Umbhali: Randy Alexander
Umhla Wokudalwa: 1 Utshazimpuzi 2021
Hlaziya Umhla: 20 Eyenkanga 2024
Anonim
Uncedo (elotuzumab) - Enye
Uncedo (elotuzumab) - Enye

Umxholo

Yintoni i-Empliciti?

I-Empliciti sisiyobisi esichaziweyo. Isetyenziselwa ukunyanga uhlobo lomhlaza wegazi obizwa ngokuba yi-myeloma emininzi kubantu abadala.

I-Empliciti imiselwe abantu abangena kwezi meko zonyango zimbini:

  • Abantu abadala ababenonyango olunye ukuya koluthathu ngaphambili kwi-myeloma yabo emininzi. Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-lenalidomide (Revlimid) kunye ne-dexamethasone.
  • Abantu abadala abanokungenani unyango lwe-myeloma ezimbini ezidlulileyo ezibandakanya i-lenalidomide (i-Revlimid) kunye ne-proteasome inhibitor, njenge-bortezomib (i-Velcade) okanye i-carfilzomib (i-Kyprolis). Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

I-Empliciti ikudidi lweziyobisi ekuthiwa zii-antibodies ze-monoclonal. La machiza enziwe elebhu evela kumaseli omzimba. I-Empliciti isebenza ngokwenza ukuba amajoni akho omzimba omelele kwaye enze iiseli zakho zomzimba zomelele. Eli chiza liyanceda ukubonisa amajoni akho omzimba apho iiseli ezininzi ze-myeloma zisemzimbeni wakho ukuze ezi seli zitshatyalaliswe.


I-Empliciti ifumaneka kumandla amabini: i-300 mg kunye ne-400 mg. Iza njengomgubo owenziwe kwisisombululo esingamanzi kwaye unikwe ukufakwa ngaphakathi (IV) ukumiliselwa (inaliti emthanjeni wakho ixesha elithile). Izifo zinikwa kwiziko lokhathalelo lwempilo kwaye zihlala malunga neyure okanye nangaphezulu.

Ukusebenza ngempumelelo

Izifundo zonyango ziye zabonisa ukuba i-Empliciti iyasebenza ekupheliseni ukuqhubela phambili (ukuwohloka) kwe-myeloma eninzi. Iziphumo zezinye zezi zifundo zichazwe apha ngezantsi.

I-Empliciti ene-lenalidomide (i-Revlimid) kunye ne-dexamethasone

Kwizilingo zeklinikhi, abantu abane-myeloma ezininzi banikwa i-Empliciti ene-lenalidomide kunye ne-dexamethasone, okanye i-lenalidomide kunye ne-dexamethasone yodwa.

Izifundo zibonise ukuba abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi wokuba isifo sabo siqhubele phambili. Ngaphezulu kweminyaka emibini ubuncinci, abo bathatha i-Empliciti nge-lenalidomide kunye ne-dexamethasone babenomngcipheko ophantsi nge-30% kunabantu ababethatha la machiza ngaphandle kwe-Empliciti.


Kwesinye isifundo esihlala iminyaka emihlanu, abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi we-27% wesifo sabo esiba mandundu kunabantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela.

I-Empliciti ene-pomalidomide (iPomalyst) kunye ne-dexamethasone

Kwezilingo zeklinikhi, abantu abane-myeloma ezininzi banikwa i-Empliciti kunye ne-pomalidomide kunye ne-dexamethasone, okanye i-pomalidomide kunye ne-dexamethasone yodwa.

Abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi we-46% wesifo sabo esiya sisiba mandundu emva kweenyanga ezilithoba zonyango, xa kuthelekiswa nabantu abathatha i-pomalidomide kunye ne-dexamethasone kuphela.

Impliciti generic

I-Empliciti ifumaneka kuphela njengonyango lwegama lophawu. Okwangoku ayifumaneki ngendlela eqhelekileyo.

I-Empliciti iqulethe iyeza elotuzumab elisebenzayo.

Iziphumo ebezingalindelekanga ze-Empliciti

I-Empliciti inokubangela iziphumo ebezingalindelekanga ezinobulali okanye ezinobuzaza. Olu luhlu lulandelayo luqulathe ezinye zeziphumo ebezingalindelekanga ezinokubakho ngelixa uthatha i-Empliciti. Olu luhlu alubandakanyi zonke iziphumo ebezingalindelekanga ezinokubakho.


Iziphumo zakho ebezingalindelekanga ziyahluka ngokuxhomekeka ekubeni uthatha i-Empliciti kunye ne-dexamethasone kunye neleneralomide (Revlimid) okanye pomalidomide (Pomalyst).

Ngolwazi oluthe kratya malunga neziphumo ebezingalindelekanga ze-Empliciti, thetha nogqirha okanye usokhemesti. Banokukunika iingcebiso malunga nendlela yokujongana nayo nayiphi na imiphumela emibi enokuthi ikhathaze.

Iziphumo eziqhelekileyo ezichaphazelekayo

Iziphumo eziqhelekileyo ezichaphazelekayo ze-Empliciti xa zithathwa nge-lenalidomide kunye ne-dexamethasone zingabandakanya:

  • ukudinwa (ukunqongophala kwamandla)
  • urhudo
  • ifiva
  • ukuqhina
  • ukukhohlela
  • usulelo, njengosulelo lwesono okanye inyumoniya
  • ukunciphisa ukutya okanye ukunciphisa umzimba
  • isifo semithambo-luvo (umonakalo kwezinye zeemvakalelo zakho)
  • iintlungu ezingalweni okanye emilenzeni
  • intloko ebuhlungu
  • ukugabha
  • cataract (ukusithela kwiliso leliso lakho)
  • iintlungu emlonyeni nasemqaleni
  • utshintsho kumanqanaba athile kuvavanyo lwegazi

Iziphumo eziqhelekileyo ezichaphazelekayo ze-Empliciti xa zithathwa nge-pomalidomide kunye ne-dexamethasone zingabandakanya:

  • ukuqhina
  • ukwanda kwenqanaba leswekile yegazi
  • usulelo, olunje nge-pneumonia okanye usulelo lwe-sinus
  • urhudo
  • iintlungu zethambo
  • ingxaki yokuphefumla
  • ukudumba kwezihlunu
  • ukudumba ezingalweni okanye emilenzeni
  • utshintsho kumanqanaba athile kuvavanyo lwegazi

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

Iziphumo ebezingalindelekanga ezimandundu

Iziphumo ebezingalindelekanga ezimandundu zinokwenzeka nge-Empliciti. Shayela ugqirha wakho ngokukhawuleza ukuba unemiphumo emibi. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Iziphumo ebezingalindelekanga ezimandundu kunye neempawu zazo zinokubandakanya oku kulandelayo:

  • Ezinye iintlobo zomhlaza, ezinje ngomhlaza wolusu. Iimpawu zingabandakanya:
    • ubuthathaka
    • ndiziva ndidiniwe
    • utshintsho kwinkangeleko yolusu lwakho kunye nee-moles
    • ukudumba kwamalungu enkovu
  • Iingxaki zesibindi. Iimpawu zingabandakanya:
    • ndiziva ndidiniwe
    • ubuthathaka
    • mthubi mhlophe wamehlo akho okanye ulusu lwakho
    • ukunciphisa ukutya
    • ukudumba kwindawo esiswini sakho
    • ndiziva ndididekile

Ezinye iziphumo ebezingalindelekanga ezimandundu, ekuxoxwa ngazo ngokubanzi apha ngezantsi, zinokubandakanya oku kulandelayo:

  • ukumnika ukumnika (kunokubangelwa kukufakwa iziyobisi ngaphakathi)
  • negazi lakho kakhulu
  • usulelo

Iinkcukacha zesiphumo

Unokuzibuza ukuba zenzeka kangaphi ezinye iziphumo ebezingalindelekanga ngeli chiza. Nazi ezinye iinkcukacha kwezinye zeziphumo ebezingalindelekanga ezinokubangelwa leli chiza.

