Umbhali: Peter Berry
Umhla Wokudalwa: 19 Eyekhala 2021
Hlaziya Umhla: 13 Ucanzibe 2024
Anonim
All About Darzalex (daratumumab)
Ividiyo: All About Darzalex (daratumumab)

Umxholo

Yintoni iDarzalex?

I-Darzalex ligama lonyango elinegama lebrendi. Isetyenziselwa ukunyanga i-myeloma emininzi, eluhlobo lomhlaza oluchaphazela iiseli ezithile ezimhlophe zegazi ezibizwa ngokuba ziiseli zeplasma.

IDarzalex iqulethe i-daratumumab. Olu luhlobo lweziyobisi olubizwa ngokuba yi-monoclonal antibody.

UDarzalex akayona ichemotherapy. Luhlobo lonyango ekujoliswe kulo kwaye ngamanye amaxesha lubizwa ngokuba yi-immunotherapy. Oku kuthetha ukuba iDarzalex yenzelwe ukusebenza kunye namajoni akho omzimba (ukuzikhusela komzimba wakho kusulelo).

Umboneleli wezempilo uya kukunika iDarzalex njenge-intravenous (IV) infusion kwiofisi kagqirha wakho okanye eklinikhi. Ukufakwa kwe-IV ngenaliti emthanjeni wakho onikwe ngaphezulu kwexesha elithile.

Isetyenziswa njani

I-Darzalex inokumiselwa yodwa okanye namanye amayeza. Ulawulo lwezoKutya kunye noLawulo lweziyobisi (FDA) luvumile ukuba iDarzalex isetyenziswe:

  • Kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zesimo ziyasetyenziswa.) Kule meko:
    • IDarzalex inokusetyenziswa kunye namayeza e-lenalidomide (Revlimid) kunye ne-dexamethasone.
    • IDarzalex inokusetyenziswa kunye namayeza e-bortezomib (Velcade), i-melphalan, kunye ne-prednisone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu olungazange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile. Kule meko, iDarzalex isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma. Kule meko, iDarzalex isetyenziswa kunye ne-bortezomib kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili ezazibandakanya i-lenalidomide kunye ne-proteasome inhibitor, eluhlobo lweziyobisi. Kule meko, iDarzalex isetyenziswa kunye namayeza e-pomalidomide (Pomalyst) kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili ebandakanya iproteasome inhibitor kunye nonyango lwe-immunomodulatory. Kule meko, iDarzalex isetyenziswa ngokwayo.
  • Kubantu abadala abaye bazama i-proteasome inhibitor kunye neyeza lokunyanga umzimba, kodwa akukho nalinye ichiza elisebenzele i-myeloma eninzi. Kule meko, iDarzalex isetyenziswa ngokwayo.

Ukusebenza ngempumelelo

Izifundo ezithandathu zeklinikhi zajonga ukuba iDarzalex yayisebenza njani ekunyangeni i-myeloma emininzi, iyodwa kwaye idityaniswe nezinye iziyobisi zokulwa nomhlaza.Ezi zifundo zibizwa ngokuba yiMAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, kunye neSIRIUS. Uphando lubonise ukuba unyango lwe-myeloma oluninzi lwalusebenza ngakumbi ukuba iDarzalex yongezwa kunyango oluqhelekileyo lomhlaza kunokuba ngaba unyango oluqhelekileyo lwalunikwa lodwa. Ngolwazi oluthe kratya malunga nokusebenza, jonga "iDarzalex yeqela le-myeloma" apha ngezantsi.


IDarzalex generic

I-Darzalex ifumaneka kuphela njengeyeza-igama lonyango. Okwangoku ayifumaneki ngendlela eqhelekileyo.

I-Darzalex iqulethe into enye esebenzayo: daratumumab.

Iziphumo ebezingalindelekanga zeDarzalex

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

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

Iziphumo eziqhelekileyo ezichaphazelekayo

Iziphumo eziqhelekileyo zeDarzalex zingabandakanya:

  • ndiziva ndidiniwe
  • ubuthathaka okanye ukungabikho kwamandla
  • ukuphazamiseka kwemisipha (ukujija)
  • isicaphucaphu okanye ukugabha
  • isisu esibuhlungu kubandakanya urhudo okanye ukuqhina
  • ukunciphisa ukutya
  • ingxaki yokulala
  • ifiva
  • Ukugodola
  • ukuphefumla kancinci okanye ukukhohlela
  • usulelo oluphezulu lokuphefumla, njengokubanda
  • i-bronchitis, uhlobo losulelo lwemiphunga
  • iintlungu zomzimba
  • intlungu edibeneyo okanye yomqolo
  • isiyezi

Ukuba iziphumo ebezingalindelekanga oziva zibonakala zinzima kakhulu okanye zingapheli, thetha nogqirha wakho okanye usokhemesti.


Iziphumo ebezingalindelekanga ezimandundu

Iziphumo ezibi kakhulu ezivela eDarzalex aziqhelekanga, kodwa zinokwenzeka. 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:

  • Ukumnika ukusabela, uhlobo uxabane. Iimpawu zingabandakanya:
    • ingxaki yokuphefumla
    • ukuqina komqala
    • Ndiziva ndinentloko elula okanye ndinesiyezi kuxinzelelo lwegazi olusezantsi
    • ukukhohlela okanye ukuvuthisa
    • impumlo egudileyo okanye exineneyo
    • isicaphucaphu okanye ukugabha
    • Ukugodola
    • ifiva
    • intloko ebuhlungu
    • ukurhawuzelela
  • I-pneumonia, uhlobo losulelo lwemiphunga. Iimpawu zingabandakanya:
    • ukukhohlela phlegm (mucus)
    • umkhuhlane kunye nokugodola
    • ukuqhawukelwa ngumphefumlo
    • iintlungu zesifuba
  • I-Hepatitis B, ukuba unayo ngaphambili. Iimpawu zingabandakanya:
    • ukwanda kokudinwa
    • ubumthubi besikhumba sakho okanye inxenye emhlophe yamehlo akho
  • I-peripheral sensory neuropathy (umonakalo we-nerve obangela ukubetha, ukuphazamiseka, okanye intlungu). Iimpawu zingabandakanya:
    • ukuba ndindisholo okanye ukurhawuzelela
    • intlungu etshayo
    • uvakalelo
    • ubuthathaka ezandleni nasezinyaweni
  • Ukudumba okuphezulu (ukudumba kwezandla neenyawo). Iimpawu zingabandakanya:
    • ukudumba kweengalo okanye imilenze
    • ulusu ololuliweyo
    • ulusu olunemingxunya (imingxunya) xa ucinezelwe imizuzwana embalwa

Ezinye iziphumo ebezingalindelekanga ezimandundu, ezichazwe ngokubanzi apha ngezantsi "Iinkcukacha zeziphumo ebezingalindelekanga," zibandakanya:


  • negazi lakho
  • thrombocytopenia, inqanaba eliphantsi leeplatelets, eziluhlobo lweeseli zegazi ezinceda ukujiya kwegazi
  • i-neutropenia, inqanaba eliphantsi lee-neutrophils, eluhlobo lweeseli ezimhlophe zegazi ezinceda ukulwa usulelo
  • i-shingles (usuleleko lwe-herpes zoster)

Iinkcukacha zesiphumo

Unokuzibuza ukuba zenzeka kangaphi ezinye iziphumo ebezingalindelekanga ngeli chiza. Nazi ezinye iinkcukacha malunga neziphumo ebezingalindelekanga ezinzulu ezinokubangelwa leli chiza.

Ukuphendula ngokuchaseneyo

Njengokuba kuninzi lweziyobisi, abanye abantu banokuphendula emva kokuthatha iDarzalex. Ayaziwa ukuba abantu basebenzisa iDarzalex kaninzi kangakanani ukuba neempendulo. Iimpawu zokuphendula kancinci kunokubandakanya:

  • ukugqabhuka kolusu okanye urticies (ukurhawuzelela okubabayo kulusu lwakho)
  • ukucheba
  • ukucoca (ukufudumala nokubomvu kwesikhumba sakho)
  • ifiva

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

Fowunela ugqirha ngoko nangoko ukuba unegciwane elibukhali eDarzalex. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Ukuphendula ngokufakwa ngaphakathi

UDarzalex unikwa ukumiliselwa ngaphakathi (IV) kwiofisi kagqirha wakho okanye eklinikhi. Le yilenaliti emthanjeni wakho enikwe ixesha elide. Njengokuba kuninzi lweziyobisi ezinikezelwa njenge-IV infusion, unokuba ne-infusion reaction emva kokufumana iDarzalex. (Impendulo yokungena ngaphakathi luhlobo lokuphendula okungafunekiyo.)

Ngexesha lezifundo zeklinikhi, iimpendulo ze-infusion zenzeka malunga nesiqingatha sabo bonke abantu abaphathwa nge-infusion yeDarzalex. Ngokwesiqhelo, iimpendulo zenzekile ngexesha lokufakwa kancinci kwaye zazithambile ukuya kumodareyitha. Uninzi lwabantu abafumene iDarzalex lwalusabela ngexesha okanye kwiiyure ezi-4 zokuphela kokufakwa. Ukuphendula ngokunyanzeliswa akunakufane kwenzeke kunyango lwexesha elizayo. Kwezi zifundo, abantu abafumene amayeza ngaphandle kweDarzalex zange banikwe iziyobisi ngohlobo lwe-infusions.

Ukuba ngaba unempendulo yokumnika engenamandla okanye emodareyitha, ugqirha wakho unokumisa kancinci ukumnika ukunyanga impendulo. Banokuqalisa kwakhona ukumiliselwa kwinqanaba eliphantsi (isantya) ukuze ufumane amayeza kancinci kancinci. Ukuba impendulo yakho yokunyuswa inzima okanye i-anaphylactic (esongela ubomi), ugqirha wakho unokuyeka unyango kunye neDarzalex kwaye aqale unyango lwezonyango.

Ukunciphisa ithuba lokuphendula ngokungeniswa, ugqirha wakho uya kukunika indibaniselwano yamachiza. Iyure enye ukuya kwiiyure ezintathu phambi kokufakwa kweDarzalex nganye, uya kufumana:

  • i-corticosteroid (ukunciphisa ukudumba)
  • i-antipyretic (ukuthintela okanye ukunciphisa umkhuhlane)
  • i-antihistamine (ukukhusela okanye ukunciphisa iimpawu zokungabikho komzimba)

Unokufumana kwakhona i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone okanye i-prednisone, ngokuqinisekileyo ngekhe ufune ukongezwa kwe-steroid.

