patient

GileadSciences28

FDA-ApprovedPatientLabeling

TRUVADA®(tru-VAH-dah)tablets

Genericname:emtricitabineandtenofovirdisoproxilfumarate

(emtriSITuhbeanandteNOE’foveerdyesoePROXilFYOUmarate)

ReadthePatientInformationthatcomeswithTRUVADAbeforeyoustarttakingitand

formationdoesnot

taketheplaceoftalkingtoyourhealthcareprovideraboutyourmedicalconditionor

uldstayunderahealthcareprovider’scarewhentakingTRUVADA.

Donotchangeorstopyourmedicinewithoutfirsttalkingwithyourhealthcare

yourhealthcareproviderorpharmacistifyouhaveanyquestions

aboutTRUVADA.

WhatisthemostimportantinformationIshouldknowaboutTRUVADA?

•SomepeoplewhohavetakenmedicinelikeTRUVADA(nucleosideanalogs)

havedevelopedariousconditioncalledlacticacidosis(buildupofanacidin

theblood).Lacticacidosiscanbeamedicalemergencyandmayneedtobetreated

urhealthcareproviderrightawayifyougetthefollowing

signsorsymptomsoflacticacidosis.

•Youfeelveryweakortired.

•Youhaveunusual(notnormal)musclepain.

•Youhavetroublebreathing.

•Youhavestomachpainwithnauaandvomiting.

•Youfeelcold,especiallyinyourarmsandlegs.

•Youfeeldizzyorlightheaded.

•Youhaveafastorirregularheartbeat.

•SomepeoplewhohavetakenmedicineslikeTRUVADAhavedeveloped

riousliverproblemscalledhepatotoxicity,withliverenlargement

(hepatomegaly)andfatintheliver(steatosis).Callyourhealthcareproviderright

awayifyougetthefollowingsignsorsymptomsofliverproblems.

•Yourskinorthewhitepartofyoureyesturnsyellow(jaundice).

•Yoururineturnsdark.

•Yourbowelmovements(stools)turnlightincolor.

•Youdon’tfeellikeeatingfoodforveraldaysorlonger.

•Youfeelsicktoyourstomach(naua).

•Youhavelowerstomacharea(abdominal)pain.

•Youmaybemorelikelytogetlacticacidosisorliverproblemsifyouare

female,veryoverweight(obe),orhavebeentakingnucleosideanalogmedicines,

likeTRUVADA,foralongtime.

GileadSciences29

•IfyouarealsoinfectedwiththehepatitisBvirus(HBV),youneedclomedical

-up

includesmedicalexamsandbloodteststocheckforHBVthatcouldbegetting

tswithhepatitisBvirusinfection,whotakeTRUVADAandthen

stopit,mayget“flare-ups”oftheirhepatitis.A“flare-up”iswhenthedia

suddenlyreturnsinaworwaythanbefore.

WhatisTRUVADA?

TRUVADAisatypeofmedicinecalledanHIV-1(humanimmunodeficiencyvirus)

nucleosideanalogrevertranscriptainhibitor(NRTI).TRUVADAcontains2

medicines,EMTRIVA®(emtricitabine)andVIREAD®(tenofovirdisoproxilfumarate,or

tenofovirDF)Aisalwaysudwithotheranti-HIV-1

Aisforadultsage18and

Ahasnotbeenstudiedinchildrenunderage18oradultsoverage65.

HIVinfectiondestroysCD4+Tcells,

largenumberofTcellsaredestroyed,

acquiredimmunedeficiencysyndrome(AIDS)develops.

TRUVADAhelpsblockHIV-1revertranscripta,achemicalinyourbody(enzyme)

AlowerstheamountofHIV-1intheblood

(viralload).TRUVADAmayalsohelptoincreathenumberofTcells(CD4+cells).

LoweringtheamountofHIV-1inthebloodlowersthechanceofdeathorinfectionsthat

happenwhenyourimmunesystemisweak(opportunisticinfections).

g-termeffectsof

takingTRUVADAmaystillget

opportunisticinfectionsorotherconditionsthathappenwithHIV-1infection.

Opportunisticinfectionsareinfectionsthatdevelopbecautheimmunesystemis

theconditionsarepneumonia,herpesvirusinfections,and

Mycobacteriumaviumcomplex(MAC)ryimportantthatyoue

yourhealthcareproviderregularlywhiletakingTRUVADA.

TRUVADAdoesnotloweryourchanceofpassingHIV-1tootherpeoplethrough

xualcontact,sharingneedles,rhealth

andthehealthofothers,itisimportanttoalwayspracticesaferxbyusingalatexor

polyurethanecondomorotherbarriertolowerthechanceofxualcontactwithmen,

vaginalcretions,orsharedirtyneedles.

WhoshouldnottakeTRUVADA?

•

endof

thisleafletforacompletelistofingredients.