Ukuphendula ngokuchaseneyo

Njengoninzi lweziyobisi, abanye abantu banokuba neempendulo emva kokuthatha i-Empliciti. Iimpawu zokuphendula kancinci kunokubandakanya:

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

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

  • ukudumba phantsi kolusu lwakho, ikakhulu kwiinkophe zakho, imilebe, izandla, okanye iinyawo
  • ukudumba kolwimi lwakho, umlomo, okanye umqala
  • ingxaki yokuphefumla

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

Iimpembelelo ukumnika

Unokuba ne-infusion reaction emva kokufumana i-Empliciti. Oku kukuphendula okunokwenzeka ukuya kuthi ga kwiiyure ezingama-24 emva kokuba ufumene ichiza ngokufakwa ngaphakathi (IV) kokufakwa.

Kwizilingo zeklinikhi, iipesenti ezili-10 zabantu abathatha i-Empliciti nge-lenalidomide kunye ne-dexamethasone babenempendulo yokumnika. Uninzi lwaba bantu babenempendulo yokumnika ngaphakathi ngexesha lokuqala lokufakwa kwe-Empliciti. Nangona kunjalo, yi-1% kuphela yabantu abathatha olu dibaniso lonyango kuye kwafuneka bayeke unyango ngenxa yeempembelelo zokungena nzulu.

Kwizilingo zeklinikhi, i-3.3% yabantu abathatha i-Empliciti kunye ne-pomalidomide kunye ne-dexamethasone babe neempembelelo ze-infusion. Olona phawu kuphela lokuphendula kwabo kukungeniswa yayiyintlungu esifubeni.

Iimpawu zokuphendula ngokungeniswa kunokubandakanya:

  • ifiva
  • Ukugodola
  • ukwanda okanye ukunciphisa uxinzelelo lwegazi
  • ukubetha kwentliziyo
  • ingxaki yokuphefumla
  • isiyezi
  • irhashalala
  • iintlungu zesifuba

Phambi kokufakwa kwakho kwe-IV ye-Empliciti, ugqirha wakho okanye umongikazi uya kukunika amayeza athile ukunceda ukuthintela impendulo engenzeki ukuba ingenzeki.

Ukuba unayo nayiphi na impendulo yempembelelo yokungeniswa ngelixa ufumana i-Empliciti, okanye ukuya kuthi ga kwiiyure ezingama-24 emva kokufakwa kwakho, xelela ugqirha wakho ngoko nangoko. Kwiimeko ezinzima, ugqirha wakho unokucebisa ukuba uyeke unyango lwe-Empliciti.

Ngamanye amaxesha, unyango lwe-Empliciti lungaqala kwakhona emva kokuphendula ngokungeniswa. Kodwa kwezinye iimeko, ukukhetha amayeza ahlukileyo kunokuba yinto ebhetele kuwe.

Usulelo

Unokuba nengozi yokwanda kosulelo ngelixa uthatha i-Empliciti. Oku kubandakanya ukosuleleka ziintsholongwane, intsholongwane, nomngundo. Ngamanye amaxesha, ezi zifo zingaba zibi kakhulu ukuba azinyangwa. Ngamanye amaxesha, kunokukhokelela kwizifo ezigwenxa okanye nokufa.

Kwezilingo zeklinikhi, usulelo lwenzeka kwiipesenti ezingama-81 zabantu abathatha i-Empliciti ngeleneralomide kunye ne-dexamethasone. Kubantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela, i-74% yayinosulelo.

Kwakhona kuvavanyo lweklinikhi, usulelo lwenzeka kuma-65% abantu abathatha i-Empliciti nge-pomalidomide kunye ne-dexamethasone. Usulelo lwenzeke kwipesenti efanayo yabantu abathatha i-pomalidomide kunye ne-dexamethasone kuphela.

Iimpawu zosulelo zinokwahluka ngokuxhomekeka kuhlobo losulelo onalo. Imizekelo yeempawu ezinokubakho zibandakanya:

  • ifiva
  • ingxaki yokuphefumla
  • Iimpawu ezinje ngomkhuhlane, ezinje ngeentlungu zomzimba kunye nokugodola
  • ukukhohlela
  • irhashalala
  • imvakalelo evuthayo xa uchama

Ukuba unayo nayiphi na imiqondiso yosulelo, thetha nogqirha wakho ngoko nangoko. Basenokucebisa ukuba uyeke ukuthatha i-Empliciti de usulelo lwakho lumke. Kananjalo baya kuncoma ukuba usulelo lwakho kufuneka lunyangwe.

Isifo semithambo-luvo

Unokuba nomonakalo wemithambo-luvo ukuba uthatha i-Empliciti. Umonakalo wemithambo unokubizwa ngokuba sisifo semithambo-luvo. Le meko inokubangela ubuthathaka kunye nentlungu edla ngokwenzeka ezandleni zakho okanye ezinyaweni. Isifo se-neripheral se-nerip ngokuqhelekileyo asihambi, kodwa sinokunyangwa ngamayeza athile.

Kwezilingo zeklinikhi, isifo semithambo-luvo senzeka kwi-27% yabantu abathatha i-Empliciti ngeleneralomide kunye ne-dexamethasone. Le meko yenzeke kwi-21% yabantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela.

Thetha nogqirha wakho ukuba unempawu zesifo semithambo yoluvo. Banokucebisa ngonyango ukuba uyalufuna.

Ukudinwa

Unokuba nokudinwa (ukungabikho kwamandla) ngelixa usebenzisa i-Empliciti. Esi yayisisiphumo secala esiqhelekileyo esibonwe ngexesha lezifundo kubantu abathatha i-Empliciti ngeleneralomide kunye ne-dexamethasone.

Kwizifundo, ukudinwa kwenzeke kuma-62% abantu abathatha i-Empliciti ngeleneralomide kunye ne-dexamethasone. Kubantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela, i-52% yayinokudinwa.

Thetha nogqirha wakho ukuba uziva ukhathele ngexesha lonyango lwakho lwe-Empliciti. Banokucebisa unyango ukuba ufuna nayiphi na kwaye bacebise ngeendlela zokunciphisa iimpawu zakho.

Urhudo

Unokuba urhudo ngelixa uthatha i-Empliciti. Kwezilingo zeklinikhi, urhudo lwenzeka kwi-47% yabantu abathatha i-Empliciti ngeleneralomide kunye ne-dexamethasone. Kubantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela, i-36% yayinesifo sohudo.

Urhudo yayiyimpembelelo esecaleni ebonwa kubantu abathatha i-Empliciti nge-pomalidomide kunye ne-dexamethasone. Kwezilingo zeklinikhi, urhudo lwenzeka kwi-18% yabantu abathatha olu dibaniso lweziyobisi. Kubantu abathatha i-pomalidomide kunye ne-dexamethasone kuphela, i-9% yayinesifo sohudo.

Thetha nogqirha wakho ukuba urhudo ngexesha lonyango lwakho lwe-Empliciti. Banokucebisa unyango ukuba ufuna nayiphi na kwaye bacebise ngeendlela zokunciphisa iimpawu zakho.

Utshintsho kumaxabiso eelebhu okanye kuvavanyo

Unokuba notshintsho kumanqanaba athile ovavanyo lwegazi ngelixa uthatha i-Empliciti. Imizekelo ibandakanya utshintsho ku:

  • iiseli zegazi
  • Uvavanyo lwesibindi okanye lwezintso
  • amanqanaba eglucose, calcium, potassium, okanye isodiyam

Ugqirha wakho unokujonga uvavanyo lwegazi rhoqo kunesiqhelo ngelixa uthatha i-Empliciti. Oku kuvumela ugqirha wakho ukuba abone ukuba ngaba kukho naluphi na utshintsho kumanqanaba ovavanyo lwegazi. Ukuba olo tshintsho luyenzeka, ugqirha wakho unokujonga uvavanyo lwakho lwegazi rhoqo okanye acebise ukuba uyeke unyango lwe-Empliciti.

Iindleko ze-Empliciti

Njengawo onke amayeza, iindleko ze-Empliciti zingahluka. Eli chiza linikezelwa ngokufakwa ngaphakathi (IV) kwiiklinikhi zononophelo lwempilo.

