Pemetrexed Reig Jofre
Package leaflet: Information for the user
Pemetrexed Reig Jofre 100 mg powder for concentrate for solution for infusion
Pemetrexed Reig Jofre 500 mg powder for concentrate for solution for infusion
pemetrexed
Readallofthisleafletcarefullybeforeyoustartreceivingthismedicinebecauseitcontainsimportantinformationforyou.
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If you have further questions, please ask your doctor or pharmacist.
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Whatisinthisleaflet:
What Pemetrexed Reig Jofre is and what it is used for
What you need to know before you use Pemetrexed Reig Jofre
How to use Pemetrexed Reig Jofre
Possible side effects
How to store Pemetrexed Reig Jofre
Contents of the pack and other information
What Pemetrexed Reig Jofre is and what it is used for
Pemetrexed Reig Jofre isamedicineusedinthetreatmentofcancer.
Pemetrexed Reig Jofre is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignantpleuralmesothelioma,aformofcancerthataffectstheliningofthelung,topatientswhohavenotreceivedpriorchemotherapy.
Pemetrexed Reig Jofre isalsogivenincombinationwithcisplatinfortheinitialtreatmentofpatientswithadvancedstageoflungcancer.
Pemetrexed Reig Jofre canbeprescribedtoyouifyouhavelungcanceratanadvancedstageifyourdiseasehasrespondedtotreatmentoritremainslargelyunchangedafterinitialchemotherapy.
Pemetrexed Reig Jofre isalsoatreatmentforpatientswithadvancedstageoflungcancerwhosediseasehasprogressedafterotherinitialchemotherapyhasbeenused.
What you need to know before you are given Pemetrexed Reig Jofre
Do not use Pemetrexed Reig Jofre
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if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of Pemetrexed Reig Jofre (listed in section 6).
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if you are breast-feeding; you must discontinue breast-feeding during treatment with Pemetrexed Reig Jofre.
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if you have recently received or are about to receive a vaccine against yellow fever.
WarningsandPrecautions
TalktoyourdoctororhospitalpharmacistbeforereceivingPemetrexed Reig Jofre.
Ifyoucurrentlyhaveorhavepreviouslyhadproblemswithyourkidneys,talktoyourdoctororhospitalpharmacistasyoumaynotbeabletoreceivePemetrexed Reig Jofre.
BeforeeachinfusionyouwillhavesamplesofyourbloodtakentoevaluateifyouhavesufficientkidneyandliverfunctionandtocheckthatyouhaveenoughbloodcellstoreceivePemetrexed Reig Jofre.Yourdoctormaydecidetochangethedoseordelaytreatingyoudependingonyourgeneralconditionandifyourbloodcellcountsaretoolow.Ifyouarealsoreceivingcisplatin,yourdoctorwillmakesurethatyouareproperlyhydratedandreceiveappropriatetreatmentbeforeandafterreceivingcisplatintopreventvomiting.
Ifyouhavehadoraregoingtohaveradiationtherapy,pleasetellyourdoctor,astheremaybeanearlyorlateradiationreactionwithPemetrexed Reig Jofre.
Ifyouhavebeenrecentlyvaccinated,pleasetellyourdoctor,asthiscanpossiblycausebadeffectswithPemetrexed Reig Jofre.
Ifyouhaveheartdiseaseorahistoryofheartdisease,pleasetellyourdoctor.
Ifyouhaveanaccumulationoffluidaroundyourlungs,yourdoctormaydecidetoremovethefluidbeforegivingyouPemetrexed Reig Jofre.
Childrenandadolescents
ThereisnorelevantuseofPemetrexed Reig Jofreinthepaediatricpopulation.
OthermedicinesandPemetrexed Reig Jofre
Pleasetellyourdoctorifyouaretakinganymedicineforpainorinflammation(swelling),suchasmedicinescalled“nonsteroidalanti-inflammatorydrugs”(NSAIDs),includingmedicinespurchased withoutadoctor’sprescription(suchasibuprofen).TherearemanysortsofNSAIDswithdifferentdurationsofactivity.BasedontheplanneddateofyourinfusionofPemetrexed Reig Jofre and/oronthestatusofyourkidneyfunction,yourdoctorneedstoadviseyouonwhichmedicinesyoucantakeandwhenyoucantakethem.Ifyouareunsure,askyourdoctororpharmacistifanyofyourmedicinesareNSAIDs.