Ukuba unesifo esibi kakhulu kwi-Darzalex emva kokuba ushiye iofisi yakho yogqirha okanye isikhungo sokungena, biza ugqirha wakho ngokukhawuleza. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Ukuphazamiseka kweseli yegazi

I-Darzalex inokubangela i-thrombocytopenia, eyehla kwinqanaba leeplatelets zakho. (Olu luhlobo lweeseli zegazi ezinceda ukujiya kwegazi.) Iimpawu zinokubandakanya ukugruzuka nokopha.

Kwizifundo zeklinikhi, malunga neepesenti ezingama-48 ukuya kuma-90% zabantu abathathe iDarzalex okanye iDarzalex ngonyango oluqhelekileyo lwe-myeloma lwalune-thrombocytopenia. Xa kuthelekiswa, iipesenti ezingama-58 ukuya kuma-88% abantu ababenonyango nje oluqhelekileyo babene-thrombocytopenia.

IDarzalex nayo inokubangela i-neutropenia. Oku kuncipha kwinqanaba le-neutrophils, oluhlobo lweeseli ezimhlophe zegazi ezinceda ukulwa nosulelo. Iimpawu zingabandakanya umkhuhlane kunye nosulelo.

Kwizifundo zeklinikhi, malunga nama-58% ukuya kuma-95% abantu abathathe iDarzalex okanye iDarzalex kunye nonyango oluqhelekileyo lwe-myeloma yayine-neutropenia. Xa kuthelekiswa, ama-40% ukuya kuma-87% abantu ababenonyango nje oluqhelekileyo babene-neutropenia.

Ngexesha lonyango lwakho lweDarzalex, ugqirha wakho uya kuhlala ejonga iplatelet yakho kunye nokubala kweeseli ezimhlophe zegazi. Kananjalo baya kukubeka esweni nokuba kukho ukutyumka, ukopha okanye usulelo. Ukuba uphuhlisa nayiphi na le miqondiso okanye iimpawu, xelela ugqirha wakho.

Izibophelelo

Ngelixa uthatha iDarzalex, unokuba nosulelo olubizwa ngokuba yi-shingles (herpes zoster). Kungenxa yokuba ukuba ne-myeloma eninzi kunye nokufumana unyango oluninzi lwe-myeloma kunokunyusa umngcipheko wosulelo.

Xa ufumana i-shingles, unokuba:

  • intlungu etshayo
  • ukurhawuzelela
  • ukurhawuzelela
  • irhashalala kunye namadyungudyungu kwicala elinye kuphela lomzimba wakho

Intsholongwane enye ebangela i-shingles nayo inokubangela irhashalala. Ukuba ukhe wanerhashalala ngaphambili, intsholongwane ayishiyi umzimba wakho emva kokuba uphinde wachacha kusulelo. Endaweni yoko, intsholongwane "iya kulala" kwimithambo-luvo yakho.

Akukho mntu waziyo ukuba kutheni, kodwa intsholongwane inokuphinda isebenze okanye "ivuke" inezinto ezithile ezinje ngezixhobo ezibuthathaka zomzimba. (Amajoni akho omzimba ayazikhusela kwizifo.)

Umhlaza okanye unyango lomhlaza lunokuwenza buthathaka amajoni akho omzimba kwaye luvuselele intsholongwane ye-herpes zoster. Xa ivuka, izibonakalisa njenge-shingles endaweni yenkukhu yenkukhu.

Kwizifundo zeklinikhi, i-shingles yaxelwa kwi-3% yabantu ababephathwa nge-Darzalex kuphela. Xa kuthelekiswa, i-shingles yenzeke kwi-2% ukuya kwi-5% yabantu abathathe iDarzalex ngolunye unyango lomhlaza.

Ukuba ubukhe wanerhashalala okanye u-shingles kwixa elidlulileyo kwaye uthatha iDarzalex, ugqirha wakho angamisela amayeza antiviral. Olu hlobo lweziyobisi lunokunceda ukuthintela i-shingles ekubeni ikhule emzimbeni wakho. Uya kudinga ukuthatha unyango lwe-antiviral kwiveki e-1 yokuqala ukufumana iDarzalex. Emva koko uya kuqhubeka ukuyithatha iinyanga ezi-3 emva kokuba ugqibile unyango ngeDarzalex.

Ukukrala kwemiphunga

Ukuthatha iDarzalex kunokukhokelela ekubeni usuleleke kusulelo lwemiphunga olubizwa ngokuba yi-pneumonia. Kungenxa yokuba ukuba une-myeloma emininzi, kunokwenzeka ukuba ufumane usulelo kunabantu abasempilweni.

Kwizifundo zonyango, i-11% ukuya kwi-26% yabantu abathathe iDarzalex iphuhlise inyumoniya. Oku kuthelekiswa ne-6% ukuya kwi-14% yabantu abathathe i-placebo (akukho nyango).

I-pneumonia yayisesona sifo sixhaphakileyo sixelwa kaninzi. Ukuya kuthi ga kwi-4% yabantu kuzo zonke izifundo zeDarzalex kuye kwafuneka bayeke ukuthatha ichiza ngenxa yenyumoniya. Ukufa ngenxa yenyumoniya kunqabile. Kodwa ukuba ukufa kwenzekile, kungenxa yenyumoniya kunye ne-sepsis (impendulo esongela ubomi kusulelo).

Iimpawu zepneumonia zinokubandakanya:

  • ukukhohlela phlegm (mucus)
  • umkhuhlane kunye nokugodola
  • ukuqhawukelwa ngumphefumlo
  • iintlungu zesifuba

Ukuba uvelisa naziphi na iimpawu zenyumoniya, xelela ugqirha wakho. Banokuphumla kwiidosi zakho zeDarzalex ukunyanga inyumoniya. Kwizifundo zeklinikhi, malunga ne-1% ukuya kwi-4% yabantu abathathe iDarzalex okanye unyango lomhlaza kuphela oluqhelekileyo kuye kwafuneka bayeke amayeza abo ngenxa yenyumoniya.

Iindleko zeDarzalex

Njengawo onke amayeza, iindleko zeDarzalex zingahluka. Ukufumana amaxabiso akhoyo ngoku eDarzalex kwindawo yakho, jonga WellRx.com. Iindleko ozifumana kwi-WellRx.com yinto onokuyihlawula ngaphandle kwe-inshurensi. Ixabiso eliya kuhlawula liya kuxhomekeka kwi-inshurensi yakho kunye nekhemisi oyisebenzisayo.

Isicwangciso sakho seinshurensi sinokufuna ukuba ufumane isigunyaziso ngaphambi kokuba bavume ukugubungela iDarzalex. Oku kuthetha ukuba ugqirha wakho uya kudinga ukuthumela isicelo kwinkampani yakho yeinshurensi ubacele ukuba bagubungele iyeza. Inkampani yeinshurensi iyakusiphonononga isicelo kwaye ikuxelele wena nogqirha ukuba isicwangciso sakho siza kuyigubungela iDarzalex.

Ukuba awuqinisekanga ukuba uyakufuna ukufumana imvume kwangaphambili yeDarzalex, nxibelelana nesicwangciso sakho seinshurensi.

Uncedo lwezezimali kunye neinshurensi

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

UJanssen Biotech, Inc., umenzi weDarzalex, unikezela ngenkqubo ebizwa ngokuba yiJanssen CarePath. Ngolwazi oluthe kratya kunye nokufumanisa ukuba uyilungele na inkxaso, tsalela umnxeba ku-844-553-2792 okanye undwendwele iwebhusayithi yenkqubo.

Umthamo weDarzalex

Umlinganiselo weDarzalex ugqirha ugqirha uya kuxhomekeka kwizinto ezininzi. Oku kubandakanya:

  • ukuba imeko yakho isandula ukufumanisa ukuba ufumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma.
  • naluphi na unyango olufumanayo kunye neDarzalex ukunyanga i-myeloma eninzi
  • ezinye iimeko zonyango onokuba nazo
  • naziphi na iziphumo ebezingalindelekanga ezingahambiyo

Olu lwazi lulandelayo luchaza iidosi eziqhelekileyo ezisetyenziswayo okanye ezicetyiswayo. Ugqirha wakho uya kumisela eyona idosi ilungele iimfuno zakho. Ukufumana okuninzi kolu nyango, kubalulekile ukuba uye kuzo zonke izikhundla zakho kwaye ungatsiba naziphi na iintsuku.

Iifom zamachiza kunye namandla

I-Darzalex iza njengesisombululo (umxube wolwelo) oya kuthi uwafumane ngohlobo lwenaliti. Isisombululo singenakubalabala kumbala otyheli. IDarzalex ifumaneka ngobukhulu obubini:

  • 100 mg / 5 mL kwi-vial yedosi enye
  • I-400 mg / 20 mL kwi-vial yedosi enye

Umboneleli wezempilo uya kudibanisa inxenye yeDarzalex kunye ne-0.9% yesodium chloride (uhlobo lwesisombululo samanzi etyuwa). Emva koko baya kukunika eli yeza ngenaliti ebekwe emthanjeni wakho. Oku kubizwa ngokuba kukufakwa ngaphakathi ngaphakathi (IV).

Ngokwesiqhelo, ugqirha wakho uya kukuqala kumthamo ocetyiswayo kodwa ngeqondo eliphantsi (isantya) sokufakwa. Ngexesha elingaphezulu, baya kulungelelanisa ukumiliselwa kwinqanaba elifanele wena. Oku kuya kuxhomekeka nakweyiphi na impendulo yokungena ngaphakathi.

Ukufakwa kwakho kokuqala kweDarzalex kungathatha malunga neeyure ezisi-7. Kungenxa yokuba ugqirha wakho uza kukufaka (akunike) amayeza akho kancinci kancinci emthanjeni wakho. Kwixesha elizayo, ukumiliselwa kuya kuhlala malunga neeyure ezi-3 ukuya kwezi-5 kuba uyakufumana unyango lunyanzeliswa ngokukhawuleza. Umboneleli wezononophelo lwempilo uya kuhlala ekubeka esweni ngexesha lokumiliselwa kwakho.

Isisombululo se-myeloma ezininzi

I-Darzalex imiselwe yodwa okanye nezinye iintlobo zonyango lomhlaza kubantu abadala abane-myeloma emininzi. Isicwangciso sonyango kunye nobude buya kuxhomekeka ekubeni usandula ukufumanisa ukuba unonyango okanye ngaba ukhe wafumana unyango lwangaphambili. UDarzalex khange afundwe ebantwaneni.

Idosi ecetyiswayo yeDarzalex yi-16 milligrams / kilogram (mg / kg) yesisindo somzimba ngokwenyani njenge-IV infusion. Umzekelo, umfazi oneepawundi ezili-110 unobunzima obumalunga nama-50 kg. Oko kuthetha ukuba idosi yakhe ecetyiswayo iDarzalex iya kuba ngama-50 kg iphindaphindwe nge-16 mg / kg, eyi-800 mg.

Abantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo

Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zokuma zisetyenziswa. Olunye ukhetho lonyango yiDarzalex ene-lenalidomide (Revlimid) kunye ne-dexamethasone. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-8: Idosi enye ngeveki (iyonke idosi ezisibhozo)
  • Iiveki 9 ukuya ku-24: Idosi enye rhoqo kwiiveki ezi-2 (iyonke idosi ezisibhozo)
  • Iveki yama-25 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Olunye ukhetho lonyango yiDarzalex ene-bortezomib (Velcade), melphalan, kunye ne-prednisone. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-6: Idosi enye ngeveki (iyonke idosi ezintandathu)
  • Iiveki 7 ukuya ku-54: Idosi enye qho kwiiveki ezi-3 (iyonke idosi ezili-16)
  • Iveki yama-55 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Abantu abadala abafumene unyango olunye okanye nangaphezulu olungakhange lusebenze kakuhle okanye uninzi lwe-myeloma lubuyile

Uya kufumana iDarzalex ngeleneralomide kunye ne-dexamethasone. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-8: Idosi enye ngeveki (iyonke idosi ezisibhozo)
  • Iiveki 9 ukuya ku-24: Idosi enye rhoqo kwiiveki ezi-2 (iyonke idosi ezisibhozo)
  • Iveki yama-25 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Abantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma (s)

Uya kufumana iDarzalex nge-bortezomib kunye ne-dexamethasone. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-9: Idosi enye ngeveki (iyonke idosi ezilithoba)
  • Iiveki 10 ukuya ku-24: Idosi enye rhoqo kwiiveki ezintathu (iyonke idosi ezintlanu)
  • Iveki yama-25 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Abantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili, kubandakanya i-lenalidomide kunye ne-proteasome inhibitor

Uya kufumana iDarzalex nge pomalidomide (Pomalyst) kunye ne-dexamethasone. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-8: Idosi enye ngeveki (iyonke idosi ezisibhozo)
  • Iiveki 9 ukuya ku-24: Idosi enye rhoqo kwiiveki ezi-2 (iyonke idosi ezisibhozo)
  • Iveki yama-25 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Abantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili, kubandakanya iproteasome inhibitor kunye nesiyobisi sokugonywa, okanye abangaphendulanga kwiproteasome inhibitor kunye neziyobisi ezinganyangekiyo.

Uya kufumana kuphela iDarzalex. Ishedyuli ecetyiswayo yile:

  • Iiveki 1 ukuya ku-8: Idosi enye ngeveki (iyonke idosi ezisibhozo)
  • Iiveki 9 ukuya ku-24: Idosi enye rhoqo kwiiveki ezi-2 (iyonke idosi ezisibhozo)
  • Iveki yama-25 ukubheka phambili: Idosi enye rhoqo kwiiveki ezi-4

Ukunciphisa ithuba lokuphendula ngokungeniswa, ugqirha wakho uya kukunika indibaniselwano yamachiza. Iyure enye ukuya kwiiyure ezintathu phambi kokufakwa kweDarzalex nganye, uya kufumana:

  • i-corticosteroid (ukunciphisa ukudumba)
  • i-antipyretic (ukuthintela okanye ukunciphisa umkhuhlane)
  • i-antihistamine (ukukhusela okanye ukunciphisa iimpawu zokungabikho komzimba).

Unokufumana kwakhona i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone okanye i-prednisone, ngokuqinisekileyo ngekhe ufune ukongezwa kwe-steroid.

Kuthekani ukuba ndiphose idosi?

Ukuba ulahlekelwa i-aphoyintimenti ye-Darzalex infusion, biza ugqirha wakho kwangoko ukuze ucwangcise kwakhona. Baya kulungelelanisa ishedyuli yakho yeedosi ukuqinisekisa ukuba ufumana inani elifanelekileyo lonyango ngexesha elifanelekileyo.

Ngaba kuya kufuneka ndisebenzise eli chiza ixesha elide?

Kwizifundo zeklinikhi, ixesha eliqhelekileyo elithathiweyo ukuze iDarzalex iqale ukusebenza yayiyinyanga enye.

Nangona kunjalo, unokunikwa iidosi zakho ixesha elide. Oku kuya kuxhomekeka kwindlela umzimba wakho uphendula ngayo eDarzalex kwaye ukuba i-myeloma yakho eninzi iqala ukuba mandundu.

Ubude bonyango buya kuxhomekeka ekubeni ngaba i-myeloma yakho isandula kufunyaniswa okanye ukuba ngaba ukhe wakufumana unyango ngaphambili.

I-Darzalex ye-myeloma emininzi

Ulawulo lokutya kunye neziyobisi (i-FDA) luvumile iDarzalex kunyango lwe-myeloma emininzi.

Olu luhlobo lomhlaza ochaphazela iiseli ezithile ezimhlophe zegazi ezibizwa ngokuba ziiseli zeplasma. Iiseli zePlasma zenza inxenye yamajoni akho omzimba kwaye ziyanceda ukulwa nosulelo emzimbeni wakho. Kwii-myeloma ezininzi, iiseli ze-plasma zitshintsha zibe ziiseli ezininzi ze-myeloma. Njengoko iiseli ezininzi ze-myeloma zikhula kwaye zisasazeka, zinokuxinanisa iiseli ezisempilweni kunye nokonakalisa ithambo elibangqongileyo.

IDarzalex ivunyiwe ukuba isetyenziswe:

  • Kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zesimo ziyasetyenziswa.) Kule meko:
    • IDarzalex inokusetyenziswa kunye namayeza e-lenalidomide (Revlimid) kunye ne-dexamethasone.
    • IDarzalex inokusetyenziswa kunye namayeza e-bortezomib (Velcade), i-melphalan, kunye ne-prednisone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu olungazange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile. Kule meko, iDarzalex isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma. Kule meko, iDarzalex isetyenziswa kunye ne-bortezomib kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili ezazibandakanya i-lenalidomide kunye ne-proteasome inhibitor, eluhlobo lweziyobisi. Kule meko, iDarzalex isetyenziswa kunye namayeza e-pomalidomide (Pomalyst) kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili ebandakanya iproteasome inhibitor kunye nonyango lwe-immunomodulatory. Kule meko, iDarzalex isetyenziswa ngokwayo.
  • Kubantu abadala abaye bazama i-proteasome inhibitor kunye neyeza lokunyanga i-immunomodulatory kodwa akukho siyobisi esisebenzele i-myeloma eninzi. Kule meko, iDarzalex isetyenziswa ngokwayo.

Ukusebenza ngempumelelo

Izifundo ezithandathu zeklinikhi zajonga ukuba iDarzalex yayisebenza njani ekunyangeni i-myeloma iyodwa kwaye idityaniswe nezinye iziyobisi zokulwa nomhlaza. Ezi zifundo zibizwa ngokuba yiMAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, kunye neSIRIUS. Uphando lubonise ukuba unyango lwalusebenza ngakumbi ukuba iDarzalex yongezwa kunyango oluqhelekileyo lomhlaza kunokuba ngaba unyango oluqhelekileyo lwalunikwa lodwa.

Isifundo seMAIA

Uphononongo lwe-MAIA lujonge abantu abasandula ukufumanisa ukuba bane-myeloma engafumaniyo kwi-autologous stem cell transplant. Abantu bafumene unyango lomhlaza oluqhelekileyo lwe-lenalidomide (i-Revlimid) kunye ne-dexamethasone yedosi ephantsi okanye unyango olufanayo kunye ne-Darzalex. Xa kuthelekiswa neqela lonyango eliqhelekileyo, iqela laseDarzalex lalinomngcipheko ophantsi we-44% we-myeloma yabo eya isiba mandundu okanye isweleke.

Kwiinyanga ezingama-42 zesifundo, i-myeloma eninzi ayizange ibe mbi ngakumbi kubantu abathathe iDarzalex kunye nonyango oluqhelekileyo. Kubantu abathathe nje unyango oluqhelekileyo, kuthathe malunga neenyanga ezingama-31.9 ngaphambi kokuba i-myeloma yamaninzi iqale ukuba mandundu. Iqondo elipheleleyo lokuphendula lalingama-47.6% kubantu abaphathwe ngeDarzalex kunye nama-24.9% kwabo bafumana unyango oluqhelekileyo. (Ukuphendula ngokupheleleyo kuthetha ukuba wonke umhlaza uhambile kwaye akukho zimpawu zesifo kuvavanyo lweelebhu, iX-reyi, okanye iimviwo zeklinikhi.)

Isifundo se-ALCYONE

Uphononongo lwe-ALCYONE lujonge abantu abasandula ukufumanisa ukuba bane-myeloma ezininzi abangakwazanga ukufumana ukufakelwa kweeseli ezizimeleyo. Aba bantu bafumene unyango lomhlaza oluqhelekileyo lwe-bortezomib (Velcade), melphalan, kunye ne-prednisone okanye olo nyango kunye neDarzalex. Xa kuthelekiswa neqela lonyango eliqhelekileyo, iqela laseDarzalex lalinomngcipheko ophantsi wama-50% we-myeloma yabo eya isiba mandundu okanye isweleke.

Kubantu abafumene unyango lweDarzalex, i-42.6% yaba nempendulo epheleleyo. Oku kwafaniswa ne-24.4% yabantu abafumana kuphela unyango oluqhelekileyo.

Isifundo sePOLLUX

Uphononongo lwe-POLLUX lujonge abantu abane-myeloma ezininzi ababenonyango olunye lwangaphambili. Abantu bathathe unyango oluqhelekileyo lwe-lenalidomide kunye ne-dexamethasone okanye unyango olufanayo kunye ne-Darzalex. Iziphumo zabonisa ukuba malunga ne-91.3% yabantu baphendule kunyango ngeDarzalex kuthelekiswa ne-74.6% yabantu abafumene unyango oluqhelekileyo kuphela.

Xa kuthelekiswa neqela lonyango eliqhelekileyo, iqela elanyangwa ngeDarzalex lalinomngcipheko ophantsi wama-63% we-myeloma yabo eya isiba mandundu. Emva kweenyanga ezili-13.5, i-19% yeqela laseDarzalex yabona i-myeloma yabo isiba mandundu okanye basweleka. Oku kwafaniswa ne-41% yeqela lonyango eliqhelekileyo.

Isifundo se-CASTOR

Isifundo se-CASTOR sikwajonge abantu abane-myeloma ezininzi ababenonyango olunye lwangaphambili. Abantu bathathe unyango oluqhelekileyo lwe-bortezomib kunye ne-dexamethasone okanye unyango olufanayo kunye neDarzalex. Iziphumo zazifana nezo zophononongo lwe-POLLUX. Phantse i-73.9% yabantu babe nempendulo kunyango ngeDarzalex ngokuthelekiswa ne-59.9% yabantu abafumene unyango oluqhelekileyo kuphela.

