Umbhali: Louise Ward
Umhla Wokudalwa: 4 Eyomdumba 2021
Hlaziya Umhla: 1 Etimnga 2024
Anonim
Emicizumab/Hemlibra® chez les personnes atteintes d’hémophilie A vivant avec inhibiteur
Ividiyo: Emicizumab/Hemlibra® chez les personnes atteintes d’hémophilie A vivant avec inhibiteur

Umxholo

Yintoni iHemlibra?

IHemlibra ligama lonyango elichaza igama likagqirha. Imiselwe ukuthintela ukopha iziqwengana okanye ukubenza bangaphantsi rhoqo kubantu abane-hemophilia A, nokuba kungabikho okanye kungenayo i-VIII (ezisibhozo) inhibitors. I-Hemlibra ivunyiwe ukuba isetyenziswe kubantu bayo yonke iminyaka.

I-Hemlibra iqulethe ichiza i-emicizumab, eyi-monoclonal antibody. Eli liyeza elenziwa kwiiseli zomzimba.

IHemlibra iza njengesisombululo esinikwa njengenaliti phantsi kolusu lwakho (subcutaneous). Umboneleli wakho wezempilo angakunika inaliti, okanye unokuzitofela ekhaya ngabantu abaneminyaka esi-7 nangaphezulu.

Kwizifundo zeklinikhi ezihlala iinyanga ezintandathu okanye nangaphezulu, iHemlibra inciphise inani lokuphuma kwegazi lilonke ngo:

  • ubuncinci iipesenti ezingama-94 kubantu abangenayo inhibitors ye-VIII
  • ubuncinci iipesenti ezingama-80 kubantu abane-VIII inhibitors

Uhlobo olutsha lweziyobisi

Ngaphambi koLawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) evunyiweyo iHemlibra, olona hlobo lonyango lusetyenziswayo ukunyanga i-hemophilia A yayiyinto ethatha indawo ye-VIII.


Abantu abane-hemophilia A abanayo i-factor VIII, iprotheni umzimba wakho kufuneka wenze amahlwili egazi. Unyango lwe-factor VIII lubeka into ye-VIII egazini lakho. Ngokwesiqhelo, into yento VIII yokutshintsha iyilebhu, kodwa inokwenziwa kwiplasma yegazi. Unyango lunikezelwa njenaliti kwenye yemithambo yakho (efakwa ngaphakathi).

I-Hemlibra yenziwe ngeeseli elebhu. Endaweni yokutshintsha i-factor VIII, iHemlibra isebenza ngokudibanisa izinto ezithile zokunqanda igazi (iiproteni) egazini. Oku kwenza ukuba igazi lijiye ngokufanelekileyo ngaphandle kwento VIII, inceda ukuthintela ukopha okungalawulekiyo.

IHemlibra sisiyobisi sokuqala esisetyenziselwa ukuthintela ukopha kubantu abane-hemophilia A nokuba benayo okanye bengenayo inhibitors ye-VIII. I-inhibitors izilwa-buhlungu (inkqubo yomzimba yokuzikhusela) ezihlasela i-VIII kwaye ziyithintele ekwenzeni amahlwili. Abanye abantu bakhulisa inhibitors xa benikwa into ye-VIII yonyango yokutshintsha, isenza ukuba unyango lungasebenzi.

IHemlibra ikwasisiyobisi sokuqala sehemophilia A ongasithatha njengenaliti phantsi kolusu lwakho (subcutaneous). Ukongeza, kukho iishedyuli ezininzi zokufaka idosi, kubandakanya iveki nganye, iiveki ezimbini, okanye iiveki ezine. Olunye unyango lwe-hemophilia A lufuna ukuba ubathathe rhoqo, ukusuka yonke imihla ukuya kumaxesha aliqela ngeveki.


Ukuvunywa kwe-FDA

Ulawulo lwezoKutya kunye noLawulo lweziyobisi (FDA) luqale lwamkelwa iHemlibra ngo-2017 kubantu abane-hemophilia A ene-factor VIII inhibitors.

Ngo-2018, i-FDA yandise imvume yayo ukuze ibandakanye abantu abane-hemophilia A abangenayo inhibitors ye-VIII.

IHemlibra generic

IHemlibra ifumaneka kuphela njengeyeza elinophawu-lwegama. Okwangoku ayifumaneki ngendlela eqhelekileyo.

I-Hemlibra iqulethe iziyobisi ezisebenzayo emicizumab, ngamanye amaxesha ebizwa ngokuba yi-emicizumab-kxwh. Isiphelo "-kxwh" sinceda ukuseta ichiza ngaphandle kwamayeza afanayo anokufumaneka kwixesha elizayo. Le yifomathi yokuqamba amagama yama-antibody monoclonal (iziyobisi ezenziwe ngeeseli zomzimba).

Ukhuseleko lweHemlibra

Ulawulo lokutya kunye neziyobisi (i-FDA) iqokelela iingxelo malunga neziphumo ezibi zeziyobisi. Uluntu kunye noononophelo lwempilo bangenisa ezi ngxelo kwi-FDA ngokusebenzisa iFomWatch Voluntary Reporting Form nangokubiza 800-FDA-1088 (800-322-1088). Zombini i-FDA kunye noGenentech, umenzi weHemlibra, bajonge ngononophelo iingxelo zokhuseleko malunga neHemlibra.


Iingxelo zokusweleka

Umenzi weHemlibra uxele ukufa kwabantu abali-10 kwihlabathi jikelele okwenzekileyo ngelixa abantu bethathe iHemlibra. Oku kusweleka kwenzeka emva kokuba i-FDA ivumile iyeza. Akucaci nokuba ichiza libangele nakuphi na ukusweleka.

Umenzi weHemlibra uyaqhubeka nokubeka iliso kukhuseleko malunga neziyobisi. Ukuba unemibuzo malunga nokuba iHemlibra ikhuselekile kuwe, thetha nogqirha wakho.

Ixabiso leHemlibra

Njengawo onke amayeza, iindleko zeHemlibra zingahluka.

Ixabiso eliza kuhlawulwa lixhomekeke kwi-inshurensi yakho kunye nekhemisi oyisebenzisayo.

Uncedo lwezezimali kunye neinshurensi

Ukuba ufuna inkxaso yemali ukuhlawulela iHemlibra, okanye ukuba ufuna uncedo ekuqondeni i-inshurensi yakho, uncedo luyafumaneka.

UGenentech, umvelisi weHemlibra, ubonelela ngenkqubo ebizwa ngokuba yiZisombululo zoFikelelo. Ngolwazi oluthe kratya kunye nokufumanisa ukuba uyakulungele na ukufumana inkxaso, tsalela umnxeba ku-877-233-3981 okanye undwendwele iwebhusayithi yenkqubo.