Pleasetellyourdoctororhospitalpharmacistifyouaretakingorhaverecentlytakenanyothermedicines,includingmedicinesobtainedwithoutaprescription.
Pregnancy,breast-feedingand fertility
Pregnancy
Ifyouarepregnant,orthinkingaboutbecomingpregnant,tellyourdoctor.TheuseofPemetrexed Reig Jofre shouldbeavoidedduringpregnancy.YourdoctorwilldiscusswithyouthepotentialriskoftakingPemetrexed Reig Jofre duringpregnancy.Womenmustuseeffectivecontraceptionduringtreatmentwith Pemetrexed Reig Jofre.
Breast-feeding
Ifyouarebreast-feeding,tellyourdoctor.
Breast-feedingmustbediscontinuedduringPemetrexed Reig Jofretreatment.
Fertility
Menareadvisednottofatherachildduringandupto6monthsfollowingtreatmentwithPemetrexed Reig Jofre andshouldthereforeuseeffectivecontraceptionduringtreatmentwithPemetrexed Reig Jofre andforupto6 monthsafterwards.Ifyouwouldliketofatherachildduringthetreatmentorinthe6monthsfollowingreceiptoftreatment,seekadvicefromyourdoctororpharmacist.Youmaywanttoseekcounselingonspermstoragebeforestartingyourtherapy.
Drivingandusingmachines
Pemetrexed Reig Jofre maymakeyoufeeltired.Becarefulwhendrivingacarorusingmachines.
Pemetrexed Reig Jofrecontainssodium
Pemetrexed Reig Jofre 500mgcontainsapproximately54mgsodiumpervial.Tobetakenintoconsiderationbypatientsonacontrolledsodiumdiet.
Pemetrexed Reig Jofre 100mgcontainsapproximately11mgsodiumpervial.
How to use Pemetrexed Reig Jofre
ThedoseofPemetrexed Reig Jofre is500milligramsforeverysquaremetreofyourbody’ssurfacearea.Yourheightandweightaremeasuredtoworkoutthesurfaceareaofyourbody.Yourdoctorwillusethisbodysurfaceareatoworkouttherightdoseforyou.Thisdosemaybeadjusted,ortreatmentmaybedelayeddependingonyourbloodcellcountsandonyourgeneralcondition.Ahospitalpharmacist,nurseordoctorwillhavemixedthePemetrexed Reig Jofre powderwith9mg/ml(0.9%)sodiumchloridesolutionforinjectionbeforeitisgiventoyou.
YouwillalwaysreceivePemetrexed Reig Jofre byinfusionintooneofyourveins.Theinfusionwilllastapproximately10minutes.
WhenusingPemetrexed Reig Jofre incombinationwithcisplatin:
Thedoctororhospitalpharmacistwillworkoutthedoseyouneedbasedonyourheightandweight.Cisplatinisalsogivenbyinfusionintooneofyourveins,andisgivenapproximately30minutesaftertheinfusionofPemetrexed Reig Jofre hasfinished.Theinfusionofcisplatinwilllastapproximately2hours.
Youshouldusuallyreceiveyourinfusiononceevery3 weeks.
Additionalmedicines:
Corticosteriods:yourdoctorwillprescribeyousteroidtablets(equivalentto4milligramofdexamethasonetwiceaday)thatyouwillneedtotakeonthedaybefore,onthedayof,andthedayafterPemetrexed Reig Jofre treatment.Thismedicineisgiventoyoutoreducethefrequencyandseverityofskinreactionsthatyoumayexperienceduringyouranticancertreatment.
Vitaminsupplementation:yourdoctorwillprescribeyouoralfolicacid(vitamin)oramultivitamincontainingfolicacid(350to1000micrograms)thatyoumusttakeonceadaywhileyouaretakingPemetrexed Reig Jofre .Youmusttakeatleast5dosesduringthesevendaysbeforethefirstdoseofPemetrexed Reig Jofre.Youmustcontinuetakingthefolicacidfor21daysafterthelastdoseofPemetrexed Reig Jofre.YouwillalsoreceiveaninjectionofvitaminB12(1000micrograms)intheweekbeforeadministrationofPemetrexed Reig Jofre andthenapproximatelyevery9weeks(correspondingto3coursesofPemetrexed Reig Jofre treatment).VitaminB12andfolicacidaregiventoyoutoreducethepossibletoxiceffectsoftheanticancertreatment.
Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.
Possible side effects
Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.
Youmustcontactyourdoctorimmediatelyifyounoticeanyofthefollowing:
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Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death.
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If you start feeling chest pain (common) or having a fast heart rate (uncommon).
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If you have pain, redness, swelling or sores in your mouth (very common).
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Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death. Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
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If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
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If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
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If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)
Thefrequencyofpossiblesideeffectslistedbelowisdefinedasfollows:
Verycommon(mayaffectmorethan1patientin10)
Common(mayaffect1to10patientsin100)
Uncommon(mayaffect1to10patientsin1,000)
Rare(mayaffect1to10patientsin10,000)
Veryrare(mayaffectlessthan1patientin10,000)
SideeffectswithPemetrexed Reig Jofre mayinclude:
Verycommon
Lowwhitebloodcells
Lowhaemoglobinlevel(anaemia)
Lowplateletcount
Diarrhoea
Vomiting
Pain,redness,swellingorsoresinyourmouth
Nausea
Lossofappetite
Fatigue(tiredness)
Skinrash
Hairloss
Constipation
Lossofsensation
Kidney:abnormalbloodtests
Common
Allergicreaction:skinrash/burningorpricklingsensation
Infectionincludingsepsis
Fever
Dehydration
Kidneyfailure
Irritationoftheskinanditching
Chestpain
Muscleweakness
Conjunctivitis(inflamedeye)
Upsetstomach
Painintheabdomen
Tastechange
Liver:abnormalbloodtests
Wateryeyes
Uncommon
Acuterenalfailure
Fastheartrate
Inflammationoftheliningoftheoesophagus(gullet)hasbeenexperiencedwithPemetrexed Reig Jofre /radiation therapy.
Colitis(inflammationoftheliningofthelargebowel,whichmaybeaccompaniedbyintestinalorrectalbleeding)
Interstitialpneumonitis(scarringoftheairsacsofthelung)
Oedema (excess fluid in body tissue, causing swelling)
Somepatientshaveexperiencedaheartattack,strokeor“mini-stroke”whilereceivingPemetrexed Reig Jofre usuallyincombinationwithanotheranticancertherapy.
Pancytopenia-combinedlowcountsofwhitecells,redcellsandplatelets.
Radiationpneumonitis(scarringoftheairsacsofthelungassociatedwithradiationtherapy)mayoccurinpatientswhoarealsotreatedwithradiationeitherbefore,duringoraftertheirPemetrexed Reig Jofre therapy.
Extremitypain,lowtemperatureanddiscolourationhavebeenreported.
Bloodclotsinthelungbloodvessels(pulmonaryembolism)
Rare
Radiationrecall(askinrashlikeseveresunburn)whichcanoccuronskinthathaspreviouslybeenexposedtoradiotherapy,fromdaystoyearsaftertheradiation.
Bullousconditions(blisteringskindiseases)-includingStevens-JohnsonsyndromeandToxicepidermalnecrolysis.
Haemolyticanaemia(anaemiaduetodestructionofredbloodcells)
Hepatitis(inflammationoftheliver)
Anaphylacticshock(severeallergicreaction)
Youmighthaveanyofthesesymptomsand/orconditions.Youmusttellyourdoctorassoonaspossiblewhenyoustartexperiencinganyofthesesideeffects.
Ifyouareconcernedaboutanysideeffects,talktoyourdoctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below) [to be completed nationally]:
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Pemetrexed Reig Jofre
Keepthis medicine outofthesight and reachofchildren.
Donotusethis medicine aftertheexpirydatewhichisstatedonthepack.
Thismedicinedoesnotrequireanyspecialstorageconditions.
ReconstitutedandInfusionSolutions:Theproductshouldbeusedimmediately.Whenpreparedasdirected,chemicalandphysicalin-usestabilityofreconstitutedandinfusionsolutionsofpemetrexedweredemonstratedfor24hoursatrefrigeratedtemperatureor25ºC.
Thismedicineisforsingleuseonly;anyunusedsolutionmustbedisposedofinaccordancewithlocalrequirement.
Contents of the pack and other information
WhatPemetrexed Reig Jofrecontains
Theactivesubstanceispemetrexed.