Xa kuthelekiswa nonyango oluqhelekileyo, unyango lweDarzalex lwalunxulunyaniswa nomngcipheko ophantsi wama-61% we-myeloma eya isiba mandundu okanye ukufa. Abantu abathathe iDarzalex nabo bakwazi ukuhlala bexolelwe ixesha elide. (Ukuxolelwa kuthetha ukuba iqondo lomhlaza lisasazeka.)

Isifundo se-EQUULEUS

Uphononongo lwe-EQUULEUS lujonge abantu abali-103 abane-myeloma ezininzi ababekhe baphathwa malunga namaxesha amane kwi-myeloma yabo emininzi. Aba bantu sele befumene iintlobo ezimbini zonyango: i-proteasome inhibitor kunye neyeza lokuchasana nomzimba. Wonke umntu kolu phando uthathe unyango oluqhelekileyo lwe-pomalidomide (Pomalyst) kunye ne-dexamethasone kunye neDarzalex. Eyona njongo iphambili yesifundo yayikukujonga ukuba bangaphi abantu abaphendulayo kunyango.

Ngokubanzi, unyango luqale ukusebenza malunga nenyanga e-1 kuninzi lwabantu. Unyango lusebenze umndilili malunga neenyanga ezili-13.6. Iimpawu ezininzi ze-myeloma zancitshiswa ngama-90% okanye ngaphezulu kuma-42% abantu. Abanye abantu babengenawo umhlaza oshiyekileyo ekupheleni kophononongo.

Isifundo se-SIRIUS

Uphononongo lwe-SIRIUS lujonge abantu abangama-106 abane-myeloma ezininzi abagula kakhulu kwaye bafumana umndilili wonyango lwangaphambili lwesihlanu. Bonke abantu abakwisifundo banikwe iDarzalex nje. Eyona njongo iphambili yesifundo yayikukujonga ukuba bangaphi abantu abaphendulayo kunyango.

Ngokubanzi, abantu abangama-31 abafumana iDarzalex baneempawu ezininzi ze-myeloma ezinciphileyo. Phantse i-64.8% yabantu abathathe iDarzalex kolu phando basinda ubuncinci iinyanga ezili-12.

Ukwehlisa ithuba lokufumana impendulo, abantu kuzo zonke ezi zifundo banikwe indibaniselwano yamachiza. Iyure enye ukuya kwiiyure ezintathu phambi kokufakwa kweDarzalex yonke, bafumana:

  • i-corticosteroid (ukunciphisa ukudumba)
  • i-antipyretic (ukuthintela okanye ukunciphisa umkhuhlane)
  • i-antihistamine (ukukhusela okanye ukunciphisa iimpawu zokungabikho komzimba)

Banokuba bafumene i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba abantu bebesele bethatha i-steroid efana ne-dexamethasone okanye i-prednisone, ngokuqinisekileyo abanakudinga ukongezwa kwe-steroid.

IDarzalex yezinye iimeko

Ukongeza kwi-myeloma emininzi, iDarzalex ifundwa njengonyango lwe-immunoglobulin light chain chain amyloidosis.

I-Darzalex ye-immunoglobulin light chain chain amyloidosis (Phantsi kwesifundo)

Ikhonkco lokukhanya kwe-Immunoglobulin i-amyloidosis (AL) yimeko apho iiproteni ezithile ezibizwa ngokuba yimixokelelwane yokukhanya zakha kumalungu akho emzimbeni wakho wonke. Ngokwesiqhelo, intliziyo yakho, izintso, udakada, nesibindi ziyachaphazeleka. Ukwakhiwa kweprotein kungonakalisa kwaye kubangele ukuba la malungu asilele.

UDarzalex akagunyaziswanga yi-FDA ukunyanga i-AL. Nangona kunjalo, kukho uphando olunqunyelweyo olusebenzisa i-Darzalex off-label ukunyanga le meko. (Ukusetyenziswa kwelebheli kuxa iichiza elivunyiweyo ukunyanga imeko enye lisetyenziselwa ukunyanga imeko eyahlukileyo.)

Kwisifundo esinye, iDarzalex yanikwa abantu abane-AL abathi, ngokomndilili, bafumana unyango ezintathu ezahlukeneyo ezingasebenziyo. UDarzalex uvelise phantse impendulo epheleleyo okanye egqibeleleyo kwi-76% yabantu abathathe iyeza. (Ukuphendula ngokupheleleyo kuthetha ukuba sonke isifo simkile kwaye akukho zimpawu zesifo kuvavanyo lweelebhu, ii-X-reyi, iimviwo zeklinikhi.) Aba bantu baneziphumo ebezingalindelekanga ezifanayo nezo zilindelweyo kubantu abathathe iDarzalex ukunyanga i-myeloma ezininzi. Kwezinye iimeko ezixeliweyo, iDarzalex yayisebenza ngokunyanga i-AL kunye nokuphucula umgangatho wobomi wabantu abathatha iyeza.

Izifundo ezingaphezulu ziyafuneka ukubonisa ukuba iDarzalex isebenza kakuhle kwaye ikhuselekile xa isetyenziswa kubantu abane-AL. Kuze kube ngoko, abaphandi bangasebenzisa iDarzalex kubantu abane-AL abangenakho ukhetho lokuqala, ukhetho olwamkelweyo lwe-FDA olusele.

Ukusetyenziswa kweDarzalex kunye nezinye iziyobisi kwi-myeloma ezininzi

I-Darzalex imiselwe yodwa okanye nezinye iintlobo zonyango lomhlaza kubantu abadala abane-myeloma emininzi. Isicwangciso sonyango kunye nobude buya kuxhomekeka ekubeni usandula ukufumanisa ukuba unonyango okanye ngaba ukhe wafumana unyango lwangaphambili.

IDarzalex ivunyiwe ukuba isetyenziswe kunye:

  • i-lenalidomide (i-Revlimid) kunye ne-dexamethasone kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizenzekelayo, iiseli zakho zokuma zisetyenziswa.)
  • i-lenalidomide kunye ne-dexamethasone kubantu abadala abafumene unyango olunye okanye nangaphezulu olungakhange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile.
  • i-bortezomib (i-Velcade), i-melphalan, kunye ne-prednisone kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweseli ye-autologous.
  • i-bortezomib kunye ne-dexamethasone kubantu abadala abafumene unyango okanye unyango lwe-myeloma.
  • pomalidomide (Pomalyst) kunye ne-dexamethasone kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye nangaphezulu. Olu nyango kufuneka lubandakanye i-lenalidomide kunye ne-proteasome inhibitor.

Izifundo ezithandathu zeklinikhi zajonga ukuba iDarzalex yayisebenza njani ekunyangeni i-myeloma emininzi, iyodwa kwaye idityaniswe nezinye iziyobisi zokulwa nomhlaza. Ezi zifundo zibizwa ngokuba yiMAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, kunye neSIRIUS. Uphando lubonise ukuba unyango lwe-myeloma oluninzi lwalusebenza ngakumbi ukuba iDarzalex yongezwa kunyango oluqhelekileyo lomhlaza kunokuba ngaba unyango oluqhelekileyo lwalunikwa lodwa. Ngolwazi malunga nezi zifundo, nceda ubone icandelo le "Darzalex for myeloma" elingentla.

Ezinye iindlela zeDarzalex

Amanye amachiza akhoyo anokunyanga i-myeloma eninzi. Abanye banokukulungela ngcono kunabanye. Ukuba unomdla ekufumaneni enye indlela yeDarzalex, thetha nogqirha wakho ukuze ufunde ngakumbi ngamanye amayeza anokukusebenzela.

Apha ngezantsi luluhlu lwamachiza acetyiswayo sisikhokelo seNational Comprehensive Cancer Network yezonyango zonyango lwe-myeloma:

  • Amachiza e-Chemotherapy, anje ngala:
    • bendamustine (Bendeka okanye iTreanda)
    • cisplatin
    • icyclophosphamide (iCytoxan)
    • doxorubicin (Doxil)
    • I-etoposide (i-Etopophos)
    • Unobumba (Alkeran)
  • Iproteasome inhibitors, ezinje:
    • ibortezomib (Velcade)
    • icarfilzomib (iKyprolis)
    • ixazomib (Ninlaro)
  • Iintsholongwane zeMonoclonal, ezinje:
    • elotuzumab (Empliciti)
  • Imbali ye-deacetylase inhibitors, enje nge:
    • ipanobinostat (Farydak)
  • Ama-immunomodulators, anjenge:
    • lenalidomide (ihlaziyiweyo)
    • pomalidomide (iPomalyst)
    • thalidomide (Thalomid)
  • ICorticosteroids, enje:
    • dexamethasone (iDecadron)

Phawula: Amanye amachiza adweliswe apha anokusetyenziswa ngaphandle kwelebheli ukunyanga i-myeloma eninzi.

IDarzalex vs. Empliciti

Usenokuzibuza ukuba iDarzalex ithelekisa njani namanye amayeza anikwe ukusetyenziswa okufanayo. Apha sijonga indlela iDarzalex kunye ne-Empliciti ezifanayo kunye ezahlukeneyo.

Malunga

IDarzalex iqulethe i-daratumumab, ngelixa i-Empliciti iqulethe i-elotuzumab. Zombini iDarzalex kunye ne-Empliciti zikudidi lweziyobisi ekuthiwa zii-monoclonal antibodies. (Udidi lweziyobisi liqela lamayeza asebenza ngendlela efanayo.) Zombini iDarzalex kunye ne-Empliciti zithathwa njengezona zijolise kunyango lwe-myeloma.

Sebenzisa

Ulawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) luvumile zombini iDarzalex kunye ne-Empliciti ukunyanga i-myeloma eninzi.

IDarzalex ivunyiwe ukuba isetyenziswe:

  • Kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zesimo ziyasetyenziswa.) Kule meko:
    • IDarzalex inokusetyenziswa kunye namayeza e-lenalidomide (Revlimid) kunye ne-dexamethasone.
    • IDarzalex inokusetyenziswa kunye namayeza e-bortezomib (Velcade), i-melphalan, kunye ne-prednisone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu olungazange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile. Kule meko, iDarzalex isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma. Kule meko, iDarzalex isetyenziswa kunye ne-bortezomib kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili ezazibandakanya i-lenalidomide kunye ne-proteasome inhibitor, eluhlobo lweziyobisi. Kule meko, iDarzalex isetyenziswa kunye namayeza e-pomalidomide (Pomalyst) kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili ebandakanya iproteasome inhibitor kunye nonyango lwe-immunomodulatory. Kule meko, iDarzalex isetyenziswa ngokwayo.
  • Kubantu abadala abaye bazama i-proteasome inhibitor kunye neyeza lokunyanga i-immunomodulatory kodwa akukho siyobisi esisebenzele i-myeloma eninzi. Kule meko, iDarzalex isetyenziswa ngokwayo.