Umthamo weHemlibra

Umthamo weHemlibra ogqitywa ngugqirha wakho uya kuxhomekeka kwizinto ezininzi. Oku kubandakanya:

  • ubunzima bakho
  • ishedyuli yonyango ugqirha wakho athatha isigqibo sokuba ilungele wena

Olu lwazi lulandelayo luchaza iidosi eziqhelekileyo ezisetyenziswayo okanye ezicetyiswayo. Nangona kunjalo, qiniseka ukuthatha idosi ekumisela ugqirha wakho. Ugqirha wakho uya kumisela eyona idosi ilungele iimfuno zakho.

Iifom zamachiza kunye namandla

IHemlibra iza ngeebhotile zedosi enye eziqukethe amandla eedosi ahlukeneyo:

  • 30 mg / mL
  • I-60 mg / 0.4 mL
  • I-105 mg / 0.7 mL
  • 150 mg / ml

Idosi nganye inikwa ngenaliti phantsi kolusu lwakho (ongama). Usebenzisa ibhotile enye ngenaliti, emva koko ulahle ibhotile kunye nolunye ulwelo olushiyekileyo kwisitya.

Ubungakanani behemophilia A

IHemlibra inikwa kuqala ekulayisheni iidosi, ezilandelwa ziidosi zokugcina. Ukulayisha iidosi ngokukhawuleza kuzisa iyeza kumanqanaba aphezulu emzimbeni wakho. Zingaphezulu kuneedosi zokugcina okanye zinikwa rhoqo.

Iidosi ezine zokuqala zeHemlibra zilayisha idosi. Banikwa njenge-3 mg / kg kanye ngeveki.

Idosi nganye emva koko idosi yesondlo. Ugqirha wakho uya kuthatha isigqibo sedosi efanelekileyo yokugcina wena. Idosi yakho ethile iya kusekelwa kubunzima bakho. Isenokuba:

  • 1.5 mg / kg kanye ngeveki
  • 3 mg / kg kanye kwiiveki ezimbini
  • I-6 mg / kg kanye kwiiveki ezine

PhawulaIkhilogram enye ubunzima bomzimba ilingana neekhilogram eziyi-2.2. Umzekelo, ukuba unobunzima beepawundi ezili-150 (68 kg), idosi yakho yokulayisha eyi-3 mg / kg ingangama-204 mg weHemlibra ngeveki.

Idosi yabantwana

Imilinganiselo yabantwana isekwe kubunzima babo, njengeedosi zabantu abadala.

Kuthekani ukuba ndiphose idosi?

Ukuba uphosa idosi yeHemlibra, yithabathe kwangoko xa ukhumbula. Emva koko thabatha idosi elandelayo ngokweshedyuli yakho yesiqhelo. Musa ukuthatha amanani amabini ngosuku olunye. Ukuthatha idosi engaphezulu kwesinye ngemini enye kuya kwandisa umngcipheko weziphumo ebezingalindelekanga ezibi.

Ngaba kuya kufuneka ndisebenzise eli chiza ixesha elide?

I-Hemlibra ayilonyango lwe-hemophilia, kwaye kufuneka ithathwe rhoqo ukuze incede ekuthinteleni ukopha. Ke ukuba ugqirha wakho uthatha isigqibo sokuba iHemlibra lukhetho olukhuselekileyo nolusebenzayo kunyango lwakho, baya kuyimisela ixesha elide.

Akukho lunyango lwe-hemophilia ngeli xesha.

Iziphumo ebezingalindelekanga zeHemlibra

IHemlibra inokubangela iziphumo ebezingalindelekanga ezinobulali okanye ezinobuzaza. Olu luhlu lulandelayo luqulathe ezinye zeziphumo ebezingalindelekanga ezinokubakho ngelixa uthatha iHemlibra. Olu luhlu alubandakanyi zonke iziphumo ebezingalindelekanga ezinokubakho.

Ngolwazi oluthe kratya malunga neziphumo ebezingalindelekanga zeHemlibra, okanye iingcebiso ngendlela yokujongana nefuthe elibi, thetha nogqirha okanye usokhemesti.

Iziphumo eziqhelekileyo ezichaphazelekayo

Iziphumo eziqhelekileyo ezichaphazela iHemlibra zinokubandakanya:

  • Impendulo yendawo yenaliti (ububomvu, iintlungu, okanye ukuthamba kujikeleze indawo apho kwafakwa khona iHemlibra)
  • intloko ebuhlungu
  • intlungu edibeneyo

Uninzi lweziphumo ebezingalindelekanga zinokuhamba zingaphelanga iintsuku okanye iiveki ezimbalwa. Ukuba zinzima kakhulu okanye azihambi, thetha nogqirha wakho okanye usokhemesti.

Iziphumo ebezingalindelekanga ezimandundu

Iziphumo ezibi kakhulu ezivela kwiHemlibra aziqhelekanga, kodwa zinokwenzeka.

Ukuphendula ngokuchaseneyo

Ukuphendula ngokuthe ngqo akuzange kwenzeke kwizilingo zeklinikhi zeHemlibra. Nangona kunjalo, njengamachiza amaninzi, abanye abantu banokuphendula emva kokuthatha iHemlibra. Iimpawu zokuphendula kancinci kunokubandakanya:

  • irhashalala
  • ukucheba
  • ukucoca (ukufudumala nokubomvu kwesikhumba sakho)

Impendulo eyingozi kakhulu inqabile kodwa inokwenzeka. Iimpawu zokungaziphathi kakuhle kunokubandakanya:

  • i-angioedema (ukudumba phantsi kolusu lwakho, ubukhulu becala kwiinkophe zakho, imilebe, izandla, okanye iinyawo)
  • ukudumba kolwimi lwakho, umlomo, okanye umqala
  • ingxaki yokuphefumla

Biza ugqirha wakho ngoko nangoko ukuba uneempendulo ezomeleleyo kwi-Hemlibra. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Amahlwili egazi (xa esetyenziswa neCCP)

Ngexesha lokunyanga iHemlibra, abanye abantu ngamanye amaxesha banokufumana iziyobisi ezinceda ukuyeka ukuphuma kwegazi, njengeprothrombin complex concentrate (aPCC). Iziphumo ebezingalindelekanga ezimandundu zinokwenzeka ukuba uthatha la machiza kunye, njengokwanda komngcipheko wamahlwili egazi. Umngcipheko mkhulu kubantu abathatha iHemlibra efumana ngaphezulu kwe-100 yeeyunithi / kg ye-PCC ngosuku ngaphezulu kweeyure ezingama-24.