Pemetrexed Reig Jofre 100mg:Eachvialcontains100milligramsofpemetrexed(aspemetrexeddisodium 2.5 H2O).
Pemetrexed Reig Jofre 500 mg:Eachvialcontains500milligramsofpemetrexed(aspemetrexeddisodium2.5 H2O).
Afterreconstitution,thesolutioncontains25mg/mlofpemetrexed.Furtherdilutionbyahealthcareproviderisrequiredpriortoadministration.
Theotheringredientsaremannitol,hydrochloricacid (for pH adjustment) andsodiumhydroxide (for pH adjustment).
WhatPemetrexed Reig Jofre lookslikeandcontentsofthepack
Pemetrexed Reig Jofre isapowderforconcentrateforsolutionforinfusioninavial.Itisawhitetofaintyellowlyophilisedpowder.
EachpackofPemetrexed Reig Jofre consistsofonePemetrexed Reig Jofre vial.Notallpacksizesmaybemarketed.
MarketingAuthorisationHolder and Manufacturer
MarketingAuthorisationHolder
<MAH in DK, IS, NO, SE, UK>
Laboratorio Reig Jofre S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain
<MAH in ES>
Laboratorio RAMÓN SALA, S.L.
C/Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain
<Local representative <in DK, NO, SE>>
Bioglan AB,
Box 50310,
SE-20213 Malmö
Sweden
Manufacturer
Laboratorio Reig Jofre S.A.
c/ Jarama 111 Pol. Ind.
45007 Toledo
Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Pemetrexed Reig Jofre
Iceland: Pemetrexed Reig Jofre 100 mg stofn fyrir innrennslisþykkni, lausn
Pemetrexed Reig Jofre 500 mg stofn fyrir innrennslisþykkni, lausn
Norway: Pemetrexed Reig Jofre
Spain: Pemetrexed Sala 100 mg polvo para concentrado para solución para perfusión EFG
Pemetrexed Sala 500 mg polvo para concentrado para solución para perfusión EFG
Sweden: Pemetrexed Reig Jofre 100 mg pulver till koncentrat till infusionsvätska, lösning
Pemetrexed Reig Jofre 500 mg pulver till koncentrat till infusionsvätska, lösning
United Kingdom: Pemetrexed 100 mg powder for concentrate for solution for infusion
Pemetrexed 500 mg powder for concentrate for solution for infusion
Thisleafletwaslastapprovedin:2015-10-05
Detailed information on this medicine is available on the website of [MS/Agency]
Thefollowinginformationisintendedformedicalorhealthcareprofessionalsonly:
Instructionsforuse,handlinganddisposal.
Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Calculate the dose and the number of Pemetrexed Reig Jofre vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
Pemetrexed Reig Jofre 100 mg:
Reconstituteeach100mgvialwith4.2mlof9mg/ml(0.9%)sodiumchloridesolutionforinjection,withoutpreservative,resultinginasolutioncontaining25mg/mlpemetrexed.Pemetrexed Reig Jofre 500mg:
Reconstituteeach500mgvialwith20mlof9mg/ml(0.9%)sodiumchloridesolutionforinjection,withoutpreservative,resultinginasolutioncontaining25mg/mlpemetrexed.
Gentlyswirleachvialuntilthepowderiscompletelydissolved.Theresultingsolutionisclearandrangesincolourfromcolourlesstoyelloworgreen-yellowwithoutadverselyaffectingproductquality.ThepHofthereconstitutedsolutionisbetween6.6and7.8. Further dilution is required.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Preparationandadministrationprecautions:Aswithotherpotentiallytoxicanticanceragents,careshouldbeexercisedinthehandlingandpreparationofpemetrexedinfusionsolutions.Theuseofglovesisrecommended.Ifapemetrexedsolutioncontactstheskin,washtheskinimmediatelyandthoroughlywithsoapandwater.Ifpemetrexedsolutionscontactthemucousmembranes,flushthoroughlywithwater.Pemetrexedisnotavesicant.Thereisnotaspecificantidoteforextravasationofpemetrexed.Therehavebeenafewreportedcasesofpemetrexedextravasation,whichwerenotassessedasseriousbytheinvestigator.Extravasationshouldbemanagedbylocalstandardpracticeaswithothernon-vesicants.
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