I-Empliciti yamkelwe ukuba isetyenziswe:

  • Kubantu abadala abafumene unyango olunye ukuya kwisithathu sangaphambili kwi-myeloma yabo emininzi. I-Empliciti isetyenziswa kunye ne-lenalidomide (Revlimid) kunye ne-dexamethasone.
  • Kubantu abadala abafumene ubuncinci unyango lwangaphambili olubandakanya i-lenalidomide kunye ne-proteasome inhibitor. I-Empliciti isetyenziswa kunye ne-pomalidomide (Pomalyst) kunye ne-dexamethasone.

Ngokwesiqhelo, i-Empliciti inikwa ukuba i-myeloma yakho eninzi ibuyile emva kolunye unyango.

Iifom zeziyobisi kunye nolawulo

Zombini iDarzalex kunye ne-Empliciti zinikezelwa njenge-intravenous (IV) infusion. Le yinaliti efakwa kancinci kancinci emva kwexesha ngenaliti ebekwe emthanjeni wakho.

YeDarzalex

I-Darzalex iza njengesisombululo (umxube wolwelo) oya kuthi uwafumane ngohlobo lwenaliti. Isisombululo asinakubala kumbala otyheli. Iyeza lifumaneka ngobukhulu obubini:

  • 100 mg / 5 mL kwi-vial yedosi enye
  • I-400 mg / 20 mL kwi-vial yedosi enye

Ukunciphisa ithuba lokuphendula ngokungeniswa, ugqirha wakho uya kukunika indibaniselwano yamachiza. Iyure enye ukuya kwiiyure ezintathu phambi kokufakwa kweDarzalex nganye, uya kufumana:

  • i-corticosteroid yokunciphisa ukudumba
  • i-antipyretic ukuthintela okanye ukunciphisa umkhuhlane
  • i-antihistamine yokuthintela okanye ukunciphisa iimpawu zokungabikho komzimba

Unokufumana kwakhona i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone okanye i-prednisone, ngokuqinisekileyo ngekhe ufune ukongezwa kwe-steroid.

Kwi-Empliciti

I-Empliciti iza njengomhlophe kumgubo omhlophe. Umboneleli wezempilo uya kukuxuba oku nesisombululo sokukunika ngenaliti. I-Empliciti iyafumaneka ngamandla amabini:

  • I-300 mg kwisitya esinye sedosi
  • I-400 mg kwisitya esinye sedosi

Ukunciphisa ithuba lokuphendula ngokungeniswa, ugqirha wakho uya kukunika indibaniselwano yamachiza. Malunga nemizuzu engama-45 ukuya kwengama-90 ngaphambi kokufakwa kwe-Empliciti, uya kufumana:

  • i-acetaminophen ukunqanda okanye ukunciphisa umkhuhlane
  • i-diphenhydramine (iBenadryl) ukuthintela okanye ukunciphisa iimpawu zokungabikho komzimba
  • ranitidine ukuthintela okanye ukunciphisa iimpawu ze uxabane
  • dexamethasone ukunciphisa ukudumba

Iziphumo kunye neengozi

I-Darzalex kunye ne-Empliciti zombini zineziyobisi ezisebenza ngokufanayo. Ke ngoko, omabini la mayeza anokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga eziqhelekileyo ezinokuthi zenzeke ngeDarzalex, kunye ne-Empliciti, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngeDarzalex:
    • ubuthathaka
    • iintlungu zomzimba okanye iintlungu ezidibeneyo
    • isicaphucaphu
    • ingxaki yokulala
    • i-bronchitis, uhlobo losulelo lwemiphunga
    • isiyezi
  • Ngaba kunokwenzeka nge-Empliciti:
    • iswekile yegazi ephezulu
    • Ukutshisa iintlungu ezingalweni okanye emilenzeni * *
  • Inokwenzeka kunye neDarzalex kunye ne-Empliciti:
    • Ndiziva ndidiniwe okanye ndingenamandla
    • isisu esibuhlungu kubandakanya urhudo okanye ukuqhina
    • ukunciphisa ukutya
    • ifiva
    • Ukugodola
    • ukuphefumla kancinci okanye ukukhohlela
    • usulelo oluphezulu lokuphefumla njengokubanda
    • ukuphazamiseka kwemisipha (ukujija)
    • ukugabha
    • i-peripheral edema, edumba izandla neenyawo

** Xa i-Empliciti isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokuthi zenzeke ngeDarzalex, kunye ne-Empliciti, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngeDarzalex:
    • thrombocytopenia, inqanaba eliphantsi leeplatelets, eziluhlobo lweeseli zegazi ezinceda ukujiya kwegazi
    • i-neutropenia, inqanaba eliphantsi lee-neutrophils, eluhlobo lweeseli ezimhlophe zegazi ezinceda ukulwa usulelo
    • i-shingles (usuleleko lwe-herpes zoster)
  • Ngaba kunokwenzeka nge-Empliciti:
    • umhlaza omtsha
    • iingxaki zesibindi
  • Inokwenzeka kunye neDarzalex kunye ne-Empliciti:
    • iimpendulo zokunyuswa
    • inyumoniya, uhlobo losulelo lwemiphunga
    • peripheral sensory neuropathy, uhlobo lomonakalo wemithambo-luvo obangela ukurhawuzelela, ukuba ndindisholo, okanye iintlungu

Ukusebenza ngempumelelo

I-Darzalex kunye ne-Empliciti zinokusetyenziswa okuvunyiweyo kwe-FDA, kodwa zombini zisetyenziselwa ukunyanga i-myeloma yabantu abadala.

La machiza awakhange athelekiswe ngokuthe ngqo kwizifundo zeklinikhi (ezibizwa ngokuba zifundo zentloko nentloko). Nangona kunjalo, uphononongo lwe-13 yezifundo zeklinikhi zeDarzalex kunye ne-Empliciti yafumanisa ukuba omabini la machiza ayasebenza ekulibaziseni ukuqhubela phambili (ukuwohloka) kwe-myeloma eninzi.

Kubantu i-myeloma yamaninzi ibuyile okanye iqhubeka nokukhula kwanasemva konyango oluninzi, izikhokelo zeNational Comprehensive Cancer Network ziyacebisa iDarzalex kuqala. Ukuba iDarzalex ayisebenzi, unyango nge-Empliciti lolunye ukhetho.

Iindleko

UDarzalex kunye ne-Empliciti bobabini abasebenzisa iziyobisi. Okwangoku azikho iintlobo zohlobo oluthile lwamayeza. Amayeza egama leBrand ahlala exabisa ngaphezu kwegeneric.

Ngokwengqikelelo ye-WellRx.com, iDarzalex ngokubanzi ixabisa ngaphantsi kwe-Empliciti. Ixabiso langempela oza kulihlawula naliphi na ichiza lixhomekeke kwisicwangciso sakho seinshurensi nakwindawo okuyo.

IDarzalex vs. iKyprolis

Njengo-Empliciti (ngasentla), ichiza iKyprolis lisebenzisa ngokufanayo nelo leDarzalex. Makhe sijonge indlela iDarzalex kunye neKyprolis ezifanayo kunye ezahlukeneyo.

Malunga

I-Darzalex iqulethe i-daratumumab, ngelixa i-Kyprolis iqulethe i-carfilzomib. Omabini la machiza athathwa njengonyango ekujoliswe kulo kwi-myeloma eninzi. Nangona kunjalo, amachiza akwiiklasi ezahlukeneyo zamachiza. (Udidi lweziyobisi liqela lamayeza asebenza ngendlela efanayo.) IDarzalex luhlobo lweziyobisi ekuthiwa yi-monoclonal antibody. I-Kyprolis luhlobo lweziyobisi ekuthiwa yi-proteasome inhibitor.

Sebenzisa

Ulawulo lwezoKutya kunye noLawulo lweziyobisi (FDA) luvumile ukuba iDarzalex isetyenziswe:

  • Kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zesimo ziyasetyenziswa.) Kule meko:
    • IDarzalex inokusetyenziswa kunye namayeza e-lenalidomide (Revlimid) kunye ne-dexamethasone.
    • IDarzalex inokusetyenziswa kunye namayeza e-bortezomib (Velcade), i-melphalan, kunye ne-prednisone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu olungazange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile. Kule meko, iDarzalex isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma. Kule meko, iDarzalex isetyenziswa kunye ne-bortezomib kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili ezazibandakanya i-lenalidomide kunye ne-proteasome inhibitor, eluhlobo lweziyobisi. Kule meko, iDarzalex isetyenziswa kunye namayeza e-pomalidomide (Pomalyst) kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili ebandakanya iproteasome inhibitor kunye nonyango lwe-immunomodulatory. Kule meko, iDarzalex isetyenziswa ngokwayo.
  • Kubantu abadala abaye bazama i-proteasome inhibitor kunye neyeza lokunyanga i-immunomodulatory kodwa akukho siyobisi esisebenzele i-myeloma eninzi. Kule meko, iDarzalex isetyenziswa ngokwayo.

I-Kyprolis ivunyiwe yi-FDA ukuba isetyenziswe:

  • Kubantu abadala abafumene unyango olunye ukuya kwisithathu sangaphambili kwi-myeloma yabo emininzi. I-Kyprolis isetyenziswa nge-dexamethasone okanye nge-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu kwi-myeloma yabo emininzi. IKyprolis isetyenziswa yodwa.

Iifom zeziyobisi kunye nolawulo

Zombini iDarzalex kunye neKyprolis zinikwa njenge-intravenous (IV) infusion. Le yinaliti efakwa kancinci kancinci emva kwexesha ngenaliti ebekwe emthanjeni wakho.

YeDarzalex

I-Darzalex iza njengesisombululo (umxube wolwelo) oya kuthi uwafumane ngohlobo lwenaliti. Isisombululo asinakubala kumbala otyheli. Iyeza lifumaneka ngobukhulu obubini:

  • 100 mg / 5 mL kwi-vial yedosi enye
  • I-400 mg / 20 mL kwi-vial yedosi enye

Ukunciphisa ithuba lokuphendula ngokungeniswa, ugqirha wakho uya kukunika indibaniselwano ye. iziyobisi. Iyure enye ukuya kwiiyure ezintathu phambi kokufakwa kweDarzalex nganye, uya kufumana:

  • i-corticosteroid yokunciphisa ukudumba
  • i-antipyretic ukuthintela okanye ukunciphisa umkhuhlane
  • i-antihistamine yokuthintela okanye ukunciphisa iimpawu zokungabikho komzimba

Unokufumana kwakhona i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone okanye i-prednisone, ngokuqinisekileyo ngekhe ufune ukongezwa kwe-steroid.