Iindidi zamahlwili egazi anokwenzeka ukuba uthatha iHemlibra ene-PCC ibandakanya:

  • I-Thrombotic microangiopathy (amahlwili egazi kunye nokulimala kwimithambo yegazi encinci, kubandakanya nezo sezintso, amehlo, ingqondo kunye namanye amalungu). Iimpawu zingabandakanya:
    • isicaphucaphu
    • ukugabha
    • ukudumba kwemilenze neengalo
    • ubuthathaka
    • ukuchama kaninzi kunesiqhelo
    • isisu esibuhlungu
    • umqolo obuhlungu
    • ubumthubi besikhumba sakho kunye namhlophe wamehlo akho
    • ukudideka
  • Amagqabantshintshi egazi kweminye imithambo yegazi, kubandakanya leyo isemiphungeni, entloko, ezingalweni nasemilenzeni. Iimpawu zingabandakanya:
    • intloko ebuhlungu
    • ingxaki yokubona
    • ukhohlela igazi
    • iintlungu zesifuba
    • ingxaki yokuphefumla
    • ukukhawuleza kwentliziyo
    • ukudumba kwemilenze neengalo
    • iintlungu emilenzeni nasezingalweni

Ukuba unempawu zegazi, biza ugqirha wakho kwangoko. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Ukuba uhlakulela i-clot yegazi ngexesha lokunyanga nge-Hemlibra kunye ne-PCC, ugqirha wakho uya kuyeka ukuthatha zombini iziyobisi ixesha. Ugqirha wakho uya kuthatha isigqibo sokuba ngaba kukhuselekile ukuba uqale ukuthatha iHemlibra kwakhona.

IHemlibra isebenzisa

Ulawulo lokutya kunye neziyobisi (i-FDA) livuma amayeza amiselweyo anjenge-Hemlibra ukunyanga iimeko ezithile.

IHemlibra yehemophilia A

IHemlibra ivunyiwe yi-FDA ukunyanga abantu bayo yonke iminyaka abane-hemophilia A. Iyavunywa ukuba isetyenziswe kubantu abane-inhibitors okanye ngaphandle kwe-factor VIII yokuthintela ukopha.

Inqaku VIII (isibhozo) yiprotein eyenzeka ngokwendalo egazini edlala indima ebalulekileyo ekwenzeni amahlwili egazi. Abantu abane-hemophilia A balahlekile i-VIII, ngoko ke igazi labo aligutyungeli. Ukungakwazi ukwenza amahlwili egazi kubeka abantu abane-hemophilia emngciphekweni wokopha okungayeki. Ngamanye amaxesha oku kungabulala.

Ngaphambi kokuba i-Hemlibra ivunyiwe, olona nyango luphambili lwe-hemophilia A lwaluyinto ye-VIII yonyango yokutshintsha. Olu nyango luthatha indawo ye-VIII engekhoyo egazini.

Kodwa abanye abantu bakhulisa inhibitors xa benikwa into yokutshintsha i-factor VIII. I-inhibitors zii-antibodies (iiprotein zenkqubo yomzimba yokuzikhusela) ezihlasela i-factor VIII, ethintela inyani ye-VIII kunyango olusebenzayo ekusebenzeni.

IHemlibra isebenza ngendlela eyahlukileyo. Endaweni yokutshintsha i-factor VIII, iHemlibra idibanisa ezinye iiproteni zegazi kunye. Oku kwenza ukuba igazi lijiye ngokufanelekileyo ngaphandle kwento VIII. Ngenxa yokuba ayibandakanyi indawo ye-VIII, iHemlibra isebenza ngokufanelekileyo nokuba zikhona inhibitors egazini.

IHemlibra yezinye iimeko

I-Hemlibra ayisetyenziselwa ukunyanga naziphi na ezinye iimeko zokopha.

IHemlibra yehemophilia B (ayisiyonto ifanelekileyo)

I-Hemlibra ayisetyenziswanga ukuthintela ukuphuma kwegazi kubantu abane-hemophilia B. Kungenxa yokuba abantu abane-hemophilia B baphoswa yinto eyahlukileyo yokujiya (iproteni yegazi) kunabantu abane-hemophilia A.

  • ihemophilia A: ilahlekile i-clotting factor VIII (ezisibhozo)
  • ihemophilia B: ilahlekile i-clotting factor IX (ezithoba)

IHemlibra ayizenzeli into elahlekileyo ye-IX. Ke ayinakusetyenziselwa ukuthintela ukopha kubantu abane-hemophilia B.

IHemlibra nabantwana

IHemlibra ivunyiwe yi-FDA ukuba isetyenziswe kubantwana bayo yonke iminyaka, nakwabasandula kuzalwa. Iyeza lisetyenziselwa injongo efanayo neyabantu abadala. I-Hemlibra inceda ukuthintela ukopha kubantu abane-hemophilia A kunye okanye ngaphandle kwe-factor VIII inhibitors.

Imiyalelo yokusebenzisa iHemlibra

Kuya kufuneka uthathe iHemlibra ngokwemiyalelo yomboneleli wakho wezempilo.

Umboneleli wakho wezempilo unokukunika inaliti yeHemlibra kwiklinikhi okanye eofisini. Okanye banokukufundisa ngendlela yokuzitofa.

Inokukunceda ukugcina ilog yezitofu zakho. Faka iinkcukacha ezinje:

  • umhla wenaliti nganye
  • indawo yenaliti
  • ulwazi ngebhotile eninzi (ungayifumana le vial) *

* Ukurekhoda ulwazi lwe-vial lot kunceda ababoneleli ngezempilo ukulandelela ukusetyenziswa kwamayeza e-biological, njenge-Hemlibra. Olu lwazi luluncedo ukuba kwenzeka isiphumo esibi.

Apha ngezantsi kukho ulwazi malunga nendlela yokufaka intsholongwane kwiHemlibra ngokwakho. Ngolwazi oluthe kratya, ividiyo, kunye nemifanekiso eluncedo, jonga iwebhusayithi yeHemlibra, kubandakanya esi sikhokelo senyathelo nenyathelo.

Ukulungiselela ukujova iHemlibra

Funda la manyathelo ngaphambi kokuba uzinike inaliti yeHemlibra.

