I-Darzalex (daratumumab)

-Delile

• Yini iDarzalex?
• Isetshenziswa kanjani
• Ukusebenza ngempumelelo
• I-Darzalex ejwayelekile
• Imiphumela emibi ye-Darzalex
• Imiphumela emibi ejwayelekile
• Imiphumela emibi kakhulu
• Imininingwane yomphumela oseceleni
• Izindleko zeDarzalex
• Usizo lwezezimali nolomshuwalense
• Isilinganiso seDarzalex
• Amafomu wezidakamizwa namandla
• Isilinganiso se-myeloma eminingi
• Kuthiwani uma ngiphuthelwa umthamo?
• Ngabe kuzodingeka ngisebenzise lesi sidakamizwa isikhathi eside?
• I-Darzalex ye-myeloma eminingi
• Ukusebenza ngempumelelo
• I-Darzalex yezinye izimo
• Ukusetshenziswa kweDarzalex nezinye izidakamizwa ze-myeloma eminingi
• Ezinye izindlela zeDarzalex
• IDarzalex vs. Empliciti
• Mayelana
• Isebenzisa
• Amafomu wezidakamizwa nokuphathwa
• Imiphumela emibi kanye nezingozi
• Ukusebenza ngempumelelo
• Izindleko
• IDarzalex vs. Kyprolis
• Mayelana
• Isebenzisa
• Amafomu wezidakamizwa nokuphathwa
• Imiphumela emibi kanye nezingozi
• Ukusebenza ngempumelelo
• Izindleko
• Isebenza kanjani iDarzalex
• Kuthatha isikhathi esingakanani ukusebenza?
• UDarzalex notshwala
• Ukusebenzisana kweDarzalex
• Ukuhlolwa kweDarzalex nelabhorethri
• Inikezwa kanjani iDarzalex
• Ukuthatha nini
• Ukuthatha iDarzalex ngokudla
• UDarzalex nokukhulelwa
• I-Darzalex ene-lenalidomide noma i-pomalidomide
• I-Darzalex nokulawulwa kokuzalwa
• I-Darzalex ene-lenalidomide noma i-pomalidomide
• UDarzalex nokuncelisa
• I-Darzalex ene-lenalidomide noma i-pomalidomide
• Imibuzo ejwayelekile ngeDarzalex
• Kungani ngidinga ukuthatha ama-steroids neminye imishanguzo lapho ngiqokelwe ukungena kwe-Darzalex infusions?
• Ngabe ngizokwazi ukuzishayela ngiye ekhaya ngemuva kokufakwa kwami ​​eDarzalex?
• Ngingayisebenzisa iDarzalex uma ngike ngaba nama-shingles?
• Ingabe iDarzalex yelapha i-myeloma eminingi?
• Izinyathelo zokuqapha zeDarzalex
• Imininingwane yobungcweti yeDarzalex
• Izinkomba
• Indlela yokusebenza
• I-Pharmacokinetics ne-metabolism
• Izimo
• Isitoreji

Yini iDarzalex?

I-Darzalex iyimithi kadokotela enegama lomuthi. Isetshenziselwa ukwelapha i-myeloma eminingi, okuwuhlobo lomdlavuza oluthinta amaseli athile amhlophe egazi abizwa ngamaseli e-plasma.

IDarzalex iqukethe i-daratumumab. Lolu uhlobo lomuthi obizwa ngokuthi i-monoclonal antibody.

I-Darzalex akuyona i-chemotherapy. Luhlobo lokwelashwa okuhlosiwe futhi kwesinye isikhathi lubizwa nge-immunotherapy. Lokhu kusho ukuthi iDarzalex yakhelwe ukusebenza namasosha akho omzimba (ukuzivikela komzimba wakho ekuthelelekeni).

Umhlinzeki wezokunakekelwa kwezempilo uzokunika iDarzalex njenge-infravenous (IV) infusion ehhovisi likadokotela wakho noma emtholampilo. Ukufakwa kwe-IV kungumjovo emthanjeni wakho onikezwa isikhathi esithile.

Isetshenziswa kanjani

I-Darzalex ingabekwa yodwa noma neminye imithi. Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvume ukuthi iDarzalex isetshenziswe:

• Kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.) Kulesi simo:
  • IDarzalex ingasetshenziswa nemithi lenalidomide (Revlimid) ne-dexamethasone.
  • I-Darzalex nayo ingasetshenziswa nemithi bortezomib (Velcade), melphalan, ne-prednisone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile. Kulesi simo, iDarzalex isetshenziswa ne-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma. Kulesi simo, iDarzalex isetshenziswa ne-bortezomib ne-dexamethasone.
• Kubantu abadala abathole imishanguzo emibili noma ngaphezulu yokwelashwa kwe-myeloma eyedlule ebandakanya i-lenalidomide ne-proteasome inhibitor, okuwuhlobo lomuthi. Kulesi simo, iDarzalex isetshenziswa nemithi pomalidomide (Pomalyst) ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa kwe-myeloma kathathu noma ngaphezulu okwedlule obekubandakanya i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni. Kulesi simo, iDarzalex isetshenziswa yodwa.
• Kubantu abadala abazame i-proteasome inhibitor nemithi yokuzivikela emzimbeni, kepha asikho isidakamizwa esisebenzele i-myeloma eminingi. Kulesi simo, iDarzalex isetshenziswa yodwa.

Ukusebenza ngempumelelo

Izifundo eziyisithupha zokwelashwa zabheka ukuthi iDarzalex yayisebenza kanjani ekwelapheni i-myeloma eminingi, iyodwa futhi ihlanganiswe nezinye izidakamizwa ezilwa nomdlavuza.Lezi zifundo zibizwa nge-MAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, ne-SIRIUS. Ucwaningo lukhombisile ukuthi ukwelashwa kwe-myeloma eminingi kwakusebenza ngempumelelo uma iDarzalex ingezwa ekwelashweni okujwayelekile komdlavuza uma ngabe le ndlela yokwelashwa ejwayelekile inikezwa yodwa. Ngemininingwane engaphezulu ngokusebenza, bheka isigaba se- “Darzalex for multiple myeloma” ngezansi.

