| Active substance(s) | Pegvisomant |
| Country of admission | gb |
| Marketing authorisation holder | Pfizer Limited |
| ATC Code | H01AX01 |
| Pharmacological groups | Anterior pituitary lobe hormones and analogues |
SOMAVERTisusedforthetreatmentofacromegaly,ahormonaldisorderresultingfromtheincreasedsecretionofgrowthhormone(GH)andIGF-I(Insulin-likegrowthfactors),whichischaracterisedbyovergrowthofbone,softtissueswelling,heartdiseaseandrelateddisorders.
SOMAVERTisaproductofbiotechnology.TheactivesubstanceinSOMAVERT,pegvisomantisknownasagrowthhormonereceptorantagonist.ThesesubstancesdecreasetheactionofGHandlevelsofIGF-Icirculatingintheblood.
If you are allergic hypersensitive to pegvisomant or any of the other ingredients ofSOMAVERT
Youmusttellyourdoctorifyouhavepreviouslyusedothermedicinesforthetreatmentofacromegalyormedicinesforthetreatmentofdiabetes.
Pleasetellyourdoctororpharmacistifyouareusingorhaverecentlyusedanyothermedicines,includingmedicinesobtainedwithoutaprescription.
Aspartofyourtreatmentyoumaybegivenothermedicines.ItisimportanttokeepusingallyourmedicinesaswellasSOMAVERTunlessyouaretoldotherwisebyyourdoctororpharmacist.
TheeffectsofSOMAVERTinpregnantwomenarenotknown,andsotheuseofSOMAVERTinpregnantwomenisnotrecommended.YouareadvisedtonotbecomepregnantwhiletakingSOMAVERTtherapy.Incaseyoubecomepregnant,youmustconsultyourdoctor.Askyourdoctororpharmacistforadvicebeforetakinganymedicine.
ItisnotknownifSOMAVERTpassesintobreastmilk.Youshouldnotbreast-feedwhiletakingSOMAVERTunlessyourdoctorhasdiscussedthiswithyou.
Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.
Thismedicinalproductcontainslessthan1mmolsodium(23mg)per10mgdose,lessthan1mmolsodium(23mg)per15mgdose,orlessthan1mmolsodium(23mg)per20mgdosei.e.essentially?sodium-free?.
AlwaysinjectSOMAVERTexactlyasyourdoctorhastoldyou.Youshouldcheckwithyourdoctororpharmacistifyouarenotsure.
Astartingdoseof80mgofSOMAVERTwillbegivensubcutaneously(justundertheskin)byyourdoctor.Followingthis,theusualdailydoseofSOMAVERTis10mg,whichisgivenbysubcutaneousinjection(justundertheskin).
Everyfourtosixweeksyourdoctorwillmakeappropriatedoseadjustments,madeinincrementsof5mgpegvisomant/day,basedonyourso-calledserumIGF-Ilevelstomaintainanoptimaltherapeuticresponse.
SOMAVERTisinjectedundertheskin.Theinjectioncanbeself-administeredorgivenbyanotherperson,forexampleyourdoctororhis/herassistant.Thedetailedinstructionsoninjectionprocedureprovidedattheendofthisleafletmustbefollowed.YoushouldcontinuetoinjectSOMAVERTforaslongasinstructedbyyourdoctor.
SOMAVERTmustbedissolvedbeforeuse.Theinjectionmustnotbemixedinthesamesyringeorvialasanyothermedicine.
Fattytissueoftheskincanbuild-upatthesiteofinjection.Toavoidthis,useaslightlydifferentplaceforyourinjectioneachtime,asdescribedinStep2ofthe?InstructionsforPreparingandGivinganInjectionofSomavert?sectionofthisleaflet.Thisgivesyourskinandtheareaunderyourskintimetorecoverfromoneinjectionbeforeitreceivesanotheroneinthesameplace.
IfyouhavetheimpressionthattheeffectofSOMAVERTistoostrongortooweak,talktoyourdoctororpharmacist.
IfyouaccidentallyinjectmoreSOMAVERTthantoldtobyyourdoctoritisunlikelytobeserious,butyoushouldcontactyourdoctororpharmacistimmediately.
IfyouforgettogiveyourselfaninjectionyoushouldinjectthenextdoseassoonasyourememberandthencontinuetoinjectSOMAVERTasprescribedbyyourdoctor.Donotinjectadoubledosetomakeupforforgottenindividualdoses.
Ifyouhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctororpharmacist.
Likeallmedicines,SOMAVERTcancausesideeffects,althoughnoteverybodygetsthem.
Commonsideeffects(likelytooccurinfewerthan1in10patients)include:
Headache, dizziness, sleepiness, uncontrolled trembling.Diarrhoea, constipation, feeling sick, being sick, feeling bloated, indigestion, gas.Sweating, itching, rash.Joint pain, muscle pain, swelling of the extremities.Increased blood cholesterol, weight gain, increased blood glucose, increased appetite.Increased blood pressure.Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fatbelow the surface of the skin at injection site.Flu-like illness, fatigue.Increased levels of substances that measure the function of the liver. These can be seen in theresults of blood tests.Abnormal dreams, problems sleeping
Uncommonsideeffects(likelytooccurinfewerthan1in100patients)include:
Decreased platelets in the blood, increased or decreased white cells in the blood, tendency tobleed.Decreased sense of touch, abnormal sense of taste, migraine.Eyestrain, eye pain, inner ear problems.Shortness of breath.Dry mouth, increased saliva, tooth problems, hemorrhoids.Blood in the urine, protein in the urine, increased urine, kidney problems
Facial swelling, dry skin, tendency to bruise, night sweats.Arthritis.Increased fatty substances in the blood, decreased blood glucose.Fever, weakness, feeling abnormal, impaired healing.Anger, lack of interest, feeling confused, increased sex drive, panic attack, loss of memory
Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnotlistedinthisleaflet,pleasetellyourdoctororpharmacist.
About17%ofpatientswilldevelopantibodiestogrowthhormoneduringtreatment.TheantibodiesdonotseemtostopSOMAVERTfromworking.
Keepoutofthereachandsightofchildren
DonotuseSOMAVERTaftertheexpirydatewhichisstatedonthevialandthecartonafterEXP.Theexpirydatereferstothelastdayofthatmonth.
Storeinarefrigerator(2-C?8-C).Donotfreeze.Keepthevialsintheoutercartoninordertoprotectfromlight.
AfterpreparingtheSOMAVERTsolutionitmustbeusedimmediately.CarefullydisposeofanySOMAVERTsolutionthathasnotbeeninjected.
DonotuseSOMAVERTifyounoticethatthesolutioniscloudyorcontainsparticulatematter.
Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelptoprotecttheenvironment.
SOMAVERTispresentedasapowderandasolventforinjection,inavial.Powderinavial(either10mg,15mg,or20mgpegvisomant)andsolventinavial(8ml).Packsizesof1and30.Notallpacksizesaremarketed.Thepowderiswhiteandthesolventisclearandcolourless.
PfizerLimited
Sandwich
KentCT139NJ
UnitedKingdom
PfizerManufacturingBelgiumNV
Rijksweg12
2870Puurs
Belgium
Foranyinformationaboutthismedicine,pleasecontactthelocalrepresentativeoftheMarketingAuthorisationHolder.
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DanmarkPfizer ApSTlf 45 44 20 11 00 NederlandPfizer bvTel 31 010 406 43 0
DeutschlandPfizer Pharma GmbHTel 49 030 550055 51000 NorgePfizer ASTlf 47 67 52 61 0
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PfizerLuxembourgSARLfilialasLietuvoje
Tel.+37052514000
DetailedinformationonthismedicineisavailableontheEuropeanMedicinesAgency(EMEA)website:http://www.emea.europa.eu.Therearealsolinkstootherwebsitesaboutrarediseasesandtreatments.
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ThefollowinginstructionsexplainhowtoprepareandinjectSOMAVERT.Pleasereadtheinstructionscarefullyandfollowthemstepbystep.Youwillbeinstructedbyyourdoctororhis/herassistantonthetechniqueofself-injection.Donotattempttoself-injectuntilyouaresurethatyouunderstandhowtoprepareandgiveaninjection.
Thepowdermustbedissolvedwiththesolventbeforeuse.