  1. Thatha igutyana (okanye iibhotile, kuxhomekeke kwidosi yakho) yeHemlibra ngaphandle kwesiqandisi imizuzu eli-15 ngaphambi kokuba ucebe ukujova. Oku kuvumela amayeza ukuba eze kubushushu begumbi ngaphambi kwenaliti yakho.
  2. Ungazami ukufudumeza isisombululo kwi-microwave okanye ngokuyiqhuba phantsi kwamanzi ashushu. Oku kunokwenza ukuba iHemlibra ikhuseleke kancinci, kwaye isenokungasebenzi ngokunjalo.
  3. Jonga ibhotile ukuze uqiniseke ukuba isisombululo sicacile ukuba sityheli. Ukuba kunamafu, umbala, okanye iqulethe amasuntswana, ungayisebenzisi. Musa ukushukumisa ibhotile.
  4. Ngelixa ulinde iHemlibra ukuba ize kubushushu begumbi, hlanganisa izinto zakho. Ngaphandle kwe-vial (s) ye-Hemlibra, uya kuyidinga: Ukusula utywala, i-cotton gauze, iibhola zomqhaphu, inaliti yokudlulisa, isirinji, inaliti yenaliti kunye nekhaka lokhuseleko, kunye nekhonteyina yokulahla
  5. Hlamba izandla zakho ngesepha namanzi.
  6. Khetha indawo yakho yenaliti. Inokuba yenye yezi ndawo zintathu: Indawo yesisu (ubuncinci ii-intshi ezimbini kude nesisu sakho), phambi kwethanga lakho, nasemva kwengalo yakho (ukuba kukho umntu okufaka inaliti)
  7. Kunqande ukujova ii-moles okanye naluphi na ulusu olubomvu, lonzakeleyo, okanye lubomvu.

Ukujova iHemlibra

Landela la manyathelo ukutofa iHemlibra.

Ukulungiselela ibhotile kunye nesirinji

Ukulungiselela ibhotile kunye nesirinji ulungele inaliti, landela la manyathelo:

  1. Susa ikepusi kwi-vial kwaye uyilahle kwindawo yakho yokulahla.
  2. Coca umphezulu wesiciko sokucoca ulwelo ngokusula utywala.
  3. Qhoboshela inaliti yokutshintshela (isesekhefini yayo yokukhusela) kwisirinji. Yenza oku ngokutyhala kunye nokujija inaliti yokudlulisa ukuya kwewotshi ide incanyathiselwe.
  4. Cothisa kancinci emva kwiplinji yesirinji ukuze uzobe emoyeni. Ugqirha wakho uza kukuxelela isixa esifanelekileyo.
  5. Bamba isirinji ngombhobho ngesandla esinye. Qinisekisa ukuba inaliti yalatha phezulu.
  6. Ngononophelo tsala ikepusi yenaliti ngqo ecaleni kwenaliti. Musa ukulahla ikepusi. Uya kuyidinga ukuphinda uhlalutye inaliti emva kokuyisebenzisa. Beka ikepusi kwindawo ecocekileyo, ethe tyaba. Musa ukubeka inaliti yokudlulisa phantsi emva kokuba ingafakwanga.

Ukuzalisa isirinji

Nanga amanyathelo okugcwalisa isirinji:

  1. Bamba ibhotile kwindawo ethe tyaba. Faka inaliti yokudlulisa ngqo ezantsi embindini wesivalo sebhotile.
  2. Ukugcina inaliti kwi-vial, thatha ibhotile kwaye uyijike ujonge ezantsi.
  3. Ngenqaku lenaliti ngaphezulu kwenqanaba lonyango, tyhala iplunger yokujova umoya kwisithuba esingaphezulu kweyeza. Musa ukujova umoya kunyango.
  4. Ukugcina umnwe kwiplunger, tsala isirinji iphela kude kube incam yenaliti iphakathi kwonyango.
  5. Cothisa kancinci iplunger ukuze ugcwalise isirinji ngaphezulu kwesixa esifunekayo kwidosi yakho. (Qaphela: Ukuba idosi yakho ingaphezulu kwesixa esisesibhotileni, gcwalisa isirinji ngawo onke amayeza asuka kwibhotile. Jonga imiyalelo yomenzi ukuba ufuna ukusebenzisa ngaphezulu kwebhotile enye yedosi oyimiselweyo.)
  6. Ukugcina isirinji kwi-vial, jonga nawaphi na amaqamza amakhulu anokukuthintela ekubeni uthathe idosi yakho emiselweyo. Ukuba ubona nayiphi na, cofa ngobunono umgqomo wesirinji ngeminwe ukuze amaqamza anyukele phezulu. Emva koko tyhala kancinci i-plunger ukuze inaliti ibe semoyeni ngaphezu kweyeza. Qhubeka utyhala umpompo ukuze ususe amaqamza kwisirinji.
  7. Jonga ukuba inani lamayeza kwisirinji ngoku lingaphantsi okanye liyafana nedosi emiselweyo. Ukuba kunjalo, tsala iplastikhi ukuze inaliti iphinde ibe phakathi kwamayeza kwakhona. Emva koko qhubeka utsala iplanja de isixa sesirinji singaphezulu kwethamo lakho elimiselweyo.
  8. Phinda amanyathelo 6 no-7 ukuqinisekisa ukuba akukho maqamza kwisirinji kwaye unedosi efanelekileyo kwisirinji.
  9. Susa isirinji kwaye ugqithise inaliti kwi-vial.

Ukulahla inaliti yokuhambisa

Nje ukuba ugcwalise isirinji, kuya kufuneka uthabathe kwaye ulahle inaliti yokudlulisa. Nantsi indlela:

  1. Bamba isirinji ngesandla esinye uze uyilayishe inaliti yokuyifaka kwikepusi yayo, oyibeke kwindawo ethe tyaba. Scoop phezulu ukuze ikepusi ityibilika ezantsi ukugquma inaliti.
  2. Qinisekisa ukuba inaliti igqunywe ngesigqubuthelo. Ngesinye isandla, cinezela ezantsi kwikepu ukuze uyiqhoboshele kwisirinji.
  3. Susa inaliti yokutshintshela kwisirinji ngokuyijija ngokuchasene newotshi kwaye uyitsale kakuhle. (Awuyi kusebenzisa inaliti yokuhambisa iyeza. Oku kunokuba buhlungu kwaye kunokubangela ukonzakala kolusu.)
  4. Yilahle kude inaliti yokuhambisa kwisitya esilahliweyo.

Ukujova iHemlibra

Xa sele ukulungele ukujova iHemlibra, landela la manyathelo:

  1. Sula indawo oyikhethileyo ngenaliti yokusula kwaye uyiyeke yome okungenani imizuzwana eli-10.
  2. Qhoboshela inaliti yenaliti kwisirinji ngokutyhala uze ujije iwotshi ide ikhuseleke ngokupheleleyo.
  3. Tsala ikhaka lokhuselo kude nenaliti (ngakumgqomo wesirinji).
  4. Ngononophelo thatha ikepusi kule naliti kwaye uyilahle kwisingxobo sokulahla esibi. Kuphephe ukubamba incam yenaliti, kwaye ungayibeki inaliti nakweyiphi na imiphezulu.
  5. Emva kokuba uyisusile ikepusi, kuya kufuneka utofe iHemlibra ngoko nangoko. Hambisa i-plunger kwisirinji ukuze ihambelane nedosi yakho emiselweyo. Umphetho ophezulu weplunger kufuneka uhambelane nenqaku ledosi yakho emiselweyo.
  6. Cofa ulusu lwakho kwindawo yenaliti oyikhethileyo.
  7. Ngokukhawuleza nangokuqinileyo, faka ngokupheleleyo inaliti kwi-45-degree okanye kwi-90 degree degree kwi-skin pinched. Sukucinezela kwiplunger okwangoku.
  8. Nje ukuba inaliti ifakwe ngokupheleleyo kulusu lwakho, yeka indawo ecinyiweyo.
  9. Cofa kancinci iplunger de ube utofe onke amayeza.
  10. Susa inaliti ngokuyikhupha kwi-engile enye oyifakileyo.