I-Darzalex ejwayelekile

IDarzalex itholakala kuphela njengomuthi wegama lomkhiqizo. Okwamanje ayitholakali ngendlela ejwayelekile.

I-Darzalex iqukethe isithako somuthi esisodwa esisebenzayo: i-daratumumab.

Imiphumela emibi ye-Darzalex

I-Darzalex ingadala imiphumela emibi noma emibi. Uhlu olulandelayo luqukethe eminye yemiphumela emibi engaba khona ngenkathi uthatha iDarzalex. Lolu hlu alufaki yonke imiphumela emibi engaba khona.

Ukuthola eminye imininingwane ngemiphumela engemihle ye-Darzalex, khuluma nodokotela wakho noma usokhemisi. Bangakunika amathiphu okuthi ungabhekana kanjani nanoma yimiphi imiphumela emibi engase ikukhathaze.

Imiphumela emibi ejwayelekile

Imiphumela emibi ejwayelekile yeDarzalex ingafaka:

• ngizizwe ngikhathele
• ubuthakathaka noma ukungabi namandla
• ukuphazamiseka kwemisipha (ukudikiza)
• isicanucanu noma ukuhlanza
• isisu esithukuthele kubandakanya uhudo noma ukuqunjelwa
• ukuncipha kokudla
• inkathazo yokulala
• imfiva
• Ukugodola
• ukuphefumula noma ukukhwehlela
• ukutheleleka okuphezulu kokuphefumula, njengomkhuhlane
• i-bronchitis, uhlobo lokutheleleka kwamaphaphu
• Ubuhlungu bomzimba
• ubuhlungu obuhlangene noma obuya emuva
• isiyezi

Uma imiphumela emibi oyizwayo ibonakala inzima kakhulu noma ingapheli, khuluma nodokotela wakho noma usokhemisi.

Imiphumela emibi kakhulu

Imiphumela emibi ebucayi evela kuDarzalex ayijwayelekile, kodwa ingenzeka. Shayela udokotela wakho ngokushesha uma unemiphumela emibi kakhulu. Shayela u-911 uma izimpawu zakho zizizwa zisongela impilo noma uma ucabanga ukuthi unezimo eziphuthumayo zezokwelapha.

Imiphumela emibi kanye nezimpawu zayo zingafaka okulandelayo:

• Ukumnika ukumnika, uhlobo lwempendulo yokungezwani komzimba. Izimpawu zingafaka:
  • inkinga yokuphefumula
  • ukuqina komphimbo
  • uzizwa unekhanda elincane noma unesiyezi ngenxa yengcindezi yegazi ephansi
  • ukukhwehlela noma ukuphefumula
  • ikhala eligijimayo noma eligcwele
  • isicanucanu noma ukuhlanza
  • Ukugodola
  • imfiva
  • ikhanda
  • ukulunywa
• I-pneumonia, uhlobo lokutheleleka kwamaphaphu. Izimpawu zingafaka:
  • ukukhwehlela isikhwehlela (amafinyila)
  • umkhuhlane namakhaza
  • ukuphelelwa umoya
  • ubuhlungu besifuba
• I-Hepatitis B, uma uke waba nayo esikhathini esedlule. Izimpawu zingafaka:
  • ukukhathala okukhulayo
  • ukuphuzi kwesikhumba sakho noma ingxenye emhlophe yamehlo akho
• I-peripheral sensory neuropathy (ukulimala kwezinzwa okubangela ukuqaqamba, ukuba ndikindiki, noma ubuhlungu). Izimpawu zingafaka:
  • ukuba ndikindiki noma ukuhayiza
  • ubuhlungu obuvuthayo
  • ukuzwela
  • ubuthakathaka ezandleni noma ezinyaweni zakho
• I-peripheral edema (ukuvuvukala kwezandla nezinyawo). Izimpawu zingafaka:
  • ukuvuvukala kwezingalo noma imilenze
  • isikhumba eseluliwe
  • isikhumba esidabulayo (imigodi) lapho sicindezelwe imizuzwana embalwa

Eminye imiphumela emibi emibi, echazwe ngokuningiliziwe ngezansi ku- "Side effect imininingwane," ifaka:

• ukusabela okweqile
• i-thrombocytopenia, izinga eliphansi lama-platelets, okuluhlobo lweseli legazi elisiza amahlule egazi
• i-neutropenia, izinga eliphansi lama-neutrophils, okuluhlobo lwamaseli amhlophe egazi asiza ukulwa nezifo
• ama-shingles (ukutheleleka kwe-herpes zoster)

Imininingwane yomphumela oseceleni

Ungase uzibuze ukuthi kaningi kangakanani imiphumela emibi ethile eba khona ngalo muthi. Nayi imininingwane ngemiphumela emibi kakhulu engadalwa yilesi sidakamizwa.

Ukusabela okweqile

Njengezidakamizwa eziningi, abanye abantu bangaba ne-allergen reaction ngemuva kokuthatha iDarzalex. Akwaziwa ukuthi abantu abasebenzisa iDarzalex banemiphumela emibi kangakanani. Izimpawu zokuphendula okuncane komzimba zingabandakanya:

• ukuqubuka kwesikhumba noma isifuba (ukubabaza kwesikhumba esikhunjeni sakho)
• ukulunywa
• ukuqhuma (ukufudumala nokubomvu esikhunjeni sakho)
• imfiva

Ukusabela okweqile okwedlulele akuvamile kodwa kungenzeka. Izimpawu zokuphendula okweqile kakhulu zingabandakanya:

• ukuvuvukala ngaphansi kwesikhumba sakho, imvamisa ezinkalweni zakho, izindebe, izandla, noma izinyawo
• ukuvuvukala kolimi lwakho, umlomo, noma umphimbo
• inkinga yokuphefumula

Shayela udokotela wakho ngokushesha uma unegciwane elinamandla lokungezwani ne-Darzalex. Shayela u-911 uma izimpawu zakho zizizwa zisongela impilo noma uma ucabanga ukuthi unezimo eziphuthumayo zezokwelapha.