Elona xabiso uza kulihlawula lixhomekeke kwisicwangciso sakho seinshurensi, indawo okuyo, kunye noncedo lonyango apho ufumana unyango lwakho.

Uncedo lwezezimali kunye neinshurensi

Ukuba ufuna inkxaso yemali ukuhlawula i-Empliciti, okanye ukuba ufuna uncedo lokuqonda i-inshurensi yakho, uncedo luyafumaneka.

IBristol-Myers Squibb, umenzi we-Empliciti, unikezela ngenkqubo ebizwa ngokuba yi-BMS Access Access. Ngolwazi oluthe kratya kunye nokufumanisa ukuba uyilungele na inkxaso, tsalela umnxeba ku-800-861-0048 okanye undwendwele iwebhusayithi yenkqubo.

Umthamo we-Empliciti

Umthamo we-Empliciti ogqirha ugqirha wakho uya kuxhomekeka kwizinto ezimbalwa. Oku kubandakanya:

  • ngawaphi amayeza owathathayo kunye ne-Empliciti
  • ubunzima bomzimba wakho

Idosi yakho inokuhlengahlengiswa ngokuhamba kwexesha ukufikelela kwisixa esifanelekileyo kuwe. Ugqirha wakho uya kuthi ekugqibeleni anike idosi encinci enika isiphumo esifunayo.

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

I-Empliciti iza njengomgubo oxutywe namanzi oyinyumba kwaye wenze isisombululo. Inikwa njenge-intravenous (IV) infusion (inaliti emthanjeni wakho ixesha elithile). Isisombululo senziwe kwaye ukumiliselwa kwe-IV kunikwa wena kwiziko lokhathalelo lwempilo.

I-Empliciti ifumaneka kumandla amabini: i-300 mg kunye ne-400 mg.

Isisombululo se-myeloma ezininzi

Umthamo we-Empliciti owufumanayo uxhomekeke kubunzima bomzimba wakho kwaye ngawaphi amayeza owathathayo nge-Empliciti.

Ukuba uthatha i-Empliciti nge-lenalidomide (Revlimid) kunye ne-dexamethasone:

  • idosi eyi-10 mg ye-Empliciti yekilogram nganye (malunga neepawundi eziyi-2.2) yesisindo somzimba wakho
  • uyakufumana iidosi zeveki ze-Empliciti kwiiveki ezisibhozo zokuqala, ezithathwa njengemijikelezo emibini, yonyango
  • emva kwemijikelo yakho yokuqala yonyango, i-Empliciti inikwa kanye kwiiveki ezimbini

Ukuba uthatha i-Empliciti nge pomalidomide (Pomalyst) kunye ne-dexamethasone:

  • idosi eyi-10 mg ye-Empliciti yekilogram nganye (malunga neepawundi eziyi-2.2) yesisindo somzimba wakho
  • uyakufumana iidosi zeveki ze-Empliciti kwiiveki ezisibhozo zokuqala, ezithathwa njengemijikelezo emibini, yonyango
  • emva kwemijikelezo yakho emibini yokuqala yonyango, idosi inyuka iye kwi-20 mg ye-Empliciti yekilogram nganye yesisindo somzimba wakho, enikwa kanye kwiiveki ezine

Njengomzekelo wokubala idosi, umntu omdala onobunzima obungama-70 eekhilogram (malunga neepawundi ezili-154) uya kufumana idosi eyi-700 mg ye-Empliciti. Oku kubalwa njengeekhilogram ezingama-70 eziphindaphindwe nge-10 mg yeyeza, elingana ne-700 mg ye-Empliciti.

Nokuba unokukhetha idosi, uya kuhlala uqhubeka uthatha i-Empliciti de i-myeloma yakho ibe mbi ngakumbi okanye ube neziphumo ebezingalunganga ezivela kwi-Empliciti.

Kuthekani ukuba ndiphose idosi?

Ukuba uphoswa ukuqeshwa kwi-Empliciti infusion yakho, hlela enye ingqesho ngokukhawuleza. Thetha nogqirha wakho malunga neyona ndlela ilungileyo yokucwangcisa idosi yakho yexesha elizayo ukuze ukwazi ukuyenza kwi-infusions yakho.

Qiniseka ukuba uthatha idosi ye-dexamethasone njengoko uyalelwe ngugqirha. Ukuba uphosa idosi ye-dexamethasone, xelela ugqirha wakho ukuba ulibele ukuyithatha. Ukulibala idosi yeli chiza kunokubangela ukuba uphendule kwi-Empliciti. Ngamanye amaxesha kunokuba nzima kakhulu.

Ngaba kuya kufuneka ndisebenzise eli chiza ixesha elide?

Ngamanye amaxesha ukusebenzisa amayeza kunokugcina i-myeloma yakho izinzile (ingabi mandundu) ixesha elide. Ukuba uthatha i-Empliciti kwaye i-myeloma yakho eninzi ayibi mbi, ugqirha wakho unokucebisa ukuba uhlale kunyango lwe-Empliciti ixesha elide.

Kwezilingo zeklinikhi, ngaphezulu kwesiqingatha sabantu abathatha i-Empliciti khange babe nokubi kwi-myeloma yabo ngaphezulu kweenyanga ezili-10. Ubude bexesha oza kulithatha i-Empliciti buxhomekeke kwindlela umzimba wakho uphendula ngayo kunyango.

Enye indlela yokuya kwi-Empliciti

Amanye amachiza okanye amayeza akhoyo anokunyanga i-myeloma eninzi. Abanye banokukulungela ngcono kunabanye. Ukuba unomdla wokufumana enye indlela eya kwi-Empliciti, thetha nogqirha wakho. Banokukuxelela ngamanye amayeza okanye unyango olunokukusebenzela.

Imizekelo yezinye iziyobisi ezingasetyenziselwa ukunyanga i-myeloma ezininzi zibandakanya:

  • ibortezomib (Velcade)
  • icarfilzomib (iKyprolis)
  • ixazomib (Ninlaro)
  • daratumumab (iDarzalex)
  • thalidomide (Thalomid)
  • lenalidomide (ihlaziyiweyo)
  • pomalidomide (iPomalyst)
  • ii-steroids ezithile, ezinje nge-prednisone okanye i-dexamethasone

Olunye unyango olunokusetyenziselwa ukunyanga i-myeloma eninzi lubandakanya:

  • imitha (isebenzisa imiqadi yamandla ukubulala iiseli zomhlaza)
  • Ukufakelwa kweseli

I-Empliciti (elotuzumab) vs. Darzalex (daratumumab)

Unokuzibuza ukuba i-Empliciti ithelekisa njani namanye amayeza amiselwe ukusetyenziswa okufanayo. Apha sijonga indlela i-Empliciti kunye neDarzalex ezifanayo kunye ezahlukeneyo.

Sebenzisa

Zombini i-Empliciti kunye neDarzalex zivunyiwe yi-Food and Drug Administration (i-FDA) ukunyanga i-myeloma yabantu abadala:

  • Sele ndizame ubuncinci unyango oludlulileyo olubandakanya i-lenalidomide (Revlimid) kunye neproteasome inhibitor, efana ne-bortezomib (Velcade) okanye i-carfilzomib (iKyprolis). Kuba bantu, nokuba yi-Empliciti okanye iDarzalex isetyenziswa kunye ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

I-Empliciti ikwachaziwe nakubantu abadala:

  • bebekhe bafumana unyango olunye ukuya kolwesithathu kwixa elidlulileyo kwi-myeloma yabo emininzi. Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-lenalidomide (Revlimid) kunye ne-dexamethasone.

UDarzalex ukwamkelwe yi-FDA ukunyanga i-myeloma ezininzi kubantu abadala abathathe unyango olunye okanye nangaphezulu ngaphambili. Kuyacetyiswa ukuba isetyenziswe yodwa kwaye idityaniswe nolunye unyango, ngokusekwe kwimbali yonyango lomntu ngamnye.