Emva kokujova iHemlibra

Nje ukuba utofe iHemlibra, landela la manyathelo:

  1. Beka inaliti phantsi kwindawo ethe tyaba. Gquma inaliti ngokucinezela ukhuseleko kwisirinji phambili kwi-90 degree degree (kude nomgqomo). Mamela isandi sokucofa. Oko kukuvumela ukuba uyazi ukuba inaliti igutyungelwe ngokupheleleyo kukhuselo lokhuseleko.
  2. Gcina inaliti kwisirinji. Sukuyisusa. Kwaye sukuyifaka endaweni yenaliti yenaliti.
  3. Yilahle ibhotile esetyenzisiweyo, iinaliti kunye nesirinji kwisikhongozeli sakho sokulahla.
  4. Ukuba ubona amathontsi egazi kwindawo yakho yenaliti, cinezela ibhola yomqhaphu okanye igawuthi kuloo ndawo. Ukuba ukopha akuyeki, biza ugqirha wakho.
  5. Kuphephe ukukhuhla indawo yenaliti.

Nini ukuthatha iHemlibra

Ugqirha wakho uza kukuxelela ukuba uyithatha kangaphi iHemlibra. Banokufuna ukuba uthathe i-Hemlibra kanye ngeveki, kanye ngeveki, okanye kube kanye kwiiveki ezine.

Thatha iHemlibra kwangolo suku lunye lweveki. Umzekelo, ukuba uthatha iHemlibra kanye ngeveki, unokukhetha ukuyithatha rhoqo ngoMvulo.

Izikhumbuzo zamayeza zinokukunceda uqiniseke ukuba awuphosi idosi.

IHemlibra kunye notywala

Akukho nxibelelwano lwaziwayo phakathi kweHemlibra kunye notywala. Nangona kunjalo, ukuba une-hemophilia A, igazi lakho alijiyiki kakuhle. Ukusela utywala kunokuthintela igazi lakho ekubeni lenze amahlwili ngokunciphisa inani lezinto ezijiyisayo egazini lakho. Ngenxa yoko, ukusela kakhulu utywala ngelixa uthatha iHemlibra kunokunciphisa ukusebenza kweHemlibra.

Ukuba usela utywala, thetha nogqirha wakho malunga nokuba ukusela ngelixa uthatha iHemlibra kukhuselekile kuwe.

Unxibelelwano lweHemlibra

IHemlibra inokusebenzisana namanye amayeza. Inokusebenzisana neemvavanyo ezithile zelebhu.

Unxibelelwano olwahlukileyo kunokubangela iziphumo ezahlukeneyo. Umzekelo, unxibelelwano oluthile lunokuphazamisa ukusebenza kakuhle kwesiyobisi. Olunye unxibelelwano lwandisa iziphumo ebezingalindelekanga okanye lubenze bube nzima ngakumbi.

IHemlibra kunye namanye amayeza

Apha ngezantsi kukho amayeza anokusebenzisana neHemlibra. Olu luhlu alunazo zonke iziyobisi ezinokusebenzisana neHemlibra.

Ngaphambi kokuba uthathe iHemlibra, thetha nogqirha wakho kunye nosokhemesti. Baxelele ngawo onke amayeza kagqirha, ekhawuntareni, kunye nezinye iziyobisi ozithathayo. Baxelele malunga nazo naziphi na iivithamini, amayeza esintu kunye nezixhasi ozisebenzisayo. Ukwabelana ngolu lwazi kunokukunceda uphephe unxibelelwano olunokubakho.

Ukuba unemibuzo malunga nokunxibelelana kweziyobisi okunokuchaphazela, buza ugqirha wakho okanye usokhemesti.

I-Hemlibra kunye ne-activated prothrombin complex concentrate (aPCC)

Ukusebenza kwe-prothrombin complex concentrate (aPCC) sisiyobisi esinceda ukuyeka ukopha. Ngelixa iHemlibra inokusetyenziswa kunye ne-PCC, ukuthatha la machiza kunye kungonyusa umngcipheko wamahlwili egazi. Lo mngcipheko mkhulu kubantu abathatha iHemlibra efumana ngaphezulu kwe-100 yeeyunithi / kg ye-PCC ngosuku ngaphezulu kweeyure ezingama-24.

Ukuba ufuna i-PCC ngelixa uthatha iHemlibra, ugqirha wakho uya kukujonga esweni imiqondiso yamahlwili egazi. Amanye amahlwili egazi anganobuzaza, kwaye kungafuneka ufumane unyango kwangoko. (Ngolwazi oluthe kratya, jonga icandelo leHemlibra).

Ukuba uphuhlisa i-clot yegazi ngelixa uthatha la machiza kunye, ugqirha wakho uya kufuna ukuba uyeke ukuthatha iHemlibra. Baza kuthatha isigqibo sokuba ngaba kukhuselekile na kuwe ukuba uqale ngokuthatha iyeza kwakhona.

I-Hemlibra kunye nezinye iziyobisi ze-hemophilia A

Ukuthatha iHemlibra ngehemophilia ethile Amachiza anokunyusa umngcipheko wamahlwili egazi. Imiyalelo ethile yedosi yokusebenzisa iHemlibra kunye nezinye ihemophilia A iziyobisi zibandakanya oku kulandelayo:

  • Yeka ukusebenzisa nayiphi na iarhente yokudlula (unyango lwabantu abane-inhibitors) kusuku olungaphambi kokuba uqale ukuthatha iHemlibra. Imizekelo yee-arhente ezidlulayo zii-anti-inhibitor coagulant complex (FEIBA) kunye ne-recaginant yabantu coagulation Factor VIIa (NovoSeven).
  • Ukuba kukho imfuneko, qhubeka nonyango lwe-VIII yokutshintsha indawo ukuya kuthi ga kwiveki enye emva kwethamo lakho lokuqala leHemlibra.

Ukuba unemibuzo malunga nendlela yokuthatha olunye unyango lwe-hemophilia kunye ne-Hemlibra, thetha nogqirha wakho.

IHemlibra kunye novavanyo oluthile lwelebhu

I-Hemlibra inokuphazamisa iziphumo zovavanyo oluthile lweelebhu kwaye inike ukufundwa okungeyonyani. Olu vavanyo lubandakanya ezinye ezijonga ukuba lithatha ixesha elingakanani igazi lakho. Olunye lolu vavanyo luvavanyo lwe-thromboplastin (aPTT) olusebenzayo.