•DonottakeTRUVADAifyouarealreadytakingATRIPLA®,Combivir

(lamivudine/zidovudine),EMTRIVA,EpivirorEpivir-HBV(lamivudine),Epzicom

(abacavirsulfate/lamivudine),Trizivir(abacavirsulfate/lamivudine/zidovudine),or

VIREADbecauthemedicinescontainthesameorsimilaractiveingredients.

GileadSciences30

•DonottakeTRUVADAtotreatyourHIVinfectionifyouarealsotakingHEPSERA®

totreatyourHBVinfection.

WhatshouldItellmyhealthcareproviderbeforetakingTRUVADA?

Tellyourhealthcareproviderifyou:

•tknowifTRUVADAcan

yourhealthcareproviderwillneedtodecideif

TRUVADAwhileyouarepregnant,talktoyour

healthcareproviderabouthowyoucanbeontheTRUVADAAntiviralPregnancy

Registry.

•uldnotbreastfeedifyouareHIV-positivebecauof

,itisnotknownifTRUVADA

reawomanwho

hasorwillhaveababy,talkwithyourhealthcareprovideraboutthebestwaytofeed

yourbaby.

•havekidneyproblemsorareundergoingkidneydialysistreatment.

•haveboneproblems.

•haveliverproblemsincludinghepatitisBvirusinfection.

Tellyourhealthcareprovideraboutallthemedicinesyoutake,including

prescriptionandnon-prescriptionmedicines,vitamins,andherbalsupplements.

Especiallytellyourhealthcareproviderifyoutake:

•Videx,VidexEC(didanosine).TenofovirDF(acomponentofTRUVADA)may

needtobefollowedmore

,thedoof

didanosinemayneedtobereduced.

•Reyataz(atazanavirsulfate)orKaletra(lopinavir/ritonavir).Themedicinesmay

increatheamountoftenofovirDF(acomponentofTRUVADA)inyourblood,

needtobefollowedmorecarefully

Amay

retakingTRUVADAand

Reyataztogether,youshouldalsobetakingNorvir(ritonavir).

ewlistwhen

piesofthislisttoallofyourhealthcare

providersandpharmacisteverytimeyouvisityourhealthcareproviderorfilla

prescription.

HowshouldItakeTRUVADA?

•the

directionsfromyourhealthcareprovider,exactlyaswrittenonthelabel.

•Aisalwaysudwith

avekidneyproblems,youmayneedtotake

TRUVADAlessoften.

GileadSciences31

•esnotaffecthow

UVADAatthesametimeeachday.

•IfyouforgettotakeTRUVADA,

ake2dosatthesame

isimportantthatyoudonotmissanydosofTRUVADAoryouranti-HIV-1

medicines.

•WhenyourTRUVADAsupplystartstorunlow,getmorefromyourhealthcare

veryimportantbecautheamountofvirusinyour

usmay

developresistancetoTRUVADAandbecomehardertotreat.

•DonotchangeyourdoorstoptakingTRUVADAwithoutfirsttalkingwithyour

derahealthcareprovider’scarewhentaking

TRUVADA.

•IfyoutaketoomuchTRUVADA,callyourlocalpoisoncontrolcenteroremergency

roomrightaway.

WhatshouldIavoidwhiletakingTRUVADA?

•“WhatshouldItellmyhealthcareproviderbeforetaking

TRUVADA?”

•AvoiddoingthingsthatcanspreadHIVinfectionsinceTRUVADAdoesnotstop

youfrompassingtheHIVinfectiontoothers.

•Donotshareneedlesorotherinjectionequipment.

•Donotsharepersonalitemsthatcanhavebloodorbodyfluidsonthem,

liketoothbrushesorrazorblades.

•practicesaferxby

usingalatexorpolyurethanecondomorotherbarriertoreducethechanceof

xualcontactwithmen,vaginalcretions,orblood.

•ATRIPLA,Combivir(lamivudine/zidovudine),EMTRIVA,EpivirorEpivir-HBV

(lamivudine),Epzicom(abacavirsulfate/lamivudine),Trizivir(abacavir

sulfate/lamivudine/zidovudine),orVIREAD.

TRUVADAshouldnotbeudwiththemedicines.

•TRUVADAshouldnotbeudwithHEPSERA.

WhatarethepossiblesideeffectsofTRUVADA?

TRUVADAmaycauthefollowingrioussideeffects(e“Whatisthemost

importantinformationIshouldknowaboutTRUVADA?”):

•Lacticacidosis(buildupofanacidintheblood).Lacticacidosiscanbeamedical

urdoctorright

awayifyougetsignsoflacticacidosis.(See“Whatisthemostimportant

informationIshouldknowaboutTRUVADA?”)

