0.7% +7.7% BaselineLDL-C>160mg/dLandTG<150mg/dL Meanbaselinelipidvalues(n=334) 307.7mg/dL 227.7mg/dL 58.1mg/dL 101.7mg/dL AllFEN(n=193) -22.4%* -31.4%* +9.8% -23.5%* Placebo(n=141) +0.2% -2.2% +2.6% +11.7% BaselineLDL-C>160mg/dLandTG≥150mg/dL Meanbaselinelipidvalues(n=242) 312.8mg/dL 219.8mg/dL 46.7mg/dL 231.9mg/dL AllFEN(n=126) -16.8%* -20.1%* +14.6%* -35.9%* Placebo(n=116) -3.0% -6.6% +2.3% +0.9% +Durationofstudytreatmentwas3to6months. *p=<0.05vs.Placebo Inasubsetofthesubjects,measurementsofapoBwere conducted.FenofibratetreatmentsignificantlyreducedapoBfrombaselineto endpointascomparedwithplacebo(-25.1%vs.2.4%,p<0.0001,n=213and143 respectively). SevereHypertriglyceridemia Theeffectsoffenofibrateonserumtriglycerideswere studiedintworandomized,double-blind,placebo-controlledclinicaltrialsof 147hypertriglyceridemicpatients.Patientsweretreatedforeightweeksunder protocolsthatdifferedonlyinthatoneenteredpatientswithbaselineTG levelsof500to1500mg/dL,andtheotherTGlevelsof350to500mg/dL.In patientswithhypertriglyceridemiaandnormalcholesterolemiawithorwithout hyperchylomicronemia,treatmentwithfenofibrateatdosagesequivalentto150 mgfenofibrateperdaydecreasedprimarilyverylowdensitylipoprotein(VLDL), triglyceridesandVLDLcholesterol.Treatmentofsomewithelevated triglyceridesoftenresultsinanincreaseofLDL-C(seeTable5). Table5:EffectsinPatientsWithSevere Hypertriglyceridemia Study1 Placebo Fenofibrate BaselineTGLevels350to499mg/dL N Baseline(Mean) Endpoint(Mean) %Change(Mean) N Baseline(Mean) Endpoint(Mean) %Change(Mean) Triglycerides 28 449 450 -0.5 27 432 223 -46.2* VLDLTriglycerides 19 367 350 2.7 19 350 178 -44.1* TotalCholesterol 28 255 261 2.8 27 252 227 -9.1* HDLCholesterol 28 35 36 4 27 34 40 19.6* LDLCholesterol 28 120 129 12 27 128 137 14.5 VLDLCholesterol 27 99 99 5.8 27 92 46 -44.7*   Study2     Placebo     Fenofibrate   BaselineTGLevels500to1500mg/dL N Baseline(Mean) Endpoint(Mean) %Change(Mean) N Baseline(Mean) Endpoint(Mean) %Change(Mean) Triglycerides 44 710 750 7.2 48 726 308 -54.5* VLDLTriglycerides 29 537 571 18.7 33 543 205 -50.6* TotalCholesterol 44 272 271 0.4 48 261 223 -13.8* HDLCholesterol 44 27 28 5.0 48 30 36 22.9* LDLCholesterol 42 100 90 -4.2 45 103 131 45.0* VLDLCholesterol 42 137 142 11.0 45 126 54 -49.4* *=P<0.05vs.Placebo Theeffectoffenofibrateoncardiovascularmorbidityand mortalityhasnotbeendetermined. MedicationGuide PATIENTINFORMATION Patientsshouldbeadvised: ofthepotentialbenefitsandrisksoffenofibrate capsules. nottousefenofibratecapsulesifthereisaknown hypersensitivitytofenofibrateorfenofibricacid. ofmedicationsthatshouldnotbetakenincombination withfenofibratecapsules. thatiftheyaretakingcoumarinanticoagulants, fenofibratecapsulesmayincreasetheiranticoagulanteffect,andincreased monitoringmaybenecessary. toinformtheirphysicianofallmedications, supplements,andherbalpreparationstheyaretakingandanychangeintheir medicalcondition. toinformaphysicianprescribinganewmedication,that theyaretakingfenofibratecapsules. tocontinuetofollowanappropriatelipid-modifyingdiet whiletakingfenofibratecapsules. totakefenofibratecapsulesoncedailyattheprescribed dose,swallowingeachcapsulewhole. toinformtheirphysicianofanymusclepain,tenderness, orweakness;onsetofabdominalpain;oranyothernewsymptoms. toreturntotheirphysician'sofficeforroutine monitoring. 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