Iifom zeziyobisi kunye nolawulo

I-Empliciti iza njengomgubo. Yenziwe isisombululo kwaye wanikwa njenge-intravenous (IV) ukumnika (inaliti emthanjeni wakho ixesha elithile). I-Empliciti ifumaneka kumandla amabini: i-300 mg kunye ne-400 mg.

Umthamo wakho we-Empliciti uyahluka ngokuxhomekeke kubunzima bomzimba wakho kunye namanye amayeza owathathayo nge-Empliciti. Ngolwazi oluthe kratya ngeedosi, jonga icandelo "Umthamo we-Empliciti" apha ngasentla.

I-Empliciti ihlala inikwa iveki nganye kwimijikelezo emibini yokuqala (iyonke iiveki ezisibhozo) zonyango. Emva koku, uyakufumana i-Empliciti rhoqo emva kweeveki ezimbini ukuya kwezine, kuxhomekeke ekubeni zeziphi iziyobisi ozisebenzisayo ne-Empliciti. Ngolwazi oluthe kratya, nceda ubone icandelo "Umthamo we-Empliciti" apha ngasentla.

UDarzalex uza njengesisombululo esingamanzi. Kwakhona kunikwa njenge-infravenous (IV) infusion. IDarzalex iyafumaneka kumandla amabini: 100 mg / 5 mL kunye ne-400 mg / 20 mL.

Umthamo wakho weDarzalex uxhomekeke kubunzima bomzimba wakho. Nangona kunjalo, ishedyuli yethamo iya kwahluka ngokuxhomekeke ekubeni zeziphi iziyobisi ozithathayo ngeDarzalex.

UDarzalex uhlala enikwa iiveki ezintandathu ukuya kwezilithoba. Emva koku, uyakufumana iDarzalex kube kanye kwiiveki ezimbini ukuya kwezine, kuxhomekeke ekubeni ubusebenzisa ixesha elingakanani.

Iziphumo kunye neengozi

I-Empliciti kunye neDarzalex zombini ziqulethe amayeza ajolise kwi-myeloma. Ke ngoko, omabini la mayeza anokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

Iziphumo zakho ebezingalindelekanga ziyahluka ngokuxhomekeka ekubeni ngawaphi amayeza owathathayo nge-Empliciti okanye iDarzalex. Ugqirha wakho unokuchaza iziphumo ebezingalindelekanga onokufumana kuzo kuxhomekeke ekubeni zeziphi iziyobisi ozithathayo.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho kwi-Empliciti, kunye neDarzalex, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka nge-Empliciti:
    • cataract (ukusithela kwiliso leliso lakho)
    • intlungu emlonyeni wakho okanye emqaleni
    • iintlungu zethambo
  • Ngaba kunokwenzeka ngeDarzalex:
    • ubuthathaka
    • isicaphucaphu
    • umqolo obuhlungu
    • isiyezi
    • ukulala (kunzima ukulala)
    • ukwanda koxinzelelo lwegazi
    • intlungu edibeneyo
  • Inokwenzeka zombini i-Empliciti kunye neDarzalex:
    • ukudinwa (ukunqongophala kwamandla)
    • urhudo
    • ukuqhina
    • ukunciphisa ukutya
    • ifiva
    • ukukhohlela
    • ukugabha
    • ingxaki yokuphefumla
    • ukudumba kwezihlunu
    • ukudumba ezingalweni okanye emilenzeni
    • ukwanda kwenqanaba leswekile yegazi
    • intloko ebuhlungu

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho ne-Empliciti, kunye neDarzalex, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka nge-Empliciti:
    • iingxaki zesibindi
    • ukuphuhlisa ezinye iintlobo zomhlaza, ezinje ngomhlaza wolusu
  • Ngaba kunokwenzeka ngeDarzalex:
    • i-neutropenia (inqanaba leseli legazi elimhlophe)
    • thrombocytopenia (inqanaba eliphantsi leplatelet)
  • Inokwenzeka zombini i-Empliciti kunye neDarzalex:
    • iimpendulo zokunyuswa
    • isifo semithambo-luvo (umonakalo kwezinye zeemvakalelo zakho)
    • usulelo, olufana nenyumoniya

Ukusebenza ngempumelelo

I-Empliciti kunye neDarzalex zombini zivunyiwe ukunyanga i-myeloma yabantu abadala.

La machiza khange athelekiswe ngokuthe ngqo kwizifundo zeklinikhi. Kodwa izifundo ezahlukileyo zifumene i-Empliciti kunye neDarzalex ukuba isebenze kunyango lwe-myeloma.

Iindleko

I-Empliciti kunye neDarzalex zombini zinegama lophawu lweziyobisi. Okwangoku azikho iintlobo zohlobo oluthile lwamayeza. Amayeza egama leBrand ahlala exabisa ngaphezu kwegeneric.

Zombini i-Empliciti kunye neDarzalex zinikwa njenge-intravenous (IV) infusions kwiziko lokhathalelo lwempilo. Imali eyiyo oza kuyihlawula nokuba yeyiphi na iyeza iya kuxhomekeka kwi-inshurensi yakho, indawo okuyo, kunye neklinikhi okanye isibhedlele apho ufumana unyango lwakho.

Impliciti vs Ninlaro

Unokuzibuza ukuba i-Empliciti ithelekisa njani namanye amayeza amiselwe ukusetyenziswa okufanayo. Apha sijonga indlela i-Empliciti kunye ne-Ninlaro ezifanayo kunye ezahlukeneyo.

Sebenzisa

Zombini i-Empliciti kunye ne-Ninlaro zamkelwe yi-Food and Drug Administration (FDA) ukunyanga i-myeloma eninzi.

I-Empliciti imiselwe abantu abangena kwezi meko zonyango zimbini:

  • Abantu abadala ababenonyango olunye ukuya koluthathu ngaphambili kwi-myeloma yabo emininzi. Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-lenalidomide (Revlimid) kunye ne-dexamethasone.
  • Abantu abadala abanokungenani unyango lwe-myeloma ezimbini ezidlulileyo ezibandakanya i-lenalidomide (i-Revlimid) kunye ne-proteasome inhibitor, njenge-bortezomib (i-Velcade) okanye i-carfilzomib (i-Kyprolis). Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

U-Ninlaro uvunyiwe ukuba anyange i-myeloma yabantu abadala abaye bazama olunye unyango olunye ngaphambili. I-Ninlaro ivunyiwe ukuba isetyenziswe ngokudibeneyo ne-lenalidomide (Revlimid) kunye ne-dexamethasone.

Iifom zeziyobisi kunye nolawulo

I-Empliciti iza njengomgubo. Yenziwe isisombululo kwaye wanikwa njenge-intravenous (IV) ukumnika (inaliti emthanjeni wakho ixesha elithile). I-Empliciti ifumaneka kumandla amabini: i-300 mg kunye ne-400 mg.

Umthamo wakho we-Empliciti uyahluka ngokuxhomekeke kubunzima bomzimba wakho kunye namanye amayeza owathathayo nge-Empliciti. Ngolwazi oluthe kratya ngeedosi, jonga icandelo "Umthamo we-Empliciti" apha ngasentla.

I-Empliciti ihlala inikwa iveki nganye kwimijikelo emibini yokuqala (iyonke iiveki ezisibhozo) zonyango. Emva koku, uyakufumana i-Empliciti rhoqo emva kweeveki ezimbini ukuya kwezine, kuxhomekeke ekubeni zeziphi iziyobisi ozisebenzisayo ne-Empliciti. Ngolwazi oluthe kratya, nceda ubone icandelo "Umthamo we-Empliciti" apha ngasentla.

I-Ninlaro iza njengee-capsules ezithathwa ngomlomo kanye ngeveki. INinlaro iyafumaneka ngamandla amathathu:

  • 2.3 mg
  • 3 mg
  • 4 mg

Iziphumo kunye neengozi

I-Empliciti kunye neNinlaro zombini ziqulethe amayeza anceda ukuphelisa iiseli ezininzi ze-myeloma. Ke ngoko, omabini la mayeza anokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

I-Ninlaro ivunyiwe kuphela ukuba ingasetyenziswa kunye ne-lenalidomide (Revlimid) kunye ne-dexamethasone. Kweli candelo, sithelekisa iziphumo ebezingalindelekanga zendibaniselwano yonyango ye-Ninlaro kunye neziphumo ebezingalindelekanga ze-Empliciti nayo ngokudibanisa ne-lenalidomide (Revlimid) kunye ne-dexamethasone.