GileadSciences32

•Seriousliverproblems(hepatotoxicity),withliverenlargement(hepatomegaly)

andfatintheliver(steatosis).Callyourhealthcareproviderrightawayifyougetany

signsofliverproblems.(See“WhatisthemostimportantinformationIshouldknow

aboutTRUVADA?”)

•“Flare-ups”ofhepatitisBvirusinfection,inwhichthediasuddenlyreturns

inaworwaythanbefore,

healthcareproviderwillmonitoryourconditionforveralmonthsafterstopping

Aisnotapprovedfor

aveadvancedliverdiaand

stoptreatmentwithTRUVADA,the“flare-up”ofhepatitisBmaycauyourliver

functiontodecline.

•avehadkidneyproblemsinthepastortakeother

medicinesthatcancaukidneyproblems,yourhealthcareprovidershoulddo

regularbloodteststocheckyourkidneys.

•Changesinbonemineraldensity(thinningbones).Laboratorytestsshow

changesinthebonesofpatientstreatedwithVIREAD,acomponentofTRUVADA.

SomeHIVpatientstreatedwithVIREADdevelopedthinningofthebones

(osteopenia)avehadboneproblemsinthe

past,yourhealthcareprovidermayneedtodoteststocheckyourbonemineral

onally,

bonepainandsofteningofthebone(whichmaycontributetofractures)mayoccur

asaconquenceofkidneyproblems.

OthersideeffectswithTRUVADAwhenudwithotheranti-HIV-1medicinesinclude:

•ChangesinbodyfathavebeeneninsomepatientstakingTRUVADAandother

hangesmayincludeincreadamountoffatinthe

upperbackandneck(“buffalohump”),breast,andaroundthemainpartofyour

body(trunk).Lossoffatfromthelegs,

andlongtermhealtheffectoftheconditionsarenotknownatthistime.

•InsomepatientswithadvancedHIVinfection(AIDS),signsandsymptomsof

inflammationfrompreviousinfectionsmayoccursoonafteranti-HIVtreatmentis

lievedthatthesymptomsareduetoanimprovementinthebody’s

immunerespon,enablingthebodytofightinfectionsthatmayhavebeenprent

oticeanysymptomsofinfection,pleainform

yourdoctorimmediately.

ThemostcommonsideeffectsofEMTRIVAorVIREADwhenudwithother

anti-HIV-1medicinesare:diarrhea,dizziness,naua,headache,fatigue,abnormal

dreams,sleepingproblems,rash,depression,onalsideeffectsare

lacticacidosis,kidneyproblems(includingdeclineorfailureofkidneyfunction),

inflammationofthepancreas,inflammationoftheliver,allergicreaction(including

swellingoftheface,lips,tongue,orthroat),shortnessofbreath,pain,fattyliver,

stomachpain,weakness,indigestion,intestinalgas,andhighvolumeofurineandthirst

painandmuscleweakness,bonepain,and

softeningofthebone(whichmaycontributetofractures)asaconquenceofkidney

GileadSciences33

scoloration(smallspotsorfreckles)mayalso

happenwithTRUVADA.

avequestionsaboutside

effects,anyneworcontinuingsymptomstoyour

althcareprovidermaybeabletohelpyou

managethesideeffects.

HowdoIstoreTRUVADA?

•KeepTRUVADAandallothermedicinesoutofreachofchildren.

•StoreTRUVADAatroomtemperature77°F(25°C).

•KeepTRUVADAinitsoriginalcontainerandkeepthecontainertightlyclod.

•hrowany

medicinesawaymakesurethatchildrenwillnotfindthem.

GeneralinformationaboutTRUVADA:

Medicinesaresometimesprescribedforconditionsthatarenotmentionedinpatient

TRUVADAforaconditionforwhichitwasnot

iveTRUVADAtootherpeople,eveniftheyhavethesame

armthem.

ould

likemoreinformation,askyourhealthcare

providerorpharmacistforinformationaboutTRUVADAthatiswrittenforhealth

einformation,youmayalsocall1-800-GILEAD-5oraccessthe

.

DonotuTRUVADAifaloverbottleopeningisbrokenormissing.

WhataretheingredientsofTRUVADA?

ActiveIngredients:emtricitabineandtenofovirdisoproxilfumarate

InactiveIngredients:Croscarmellosodium,lactomonohydrate,magnesium

stearate,microcrystallinecellulo,andpregelatinizedstarch(glutenfree).Thetablets

arecoatedwithOpadryIIBlueY-30-10701containingFD&CBlue#2aluminumlake,

hydroxypropylmethylcellulo2910,lactomonohydrate,titaniumdioxide,and

triacetin.

℞Only

November2009

TRUVADA,EMTRIVA,HEPSERAandVIREADareregisteredtrademarksofGilead

Sciences,AisatrademarkofBristol-MyersSquibb&GileadSciences,

ertrademarksreferencedhereinarethepropertyoftheirrespective

owners.

21-752-GS-023