Ukumnika ukusabela

I-Darzalex inikezwa ukumnika okufakwa emthanjeni (IV) ehhovisi likadokotela wakho noma emtholampilo. Lo ngumjovo emthanjeni wakho onikezwa isikhathi esithile. Njengemithi eminingi enikezwa njengokufakwa kwe-IV, ungaba nokuphendula kokumnika ngemuva kokuthola iDarzalex. (Ukuphendula kwe-infusion luhlobo lokuphendula okweqile.)

Ngesikhathi sokuhlolwa komtholampilo, ukusabela kokumnika kwenzeka cishe engxenyeni yabo bonke abantu abaphathwe ukumnika kweDarzalex. Imvamisa, ukusabela kwenzeke ngesikhathi sokumnika kokuqala futhi bekumnene kuya kokulingene. Iningi labantu abathole iDarzalex lalinokuphendula phakathi noma ngaphakathi kwamahora ama-4 kokuphela kokufakwa. Ukusabela kwe-infusion mancane amathuba okuthi kwenzeke ngezokwelapha ezizayo. Ezifundweni, abantu abathole imishanguzo ngaphandle kweDarzalex abanikwanga imishanguzo ngendlela yokumnika.

Uma unempendulo yokumnika emnene noma elinganiselayo, udokotela wakho angamisa isikhashana ukumnika kwakho ukwelapha ukusabela. Bangase baqale kabusha ukumnika ngezinga eliphansi (isivinini) ukuze uthole umuthi ngokunensa. Uma ukusabela kwakho kokumnika okunzima noma i-anaphylactic (kusongela impilo), udokotela wakho angayeka ngokuphelele ukwelashwa ngeDarzalex bese eqala ukunakekelwa kwezimo eziphuthumayo.

Ukwehlisa ithuba lokuphendula ukumnika, udokotela wakho uzokunika inhlanganisela yezidakamizwa. Ihora elilodwa kuya kwamathathu ngaphambi kokufakwa komunye nomunye kwe-Darzalex, uzothola:

• i-corticosteroid (ukunciphisa ukuvuvukala)
• i-antipyretic (ukuvimbela noma ukunciphisa umkhuhlane)
• i-antihistamine (ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba)

Ungase futhi uthole usuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze ugweme ukusabela okubambezelekile. Kepha uma usuvele uthatha i-steroid efana ne-dexamethasone noma i-prednisone, cishe ngeke udinge ukukhushulwa okwengeziwe kwe-steroid.

Uma unesifo esibi kakhulu ku-Darzalex ngemuva kokuphuma ehhovisi likadokotela wakho noma esikhungweni sokumnika, shayela udokotela wakho ngokushesha. Shayela u-911 uma izimpawu zakho zizizwa zisongela impilo noma uma ucabanga ukuthi unezimo eziphuthumayo zezokwelapha.

Ukuphazamiseka kwamangqamuzana egazi

I-Darzalex ingadala i-thrombocytopenia, eyehla ezingeni lama-platelet akho. (Lezi wuhlobo lwengqamuzana legazi elisiza ukunqamuka kwegazi.) Izimpawu zingafaka ukulimaza nokopha.

Ezifundweni zomtholampilo, cishe abantu abangama-48% kuya kuma-90% abathathe iDarzalex noma iDarzalex ngemithi ejwayelekile yokwelashwa kwe-myeloma babe ne-thrombocytopenia. Uma kuqhathaniswa, ama-58% kuya kuma-88% abantu ababenokwelashwa okujwayelekile nje babene-thrombocytopenia.

IDarzalex nayo ingadala i-neutropenia. Lokhu kwehla ezingeni lama-neutrophils, okuluhlobo lwamaseli amhlophe egazi asiza ukulwa nezifo. Izimpawu zingafaka umkhuhlane nokutheleleka.

Ezifundweni zokwelashwa, abantu abangaba ngu-58% kuya ku-95% abathathe iDarzalex noma iDarzalex kanye nokwelashwa okujwayelekile kwe-myeloma abane-neutropenia. Uma kuqhathaniswa, ama-40% kuya kuma-87% abantu ababenokwelashwa okujwayelekile nje babene-neutropenia.

Ngesikhathi sokwelashwa kwakho kweDarzalex, udokotela wakho uzohlola njalo ukubalwa kweplatelet yakho namaseli amhlophe egazi. Futhi bazokuqapha nganoma yikuphi ukulinyazwa, ukopha, noma izifo. Uma uthuthukisa noma yiziphi zalezi zimpawu noma izimpawu, tshela udokotela wakho.

Amaswazi

Ngenkathi uthatha iDarzalex, ungahlakulela ukutheleleka okubizwa nge-shingles (herpes zoster). Lokhu kungenxa yokuthi ukuba ne-myeloma eminingi nokuthola ukwelashwa okuningi kwe-myeloma kungakhuphula ubungozi bokutheleleka.

Uma uthola ama-shingles, ungahle ube:

• ubuhlungu obuvuthayo
• ukuncinza
• ukulunywa
• ukuqubuka namabhamuza ohlangothini olulodwa kuphela lomzimba wakho

Igciwane elifanayo elibangela ama-shingles lingadala nenkukhu. Uma uke waba ne-chickenpox esikhathini esedlule, igciwane alishiyi umzimba wakho ngemuva kokululama ekutheleleni. Esikhundleni salokho, igciwane "limane lilale" emithanjeni yakho.

Akekho owazi kahle ukuthi kungani, kepha igciwane lingavuselela noma "livuke" ngezimbangela ezithile ezifana namasosha omzimba abuthakathaka. (Amasosha omzimba wakho avikela umzimba wakho ezifweni.)

Ukwelashwa komdlavuza noma komdlavuza kungenza buthakathaka amasosha akho omzimba futhi kuvuselele igciwane le-herpes zoster. Lapho iphaphama, iziveza njengama-shingles esikhundleni senkukhu.