Iziphumo zakho ebezingalindelekanga ziyahluka ngokuxhomekeka ekubeni ngawaphi amayeza owathathayo kunye ne-Empliciti okanye iNinlaro. Ugqirha wakho unokuchaza iziphumo ebezingalindelekanga onokufumana kuzo kuxhomekeke ekubeni zeziphi iziyobisi ozithathayo.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho kwi-Empliciti, kunye neNinlaro, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngokudibanisa unyango lwe-Empliciti:
    • ukudinwa (ukunqongophala kwamandla)
    • ifiva
    • ukukhohlela
    • ukunciphisa ukutya
    • intloko ebuhlungu
    • cataract (ukusithela kwiliso leliso lakho)
    • iintlungu emlonyeni wakho
  • Inokwenzeka ngokudityaniswa konyango lweNinlaro:
    • isicaphucaphu
    • ukugcinwa kolwelo, kunokubangela ukudumba
    • umqolo obuhlungu
  • Inokwenzeka ngokudibanisa unyango kunye ne-Empliciti kunye neNinlaro:
    • urhudo
    • ukuqhina
    • ukugabha

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho ne-Empliciti, kunye neNinlaro, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngokudibanisa unyango lwe-Empliciti:
    • iimpendulo zokunyuswa
    • izifo ezinzulu
    • ukuphuhlisa ezinye iintlobo zomhlaza
  • Inokwenzeka ngokudityaniswa konyango lweNinlaro:
    • thrombocytopenia (inqanaba eliphantsi leplatelet)
    • irhashalala enkulu yesikhumba
  • Inokwenzeka ngokudibanisa unyango kunye ne-Empliciti kunye neNinlaro:
    • isifo semithambo-luvo (umonakalo kwezinye zeemvakalelo zakho)
    • iingxaki zesibindi

Ukusebenza ngempumelelo

I-Empliciti kunye ne-Ninlaro bobabini bavunyelwe ukunyanga i-myeloma yabantu abadala.

La machiza khange athelekiswe ngokuthe ngqo kwizifundo zeklinikhi. Kodwa izifundo ezahlukileyo zifumene i-Empliciti kunye neNinlaro ukuba isebenze kunyango lwe-myeloma.

Iindleko

I-Empliciti kunye neNinlaro omabini la magama anegama lophawu. Okwangoku azikho iintlobo zohlobo oluthile lwamayeza. Amayeza egama leBrand ahlala exabisa ngaphezu kwegeneric.

I-Empliciti inikezelwa njenge-intravenous (IV) infusion kwiziko lokhathalelo lwempilo. Njengezingxobo ze-Ninlaro zihanjiswa ezikhemesti ezikhethekileyo. Imali eyiyo oza kuyihlawula nokuba yeyiphi na amayeza ixhomekeke kwi-inshurensi yakho, indawo okuyo, nokuba ufumana unyango kwikliniki okanye esibhedlele.

Impliciti ye-myeloma emininzi

Ulawulo lokutya kunye neziyobisi (i-FDA) livuma amayeza amiselweyo anje nge-Empliciti ukunyanga i-myeloma eninzi. Le meko luhlobo lomhlaza oluchaphazela iiseli zakho zeplasma. Ezi seli luhlobo lweeseli ezimhlophe zegazi ezinceda umzimba wakho ukuba ulwe iintsholongwane kunye nosulelo.

Nge-myeloma emininzi, umzimba wakho wenza iiseli ze-plasma ezingaqhelekanga. Iiseli ze-plasma ezingaqhelekanga, ezibizwa ngokuba ziiseli ze-myeloma, zixinanisa iiseli zakho zeplasma esempilweni. Oku kuthetha ukuba uneeseli zeplasma ezinempilo ezinokulwa iintsholongwane. Iiseli ze-Myeloma nazo zenza iprotheni ebizwa ngokuba yi-M protein. Le protein inokwakha emzimbeni wakho kwaye yonakalise amanye amalungu akho.

I-Empliciti imiselwe abantu abangena kwezi meko zonyango zimbini:

  • Abantu abadala ababenonyango olunye ukuya koluthathu ngaphambili kwi-myeloma yabo emininzi. Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-lenalidomide (Revlimid) kunye ne-dexamethasone.
  • Abantu abadala abanokungenani unyango lwe-myeloma ezimbini ezidlulileyo ezibandakanya i-lenalidomide (i-Revlimid) kunye ne-proteasome inhibitor, njenge-bortezomib (i-Velcade) okanye i-carfilzomib (i-Kyprolis). Kuba bantu, i-Empliciti isetyenziswa ngokudibanisa ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

Ukusebenza kunyango lwe-myeloma emininzi

Izifundo zonyango ziye zabonisa ukuba i-Empliciti iyasebenza ekupheliseni ukuqhubela phambili (ukuwohloka) kwe-myeloma eninzi. Iziphumo zezinye zezi zifundo zichazwe apha ngezantsi.

I-Empliciti ene-lenalidomide (i-Revlimid) kunye ne-dexamethasone

Kwizilingo zeklinikhi, abantu abane-myeloma ezininzi banikwa i-Empliciti ene-lenalidomide kunye ne-dexamethasone, okanye i-lenalidomide kunye ne-dexamethasone yodwa.

Izifundo zibonise ukuba abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi wokuba isifo sabo siqhubele phambili. Ngaphezulu kweminyaka emibini ubuncinci, abo bathatha i-Empliciti nge-lenalidomide kunye ne-dexamethasone babenomngcipheko ophantsi nge-30% kunabantu ababethatha la machiza ngaphandle kwe-Empliciti.

Kwesinye isifundo esihlala iminyaka emihlanu, abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi we-27% wesifo sabo esiba mandundu kunabantu abathatha i-lenalidomide kunye ne-dexamethasone kuphela.

I-Empliciti ene-pomalidomide (iPomalyst) kunye ne-dexamethasone

Kwezilingo zeklinikhi, abantu abane-myeloma ezininzi banikwa i-Empliciti kunye ne-pomalidomide kunye ne-dexamethasone, okanye i-pomalidomide kunye ne-dexamethasone yodwa.

Abantu abathatha indibaniselwano ye-Empliciti babenomngcipheko ophantsi we-46% wesifo sabo esiya sisiba mandundu emva kweenyanga ezilithoba zonyango, xa kuthelekiswa nabantu abathatha i-pomalidomide kunye ne-dexamethasone kuphela.

Ukusetyenziswa kwe-Empliciti nezinye iziyobisi

I-Empliciti inikwa namanye amayeza xa isetyenziselwa ukunyanga i-myeloma eninzi.

Amayeza amaninzi e-myeloma asetyenziswa kunye ne-Empliciti

I-Empliciti ihlala isetyenziswa ngokudibanisa ne-steroid ebizwa ngokuba yi-dexamethasone. Ihlala isetyenziswa ngokudibeneyo kunye neleneralomide (Revlimid) okanye pomalidomide (Pomalyst). Ukusebenzisa la mayeza nge-Empliciti kunceda ichiza ukuba lisebenze ngakumbi ekunyangeni i-myeloma eninzi.

Unyango lwangaphambi kokufakwa kunye ne-Empliciti

Ngaphambi kokuba ufumane ukumiliselwa kwakho nge-intravenous (IV) ye-Empliciti, uya kuthatha amayeza athile abizwa ngokuba ngamayeza ngaphambi kokufakwa. La machiza asetyenziselwa ukunceda ukuthintela iziphumo ebezingalindelekanga (kubandakanya ukusabela kokungeniswa) okubangelwa lunyango lwe-Empliciti.