YeKyprolis

I-Kyprolis iza kwikhekhe okanye kwifom yefowder kwibhokisi yedosi enye. Iza ngamandla amathathu: i-10 mg, i-30 mg, kunye ne-60 mg.

Ukunciphisa ithuba lokuba ne-infusion reaction, ugqirha wakho uya kukunika i-steroid. Uya kufumana i-steroid imizuzu engama-30 ukuya kwiiyure ezingama-4 ngaphambi kokufakwa kwakho kweKyprolis. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone, ugqirha wakho ngekhe afune ukukunika idosi eyongezelelweyo.

Iziphumo kunye neengozi

UDarzalex kunye neKyprolis banokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga eziqhelekileyo ezinokuthi zenzeke ngeDarzalex, kunye neKyprolis, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngeDarzalex:
    • ubuthathaka okanye ukungabikho kwamandla
    • i-bronchitis, uhlobo losulelo lwemiphunga
    • iintlungu zomzimba okanye iintlungu ezidibeneyo
  • Ngaba kunokwenzeka ngeKyprolis:
    • ubalo lweeseli ezibomvu ezisezantsi
    • ubalo lweeseli ezimhlophe ezisezantsi
    • ingxaki yokuphefumla
    • ukunciphisa amanqanaba e-potassium
  • Ngaba kunokwenzeka ngeDarzalex kunye neKyprolis:
    • ukuphazamiseka kwemisipha (ukujija)
    • ingxaki yokulala
    • ndiziva ndidiniwe
    • isisu esibuhlungu kubandakanya urhudo okanye ukuqhina
    • ifiva
    • Ukugodola
    • ukuqhawukelwa ngumphefumlo
    • ukukhohlela
    • usulelo oluphezulu lokuphefumla, njengokubanda
    • isicaphucaphu okanye ukugabha
    • ukunciphisa ukutya
    • i-peripheral edema, edumba izandla neenyawo
    • isiyezi

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokuthi zenzeke ngeDarzalex, kunye neKyprolis, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka ngeDarzalex:
    • i-neutropenia, inqanaba eliphantsi lee-neutrophils, eluhlobo lweeseli ezimhlophe zegazi ezinceda ukulwa nosulelo
    • i-shingles (usuleleko lwe-herpes zoster)
    • peripheral sensory neuropathy, uhlobo lomonakalo wemithambo-luvo obangela ukurhawuzelela, ukuba ndindisholo, okanye iintlungu
  • Ngaba kunokwenzeka ngeKyprolis:
    • umonakalo wemiphunga njengokuphuma kwegazi, amahlwili egazi, ukudumba, okanye usulelo emiphungeni
    • ukulimala kwentliziyo okanye ukusilela kwentliziyo
    • iingxaki zesibindi, njengokunyuka kwinqanaba leeproteni zesibindi okanye ukusilela kwesibindi
    • ukusilela kwezintso
    • I-tumor lysis syndrome, imeko apho iiseli zomhlaza zifa ngokukhawuleza kwaye iziqulatho zazo zichitheka egazini lakho
    • Isifo se-encephalopathy esibuyayo esingasemva, sisifo semithambo-luvo kwingqondo
    • igazi elonyukayo
    • uxinzelelo lwegazi kwimiphunga, uxinzelelo lwegazi oluphezulu emiphungeni
    • amahlwili egazi
    • iingxaki zokopha kakhulu njengokuphuma esiswini, emiphungeni, okanye kwingqondo
  • Ngaba kunokwenzeka ngeDarzalex kunye neKyprolis:
    • iimpendulo zokunyuswa
    • thrombocytopenia, inqanaba eliphantsi leeplatelets, eluhlobo lweeseli zegazi ezinceda ukujiya kwegazi
    • inyumoniya, uhlobo losulelo lwemiphunga

Ukusebenza ngempumelelo

UDarzalex kunye neKyprolis banezinto ezahlukileyo ezamkelweyo ze-FDA, kodwa zombini zisetyenziselwa ukunyanga i-myeloma ezininzi.

Ukusetyenziswa kweDarzalex kunye neKyprolis ye-myeloma ezininzi khange kuthelekiswa ngqo kwizifundo zeklinikhi. Nangona kunjalo, izifundo zifumene zombini iDarzalex kunye neKyprolis ukuba isebenze kunyango lwe-myeloma.

Ngoku abaphandi bafunda ngokusetyenziswa kwala machiza mabini kunye ne-dexamethasone ukunyanga olu hlobo lomhlaza. Iziphumo zibonise ukuba abantu ababesele bephathwe i-myeloma emininzi baphendule kakuhle kunyango oludibeneyo. Kodwa kufuneka iimvavanyo ezingaphezulu ngaphambi kokuba i-FDA ivume unyango oludibeneyo lweDarzalex kunye neKyprolis ye-myeloma emininzi.

Iindleko

UDarzalex kunye neKyprolis bobabini abasebenzisa iziyobisi. Okwangoku azikho iintlobo zohlobo oluthile lwamayeza. Amayeza egama leBrand ahlala exabisa ngaphezu kwegeneric.

Ngokwengqikelelo kwi-WellRx.com, iDarzalex ngokubanzi ixabisa ngaphantsi kweKyprolis. Elona xabiso uzakuhlawula ngalo naliphi na ichiza liya kuxhomekeka kwisicwangciso sakho seinshurensi nakwindawo okuyo.

Isebenza njani iDarzalex

I-myeloma emininzi ngumhlaza oqala kuhlobo lweseli emhlophe yegazi ebizwa ngokuba yiplasma. Iiseli zePlasma zenza inxenye yamajoni akho omzimba kwaye ziyanceda ukulwa nosulelo emzimbeni wakho.

Ngamanye amaxesha utshintsho olukhawulezileyo kwiijeni zakho, ezibizwa ngokuba ziinguqulelo, zinokuguqula iiseli ezisempilweni zibe ngumhlaza. (Imfuza siseti yemiyalelo enceda ukulawula indlela iiseli zakho ezikhula kunye nokuziphatha ngayo). Xa iiseli ze-plasma zitshintsha zibe ziiseli ezininzi ze-myeloma, ziqala ukwakha kumongo wethambo (ngaphakathi kumathambo akho). Njengoko iiseli ezininzi ze-myeloma zikhula kwaye zisasazeka, banokuxinanisa iiseli ezisempilweni kunye nokonakalisa ithambo elibangqongileyo.

I-Darzalex sisiyobisi esenziwe ngumntu esibizwa ngokuba yi-monoclonal antibody. (Ii-antibodies zeMonoclonal ziiproteni kumajoni akho omzimba. Ziyilelwe ukujolisa kwaye zihlasele indawo ethile yeseli yomhlaza.)

Xa iiseli ze-plasma zijika zibe ziiseli ezininzi ze-myeloma, zikhula njengesixa esikhulu seprotein ebizwa ngokuba yi-CD38 kumphezulu wazo. I-monoclonal antibody Darzalex isebenza ngokudibanisa kwiprotein ye-CD38 kwiseli ye-myeloma. Ngokwenza oku, iDarzalex ibulala ngokuthe ngqo okanye inceda amajoni akho omzimba atshabalalise iiseli ezininzi ze-myeloma.

Kuthatha ixesha elingakanani ukusebenza?

Kwizifundo zeklinikhi, ixesha eliqhelekileyo elithathe iDarzalex ukuqala ukusebenza yayiyinyanga enye. Nangona kunjalo, unokunikwa iidosi zakho ixesha elide. Oku kuxhomekeke kwindlela umzimba wakho uphendula ngayo kwiDarzalex kwaye ukuba i-myeloma yakho eninzi iqala ukuba mandundu. Ubude bonyango buxhomekeke nokuba i-myeloma yakho isandula ukufumanisa ukuba sele unonyango ngaphambili.

UDarzalex kunye notywala

Akukho nxibelelwano lwaziwayo phakathi kweDarzalex kunye notywala. Kodwa kuyacetyiswa ukuba ukuthintele ukusela utywala ngelixa uthatha iDarzalex. Oku kunxulumene nokuba kuthatha ixesha elingakanani ukufumana amayeza.

I-Darzalex inikezelwa njenge-intravenous (IV) infusion. Le yilenaliti emthanjeni wakho enikwe ixesha elide. I-infusions yeDarzalex inokuhlala kwiiyure ezi-3 ukuya kwezi-7. Ke kubalulekile ukuba uhlale unamanzi ngaphambi nangexesha lokumiliselwa kwakho. Iziselo ezinxilisayo zinokukwenza ungabi namanzi emzimbeni, ke thintela utywala ngelixa uthatha iDarzalex.

Ukuba unemibuzo malunga notywala kunye neDarzalex, buza ugqirha wakho.

Unxibelelwano lweDarzalex

Ngaphambi kokuba uthathe iDarzalex, qiniseka ukuxelela ugqirha wakho kunye nosokhemesti ngayo yonke into emiselweyo, 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.

Darzalex kunye novavanyo lwelabhoratri

Ukuthatha iDarzalex kunokutshintsha iziphumo zovavanyo oluthile lweelebhu.

Uhlobo lwegazi elebhu iimpazamo

Ukuba uthatha iDarzalex kwaye kuvavanyo lwegazi ukuze uhambelane nodidi lwegazi lakho, iziphumo zisenokungalungi. Iimpazamo kwezi mvavanyo zinokufikelela kwiinyanga ezi-6 emva kwedosi yakho yokugqibela yeDarzalex.

I-Darzalex isebenza ngokuncamathisela kwiprotein ye-CD38 kumphezulu weseli ye-myeloma kunye nokonakalisa iproteni. Ngamanye amaxesha iiseli ezibomvu zegazi zinokuba neeproteni ze-CD38 kuzo. IDarzalex inokuzifaka ngempazamo kwiprotein ye-CD38 kwiseli ebomvu endaweni yeseli ye-myeloma. Xa oku kusenzeka, itshintsha indlela iseli ebomvu 'ejonga ngayo' kuvavanyo lwegazi. Nangona kunjalo, iDarzalex ayizukuchaphazela uhlobo lwegazi lakho.

Ukuthintela iimpazamo zokuchwetheza igazi, ugqirha wakho uya kuvavanya uhlobo lwegazi lakho ngaphambi kwedosi yakho yokuqala yeDarzalex. Bayakwenza oku xa kunokwenzeka ukuba utofelwe igazi kwixa elizayo.