Ezifundweni zomtholampilo, ama-shingles abikwa kuma-3% wabantu abaphathwa nge-Darzalex kuphela. Uma kuqhathaniswa, ama-shingles enzeka kubantu abangu-2% kuya ku-5% abathathe iDarzalex ngomuthi owengeziwe womdlavuza.

Uma uke waba ne-chickenpox noma i-shingles esikhathini esedlule futhi uthatha iDarzalex, udokotela wakho angakunikeza umuthi wokulwa namagciwane. Lolu hlobo lomuthi lungasiza ukuvimbela ama-shingles ukuthi akhule emzimbeni wakho. Uzodinga ukuthatha imishanguzo yegciwane lengculaza kungakapheli isonto elilodwa uthole iDarzalex kuqala. Ngemuva kwalokho uzoqhubeka nokuyithatha izinyanga ezintathu ngemuva kokuqeda ukwelashwa ngeDarzalex.

Inyumoniya

Ukuthatha iDarzalex kungaholela ekutheni ukhule ube nesifo samaphaphu esibizwa nge-pneumonia. Lokhu kungenxa yokuthi uma une-myeloma eminingi, maningi amathuba okuthi uthole izifo kunabantu abaphilile.

Ezifundweni zokwelashwa, abantu abangu-11% kuya ku-26% abathathe iDarzalex baba ne-pneumonia. Lokhu kuqhathaniswa nabantu abangu-6% kuya kwabangu-14% abathathe i-placebo (alukho umuthi).

I-pneumonia kwaba ukutheleleka okunzima okubikwa kakhulu. Kuze kufike ku-4% wabantu kuzo zonke izifundo zeDarzalex bekufanele bayeke ukuthatha umuthi ngenxa ye-pneumonia. Ukufa ngenxa ye-pneumonia kwakungavamile kakhulu. Kodwa uma kwenzeka ukufa, kwakungenxa ye-pneumonia ne-sepsis (impendulo esongela impilo ekuthelelekeni).

Izimpawu ze-pneumonia zingabandakanya:

• ukukhwehlela isikhwehlela (amafinyila)
• umkhuhlane namakhaza
• ukuphelelwa umoya
• ubuhlungu besifuba

Uma uba nezimpawu zenyumoniya, tshela udokotela wakho. Bangamisa isikhashana imithamo yakho ye-Darzalex ukwelapha inyumoniya. Ezifundweni zomtholampilo, cishe u-1% kuya ku-4% wabantu abathathe iDarzalex noma ukwelashwa komdlavuza okujwayelekile kuphela kwakufanele bayeke imishanguzo yabo ngenxa ye-pneumonia enamandla.

Izindleko zeDarzalex

Njengayo yonke imithi, izindleko zeDarzalex zingahluka. Ukuthola izintengo zamanje zeDarzalex endaweni yangakini, hlola i-WellRx.com. Izindleko ozithola ku-WellRx.com yilokho ongakukhokha ngaphandle komshwalense. Inani langempela ozolikhokha lizoya ngokutholakala komshuwalense wakho nasekhemisi oyisebenzisayo.

Uhlelo lwakho lomshuwalense lungadinga ukuthi uthole ukugunyazwa kwangaphambili ngaphambi kokuvumela ukufakwa kweDarzalex. Lokhu kusho ukuthi udokotela wakho uzodinga ukuthumela isicelo enkampanini yakho yomshuwalense ebacela ukuthi bamboze umuthi. Inkampani yomshwalense izosibuyekeza isicelo bese ikwazisa wena nodokotela wakho ukuthi uhlelo lwakho luzohlanganisa i-Darzalex.

Uma ungaqiniseki ukuthi uzodinga ukuthola ukugunyazwa kwangaphambili kweDarzalex, xhumana nohlelo lwakho lomshuwalense.

Usizo lwezezimali nolomshuwalense

Uma udinga ukwesekwa kwezezimali ukukhokhela iDarzalex, noma uma udinga usizo lokuqonda umshuwalense wakho, usizo luyatholakala.

UJanssen Biotech, Inc., umkhiqizi weDarzalex, unikela ngohlelo olubizwa ngeJanssen CarePath. Ukuthola eminye imininingwane nokuthola ukuthi ukulungele yini ukwesekwa, shayela ku-844-553-2792 noma uvakashele iwebhusayithi yohlelo.

Isilinganiso seDarzalex

Umthamo weDarzalex odokotela wakho onqumayo uzoncika ezicini ezithile. Lokhu kufaka phakathi:

• uma isimo sakho sisanda kutholakala noma uthole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma
• noma yikuphi okunye ukwelashwa okutholayo kanye neDarzalex ukwelapha i-myeloma eminingi
• ezinye izimo zezokwelapha ongahle ube nazo
• noma yimiphi imiphumela emibi engapheli

Imininingwane elandelayo ichaza imithamo esetshenziswa kakhulu noma enconywayo. Udokotela wakho uzonquma isilinganiso esihle kakhulu ukuhlangabezana nezidingo zakho. Ukuze uthole okuningi ngalokhu kwelashwa, kubalulekile ukuya kukho konke ukuqokwa kwakho futhi ungeqi noma yiziphi izinsuku.

Amafomu wezidakamizwa namandla

I-Darzalex iza njengesisombululo (ingxube ye-liquid) oyothola ngesimo somjovo. Isixazululo singaba nombala ophuzi ophuzi. IDarzalex itholakala ngosayizi ababili:

• 100 mg / 5 mL esitsheni esisodwa somthamo owodwa
• 400 mg / 20 mL esitsheni esisodwa somthamo owodwa

Umhlinzeki wezokunakekelwa kwempilo uzoxuba ingxenye yeDarzalex ne-0.9% sodium chloride (uhlobo lwesisombululo samanzi anosawoti). Bese bezokunikeza lo muthi ngenaliti efakwe emthanjeni wakho. Lokhu kubizwa ukumnika okufakwa emthanjeni (IV).