Uya kufumana la mayeza alandelayo ngaphambi kokumnika malunga nemizuzu engama-45 ukuya kwengama-90 ngaphambi konyango lwakho lwe-Empliciti:

  • Dexamethasone. Uyakufumana i-8 mg ye-dexamethasone ngenaliti ye-IV.
  • IDiphenhydramine (iBenadryl). Uya kuthatha i-25 mg ukuya kwi-50 mg ye-diphenhydramine ngaphambi kokufakwa kwe-Empliciti. I-Diphenhydramine inokunikwa ngenaliti (IV) ngenaliti okanye njengecwecwe elithathwa ngomlomo.
  • I-Acetaminophen (iTylenol). Uya kuthatha kwakhona i-650 mg ukuya kwi-1,000 mg ye-acetaminophen ngomlomo.

Isebenza njani i-Empliciti

I-Multiple myeloma luhlobo lomhlaza oluchaphazela iiseli ezithile ezimhlophe zegazi ezibizwa ngokuba ziiseli zeplasma. Ezi seli zinceda umzimba wakho ukulwa iintsholongwane kunye nosulelo. Iiseli zePlasma ezichaphazeleka yi-myeloma ezininzi ziba ngumhlaza kwaye zibizwa ngokuba ziiseli ze-myeloma.

I-Empliciti isebenza kuhlobo olwahlukileyo lweseli emhlophe yegazi ebizwa ngokuba siseli sendalo sokubulala (NK). Iiseli ze-NK zisebenza emzimbeni wakho ukubulala iiseli ezingaqhelekanga, ezinje ngeeseli zomhlaza okanye iiseli ezisulelwe ziintsholongwane.

I-Empliciti isebenza ngokwenza (ukuvula) iiseli zakho ze-NK. Oku kunceda iiseli zakho ze-NK zifumane iiseli zeplasma ezingaqhelekanga ezichaphazeleka yi-myeloma ezininzi. Iiseli ze-NK emva koko zitshabalalisa ezo seli zingavumelekanga. I-Empliciti isebenza ngokufumana iiseli ze-myeloma zeeseli zakho ze-NK.

I-Empliciti ibizwa ngokuba sisiyobisi se-immunotherapy. La machiza asebenza kunye namajoni akho omzimba ukunceda umzimba wakho ukuba ulwe neemeko ezithile.

Kuthatha ixesha elingakanani ukusebenza?

I-Empliciti iqala ukusebenza emzimbeni wakho emva kokuba ufumene ukumnika okokuqala. Nangona kunjalo, ngekhe uqaphele ukuba i-Empliciti iqala nini ukusebenza. Ugqirha wakho uya kuba nakho ukujonga ukuba iyasebenza na ngokwenza uvavanyo oluthile. Ukuba unemibuzo malunga nokuba i-Empliciti isebenza kanjani kuwe, thetha nogqirha wakho.

I-Empliciti kunye notywala

Akukho nxibelelwano lwaziwayo phakathi kwe-Empliciti kunye notywala. Nangona kunjalo, i-Empliciti inokubangela iingxaki zesibindi. Ukusela utywala kunokudodobalisa ukusebenza kwesibindi.

Thetha nogqirha wakho ngaphambi kokuba usele utywala ngelixa uthatha i-Empliciti. Banokukucebisa ukuba ngaba kukhuselekile ukuba usele utywala ngelixa usebenzisa eli chiza.

Unxibelelwano lwe-Empliciti

I-Empliciti ayisebenzisi ngokubanzi namanye amayeza. Nangona kunjalo, amayeza asetyenziswa ne-Empliciti ayaziwa ukunxibelelana nezinye iziyobisi.

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

Unyango lwe-Empliciti lunokuchaphazela iziphumo zovavanyo oluthile lweelebhu.

Uvavanyo lwe-Empliciti kunye nelabhoratri

I-Empliciti inokuchaphazela iziphumo zovavanyo oluthile ezisetyenziselwa ukujonga iprotheyini ye-M emzimbeni wakho. Iprotein M iveliswa ziiseli ezininzi ze-myeloma. Inqanaba eliphezulu le-M protein lithetha ukuba umhlaza wakho uqhubele phambili.

Ugqirha wakho uya ku-odola uvavanyo lokujonga iprotheyini ye-M emzimbeni wakho ngexesha lonyango lwe-Empliciti. Oku kuvumela ugqirha wakho ukuba abone ukuba umzimba wakho uphendula njani kwichiza.

Nangona kunjalo, i-Empliciti inokutshintsha iziphumo zovavanyo lwakho lweeproteni ze-M. Oku kunokwenza kube nzima kugqirha wakho ukuba azi ukuba i-myeloma yakho iphucula okanye hayi. I-Empliciti inokuyenza ibonakale ngathi uneprotein engaphezulu kweM kunokuba uyenzile. Ukusebenza ngoku, ugqirha wakho unoku-odola iimvavanyo zelebhu ezingachaphazeleki yi-Empliciti yokujonga unyango lwakho.

Olunye unxibelelwano lweziyobisi

I-Empliciti ihlala ithathwa nge-dexamethasone kunye ne-pomalidomide (Pomalyst) okanye i-lenalidomide (Revlimid). Ngelixa kungekho kunxibelelana kwaziwayo kweziyobisi ne-Empliciti, kukho unxibelelwano olwaziwayo lweziyobisi ezisetyenziswa kunye nazo.

Qiniseka ukuba uxoxa nogqirha wakho okanye usokhemesti nakuphi na ukudibana okunokubakho ngokudityaniswa kwamachiza owathathayo.

Inikwa njani i-Empliciti

Kuya kufuneka uthathe i-Empliciti ngokomyalelo kagqirha wakho okanye ngemiyalelo yezempilo. I-Empliciti inikwa ngokufakwa ngaphakathi, ngaphakathi (IV), ngesiqhelo kusetyenziswa umthambo engalweni yakho. Iziyobisi ezinikwa ukumiliselwa kwe-IV zinikwa kancinci kancinci kwithuba lexesha. Kungathatha iyure okanye nangaphezulu ukufumana idosi epheleleyo ye-Empliciti.

I-Empliciti inikwa kuphela kwiofisi kagqirha okanye kwiklinikhi yokhathalelo lwempilo. Ngelixa ufumana ukumiliselwa kwakho, uya kujongwa ngeempendulo ezichaseneyo okanye ukumnika.

Nini ukuthatha

I-Empliciti inikwa kumjikelo wonyango weentsuku ezingama-28. Ulithatha kangaphi eli chiza kuxhomekeke kwamanye amayeza owathathayo nge-Empliciti. Ishedyuli eqhelekileyo xa uza kuthatha i-Empliciti imi ngolu hlobo lulandelayo:

  • Ukuba uthatha i-Empliciti nge-lenalidomide (Revlimid) kunye ne-dexamethasone, uyakufumana i-Empliciti kanye ngeveki kwimijikelo emibini yokuqala (iiveki ezisibhozo zizonke) zonyango. Emva koko, uyakufumana i-Empliciti kanye qho ngeveki.
  • Ukuba uthatha i-Empliciti nge pomalidomide (Pomalyst) kunye ne-dexamethasone, uyakufumana i-Empliciti kanye ngeveki kwimijikelezo emibini yokuqala (iiveki ezisibhozo zizonke) zonyango. Emva koko, uyakufumana i-Empliciti kanye kumjikelo ngamnye, eyidosi enye rhoqo kwiiveki ezine.

Ugqirha wakho uya kubeka iliso kunyango lwakho kwaye anqume ukuba zingaphi imijikelezo ye-Empliciti oyifunayo.

I-Empliciti kunye nokukhulelwa

Akuzange kubekho zifundo ze-Empliciti kubafazi abakhulelweyo. Izifundo zezilwanyana ekukhulelweni nazo azikenziwa ngeli chiza.

Nangona kunjalo, i-lenalidomide (i-Revlimid) kunye ne-pomalidomide (iPomalyst), ezisetyenziswa nganye ne-Empliciti, zinokubangela ingozi enkulu kumntwana okhulayo. La machiza akufuneki asetyenziswe ngexesha lokukhulelwa. Sebenzisa la machiza ngexesha lokukhulelwa kunokubangela iziphene zokuzalwa okanye ukuphuma kwesisu.