IHemlibra inokuchaphazela iziphumo zovavanyo kangangeenyanga ezintandathu emva kwedosi yakho yokugqibela. Xa ufuna ukufumana iimvavanyo zebhu, xelela ugqirha wakho malunga naluphi na unyango lwangoku okanye oludlulileyo lweHemlibra ukuze bakwazi uku-odola iimvavanyo ezifanelekileyo.

Ezinye iindlela zeHemlibra

Olunye unyango luyafumaneka olunokuthintela ukopha okanye linciphise inani lokopha kubantu abane-hemophilia A. Ezinye zinokukulungela ngcono kunabanye. Ukuba unomdla wokufumana enye indlela eya kwiHemlibra, thetha nogqirha wakho.

IHemlibra yahlukile kuba:

  • isebenza ngokwahlukileyo kunyango oluqhelekileyo (into VIII yokutshintsha iimveliso)
  • isebenza kubantu abane-inhibitors nangaphandle kwe-factor VIII
  • lunyango lokuqala onokuthi uluthathe njengenaliti engaphantsi (inaliti phantsi kolusu), endaweni yokufakwa ngaphakathi (ngenaliti emthanjeni)
  • ihlala isebenza egazini ixesha elide, ukuze ukwazi ukuyithatha ngeveki, kanye ngeveki, okanye kanye ngenyanga
  • ayenziwanga ngeplasma yomntu okanye ngegazi
  • ayibangeli ukuba i-VIII inhibitors iphuhle

Olunye unyango lwe-hemophilia A lubandakanya i-anti-inhibitor coagulant complex (FEIBA), eyi-prothrombin complex concentrate (aPCC).

Unyango oluninzi olwahlukileyo lwe-VIII lonyango olwenziweyo luyafumaneka olunokusetyenziswa rhoqo ukunceda ukuthintela ukopha, kubandakanya:

  • Adynovate
  • Ukwabelana
  • Jivi
  • Uhambo
  • Novoeight

Ugqirha wakho uza kuthetha nawe malunga noncedo kunye nokunyanzeliswa kwonyango olwahlukileyo lwe-hemophilia A. Baza kusebenza nawe ukufumana unyango olulungele iimfuno zakho.

Isebenza njani iHemlibra

IHemophilia A sisifo esophayo. Kubangelwa yinto engekhoyo ekunqandeni ebizwa ngokuba yi-factor VIII (ezisibhozo). Izinto zokuvala ziiproteni ezisegazini ezinceda ukulawula ukopha.

Ngaphandle kwento VIII, igazi lakho alinakwenza ihlwili xa wopha okanye wenzakele. Oku kunokukhokelela ekubeni kuphume igazi eliyingozi.

IHemlibra yi-monoclonal antibody, eyinkqubo yeseli yomzimba eyenziwe elebhu. Yenziwe ngeeseli zezilwanyana kwaye ayiqulathanga nayiphi na iplasma yomntu okanye igazi.

Iintsholongwane, ezithi zivele ngokwendalo emzimbeni, zincamathele kwiimolekyuli ezithile egazini. IHemlibra ibophelela kwiimolekyuli ezimbini: i-activated factor IX (elithoba) kunye ne-clotting factor X (ishumi).

Ngokwesiqhelo, factor VIII amakhonkco factor IX kunye X. Kodwa kwi-hemophilia A, factor VIII ilahlekile. IHemlibra isebenza ngokudlala indima eyayiza kudlalwa yinto VIII. Izisa i-factor IX kunye ne-X ngokudibeneyo ukuze bancede ifom yegazi. Oku kunceda ukunciphisa inani lokopha okunokubakho.

I-Hemlibra isebenza njani kubantu abane-inhibitors?

Abanye abantu abane-hemophilia, amajoni abo omzimba enza amajoni omzimba (iiprotein zomzimba) kwi-factor VIII xa enikwa njengonyango. Ezi antibodies zihlasela i-factor VIII, ethintela unyango lwe-factor VIII ekusebenzeni.

I-Hemlibra isebenza ngendlela eyahlukileyo kunyango lwe-VIII lonyango oluthathe indawo. Endaweni yokutshintsha i-factor VIII, iHemlibra idlala indima VIII ngewayedlale ngayo ngokudibanisa ezinye iiproteni zegazi enye kwenye. Oku kwenza ukuba igazi lijiye ngokufanelekileyo ngaphandle kwento VIII. Ngenxa yoko, iHemlibra isebenza ngokufanelekileyo nokuba kukho inhibitors egazini.

Kuthatha ixesha elingakanani ukusebenza?

Ayaziwa ukuba uza kuqala ngokukhawuleza njani ukubona ukuphuma kwegazi ezimbalwa emva kokuqala iHemlibra. Ulingo lwezonyango lubonakalise ukuba abantu banegazi elimbalwa kwisithuba seenyanga ezintandathu zokuthatha iHemlibra. Nangona kunjalo, iziphumo zolingo azibonisanga xa kuncitshiswe ukuphuma kwegazi kuqala.

Oko kwathiwa, siyazi ukuba emva kwenaliti, kuthatha usuku olunye ukuya kwezimbini ukuba igazi lakho lifumane iHemlibra. Kwaye amanqanaba azinzileyo eziyobisi agcinwa egazini lakho emva kweeveki ezine zokuqala zomthamo.

Ukuba unemibuzo malunga nokuba uza kubona nini isiphumo esivela kwiHemlibra, thetha nogqirha wakho.

IHemlibra kunye nokukhulelwa

Ayaziwa nokuba i-Hemlibra ikhuselekile ukuthatha ngexesha lokukhulelwa. Akukhange kubekho zifundo zabantu nezilwanyana zokuvavanya ukhuseleko lokusetyenziswa kweHemlibra ngexesha lokukhulelwa.

Ukuba uthatha iHemlibra kwaye ucinga ukukhulelwa, thetha nogqirha wakho malunga nokuba kufuneka uqhubeke na ukuthatha iHemlibra.

Qiniseka ukuba usebenzisa ulawulo lokuzalwa ngelixa uthatha iHemlibra ukuba ugqirha wakho uthi akukhuselekanga ukuba ukhulelwe ngexesha lonyango.

IHemlibra kunye nokuncancisa

Ayaziwa nokuba iHemlibra idlula kubisi lomntu lwebele. Ukuba uncelisa umntwana wakho kwaye ucinga ukuthatha iHemlibra, thetha nogqirha wakho malunga nokuba eli chiza likhuselekile na kumntwana wakho.

Imibuzo eqhelekileyo malunga neHemlibra

Nazi iimpendulo kwimibuzo ebuzwa rhoqo malunga neHemlibra.