Imvamisa, udokotela wakho uzokuqala kumthamo onconyiwe kepha ngezinga eliphansi (isivinini) sokumnika. Ngokuhamba kwesikhathi, bazolungisa ukumnika kuzinga elifanele wena. Lokhu kuzoya nganoma yikuphi ukusabela kokumnika onakho.

Ukufakwa kwakho kokuqala kweDarzalex kungathatha cishe amahora ayi-7. Lokhu kungenxa yokuthi udokotela wakho uzokunika (akunike) imithi yakho kancane kancane emthanjeni wakho. Esikhathini esizayo, ukumnika kuzohlala cishe emahoreni ama-3 kuye kwayi-5 ngoba uzobe ufaka umuthi ngokushesha. Umhlinzeki wezokunakekelwa kwempilo uyohlale ekuqapha ngesikhathi sokumunyelwa.

Isilinganiso se-myeloma eminingi

I-Darzalex inqunyelwe yona noma nezinye izinhlobo zokwelashwa komdlavuza kubantu abadala abane-myeloma eminingi. Uhlelo lokwelashwa nobude buzoncika ekutheni usanda kutholakala yini noma uke waba nokwelashwa kwangaphambilini. UDarzalex akazange afundwe ezinganeni.

Umthamo onconyiwe weDarzalex ungama-16 milligrams / kilogram (mg / kg) wesisindo sangempela somzimba njengokufakwa kwe-IV. Isibonelo, owesifazane ongamakhilogremu ayi-110 unesisindo esingaba ngama-50 kg. Lokho kusho ukuthi umthamo wakhe ophakanyisiwe weDarzalex uzoba yi-50 kg iphindwe nge-16 mg / kg, eyi-800 mg.

Abantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous

Ngokufakelwa kwe-autologous stem cell, amaseli akho ama-stem ayasetshenziswa. Enye indlela yokwelashwa yiDarzalex ene-lenalidomide (Revlimid) ne-dexamethasone. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuya ku-8: Umthamo owodwa isonto ngalinye (ngenani lamanani ayisishiyagalombili)
• Emaviki 9 kuya ku-24: Umthamo owodwa njalo emavikini ama-2 (isiyonke semithamo eyisishiyagalombili)
• Isonto 25 kuqhubeke: Umthamo owodwa njalo emavikini amane

Enye indlela yokwelashwa yiDarzalex ene-bortezomib (Velcade), i-melphalan, ne-prednisone. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuye ku-6: Umthamo owodwa ngesonto (ngenani lamanani ayisithupha)
• Emaviki 7 kuya ku-54: Umthamo owodwa njalo emavikini amathathu (ngenani lamanani ayi-16 esewonke)
• Isonto 55 kuqhubeke: Umthamo owodwa njalo emavikini amane

Abantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile

Uzothola i-Darzalex nge-lenalidomide ne-dexamethasone. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuya ku-8: Umthamo owodwa ngesonto (wenani lamanani ayisishiyagalombili)
• Emaviki 9 kuya ku-24: Umthamo owodwa njalo emavikini ama-2 (isiyonke semithamo eyisishiyagalombili)
• Isonto 25 kuqhubeke: Umthamo owodwa njalo emavikini amane

Abantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma

Uzothola i-Darzalex nge-bortezomib ne-dexamethasone. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuya ku-9: Umthamo owodwa isonto ngalinye (ngenani lamanani ayisishiyagalolunye)
• Emaviki 10 kuya ku-24: Umthamo owodwa njalo emavikini amathathu (inani eliphelele lamanani amahlanu)
• Isonto 25 kuqhubeke: Umthamo owodwa njalo emavikini amane

Abantu abadala abathole ukwelashwa kwe-myeloma kabili noma ngaphezulu okwedlule, kufaka phakathi i-lenalidomide ne-proteasome inhibitor

Uzothola i-Darzalex nge pomalidomide (Pomalyst) ne-dexamethasone. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuya ku-8: Umthamo owodwa isonto ngalinye (ngenani lamanani ayisishiyagalombili)
• Emaviki 9 kuya ku-24: Umthamo owodwa njalo emavikini ama-2 (isiyonke semithamo eyisishiyagalombili)
• Isonto 25 kuqhubeke: Umthamo owodwa njalo emavikini amane

Abantu abadala abathole ukwelashwa kwe-myeloma okuthathu noma ngaphezulu okwedlule, kufaka phakathi i-proteasome inhibitor kanye nesidakamizwa sokuzivikela emzimbeni, noma abangaphendulanga i-proteasome inhibitor kanye nomuthi wokugomela emzimbeni.

Uzokwamukela kuphela iDarzalex. Isheduli yesilinganiso esinconyiwe yile:

• Amaviki 1 kuya ku-8: Umthamo owodwa isonto ngalinye (ngenani lamanani ayisishiyagalombili)
• Emaviki 9 kuya ku-24: Umthamo owodwa njalo emavikini amabili (inani eliphelele lamanani ayisishiyagalombili)
• Isonto 25 kuqhubeke: Umthamo owodwa njalo emavikini amane

Ukwehlisa ithuba lokuphendula ukumnika, udokotela wakho uzokunika inhlanganisela yezidakamizwa. Ihora elilodwa kuya kwamathathu ngaphambi kokufakwa komunye nomunye kwe-Darzalex, uzothola:

• i-corticosteroid (ukunciphisa ukuvuvukala)
• i-antipyretic (ukuvimbela noma ukunciphisa umkhuhlane)
• i-antihistamine (ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba).

Ungase futhi uthole usuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze ugweme ukusabela okubambezelekile. Kepha uma usuvele uthatha i-steroid efana ne-dexamethasone noma i-prednisone, cishe ngeke udinge ukukhushulwa okwengeziwe kwe-steroid.

Kuthiwani uma ngiphuthelwa umthamo?

Uma uphuthelwa i-aphoyintimenti yokufakwa kwe-Darzalex, shayela udokotela wakho khona manjalo ukuze uhlele kabusha. Bazolungisa uhlelo lwakho lokulinganisa ukuze baqiniseke ukuthi uthola inani elifanele lezokwelapha ngesikhathi esifanele.