Ngenxa yokuba i-Empliciti ivunyelwe kuphela ukuba ingasetyenziswa kunye ne-lenalidomide (i-Revlimid) okanye i-pomalidomide (i-Pomalyst), i-Empliciti nayo kufuneka ithintelwe ngexesha lokukhulelwa. Abantu abathatha i-Empliciti kufuneka basebenzise ulawulo lokuzalwa xa kufuneka njalo. Jonga icandelo elilandelayo, "i-Empliciti kunye nolawulo lokuzalwa," ngeenkcukacha ezithe kratya.

Ukuba unemibuzo malunga nokusebenzisa i-Empliciti ngexesha lokukhulelwa, thetha nogqirha wakho.

I-Empliciti kunye nolawulo lokuzalwa

Ayaziwa ukuba i-Empliciti ikhuselekile ukuthatha ngexesha lokukhulelwa.

Nangona kunjalo, i-lenalidomide (i-Revlimid) kunye ne-pomalidomide (iPomalyst), ezisetyenziswa nganye ne-Empliciti, zinokubangela ingozi enkulu kumntwana okhulayo. La machiza akufuneki asetyenziswe ngexesha lokukhulelwa. Ngenxa yokuba i-Empliciti ivunyiwe kuphela ukuba ingasetyenziswa kunye ne-lenalidomide okanye i-pomalidomide, i-Empliciti kufuneka ithintelwe ngexesha lokukhulelwa.

Ngenxa yoku, kuye kwenziwa inkqubo ekhethekileyo yokunceda ukukhusela ukukhulelwa kubantu abasebenzisa la mayeza. Le nkqubo ibizwa ngokuba yinkqubo yoVavanyo loMngcipheko kunye neNkqubo yokuNciphisa (REMS).

Bobabini abantu ababhinqileyo nabesilisa abasebenzisa i-Empliciti kufuneka bavume kwaye balandele imiyalelo ye-Revlimid REMS okanye iPomalyst REMS. Uya kulandela inkqubo ye-REMS nokuba yeyiphi na iyeza olithathayo kunye ne-Empliciti. Inkqubo nganye ineemfuno ezithile ekufuneka zilandelwe ukuze uqhubeke nokuthatha i-lenalidomide okanye i-pomalidomide.

Ukongeza ekufuneni abantu abathatha i-Empliciti ukuba basebenzise ulawulo lokuzalwa, inkqubo ye-REMS ifuna ukuba:

  • kuvavanywa rhoqo ukukhulelwa, ukuba ulibhinqa usebenzisa ichiza
  • uyavuma ukuba unganikeli naliphi na igazi okanye isidoda ngelixa usebenzisa ichiza

Ulawulo lokuzalwa kwabasetyhini

Ukuba ungabafazi abakwaziyo ukukhulelwa, kuya kufuneka ukuba ube neemvavanyo ezimbini zokukhulelwa ezingalunganga ngaphambi kokuba uqale ukusebenzisa iilennomomidi okanye i-pomalidomide.

Ngelixa uthatha elinye lala machiza, kuya kufuneka usebenzise iindlela ezimbini zolawulo lokuzalwa okanye uyeke ukwabelana ngesondo ngexesha lonyango. Kuya kufuneka uqhubeke nokusebenzisa ukuzalwa kokuthintela okanye ungabinanto yokwabelana ngesondo ubuncinci iiveki ezine emva kokuba uyekile unyango.

Ulawulo lokuzalwa kwamadoda

Ukuba uyindoda ethatha i-Empliciti kunye ne-lenalidomide okanye i-pomalidomide, kwaye usabelana ngesondo nabasetyhini abakwaziyo ukukhulelwa, kuya kufuneka usebenzise ulawulo lokuzalwa (njengeikhondom) ngexesha lonyango. Oku kubalulekile ukwenza nokuba iqabane lakho lisebenzisa ulawulo lokuzalwa. Kuya kufuneka uqhubeke nokusebenzisa ulawulo lokuzalwa ubuncinci iiveki ezine emva kokuba uyekile unyango.

Impliciti kunye nokuncancisa

Akukho zifundo zibonisa ukuba i-Empliciti idlulela kubisi lwebele lomntu okanye ukuba ibangela naziphi na iziphumo kumntwana oncelisayo.

Ayaziwa nokuba i-lenalidomide (i-Revlimid) kunye ne-pomalidomide (iPomalyst) inokubangela naziphi na iimpembelelo ebantwaneni. Nangona kunjalo, ngenxa yomngcipheko weziphumo ebezingalindelekanga ezibi ebantwaneni, ukuncancisa kufuneka kuthintelwe ngelixa uthatha i-Empliciti.

Imibuzo eqhelekileyo malunga ne-Empliciti

Nazi iimpendulo kwimibuzo ebuzwa rhoqo malunga ne-Empliciti.

Ngaba i-Empliciti chemotherapy?

Hayi, i-Empliciti ayithathwa njenge-chemotherapy (amayeza emveli asetyenziselwa ukunyanga umhlaza). I-Chemotherapy isebenza ngokubulala iiseli emzimbeni wakho eziphindaphindayo (zisenza iiseli ezininzi). Nangona oku kubulala iiseli zomhlaza, kunokubulala nezinye iiseli ezisempilweni.

Ngokungafaniyo ne-chemotherapy eqhelekileyo, i-Empliciti lonyango ekujoliswe kulo. Olu hlobo lweziyobisi lusebenza kwiiseli ezithile (ezibizwa ngokuba ziiseli zombulali zendalo), ukujolisa iiseli zomhlaza. Kuba i-Empliciti ijolise kwiqela elikhethekileyo leeseli, alichaphazeli iiseli zakho ezisempilweni kakhulu. Oku kuthetha ukuba kunokubangela iziphumo ebezingalindelekanga ezimbalwa kune-chemotherapy eqhelekileyo.

Kuza kwenzeka ntoni kunyango lwam lwe-Empliciti?

I-Empliciti inikwa njenge-intravenous (IV) infusion (inaliti emthanjeni wakho kwisithuba sexesha). IV ihlala ibekwa engalweni yakho.

Ngokwesiqhelo uya kufumana idosi enye ye-Empliciti veki nganye kwimijikelo emibini yokuqala yonyango. (Umjikelo ngamnye ziintsuku ezingama-28.) Emva koko unokufumana ukumiliselwa kube kanye emva kweeveki ezimbini okanye kube kanye kwiiveki ezine. Eli candelo leshedyuli yakho yedosi lixhomekeke kumayeza owathathayo kunye ne-Empliciti.

Ubude bexesha lokungeniswa ngalunye kuxhomekeke kubunzima bomzimba wakho kunye nokuba mangaphi amathamo e-Empliciti osele uyifumene.

Emva kwethamo lakho lesibini le-Empliciti, ukumiliselwa kwakho akufuneki kuthathe ixesha elingaphezulu kweyure enye. Kunokuba luncedo ukuzisa into yokwenza ngexesha lokumiliselwa kwakho ukwenza ixesha lidlule ngokukhawuleza. Umzekelo, ungazisa incwadi okanye iphephancwadi oza kulifunda okanye umculo oza kuwumamela.

Ngaphambi kokufumana ukumiliselwa kwakho kwe-Empliciti, uya kufumana ezinye iziyobisi ukunceda ukuthintela iziphumo ebezingalindelekanga ezithile, kubandakanya ukuphendula ukumnika. La machiza abizwa ngokuba ngamayeza ngaphambi kokufakwa.

Amayeza amayeza kwangaphambili aza kumnika ngaphambi kokufakwa kwe-Empliciti:

  • idiphenhydramine (iBenadryl)
  • dexamethasone
  • i-acetaminophen (iTylenol)

Ndingazi njani ukuba i-Empliciti iyandisebenzela?

I-Empliciti isebenza ngokunceda amajoni akho omzimba ukulwa neeseli ezininzi ze-myeloma. Ugqirha wakho unokujonga indlela omzimba wakho ophendula ngayo kunyango ngoku-odola uvavanyo lokujonga iiprotheyini ze-M.