Ngaba iHemlibra ingasetyenziswa kubantu abangenazo inhibitors?

Ewe. IHemlibra ivunyiwe yi-FDA ukuba isetyenziswe kubantu abane-hemophilia A abangenazo i-inhibitors (kunye nabantu abanayo). Izifundo zonyango ziye zafanisa iHemlibra nonyango. Bajonge kumaqela amabini abantu ngaphandle kwe-inhibitors: abantwana abangamadoda abaneminyaka eli-12 nangaphezulu, kunye nabantu abadala. La maqela mabini athathe amayeza ubuncinci iiveki ezingama-24 kwaye:

  • Iipesenti ezingama-95 zegazi ezimbalwa xa uthatha i-1.5 mg / kg yeHemlibra veki nganye
  • Ipesenti zeepesenti ezimbalwa zegazi xa uthatha i-3 mg / kg yeHemlibra rhoqo kwiiveki ezimbini

Ukusebenza kweHemlibra kwizifundo kwakufana phakathi kwabantu abane-inhibitors kwaye ngaphandle kwe-inhibitors.

Ngaba i-hemlibra isetyenziselwa ukunyanga i-hemophilia B?

Hayi, iHemlibra ayisetyenziselwa ukuthintela ukopha kubantu abane-hemophilia B.

Abantu abane-hemophilia B balahlekile into eyahlukileyo yokunqanda kunabantu abane-hemophilia A:

  • ihemophilia A: ukulahleka kwento VIII
  • ihemophilia B: ilahlekile i-clotting factor IX

IHemlibra yenzelwe ngokukodwa ukunceda abantu abalahlekileyo kwi-VIII. Ke ngoko, ngekhe isebenze kubantu abalahlekileyo i-clotting factor IX.

Ngaba iHemlibra iyayinyanga ihemophilia?

Akukho lunyango lwe-hemophilia ngeli xesha. IHemlibra isebenza ukunqanda iziqwengana zokopha, kodwa ayisinyangi isifo.

Ngaba iHemlibra yenziwe ngeplasma yegazi?

Hayi, iHemlibra ayenziwanga ngeplasma yegazi. Yintsholongwane (inkqubo yomzimba yokuzikhusela) eyenziwe ngeeseli elebhu. Akukho plasma yomntu okanye iiseli zegazi lomntu ezisetyenziselwa ukwenza iHemlibra.

I-Hemlibra ihlanjululwe kwaye iyacocwa. Kananjalo ayiqulathanga naziphi na iintsholongwane ezinokosulela abantu.

Ngaba iHemlibra iwonyusa umngcipheko wam wamahlwili egazi?

I-Hemlibra inokunyusa umngcipheko wamahlwili egazi ukuba athathwe nge-prothrombin activated complex (aPCC). Eli liyeza elinceda ukuyeka ukopha ngokwanda kwegazi.

Izifundo zonyango ziye zajonga abantu abathathe iHemlibra banyangwa nge-PCC. Abantu abathathu babene-thrombotic microangiopathy (amahlwili egazi kwimithambo yegazi encinci). Abantu ababini babenemicimbi ye-thrombotic (yegazi) kweminye imithambo yegazi. Kwimeko nganye kwezi, idosi epheleleyo ye-PCC yayingaphezulu kweeyunithi ezili-100 / kg ngemini ngaphezulu kweeyure ezingama-24.

Ukuba ufuna unyango nge-PCC ukumisa ukopha ngelixa uthatha iHemlibra, thetha nogqirha wakho. Ngokudibeneyo ninokuthetha ngomngcipheko wegazi.

Ngaba eli chiza liza kubangela nayiphi na imiba kuvavanyo lwam lwelebhu rhoqo?

Kusenokwenzeka. IHemlibra inokuchaphazela iziphumo ezivela kuvavanyo lweelebhu ezilinganisa ukuba igazi lakho lihlangana njani kakuhle. Olunye lolu vavanyo luvavanyo lwe-thromboplastin (aPTT) olusebenzayo. IHemlibra ihlala emzimbeni wakho ixesha elide, kwaye inokuchaphazela iziphumo zovavanyo ukuya kuthi ga kwiinyanga ezintandathu emva kwedosi yakho yokugqibela. Qiniseka ukuba uxelela ugqirha wakho malunga naluphi na unyango lwangoku okanye oludlulileyo lweHemlibra ngaphambi kokuba uthathe naluphi na uvavanyo lwelebhu.

Izilumkiso zeHemlibra

Eli chiza liza nesilumkiso esivela kuLawulo lokutya kunye neDrug (FDA).

Isilumkiso se-FDA: I-thrombotic microangiopathy kunye neziganeko ze-thrombotic

Eli chiza linesilumkiso esibhokisiweyo. Esi sisilumkiso esibi kakhulu esivela kwi-FDA. Isilumkiso esinebhokisi silumkisa oogqirha kunye nezigulana malunga neziyobisi ezinokuba yingozi.

Ukuthatha i-Hemlibra kunye nokufumana i-prothrombin complex concentrate (aPCC) yokuphuma kwegazi kunokunyusa umngcipheko wamahlwili egazi. Iziganeko ze-Thrombotic (ii-clots zegazi) zinokwenzeka kwizitho ezinkulu okanye kumalungu omzimba, kubandakanya umphunga, intloko, iingalo, okanye imilenze. Ziyenzeka nakwimithambo yegazi encinci kwizitho ezinjengezintso kunye nengqondo. Ukuqina kwegazi kunokuba yingozi kwaye kufuna unyango kwangoko.

Izifundo zonyango ziye zajonga abantu abathathe iHemlibra banyangwa nge-PCC. Abantu abathathu babene-thrombotic microangiopathy (amahlwili egazi kwimithambo yegazi encinci). Abantu ababini babenemicimbi ye-thrombotic (yegazi) kweminye imithambo yegazi. Kwimeko nganye kwezi, idosi epheleleyo ye-PCC yayingaphezulu kweeyunithi ezili-100 / kg ngemini ngaphezulu kweeyure ezingama-24.

Ukuba uhlakulela i-clot yegazi ngexesha lokunyanga nge-Hemlibra kunye ne-PCC, ugqirha wakho uya kuyeka ukuthatha zombini iziyobisi ixesha. Ugqirha wakho uya kuthatha isigqibo sokuba ngaba kukhuselekile ukuba uqale ukuthatha iHemlibra kwakhona.

Phawula: Ngolwazi oluthe kratya malunga neziphumo ezibi ezinokubakho zeHemlibra, jonga icandelo leziphumo ebezingalindelekanga zeHemlibra apha ngasentla.

Ukugqithisa kweHemlibra

Ukuthatha kakhulu iHemlibra kunokunyusa umngcipheko weziphumo ebezingalindelekanga ezibi.