Thisinjectionshouldnotbemixedinthesamesyringeorvialwithanyothermedicine.
Thereare2methodsforpreparingtheSOMAVERTsolution.Pleasediscusswithyourhealthcareprofessionalwhichmethodisbestforyou:
a)TheVialAdapterMethod(MIXJECT?),
b)TheNon-VialAdapterMethod.
Wash your hands thoroughly.Collect1 vial of powder SOMAVERT,1 vial of solvent Water for Injections,1 luer-lock syringe of 1ml for both reconstituting the SOMAVERT solution and giving theinjection is recommended. However, other sizes and types of syringes can be used for thepreparation and injection of SOMAVERT. Please consult your healthcare professional for furtherinformation.2 MIXJECT vial adapters,1 detachable needle 25 to 30 gauge,Alcohol or antiseptic swabs and a proper disposal container for used needles and syringes.Inspect the expiry dates on both the vial label and the syringe label. They should not be used afterthe month and year shown
Afterreconstitutionwith1mlofsolvent,1mloftheclearsolutioncontainseither10mg,15mg,or20mgpegvisomant.
Figure
1.RemovetheprotectiveplasticcapsfromthetopsofbothvialofsolventandvialofSOMAVERT(Fig.1).Takecarenottotouchtherubbervialstoppers.Atthispoint,thestoppersareclean.Ifthestoppersaretouchedorotherwisecontaminated,youmustcleanthemwithanantisepticoralcoholswabbeforeinsertingavialadapterthroughthestopper.
2.Openonlyoneofthevialadaptersbypeelingbacktheprotectivecover.Leavetheadapterintheplasticpackaginganddonottouchthespikeoftheadapter.
Figure
3.Whileholdingtheplasticadapterpackaging,placetheadapteroverthesolventvialandinsertthepiercingspikeofthevialadapterallthewayinthroughtherubberstopperofthesolventvial,usingapushingmotion.(Fig.2).Removetheplasticpackagingfromthevialadapteranddiscard.
Figure
4.Removethesyringefromtheprotectivepackaging.Pulltheplungerofthesyringeouttothe1mlmark.Holdthesolventvial,placedonaflatsurface,withonehandandconnectthetipofthesyringetothevialadapterbytwistingthesyringeonthevialadapterclockwise(Fig.3).Gentlypushtheplungeruntiltheairisinjectedintothevial.
Figure
5.Securelygraspthesolventvial,adapterandsyringeassembly.Carefullyturnthevial,adapterandsyringeassemblyupsidedown.Bringtoeyelevel(Fig.4).
6.Slideonehandcarefullydownthesolventvialsothatwithyourthumbandforefingeryoucansecurelygrasptheneckofthevial,andwithyourotherfingers,theupperpartofthesyringe.Withtheotherhand,slowlypullthesyringeplungerdowntoslightlypastthe1mlmark.
Examinethesolutioninthesyringeforairbubbles.Ifbubblesarepresent,tapthesyringebarreluntilthebubblesrisetothetopofthesyringe.Carefullypushtheplungeruptoejectonlytheairbubblesbackintothevial.Recheckthat1mlofsolventremainsinthesyringe.
Carefullyturnthesolventvial,adapterandsyringeassemblyandplacethemuprightonacleansurface.Donotremovethesyringefromtheadapteratthispoint.
Figure
7.Asexplainedforthefirstvialadapter,opennowthesecondvialadapterbypeelingbacktheprotectivecover.Donottouchthevialadapter.Donotremovetheadapterfromtheplasticpackaging.Whileholdingtheplasticadapterpackaging,placetheadapterovertheSOMAVERTvialandinsertthepiercingspikeofthevialadapterallthewayinthroughtherubberstopperoftheSOMAVERTvial,usingapushingmotion(Fig.5).Removetheplasticpackagingfromthevialadapteranddiscard.
Figure
8.DisconnectthesyringefromthesolventvialadapterandattachittothevialadapteronthevialofSOMAVERT.TiltthevialofSOMAVERT,adapterandsyringeassemblytothesideandgentlyinjectthesolventdowntheinnersideofthevialofSOMAVERT(Fig6).Discardthesolventvialasdirectedbyyourhealthcareprovider.
