Simeprevir is a hepatitis C protease inhibitor used to treat chronic hepatitis C in combination with other medicines. It works by preventing the spread of the hepatitis C virus in the body. Do not use simeprevir if allergic to any ingredients, have severe liver problems, or are not also taking other drugs to treat hepatitis C infection. Simeprevir may interact with many other medications and herbal or dietary supplements, so be sure to discuss any other products you are taking with your doctor or pharmacist before using simeprevir. Carefully follow dosage instructions and continue treatment for the full prescribed period, even if symptoms improve, to avoid developing resistance to the medication.

1. TreatingchronichepatitisC(CHC) incertainpatients.Itmustbe usedin combinationwithcertain
othermedicinestotreatCHC.
SimeprevirisahepatitisCprotease inhibitor.Itreducesthe amountof hepatitisCvirus(HCV) inthe
bodyby preventing the spreadof the HCV withinthe body.
Do NOT use simeprevirif:
youare allergictoany ingredientinsimeprevir
youhave severe liverproblems
youare NOT takingotherdrugsto treat HCV infection
youare takingcarbamazepine,cisapride,clarithromycin,cobicistat,cyclosporine,delavirdine,
dexamethasone,efavirenz,erythromycin,etravirine,fluconazole,HIV proteaseinhibitors(eg,
ritonavir),itraconazole,ketoconazole,milkthistle,nevirapine,oxcarbazepine,phenobarbital,
phenytoin,posaconazole, rifabutin,rifampin,rifapentine,St.John’swort,telithromycin,or
voriconazole
Before usingsimeprevir:
Some medical conditionsmayinteractwithsimeprevir.Tell yourdoctororpharmacistif youhave
any medical conditions,especiallyif anyof the followingapplytoyou:
if you are pregnant,planningtobecome pregnant,orare breast-feeding
if you are able to become pregnant
if you are takingany prescriptionornonprescriptionmedicine,herbal preparation,ordietary
supplement
if you have allergiestomedicines,foods,orothersubstances,includingsulfadrugs
if you have otherliverproblems(eg,cirrhosis,hepatitisBinfection)orhave hada livertransplant
if you are receivingphototherapy
if you have evertakenanymedicine totreatHCV infection

2. if you are takingsofosbuvirwithsimeprevirtotreatHCV infectionandare alsotakingamiodarone.
The risk of slowheartbeatmaybe increased,especiallyif youare takinga betablocker(eg,
metoprolol),have heartproblems,orhave certainliver problems
Some MEDICINESMAY INTERACTwithsimeprevir.Tell yourhealthcare providerif youare takingany
othermedicines,especiallyanyof the following:
Many prescriptionandnonprescriptionmedicines(eg,usedforanxiety,asthmaorotherlungor
breathingproblems,bloodthinning,cancer,depressionorothermental ormoodproblems,erectile
dysfunction,highbloodpressure,highcholesterol,HIV,immune systemsuppression,infections,
inflammation,irregularheartbeatorotherheartproblems,nausea andvomiting,pulmonaryarterial
hypertension(PAH),seizures,sleep,stomachorbowel problems),multivitaminproducts,andherbal
or dietarysupplementsbecausetheymayinteractwithsimeprevir.As
How to use simeprevir:
Use simeprevirasdirectedby yourdoctor.Checkthe label onthe medicine forexactdosing
instructions.
An extrapatientleafletisavailablewithsimeprevir.Talktoyourpharmacistif youhave questions
aboutthisinformation.
Simeprevirmustbe takenwithcertainothermedicines totreatCHC.Some of these medicinescome
withtheirownMedicationGuides.If the othermedicineshave aMedicationGuide,be sure toread
it eachtime youget themfilled.
Take simeprevirbymouthwithfood.
Swallowsimeprevirwhole.Donotbreak,crush,or chew before swallowing.
Simeprevirworksbestif itistakenat the same timeseachday.
Continue totake simeprevirevenif youfeel well.Donotmissanydoses.
If you missa dose of simeprevir,take itassoonas possible withfood.If itisless than12 hours
before yournextdose,skipthe misseddose andgoback to yourregulardosingschedule.Donot
take 2 dosesat once.
Importantsafetyinformation:

3. Tell yourdoctor or dentistthatyoutake simeprevirbefore youreceive anymedical ordental care,
emergencycare,orsurgery.
Simeprevirmaycause rashesandskinreactionsto sunlight,whichmaybe severe.Sometimes,this
has ledtothe needtogo to the hospital.Thisismostcommonduringthe first4 weeksof treatment,
but can happenat any time duringtreatment.Thisriskmaybe higherinpatientsof East Asian
descent.Limitsunlightexposure andavoidthe use of sunlamps,tanningbeds,orothertypesof light
therapyduringtreatmentwithsimeprevir.Use asunscreen,andweara hat, sunglasses,and
protective clothingif youmustbe outside formore thana shorttime.Call yourdoctor rightaway if
youhave burning,redness,swelling,orblistersonyourskin;mouthsoresorulcers;or red or
inflamedeyes.
Casesof slowheartbeatandthe needto geta pacemakerhave happenedwhenanHCV medicine
(sofosbuvir) wasgivenwithamiodarone andcertainotherHCV medicines(includingsimeprevir).
Sometimes,thishasbeenfatal.Slowheartbeathashappenedupto2 weeksafterstartingHCV
treatment. Youwill needtobe monitoredcloselyif youwillbe takingamiodaronewithHCV
treatment.Follow whatyourdoctorhastoldyou to do.Call your doctorright awayif you have
symptomsof slowheartbeat(eg,chestpain,confusion,dizzinessorlightheadedness,faintingor
near-fainting,memoryproblems,shortnessof breath,tirednessorweakness).
Simeprevirdoesnotstopthe spreadof HCV to othersthroughbloodor sexual contact.Donot have
any kindof sex withoutprotection(eg,latex orpolyurethane condoms) if youhave HCV infection.Do
not share needles,injectionsupplies,oritemslike toothbrushesorrazors.Talkwithyour healthcare
provideraboutwaysto preventthe spreadof HCV to others.
Do not change yourdose or stop takingsimepreviroranyof yourmedicineswithoutcheckingwith
your doctor.
Whenyour medicine supplyislow,getmore fromyourdoctoror pharmacistas soonas youcan. Do
not stoptakingsimeprevir,evenforashortperiodof time.If youdo, the virusmaygrow resistantto
the medicine andbecome hardertotreat.
Simeprevirmustbe takenalongwithcertainothermedicinestotreatCHC.Be sure you know about
all of the warnings,benefits,andrisksof the othermedicines.Discussanyquestionsorconcerns
withyourdoctor.
If you stoptakingany of your othermedicinestotreatCHC,talkwithyour doctor.You may needto
stoptakingsimepreviraswell.
If you may become pregnant,youmustuse aneffective formof birthcontrol whileyoutake
simeprevir.If youhave questions abouteffectivebirthcontrol,talkwithyourdoctor.
Lab testsmay be performedwhileyouuse simeprevirandforseveral monthsafteryoustop
simeprevir.These testsmaybe usedtomonitoryourconditionorcheckfor side effects.Be sure to
keepall doctorand labappointments.
PREGNANCYandBREAST-FEEDING:It is notknownif simeprevircancause harm to the fetus.If you
thinkyoumay be pregnant,contact yourdoctor. Youwill needtodiscussthe benefitsandrisksof

4. usingsimeprevirwhile youare pregnant.Itisnot knownif thismedicineisfoundinbreastmilk.Do
not breast-feedwhile takingsimeprevir.
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