Ngabe kuzodingeka ngisebenzise lesi sidakamizwa isikhathi eside?

Ezifundweni zomtholampilo, isikhathi esimaphakathi esithathile ukuthi iDarzalex iqale ukusebenza bekuyinyanga eyodwa.

Kodwa-ke, unganikezwa imithamo yakho isikhathi eside. Lokhu kuzoya ngokuthi umzimba wakho uphendula kanjani kuDarzalex futhi uma i-myeloma yakho eminingi iqala ukuba yimbi.

Ubude bezokwelapha buzoncika nokuthi ngabe i-myeloma yakho eminingi isanda kutholakala noma ngabe uke waba nokwelashwa esikhathini esedlule.

I-Darzalex ye-myeloma eminingi

Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvume iDarzalex ekwelapheni i-myeloma eminingi.

Lolu uhlobo lomdlavuza oluthinta amaseli athile amhlophe egazi abizwa ngamaseli e-plasma. Amaseli e-Plasma akha ingxenye yamasosha akho omzimba futhi asiza ukulwa nezifo emzimbeni wakho. Ezingxenyeni eziningi ze-myeloma, amaseli e-plasma ashintsha abe amaseli amaningi e-myeloma. Njengoba amangqamuzana amaningi e-myeloma ekhula futhi esakazeka, angagcwala amangqamuzana anempilo futhi alimaze amathambo abazungezile.

IDarzalex ivunyelwe ukusetshenziswa:

• Kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.) Kulesi simo:
  • IDarzalex ingasetshenziswa nemithi lenalidomide (Revlimid) ne-dexamethasone.
  • I-Darzalex nayo ingasetshenziswa nemithi bortezomib (Velcade), melphalan, ne-prednisone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile. Kulesi simo, iDarzalex isetshenziswa ne-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma. Kulesi simo, iDarzalex isetshenziswa ne-bortezomib ne-dexamethasone.
• Kubantu abadala abathole imishanguzo emibili noma ngaphezulu yokwelashwa kwe-myeloma eyedlule ebandakanya i-lenalidomide ne-proteasome inhibitor, okuwuhlobo lomuthi. Kulesi simo, iDarzalex isetshenziswa nemithi pomalidomide (Pomalyst) ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa kwe-myeloma kathathu noma ngaphezulu okwedlule obekubandakanya i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni. Kulesi simo, iDarzalex isetshenziswa yodwa.
• Kubantu abadala abazame i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni kepha akukho muthi osebenzele i-myeloma eminingi. Kulesi simo, iDarzalex isetshenziswa yodwa.

Ukusebenza ngempumelelo

Izifundo eziyisithupha zokwelashwa zabheka ukuthi iDarzalex yayisebenza kanjani ekwelapheni i-myeloma eminingi iyodwa futhi ihlanganiswe nezinye izidakamizwa ezilwa nomdlavuza. Lezi zifundo zibizwa nge-MAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, ne-SIRIUS. Ucwaningo lukhombisile ukuthi ukwelashwa kwakusebenza kangcono uma iDarzalex ingezwa ekwelashweni okujwayelekile komdlavuza uma ngabe le ndlela yokwelashwa ejwayelekile inikezwa yodwa.

Ucwaningo lwe-MAIA

Ucwaningo lwe-MAIA lubheke abantu abasanda kutholakala ukuthi bane-myeloma eminingi abangakwazanga ukuthola ukufakelwa kwe-stem cell autologous. Abantu bathole ukwelashwa okujwayelekile komdlavuza we-lenalidomide (Revlimid) kanye ne-dexamethasone yedosi ephansi noma ukwelashwa okufanayo ne-Darzalex. Uma kuqhathaniswa neqembu lokwelashwa elijwayelekile, iqembu laseDarzalex lalinengcuphe ephansi engama-44% yokuthi i-myeloma yabo ibe yimbi noma ifa.

Ezinyangeni ezingama-42 zocwaningo, i-myeloma eminingi ayizange ibe yimbi kakhulu kubantu abathatha iDarzalex kanye nokwelashwa okujwayelekile. Kubantu abathathe ukwelashwa okujwayelekile, kuthathe cishe izinyanga ezingama-31.9 ngaphambi kokuthi i-myeloma yabo eminingi iqale ukuba yimbi. Izinga lokuphendula eliphelele lalingu-47.6% wabantu abaphathwa nge-Darzalex kanye nama-24.9% kulabo abathola ukwelashwa okujwayelekile nje. (Impendulo ephelele isho ukuthi wonke umdlavuza awusekho futhi azikho izimpawu zesifo ekuhlolweni kwelabhu, i-X-ray, noma izivivinyo zomtholampilo.)

Ucwaningo lwe-ALCYONE

Ucwaningo lwe-ALCYONE lubheke abantu abasanda kutholakala ukuthi bane-myeloma eminingi abangakwazanga ukuthola ukufakelwa kwe-stem cell autologous. Laba bantu bathole ukwelashwa okujwayelekile komdlavuza we-bortezomib (Velcade), i-melphalan, ne-prednisone noma lokho kwelashwa kanye ne-Darzalex. Uma kuqhathaniswa neqembu lokwelashwa elijwayelekile, iqembu laseDarzalex lalinengozi engaphansi ngama-50% yokuthi i-myeloma yabo ibe yimbi noma ifa.

Kubantu abathole ukwelashwa kweDarzalex, ama-42.6% abe nempendulo ephelele. Lokhu kwaqhathaniswa nabantu abangama-24.4% abathola ukwelashwa okujwayelekile kuphela.

Ucwaningo lwe-POLLUX

Ucwaningo lwe-POLLUX lubheke abantu abane-myeloma eningi abebenokwelashwa okungenani okukodwa kwangaphambilini. Abantu bathathe ukwelashwa okujwayelekile kwe-lenalidomide ne-dexamethasone noma ukwelashwa okufanayo ne-Darzalex. Imiphumela ikhombise ukuthi cishe abantu abangama-91.3% baphendule ekwelashweni ngeDarzalex ngokuqhathanisa nabantu abangaba ngu-74.6% abathole ukwelashwa okujwayelekile kuphela.