Figure
9.HoldthevialofSOMAVERTwiththeadapterandsyringestillattacheduprightbetweenyourhandsandgentlyrollittodissolvethepowder(Fig.7).DONOTSHAKETHEVIAL.Thesolutionshouldbeclearafterthepowderisdissolved.Ifthesolutioniscloudyorhazy,donotinjectit.Notifyyourpharmacyandrequestareplacementvial.Donotthrowthevialawaybecausethepharmacymayrequestthatyoureturnit.
10.SecurelygraspthevialcontainingtheSOMAVERTreconstitutedsolution,vialadapterandsyringeassembly.Carefullyturnthevial,adapterandsyringeassemblyupsidedown.Bringtoeyelevel.
Figure
11.Asbefore,slideonehandcarefullydownthevialsothatwithyourthumbandforefingeryoucansecurelygrasptheneckofthevial,andwithyourotherfingers,theupperportionofthesyringe.Withtheotherhand,slowlypullthesyringeplungerdowntowithdrawthefullcontentsofthevial(1ml).(Fig.8).
Visuallyinspectthesyringeforairbubbles.Ifbubblesarepresent,tapthesyringebarreluntilthebubblesrisetothetopofthesyringe.Carefullypushtheplungeruptoejectonlytheairbubblesbackintothevial.Recheckthat1mlofthesolutionremainsinthesyringe.CarefullyturnthevialcontainingtheSOMAVERTreconstitutedsolution,adapterandsyringeassemblyandplacethemuprightonacleansurface.Donotremovethesyringefromtheadapteratthispoint.
Figure 912. Open the needle packaging so that only the end of the needle to be connected to the syringe isexposed. The needle should be partially left in its protective packaging. Lay the needle with itsprotective packaging on the tabletop. Disconnect the syringe from the vial. Discard theprotective packaging and attach the needle to the syringe. Keep the plastic cap on the needlewhile preparing the site for injection Fig. 9. Once reconstituted, SOMAVERT should be usedimmediately. Please proceed to STEP 2. GIVING THE INJECTION
Wash your hands thoroughly.Collect one vial of powder SOMAVERT and one vial of solvent Water for Injections, one 3-mlsyringe with a 21-gauge, 1-inch detachable needle, one standard 1 ml insulin syringe, alcohol orantiseptic swabs and a proper disposal container for used needles.Inspect the expiry dates on both the vial label and the syringe label. They should not be used afterthe month and year shown
Afterreconstitutionwith1mlofsolvent,1mloftheclearsolutioncontainseither10mg,15mg,or20mgpegvisomant.
Removetheprotectiveplasticcapsfromthetopsofbothvials.Takecarenottotouchtherubbervialstoppers.Atthispoint,thestoppersareclean.Ifthestoppersaretouchedorotherwisecontaminated,youmustcleanthemwithanantisepticoralcoholswabbeforeinsertinganeedlethroughthestopper.
Carefullyremovethecapfromtheneedleofthelargersyringe(3ml)andsetthecapaside.Thisisthesolventsyringe.
Figure
1.Pulltheplungerofthesolventsyringedowntothe1mlmark.Withonehand,securelyholdthevialofsolventand,withtheotherhand,inserttheneedleofthesolventsyringestraightthroughthecenteroftherubberstopperanddeepintothevial.Gentlypushtheplungeruntiltheairisinjectedintothevial.(Fig.1)
Figure
2.Securelygraspthesolventvialandsyringeassembly,withtheneedlestilldeeplyinsertedintothevial.Carefullyturnthevialandsyringeassemblyupsidedown.Bringtoeyelevel.(Fig.2)
Figure
3.Slideonehandcarefullydownthesolventvialsothatwithyourthumbandforefingeryoucansecurelygrasptheneckofthevial,andwithyourotherfingers,theupperpartofthesyringe.Withtheotherhand,slowlypullthesyringeplungerdowntoslightlypastthe1mlmark.