Inikwa njani iDarzalex

Ukufumana idosi yakho yeDarzalex, uya kuya kugqirha okanye kwiziko lokumnika. Iyeza liza njengesisombululo (umxube wolwelo). Umboneleli wezempilo uya kudibanisa iDarzalex kunye ne-0.9% yesodium chloride (uhlobo lwesisombululo samanzi etyuwa). Emva koko baya kukunika eli yeza ngokuhamba kwexesha ngenaliti ebekwe emthanjeni wakho. Oku kubizwa ngokuba kukufakwa ngaphakathi ngaphakathi (IV). Unokufumana iDarzalex ngokwayo okanye ngezinye iindlela zonyango.

Ugqirha wakho uya kuthatha isigqibo sokuba ingakanani iDarzalex yokukunika ngokusekwe kubunzima bakho kunye nesicwangciso sakho sonyango. Umboneleli wezempilo uya kuhlala ekubeka iliso ngexesha lokufakwa.

Nini ukuthatha

Ugqirha wakho uya kuthatha isigqibo malunga nexesha phakathi kwamayeza kunye nokuba zingaphi iindlela zonyango oza kuzifuna. Oku kuya kusekelwe ekubeni uthatha iDarzalex yedwa okanye nezinye iindlela zonyango. Buza ugqirha wakho ukuba acebise olona suku kunye nexesha elifanelekileyo lokufumana ukumiliselwa kwakho ngokusekwe kwinkqubo yakho yemihla ngemihla.

Ufumana kangaphi iDarzalex kunye nobude bexesha lokunyuswa kuya kuncipha ngokuhamba kwexesha. Ukufakwa kwakho kokuqala kweDarzalex kungathatha malunga neeyure ezisi-7. Kungenxa yokuba ugqirha wakho uya kufaka amayeza kancinci kancinci kumthambo wakho. I-infusions kwixa elizayo iya kuthatha ixesha elincinci kwaye ihlale malunga neeyure ezi-3 ukuya kwezi-5 kuba uyakufumana unyango lunyanzeliswa ngokukhawuleza.

Ukuthatha iDarzalex ngokutya

Amaxesha okunyuswa kweDarzalex anokuvela kwiiyure ezi-3 ukuya kwezi-7, kuxhomekeke kwisicwangciso sakho sonyango. Kungenxa yoko le nto kungumbono olungileyo ukuza uzilungiselele ngokutya okulula kunye neziselo ukuba kulungile nogqirha wakho.

UDarzalex kunye nokukhulelwa

UDarzalex akazange afundwe kwabasetyhini abakhulelweyo okanye kwizilwanyana. Kodwa iDarzalex yi-monoclonal antibody, eluhlobo lweziyobisi olujolise kwiiseli zomhlaza. Kwaye ii-antibodies ze-monoclonal ziyaziwa ukuwela i-placenta. (I-placenta lilungu ngaphakathi kwesibeleko sakho elihambisa izakhamzimba ezisuka emzimbeni wakho ziye kusana lwakho.)

Ngokusekwe kwindlela esebenza ngayo iDarzalex, amayeza anokubangela ukwehla kwamathambo kusana olungekazalwa. Inokunciphisa inani legazi kunye neeseli zomzimba ezenziwa ngumntwana okhulayo.

Ngaphambi kokuba uqale ukuthatha iDarzalex, qiniseka ukuxelela ugqirha wakho ukuba ukhulelwe, unokukhulelwa, okanye ucwangcise ukukhulelwa.

I-Darzalex ene-lenalidomide okanye i-pomalidomide

UDarzalex ngamanye amaxesha uthathwa kunye neziyobisi ezibizwa ngokuba yileneralomide (Revlimid) okanye pomalidomide (Pomalyst) ye-myeloma eninzi. I-Lenalidomide kunye ne-pomalidomide bobabini banesilumkiso esibhokisi * seziphene zokuzalwa ezinobungozi. Ukuba ungumfazi kwaye ugqirha wakho ukumisela iDarzalex ngeleneralomide okanye pomalidomide, akufuneki ukhulelwe:

  • iiveki ezi-4 ubuncinci ngaphambi kokuqala unyango
  • ngelixa uthatha unyango
  • ngalo naliphi na ikhefu kunyango
  • ubuncinci iiveki ezi-4 emva kokumisa i-lenalidomide okanye i-pomalidomide

Ukuba unemibuzo malunga nokuthatha iDarzalex, lenalidomide, okanye pomalidomide ngelixa ukhulelwe, thetha nogqirha wakho.

UDarzalex kunye nolawulo lokuzalwa

Ukuba kukho ithuba lokuba ungakhulelwa, kuyacetyiswa ukuba usebenzise ulawulo lokuzalwa ngelixa uthatha iDarzalex. Kuya kufuneka uqhubeke usebenzisa ulawulo lokuzalwa kangangeenyanga ezi-3 emva kokuba unyango lwakho lweDarzalex lugqityiwe. Kungenxa yokuba iyeza linokuhlala kwinkqubo yakho okwexeshana emva kokuba uyekile ukulithatha.

Ukuba uyindoda kwaye ubelana ngesondo nomntu obhinqileyo, kukho ithuba lokukhulelwa ukuba kwenzeke. Cinga ukusebenzisa indlela yothintelo lolawulo lokuzalwa, njengekhondom, nokuba iqabane lakho owabelana nalo ngesondo lisebenzisa nolawulo lokuzalwa.

I-Darzalex ene-lenalidomide okanye i-pomalidomide

Ngamanye amaxesha, ungathatha iDarzalex ngamayeza abizwa ngokuba yileneralomide (Revlimid) okanye pomalidomide (Pomalyst). Ukuba ungumfazi kwaye uthatha iDarzalex ngeleneralomide okanye pomalidomide, kuya kufuneka uvume ukusebenzisa iindlela ezimbini zolawulo lokuzalwa. Kuya kufuneka uqale ukusebenzisa ulawulo lokuzalwa ubuncinci iiveki ezi-4 ngaphambi kokuba uqale unyango ngamachiza. Qhubeka usebenzisa ulawulo lokuzalwa ngelixa uthatha iDarzalex kunye neleneralomide okanye pomalidomide, kwaye nangaliphi na ikhefu kunyango. Kuya kufuneka ugcine ukusebenzisa ulawulo lokuzalwa ubuncinci iiveki ezi-4 emva kokuba uyekile ukuthatha i-lenalidomide okanye i-pomalidomide.

I-Lenalidomide kunye ne-pomalidomide zinokudlula kwisidoda somntu. Ke onke amadoda kufuneka asebenzise i-latex okanye eyenziweyo ikhondomu xa usabelana ngesondo nowasetyhini onokukhulelwa. Amadoda afanele asebenzise le ndlela yolawulo lokuzalwa ngexesha elifanayo leqabane labo lokwabelana ngesondo lithatha ulawulo lokuzalwa.

Ukuba usebenza ngesondo kwaye wena okanye iqabane lakho lezesondo unokukhulelwa, thetha nogqirha wakho. Banokukunceda uthathe isigqibo malunga neemfuno zakho zolawulo lokuzalwa ngelixa usebenzisa iDarzalex.

UDarzalex kunye nokuncancisa

Ayaziwa ukuba iDarzalex ingadlula kubisi lwebele okanye ukuba ichiza linokuchaphazela njani ubisi lwebele. Kwakhona akwaziwa ukuba iDarzalex inokuchaphazela umntwana oncelisayo.

I-Darzalex ene-lenalidomide okanye i-pomalidomide

Ngamanye amaxesha, ungathatha iDarzalex ngamayeza abizwa ngokuba yileneralomide (Revlimid) okanye pomalidomide (Pomalyst). Ukuba ungumfazi oncelisayo, akufanele usebenzise i-lenalidomide okanye i-pomalidomide. Ayaziwa ukuba eli yeza linokudlula kubisi lwakho lwebele kwaye lonzakalise umntwana wakho.

Ukuba ufuna ukuncancisa umntwana wakho kwaye ucinga ngokuthatha iDarzalex, thetha nogqirha wakho. Banokukuxelela malunga neenzuzo kunye neengozi zokusebenzisa eli yeza ngelixa uncancisa.

Imibuzo eqhelekileyo malunga neDarzalex

Nazi iimpendulo kwimibuzo ebuzwa rhoqo malunga neDarzalex.

Kutheni le nto kufuneka ndithathe ii-steroids kunye namanye amayeza ngexesha lokuqeshwa kwam eDarzalex infusions?

Xa ufumana iDarzalex, unokufumana into engavumiyo. Ukukunceda ukukhusela oku, ugqirha wakho unokukunika amayeza abizwa ngokuba yi-corticosteroids kunye nezinye iziyobisi.

Umboneleli wezempilo uya kukunika iDarzalex njenge-intravenous (IV) infusion kwiofisi kagqirha wakho okanye eklinikhi. Le yilenaliti emthanjeni wakho enikwe ixesha elide. Iyure enye ukuya kwiiyure ezintathu ngaphambi kokufakwa kwe-Darzalex nganye, uhlala ufumana la machiza alandelayo:

  • i-corticosteroid (ukunciphisa ukudumba)
  • i-antipyretic (ukuthintela okanye ukunciphisa umkhuhlane)
  • i-antihistamine (ukukhusela okanye ukunciphisa iimpawu zokungabikho komzimba)

Unokufumana kwakhona i-corticosteroid usuku olu-1 emva kokufakwa ukuze kuthintelwe ukuphendula kade. Kodwa ukuba sele uthatha i-steroid enje nge-dexamethasone okanye i-prednisone, ngokuqinisekileyo ngekhe ufune ukongezwa kwe-steroid.

Ukuba unemibuzo malunga naluphi na unyango olunikezwe nge-Darzalex infusions, cela ugqirha wakho.

Ngaba ndiza kuba nakho ukuziqhubela ekhaya emva kokufakwa kweDarzalex?

Akucetyiswa. Kungenxa yokuba kuqhelekile ukuba uzive udiniwe emva kokufakwa okanye nokuba ungene. (Jonga "iimpembelelo ze-infusion" kwicandelo "Iinkcukacha zeziphumo ebezingalindelekanga" kwicandelo elingentla ukuze ufunde ngakumbi.) Ke ukuze ukhuseleke, ilungu losapho, umhlobo, okanye umntu okhathalelayo ukuqhubele ukuya nokubuya kulungiselelo lokumnika.

Nika ingqalelo kwindlela oziva ngayo emva kokungena kwakho kwaye ugcine idayari yeempawu zakho. Oku kunokukunceda uthathe isigqibo sokuba ungaziqhuba, ukuba uyafuna.

Kwimeko apho ungafumani mqhubi, uJanssen Biotech, Inc., umenzi weDarzalex, angakwazi ukunceda. Ungathetha nomququzeleli weJanssen CarePath malunga nokuya nokubuya kwizikhundla zakho kunye nokufumana uncedo ngeendleko zokuhamba. Ukuze ufunde okungakumbi, tsalela umnxeba ku-844-553-2792 okanye undwendwele iwebhusayithi yeDarzalex.