Iiproteni ze-M ziveliswa ziiseli ezininzi ze-myeloma. Ezi proteni zinokwakha emzimbeni wakho kwaye zibangele ukonakala kwamanye amalungu akho. Inqanaba eliphezulu le-M protein ibonakala kubantu abane-myeloma ephezulu kakhulu.

Ugqirha wakho unokujonga amanqanaba akho eeproteni M ukubona ukuba uphendula njani kunyango. Amanqanaba eeprotein anokuvavanywa ngokujonga isampulu yegazi okanye umchamo.

Ugqirha wakho unokujonga kwakhona impendulo yakho kunyango ngoku-odola ukuskena kwethambo. Ezi skena ziya kubonisa ukuba ngaba uneenguqu ezithile zethambo ezibangelwa zii-myeloma ezininzi.

Ngaba ukusebenzisa i-Empliciti kunokubangela ukuba ndibe nezinye iintlobo zomhlaza?

Inokwenzeka. Ukusebenzisa i-Empliciti ukunyanga i-myeloma eninzi kunokunyusa umngcipheko wokuba nezinye iintlobo zomhlaza.

Kwizilingo zeklinikhi, i-9% yabantu abathatha i-Empliciti nge-lenalidomide (i-Revlimid) kunye ne-dexamethasone yavelisa olunye uhlobo lomhlaza. Kubantu abathatha kuphela i-lenalidomide kunye ne-dexamethasone, i-6% ineziphumo ezifanayo. Iindidi zomhlaza eziye zaphuhliswa ngumhlaza wolusu kunye nezidumba eziqinileyo, ezinjengesifuba okanye umhlaza webele.

Kwizilingo zeklinikhi, i-1.8% yabantu abathatha i-Empliciti kunye ne-pomalidomide (Pomalyst) kunye ne-dexamethasone yavelisa olunye uhlobo lomhlaza. Kubantu abathatha i-pomalidomide kunye ne-dexamethasone kuphela, akukho namnye owakha olunye uhlobo lomhlaza.

Ngexesha lonyango kunye ne-Empliciti, ugqirha wakho unoku-odola uvavanyo lwegazi olongezelelekileyo okanye iskena esokujonga esweni umhlaza omtsha ophuhlisayo.

Amanyathelo okuthintela

Ngaphambi kokuba uthathe i-Empliciti, thetha nogqirha wakho malunga nembali yakho yezempilo. I-Empliciti isenokungakulungeli ukuba uneemeko ezithile zonyango. Oku kubandakanya:

  • Ukukhulelwa. Ayaziwa ukuba i-Empliciti inobungozi kumntwana okhulayo. Nangona kunjalo, i-Empliciti isetyenziswa kunye neleneralomide (Revlimid) okanye pomalidomide (Pomalyst). Omabini la machiza ayaziwa ukuba abangela iziphene zokuzalwa. Ngenxa yoku, abantu abathatha i-lenalidomide okanye i-pomalidomide kufuneka basebenzise ulawulo lokuzalwa ukuthintela ukukhulelwa ngelixa besebenzisa la mayeza. Ngolwazi oluthe kratya, nceda ubone icandelo "Empliciti kunye nokukhulelwa" apha ngasentla.
  • Ukuncancisa. Ayaziwa ukuba i-Empliciti iyadlula kubisi lomntu. Nangona kunjalo, ngenxa yomngcipheko weziphumo ebezingalindelekanga ezibi ebantwaneni, ukuncancisa kufuneka kuthintelwe ngelixa uthatha i-Empliciti. Ngolwazi oluthe kratya, nceda ubone icandelo "Empliciti kunye nokuncancisa" apha ngasentla.
  • Usulelo lwangoku. Akufanele uqale ukuthatha i-Empliciti ukuba unesifo esisebenzayo. Oku kubandakanya ukubanda okuqhelekileyo, umkhuhlane, okanye olunye usulelo lwebacteria kunye nentsholongwane. Ugqirha wakho unokucebisa ukuba uqale i-Empliciti emva kokuba unyangwe naluphi na usulelo. Kungenxa yokuba i-Empliciti inokuwenza buthathaka amajoni akho omzimba, enza ukuba kube nzima ukulwa nosulelo.

Phawula: Ngolwazi oluthe kratya malunga neziphumo ezibi ezinokubakho zeEmpliciti, jonga icandelo lempembelelo ze- "Empliciti" ngasentla.

Ulwazi lobungcali kwi-Empliciti

Olu lwazi lulandelayo lubonelelwe ngoochwephesha kunye nabanye abaqeqeshi bezempilo.

Iimpawu

I-Empliciti ibonakalisiwe ukunyanga i-myeloma eninzi ebantwini abangena kwezi meko zimbini zonyango:

  • Abantu abadala ababekhe bafumana unyango olunye ukuya kolwesithathu. Kwaba bantu, i-Empliciti isetyenziswa kunye ne-lenalidomide (Revlimid) kunye ne-dexamethasone.
  • Abantu abadala abasele befumene okungenani iindlela ezimbini zonyango ezibandakanya i-lenalidomide (Revlimid) kunye nayiphi na inhibitor yeproteasome. Kwaba bantu, i-Empliciti isetyenziswa kunye ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

I-Empliciti ayiboniswanga ukuba isetyenziswe kubantu abangaphantsi kweminyaka eli-18 ubudala.

Indlela yokusebenza

I-Empliciti yintsholongwane ye-IgG1 monoclonal antibody. I-Empliciti isebenza ngokujolisa kwi-Signaling Lymphocytic Activation Molecule ilungu loSapho 7 (SLAMF7).

I-SLAMF7 ayichazwa nje kuphela kwiiseli zombulali (NK) kunye neeseli zeplasma egazini, kodwa nakwiiseli ezininzi ze-myeloma. I-Empliciti isebenza ngokuququzelela ukutshatyalaliswa kweeseli ze-myeloma ngokusebenzisa i-cytotoxicity yeseli exhomekeke ku-antibody (ADCC). Oomatshini basebenza ngenxa yokunxibelelana phakathi kweeseli ze-NK kunye neeseli ezinesifo se-myeloma. Olunye uphononongo lubonisa ukuba i-Empliciti inokunceda ekuvuseleleni iiseli ze-NK, eziya kuthi emva koko zitshabalalise iiseli ze-myeloma.

I-Pharmacokinetics kunye ne-metabolism

Ukucocwa kwe-Empliciti kuyanda njengoko ubunzima bomzimba bonyuka. I-Empliciti ibonise i-pharmacokinetics engekho mgaqweni, apho ukonyuka kwethamo kubangele ukubonakaliswa okukhulu kwesiyobisi kunokuba bekuxelwe kwangaphambili.

Ukungqinelana

I-Empliciti ayinangqinisiso ethile. Nangona kunjalo, kufanele kuthintelwe kwabasetyhini abakhulelweyo xa bethathwa njengoko kubonisiwe, okubandakanya ukusetyenziswa kwe-pomalidomide okanye i-lenalidomide.

Ukugcina

I-Empliciti iyafumaneka nokuba yi-300 mg okanye i-400 mg ye-lyophilized powder kwisitya esinye sokusetyenziswa. Umgubo kufuneka uphinde uphinde uhlanjululwe ngaphambi kokuba ulawulwe.

I-Empliciti powder kufuneka igcinwe kwifriji (kubushushu be-36 ° F ukuya kwi-46 ° F / 2 ° C ukuya kwi-8 ° C) kwaye ikhuselwe ekukhanyeni. Musa ukumisa okanye ugungqise iibhotile.

Xa umgubo uphinde wenziwa kwakhona, isisombululo kufuneka sifakwe kwiiyure ezingama-24. Emva kokuxuba, ukuba ukumnika kungasetyenziswanga kwangoko, kufuneka kwakhona kukhuselwe kwisikhenkcisi ekukhanyeni. Isisombululo se-Empliciti kufuneka sigcinwe ubuninzi beeyure eziyi-8 (iiyure ezingama-24 zizonke) kubushushu begumbi kunye nokukhanya kwegumbi.

Iphepha elichazayo ukuba awusenanto oyifunayo: 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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