Iimpawu libanda

Iimpawu zokuthatha kakhulu iHemlibra zinokubandakanya:

  • intloko ebuhlungu
  • intlungu edibeneyo

Ukuthatha i-Hemlibra kakhulu kunokwandisa umngcipheko wamahlwili egazi. Ngamanye amaxesha, unokufuna unyango kwangoko. (Ngolwazi oluthe kratya malunga negazi elinokubakho, jonga icandelo leempembelelo zeHemlibra apha ngasentla.

Kufuneka wenze ntoni xa uthe wagqithisa?

Ukuba ucinga ukuba uthathe kakhulu eli chiza, tsalela ugqirha wakho. Ungabiza uMbutho waseMelika wamaZiko oLawulo lweTyhefu ku-800-222-1222 okanye usebenzise isixhobo esikwi-Intanethi. Kodwa ukuba unempawu ezinzima, tsalela umnxeba ku-911 okanye uye kwigumbi likaxakeka elikufutshane ngoko nangoko.

Ukuphelelwa yisikhathi, ukugcinwa kunye nokulahlwa kweHemlibra

Xa ufumana iHemlibra ekhemesti, usokhemesti uya kongeza umhla wokuphelelwa kwileyibhile esebhotileni. Lo mhla uqhele ukuba ngunyaka omnye ukusukela kumhla wokukhutshwa kwamayeza.

Umhla wokuphelelwa unceda ekuqinisekiseni ukusebenza kwamayeza ngeli xesha. Isimo sangoku soLawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) kukuphepha ukusebenzisa amayeza aphelelwe lixesha. Ukuba awusebenzisanga iyeza elidlulileyo, thetha nopharmist. Usenokukwazi ukuyisebenzisa.

Ukugcina

Ukuhlala ixesha elingakanani iyeza lihlala lilungile kunokuxhomekeka kwizinto ezininzi, kubandakanya ukuba uligcina phi kwaye phi na iyeza.

Gcina iibhola zakho zeHemlibra kwifriji. Zibeke kwisitya esitywinwe ngokuqinileyo kwaye singanyangeki ukukhanya. Ukuba kuyimfuneko, ungathatha iibhotile ngaphandle kweentsuku ezisixhenxe kwifriji. Emva koko kuya kufuneka uzibeke kwifriji. Musa ukugcina iibhotile kumaqondo obushushu aphezulu kune-86 ° F (30 ° C) xa bephuma kwisibandisi.

Emva kokuvula ibhotile, yisebenzise kwangoko. Lahla nayiphi na indawo yesisombululo ongasisebenzisiyo.

Ukulahla

Ukuba akusafuneki ukuba uthathe iHemlibra kwaye unamayeza ashiyekileyo, kubalulekile ukulahla ngokukhuselekileyo. Oku kunceda ukuthintela abanye, kubandakanya abantwana kunye nezilwanyana zasekhaya, ekubeni bathathe iyeza ngengozi. Kuyanceda ukugcina ichiza lingonzakalisi okusingqongileyo.

Emva kokusetyenziswa, qiniseka ukubeka izinto ezinje ngeebhotile, iinaliti ezineenaliti, kunye neesirinji kwisikhongozeli sakho sokulahla.

Iwebhusayithi ye-FDA ibonelela ngeengcebiso ezininzi eziluncedo ngokulahla amayeza. Unokucela ikhemesti yakho ukuba ikwazi ukuba ulahla njani na amayeza akho.

Ulwazi lobungcali lweHemlibra

Olu lwazi lulandelayo lubonelelwe ngoochwephesha kunye nabanye abaqeqeshi bezempilo.

Iimpawu

I-Hemlibra (emicizumab-kxwh) ivunyiwe yi-FDA ukuba isetyenziswe njengeprophylaxis yesiqhelo yokuthintela okanye ukunciphisa ukuphindaphindeka kweziqendu zokopha kwizigulana zeminyaka yonke ene-hemophilia A (ukusweleka kwento VIII) kunye okanye ngaphandle kwento VIII inhibitors.

Indlela yokusebenza

I-Hemlibra yi-bispecific (ineziza ezibini ezahlukeneyo ze-antigen-binding). ukudibanisa ukuqhubekeka ukuqhubeka, ukwandisa ukwakheka kwehlwili. IHemlibra ihlala isebenza phambi kobukho be-VIII inhibitors.

I-Pharmacokinetics kunye ne-metabolism

Kuthetha ukufakwa kwesiqingatha sobomi ziintsuku eziyi-1.6 emva kokufakwa ngaphakathi. Ukungafumaneki ngokupheleleyo kwe-bioavailability kuphakathi kweipesenti ezingama-80.4 kunye neepesenti ezingama-93.1.

Kuthetha ukupheliswa kwesiqingatha sobomi ziintsuku ezingama-26.9.

Ukungqinelana

Akukho zichasene nokusetyenziswa kweHemlibra.

Ukugcina

Iibhola ze-Hemlibra kufuneka zigcinwe kwifriji kwi-36 ° F ukuya kwi-46 ° F (2 ° C ukuya kwi-8 ° C) kwisitya sokuqala, sikhuselwe ekukhanyeni. Imiphanda ayifanele ibe ngumkhenkce okanye ishukunyiswe. Xa kufuneka, iibhotile ezingavulwanga zingagcinwa ngaphandle kwefriji emva koko zibuyiselwe kwifriji ixesha elingekho ngaphezulu kweentsuku ezisixhenxe kubushushu obungadluli kuma-86 ° (30 ° C). Nje ukuba ususwe kwibhotile, lahla icandelo elingasetyenziswanga ukuba alisetyenziswanga kwangoko.

Ukuziphendulela: Iindaba zezoNyango namhlanje zenze zonke iinzame zokuqinisekisa ukuba zonke iinkcukacha zichanekile, zibanzi kwaye zihlaziyiwe. Nangona kunjalo, eli nqaku akufuneki lisetyenziswe endaweni yolwazi kunye nobuchule bengcali yezempilo enelayisensi. Kuya kufuneka usoloko uqhagamshelana nogqirha wakho okanye nolunye uqeqesho kwezonyango ngaphambi kokuba uthathe nawaphi na amayeza. Ulwazi lweziyobisi oluqulethwe apha luyakwazi ukutshintsha kwaye alujoliswanga ekusetyenzisweni konke okunokwenzeka, imikhombandlela, izilumkiso, izilumkiso, ukuhlangana kweziyobisi, ukungahambelani komzimba, okanye iziphumo ezibi. Ukungabikho kwezilumkiso okanye olunye ulwazi ngesiyobisi esinikiweyo akubonisi ukuba indibaniselwano yeziyobisi ikhuselekile, iyasebenza, okanye ifanelekile kuzo zonke izigulana okanye konke ukusetyenziswa okuthile.

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