Uma kuqhathaniswa neqembu lokwelashwa elijwayelekile, iqembu elaphathwa ngeDarzalex lalinengozi engaphansi kwama-63% yokuthi i-myeloma yabo eminingi iye iba yimbi. Ngemuva kwezinyanga eziyi-13.5, i-19% yeqembu leDarzalex yabona ukuthi i-myeloma yabo eminingi iba yimbi noma badlula emhlabeni. Lokhu kwaqhathaniswa ne-41% yeqembu lokwelashwa elijwayelekile.

Ucwaningo lwe-CASTOR

Ucwaningo lwe-CASTOR lubuye lwabheka abantu abane-myeloma eminingi ababenokwelashwa okungenani okukodwa kwangaphambilini. Abantu bathathe ukwelashwa okujwayelekile kwe-bortezomib ne-dexamethasone noma ukwelashwa okufanayo ne-Darzalex. Imiphumela ibifana naleyo yocwaningo lwe-POLLUX. Cishe abantu abangama-73.9% babe nempendulo ekwelashweni ngeDarzalex uma kuqhathaniswa nabantu ababalelwa ku-59.9% abathola ukwelashwa okujwayelekile kuphela.

Uma kuqhathaniswa nokwelashwa okujwayelekile, ukwelashwa kweDarzalex kwakuxhunyaniswe nengozi ephansi engama-61% ye-myeloma eminingi eba yimbi noma yokufa. Abantu abathathe iDarzalex nabo bakwazile ukuhlala kuthethelelo isikhathi eside. (Ukuxolelwa kusho ukuthi izinga lokusabalala komdlavuza lehlile.)

Ucwaningo lwe-EQUULEUS

Ucwaningo lwe-EQUULEUS lubheke abantu abangu-103 abane-myeloma eningi abake baphathwa cishe amahlandla amane nge-myeloma yabo eminingi. Laba bantu basebevele bathole izinhlobo ezimbili zokwelashwa: i-proteasome inhibitor kanye nomuthi wokuzivikela emzimbeni. Wonke umuntu ocwaningweni uthathe ukwelashwa okujwayelekile kwe-pomalidomide (Pomalyst) ne-dexamethasone kanye ne-Darzalex. Inhloso enkulu yalolu cwaningo bekungukubona ukuthi bangaki abantu abasabela ekwelashweni.

Sekukonke, ukwelashwa kwaqala ukusebenza cishe inyanga eyodwa kubantu abaningi. Ukwelashwa kusebenze cishe izinyanga ezingaba ngu-13.6. Izimpawu eziningi ze-myeloma zancipha ngo-90% noma ngaphezulu kubantu abangama-42%. Abanye abantu baze basala nomdlavuza ekupheleni kwesifundo.

Ucwaningo lwe-SIRIUS

Ucwaningo lwe-SIRIUS lubheke abantu abangu-106 abane-myeloma eminingi ababegula kakhulu futhi bathole isilinganiso semithi yokwelashwa emihlanu edlule. Bonke abantu abasesifundweni banikezwe iDarzalex nje. Inhloso enkulu yalolu cwaningo bekungukubona ukuthi bangaki abantu abasabela ekwelashweni.

Ngokuvamile, abantu abangama-31 abathola iDarzalex banezimpawu zabo eziningi ze-myeloma ezinciphile. Cishe abantu abangama-64.8% abathathe iDarzalex kulolu cwaningo basinda okungenani izinyanga eziyi-12.

Ukwehlisa ithuba lokuthola ukumnika, abantu kuzo zonke lezi zifundo banikezwa inhlanganisela yemithi. Ihora elilodwa kuya kwamathathu ngaphambi kokufakwa konke kweDarzalex, bathola:

• i-corticosteroid (ukunciphisa ukuvuvukala)
• i-antipyretic (ukuvimbela noma ukunciphisa umkhuhlane)
• i-antihistamine (ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba)

Kungenzeka ukuthi bathole nosuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze kugwenywe ukusabela okubambezelekile. Kepha uma abantu bebevele bethatha i-steroid efana ne-dexamethasone noma i-prednisone, kungenzeka ukuthi abadingi ukukhushulwa okungaphezulu kwe-steroid.

I-Darzalex yezinye izimo

Ngokungeziwe i-myeloma eminingi, iDarzalex ifundwa njengokwelashwa kwe-immunoglobulin light chain amyloidosis.

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

I-immunoglobulin light chain amyloidosis (AL) yisimo lapho amaprotheni athile abizwa ngokuthi amaketanga alula akha izitho zakho emzimbeni wakho wonke. Imvamisa, inhliziyo yakho, izinso, ubende, nesibindi kuyathinteka. Ukwakhiwa kwamaprotheni kungalimaza futhi kubangele ukuthi lezi zitho zehluleke.

I-Darzalex ayivunyelwe yi-FDA ukwelapha i-AL. Kodwa-ke, kukhona ucwaningo olulinganiselwe olusebenzisa i-Darzalex off-label ukwelapha lesi simo. (Ukusetshenziswa okungekho kwelebula kulapho umuthi ovunyelwe ukwelapha umbandela owodwa usetshenziselwa ukwelapha isimo esihlukile.)

Kokunye ukuhlola, iDarzalex yanikezwa abantu abane-AL ababekade, ngokwesilinganiso, bathole ukwelashwa okuthathu okwehlukile okwakungasebenzi. IDarzalex ikhiqize impendulo ecishe iphelele noma ephelele kubantu abangama-76% abathathe lo muthi. (Ukuphendula okuphelele kusho ukuthi sonke isifo asisekho futhi azikho izimpawu zesifo ekuhlolweni kwelebhu, i-X-ray, izivivinyo zomtholampilo.) Laba bantu baba nemiphumela emibi efana naleyo ebilindelwe kubantu abathathe iDarzalex ukwelapha i-myeloma eminingi. Kwamanye amacala abikiwe, iDarzalex ibisebenza ekwelapheni i-AL nasekuthuthukiseni ikhwalithi yempilo yabantu abathathe lesi sidakamizwa.