Examinethesolutioninthesyringeforairbubbles.Ifbubblesarepresent,tapthesyringebarreluntilthebubblesrisetothetopofthesyringe.Carefullypushtheplungeruptoejectonlytheairbubblesbackintothevial.Recheckthat1mlofsolventremainsinthesyringe,thenwithdrawtheneedlefromthevial.(Fig3)
Figure
4.Inserttheneedleofthesolventsyringestraightthroughthestopperofthevialwiththepowder(SOMAVERT).TiltthesyringetothesideandgentlyinjectthesolventdowntheinnersideofthevialofSOMAVERT.Whenthesolventsyringeisempty,withdrawitfromthevial.Discardthesolventvial,syringe,andneedleasdirectedbyyourhealthcareprovider.Tominimiseaccidentalinjury,recaptheneedleonlyifinstructedtodosobyyourhealthcareprovider,andinthemannerdemonstratedtoyoubyyourhealthcareprovider.(Fig4)
Figure
5.HoldthevialofSOMAVERTuprightbetweenyourhandsandgentlyrollittodissolvethepowder. DONOTSHAKETHEVIAL.Thesolutionshouldbeclearafterthepowderisdissolved.Ifthesolutioniscloudyorhazy,donotinjectit.Notifyyourpharmacyandrequestareplacementvial.Donotthrowthevialawaybecausethepharmacymayrequestthatyoureturnit. InjectSOMAVERTimmediately.(Fig.5)
Figure
6.CleantherubberstopperofthevialofSOMAVERTwithanantisepticoralcoholswab.Removethecapfromthesyringe(1ml).Pullthesyringeplungerdowntothe1-mlmark.Withonehand,securelyholdthevial.Withtheotherhand,inserttheneedlestraightthroughthecenteroftherubberstopperanddeepintothevial.Gentlypushtheplungeruntiltheairisinjectedintothevial.Securelygraspthevialandsyringeassembly,withtheneedlestilldeeplyinsertedintothevial.Carefullyturnthevialandsyringeassemblyupsidedown.Bringtoeyelevel.(Fig.6)
Figure
7.Asbefore,slideonehandcarefullydownthevialsothatwithyourthumbandforefingeryoucansecurelygrasptheneckofthevial,andwithyourotherfingers,theupperportionofthesyringe.Withtheotherhand,slowlypullthesyringeplungerdowntowithdrawthefullcontentsofthevial(1ml).Tokeeptheneedletipwithintheliquid,youmayhavetoslowlybackitoutofthestopperasyoudrawouttheliquid.
Visuallyinspectthesyringeforairbubbles.Ifbubblesarepresent,tapthesyringebarreluntilthebubblesrisetothetopofthesyringe.Carefullypushtheplungeruptoejectonlytheairbubblesbackintothevial.Recheckthat1mlofthesolutionremainsinthesyringe,thenwithdrawtheneedlefromthevial.
Recaptheneedleasdirectedbyyourhealthcareprovidertominimiseaccidentalinjurywhilepreparingthesiteforinjection.(Fig.7)
Chooseaninjectionsiteontheupperarm,upperthigh,abdomenorbuttocks.Alwaysmoveontoadifferentareawitheachday?sinjection.Itmaybehelpfultokeeparecordofeachday?sinjectionsiteasyoutakeyourdailydoseofSOMAVERT.Donotuseanareathathasarashorbrokenskin,orisbruisedorlumpy.
Cleanthesitewithanantisepticoralcoholswab,lettheskindrybeforeinjectingtheproduct.Uncaptheneedleifpreviouslyrecapped.
Figure
a.With one hand, gently pinch up the skin at the site of injection. Hold the syringe with the otherhand, and in a single, smooth motion, push the needle completely into the skin straight down ata 90-degree angle. Fig. A
Figure
b.Be sure to keep the needle all the way into the skin while you slowly push the syringe plungerdown until the barrel is empty
Releasethepinchedskinandpulltheneedlestraightout.(Fig.B)
Figure
c.Do not rub the injection area. A small amount of bleeding may occur. If necessary, apply aclean, dry cotton swab over the area and press gently for 1 or 2 minutes, or until the bleeding hasstopped. Fig. C
Thesyringeandneedleshould NEVERbereused.Disposeoftheneedleandsyringeasinstructedbyyourdoctor,nurseorpharmacist.
Last updated on 19.08.2022
The following drugs also contain the active ingredient Pegvisomant. Consult your doctor about a possible substitute for SOMAVERT20mgpowderandsolventforsolutionforinjection
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