Ndingayisebenzisa iDarzalex ukuba ndinee-shingles?

Ewe ungasebenzisa iDarzalex ukuba unesifo esibizwa ngokuba yi-shingles. Kodwa ngaphambi kokuba uthathe iDarzalex, kubalulekile ukuba uxelele ugqirha wakho ukuba uke waba ne-shingles okanye i-chickenpox. (Intsholongwane enye ebangela i-shingles nayo inokubangela inkukhu yenkukhu.)

Ukuba ukhe wanerhashalala ngaphambili, intsholongwane ayishiyi umzimba wakho emva kokuba uphinde wachacha kusulelo. Endaweni yoko, intsholongwane "iya kulala" kwimithambo-luvo yakho.

Akukho mntu waziyo ukuba kutheni, kodwa intsholongwane inokuphinda isebenze okanye "ivuke" inezinto ezithile ezinje ngezixhobo ezibuthathaka zomzimba. (Amajoni akho omzimba ayazikhusela kwizifo.)

Unyango lomhlaza olufana neDarzalex lunokuwenza buthathaka amajoni akho omzimba kwaye luvuselele intsholongwane. Xa ivuka, izibonakalisa njenge-shingles endaweni yenkukhu yenkukhu.

Ke ukuba une-shingles okanye irhashalala, ugqirha wakho uya kukuyalela amayeza antiviral ukuthintela i-shingles ekubeni iphinde ikhule emzimbeni wakho. Uya kudinga ukuthatha unyango lwe-antiviral kwiveki e-1 yokuqala ukuthatha iDarzalex. Emva koko uya kuqhubeka uthatha i-antiviral kwiinyanga ezi-3 emva kokuba ugqibile unyango ngeDarzalex.

Ukuba awuqinisekanga ukuba unayo i-shingles okanye i-chickenpox, thetha nogqirha wakho.

Ngaba iDarzalex yonyango i-myeloma emininzi?

Okwangoku, akukho lunyango lwe-myeloma ezininzi. Kodwa into enokuyenza iDarzalex kukuphucula umgangatho kunye nobude bobomi, kuxhomekeke kwisifo sakho. Ugqirha wakho unokukuxelela ngakumbi.

Izikhuselo zeDarzalex

Ngaphambi kokuba uthathe iDarzalex, thetha nogqirha wakho malunga nembali yakho yezempilo. IDarzalex isenokungakulungeli ukuba uneemeko ezithile zonyango okanye ezinye izinto ezichaphazela impilo yakho. Oku kubandakanya:

  • IHepatitis B. Ukuba unayo i-hepatitis B okanye unayo ngaphambili, ukuthatha iDarzalex kunokubangela ukuba iphinde isebenze. Ngaphambi kokuba uqale ukuthatha iDarzalex, ugqirha wakho uya kukujonga i-hepatitis B. Baza kukujonga kwakhona emva kokuba ulugqibile unyango lwakho. Iimpawu ze-hepatitis B zibandakanya ukudinwa okuya kusiba kubi, kunye nombala otyheli wolusu lwakho kunye nomhlophe wamehlo akho. Ukuba uyazibona ezi mpawu, xelela ugqirha wakho.
  • Izibophelelo. Ngelixa uthatha iDarzalex, unokuhlakulela usulelo olubizwa ngokuba yi-shingles. Intsholongwane enye ebangela i-shingles nayo inokubangela irhashalala. Ke ukuba ubukhe wanerhashalala okanye i-shingles kwixa elidlulileyo kwaye uthatha iDarzalex, ugqirha wakho unokumisela amayeza antiviral. Olu hlobo lweziyobisi lunokunceda ukuthintela i-shingles ekubeni ikhule emzimbeni wakho.
  • Isifo esinganyangekiyo semiphunga (COPD). Ukuba unembali yesifo sokuphefumla esibizwa ngokuba sisifo esinganyangekiyo semiphunga (COPD), xelela ugqirha ngaphambi kokuba uthathe iDarzalex. Banokunika i-inhaler ukukunceda uphefumle lula kunye ne-corticosteroids ukunceda ukunciphisa ukudumba emiphungeni yakho.
  • Ukukhulelwa. UDarzalex akafundanga kwabasetyhini abakhulelweyo. Kodwa luhlobo lweziyobisi ezinokuthi ziwele i-placenta. (Umkhaya ngumzimba osesibelekweni sakho ogqithisela izondlo emzimbeni wakho usiya emntwaneni wakho.) Ngolwazi oluthe kratya, nceda ubone icandelo le "Darzalex kunye nokukhulelwa" apha ngasentla.
  • Ukuncancisa. Ayaziwa ukuba kukhuselekile na ukuncancisa ngelixa uthatha iDarzalex. Ngolwazi oluthe kratya, nceda ubone icandelo "Darzalex kunye nokuncancisa" apha ngasentla.

Xelela umboneleli wakho wokhathalelo lwempilo ukuba uphuhlisa nayiphi na kwezi meko ngexesha okanye emva konyango ngeDarzalex.

Phawula: Ngolwazi oluthe kratya malunga neziphumo ezibi ezinokubakho zeDarzalex, jonga icandelo le- "Darzalex Side Effects" icandelo elingentla.

Ulwazi lobungcali lweDarzalex

Olu lwazi lulandelayo lubonelelwe ngoochwephesha kunye nabanye abaqeqeshi bezempilo.

Iimpawu

Ulawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) luvumile lwaza lwabonisa iDarzalex ukuba isetyenziswe:

  • Kubantu abadala abane-myeloma esandula ukufumanisa ukuba abanakufumana ukufakelwa kweeseli ezizimeleyo. (Ngokufakelwa kweeseli ezizimeleyo, iiseli zakho zesimo ziyasetyenziswa.) Kule meko:
    • IDarzalex inokusetyenziswa kunye namayeza e-lenalidomide (Revlimid) kunye ne-dexamethasone.
    • IDarzalex inokusetyenziswa kunye namayeza e-bortezomib (Velcade), i-melphalan, kunye ne-prednisone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu olungazange lusebenze kakuhle okanye i-myeloma yamaninzi ibuyile. Kule meko, iDarzalex isetyenziswa kunye ne-lenalidomide kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango olunye okanye nangaphezulu lwangaphambili lwe-myeloma. Kule meko, iDarzalex isetyenziswa kunye ne-bortezomib kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma ezimbini okanye ngaphezulu ngaphambili ezazibandakanya i-lenalidomide kunye ne-proteasome inhibitor, eluhlobo lweziyobisi. Kule meko, iDarzalex isetyenziswa kunye namayeza e-pomalidomide (Pomalyst) kunye ne-dexamethasone.
  • Kubantu abadala abafumene unyango lwe-myeloma kathathu okanye nangaphezulu ngaphambili ebandakanya iproteasome inhibitor kunye nonyango lwe-immunomodulatory. Kule meko, iDarzalex isetyenziswa ngokwayo.
  • Kubantu abadala abaye bazama i-proteasome inhibitor kunye neyeza lokunyanga i-immunomodulatory kodwa akukho siyobisi esisebenzele i-myeloma eninzi. Kule meko, iDarzalex isetyenziswa ngokwayo.

Indlela yokusebenza

I-Darzalex yi-monoclonal antibody kwaye inqanda okanye itshabalalise ukukhula kweseli ithumba kwiiseli ezininzi ze-myeloma. Xa iiseli ze-plasma zijika zibe ziiseli ezininzi ze-myeloma, zikhula zininzi iiproteni zomhlaba ezibizwa ngokuba yi-CD38. Iithagethi zeDarzalex kwaye zinamathela kwezi proteni ze-CD38. Ngokusebenzisa i-immune-mediated and direct on-tumor actions, iDarzalex inqanda ukukhula kweeseli ezininzi ze-myeloma kwaye iqale inkqubo ye-apoptosis (ukufa kweseli).

I-Pharmacokinetics kunye ne-metabolism

Akukho mahluko mkhulu ngokwezonyango kwi-pharmacokinetics ye-Darzalex njenge-monotherapy okanye unyango oludibeneyo lubonwa ngokusekwe kubantu abathile.

Ukulandela ukumiliselwa kwethamo elicetyiswayo leDarzalex kuphela okanye njengonyango oludibeneyo, ukugxila kwegazi kweDarzalex phantse kwaphindeka kathathu ekupheleni kwethamo leveki nganye xa kuthelekiswa nedosi yokuqala.

Ukwahlula idosi yokuqala yeDarzalex kukhokelela kwiziphumo ezahlukeneyo zegazi kunokuba umntu afumane idosi yokuqala epheleleyo. Nangona kunjalo, iincopho ezifanayo kunye nemikhombe yokujongwa kwegazi yabonwa kwaye yaxelwa kwangaphambili emva kokufumana idosi yokwahlulahlula okwesibini kwiveki yoku-1, usuku 2 lonyango.

Xa iDarzalex yanikezelwa yodwa, inqanaba lokuxinana kwegazi okuzinzileyo (ilizwe elizinzileyo) lafikelelwa malunga neenyanga ezintlanu kwisithuba seveki ezine (nge-21st infusion). Kwimeko ezinzileyo, iDarzalex kuthetha ukuba umyinge wokuqokelelwa kobuninzi begazi kwakuyi-1.6.

Ukuhanjiswa:

  • monotherapy: 4.7 ± 1.3 L
  • indibaniselwano yonyango: 4.4 ± 1.5 L

Ukupheliswa kwesiqingatha-sobomi se-monotherapy kunye nonyango oludibeneyo yayili-18 ± 9 yeentsuku. Ukucocwa kweDarzalex kuye kwancipha ngomthamo owandayo kunye nedosi eninzi. Ukucoca kuqikelelwa ukuba yi-171.4 ± 95.3 ml / ngosuku. Njengoko ubunzima bomzimba bukhula, ivolumu yokuhambisa kunye nenqanaba apho iDarzalex isuswe khona emzimbeni yanda.

Ukungqinelana

I-Darzalex iyaphikiswa kwizigulana ezinembali yeempendulo ze-anaphylactic ezinzima kwi-daratumumab okanye nayiphi na into eyamkelekileyo yefomula yeziyobisi. Iimeko ezinzima ze-neutropenia, i-thrombocytopenia, okanye i-infusion reaction ngenxa yonyango inokufuna ukuba iDarzalex imiswe okanye imiswe ngokusisigxina.

Ukugcina

I-Darzalex kufuneka igcinwe kwifriji kwi-36 ° F ukuya kwi-46 ° F (2 ° C ukuya kwi-8 ° C).

Musa ukushukumisa okanye ukubamba iDarzalex. Iyeza kufuneka likhuselwe ekukhanyeni. I-Darzalex ayiqulathanga naluphi na ulondolozo.

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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