Kudingeka izifundo eziningi ukufakazela ukuthi iDarzalex isebenza kahle futhi iphephile uma isetshenziswa kubantu abane-AL. Kuze kube yileso sikhathi, abacwaningi bangasebenzisa iDarzalex kubantu abane-AL abangasenakho ukukhetha kokuqala, izinketho zokwelashwa ezivunyelwe yi-FDA ezisele.

Ukusetshenziswa kweDarzalex nezinye izidakamizwa ze-myeloma eminingi

I-Darzalex inqunywe yodwa noma nezinye izinhlobo zokwelashwa komdlavuza kubantu abadala abane-myeloma eminingi. Uhlelo lokwelashwa nobude buzoncika ekutheni usanda kutholakala yini noma uke waba nokwelashwa kwangaphambilini.

IDarzalex ivunyelwe ukusetshenziswa kanye ne:

• i-lenalidomide (i-Revlimid) ne-dexamethasone kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.)
• i-lenalidomide ne-dexamethasone kubantu abadala abathole ukwelashwa okukodwa noma ngaphezulu okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile.
• i-bortezomib (i-Velcade), i-melphalan, ne-prednisone kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous.
• i-bortezomib ne-dexamethasone kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule kwe-myeloma.
• pomalidomide (Pomalyst) ne-dexamethasone kubantu abadala abathole ukwelashwa okubili noma ngaphezulu okwedlule kwe-myeloma. Lezi zindlela zokwelapha kufanele ukuthi zifake i-lenalidomide kanye ne-proteasome inhibitor.

Izifundo eziyisithupha zokwelashwa zabheka ukuthi iDarzalex yayisebenza kanjani ekwelapheni i-myeloma eminingi, iyodwa futhi ihlanganiswe nezinye izidakamizwa ezilwa nomdlavuza. Lezi zifundo zibizwa nge-MAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, ne-SIRIUS. Ucwaningo lukhombisile ukuthi ukwelashwa kwe-myeloma eminingi kwakusebenza ngempumelelo uma iDarzalex ingezwa ekwelashweni okujwayelekile komdlavuza uma ngabe le ndlela yokwelashwa ejwayelekile inikezwa yodwa. Ngemininingwane mayelana nalezi zifundo, sicela ubheke isigaba se- "Darzalex for multiple myeloma" ngenhla.

Ezinye izindlela zeDarzalex

Ezinye izidakamizwa ziyatholakala ezingelapha i-myeloma eminingi. Ezinye zingakulungela kangcono kunabanye. Uma unentshisekelo yokuthola enye indlela ye-Darzalex, khuluma nodokotela wakho ukuze ufunde kabanzi ngeminye imithi engakusebenzela kahle.

Ngezansi kunohlu lwemithi enconywe imihlahlandlela yeNational Comprehensive Cancer Network yokwelapha i-myeloma eminingi:

• Izidakamizwa ze-Chemotherapy, njenge:
  • bendamustine (Bendeka noma iTreanda)
  • umabhebhana
  • i-cyclophosphamide (iCytoxan)
  • i-doxorubicin (Doxil)
  • I-etoposide (Etopophos)
  • i-melphalan (Alkeran)
• Ama-Proteasome inhibitors, anjenge:
  • i-bortezomib (Velcade)
  • i-carfilzomib (Kyprolis)
  • ixazomib (Ninlaro)
• Ama-antibody e-monoclonal, njenge:
  • i-elotuzumab (Empliciti)
• I-histone deacetylase inhibitors, efana:
  • i-panobinostat (Farydak)
• Ama-immunomodulators, anjenge:
  • lenalidomide (Revlimid)
  • pomalidomide (Pomalyst)
  • thalidomide (Thalomid)
• AmaCorticosteroids, anjenge:
  • i-dexamethasone (i-Decadron)

Qaphela: Ezinye zezidakamizwa ezibalwe lapha zingasetshenziswa ngaphandle kwelebula ukwelapha i-myeloma eminingi.

IDarzalex vs. Empliciti

Ungase uzibuze ukuthi iDarzalex iqhathanisa kanjani neminye imithi enqunyelwe ukusetshenziswa okufanayo. Lapha sibheka ukuthi iDarzalex ne-Empliciti zifana kanjani futhi zehlukile.

Mayelana

IDarzalex iqukethe i-daratumumab, kanti i-Empliciti iqukethe i-elotuzumab. Kokubili iDarzalex ne-Empliciti kungokwesigaba semithi ebizwa ngama-antibody monoclonal. (Isigaba semithi siyiqembu lemithi esebenza ngendlela efanayo.) Kokubili iDarzalex ne-Empliciti kubhekwa njengezindlela zokwelashwa eziqondisiwe ze-myeloma eminingi.

Isebenzisa

Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvume iDarzalex ne-Empliciti ukwelapha i-myeloma eminingi.

IDarzalex ivunyelwe ukusetshenziswa:

• Kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.) Kulesi simo:
  • IDarzalex ingasetshenziswa nemithi lenalidomide (Revlimid) ne-dexamethasone.
  • I-Darzalex nayo ingasetshenziswa nemithi bortezomib (Velcade), melphalan, ne-prednisone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile. Kulesi simo, iDarzalex isetshenziswa ne-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma. Kulesi simo, iDarzalex isetshenziswa ne-bortezomib ne-dexamethasone.
• Kubantu abadala abathole imishanguzo emibili noma ngaphezulu yokwelashwa kwe-myeloma eyedlule ebandakanya i-lenalidomide ne-proteasome inhibitor, okuwuhlobo lomuthi. Kulesi simo, iDarzalex isetshenziswa nemithi pomalidomide (Pomalyst) ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa kwe-myeloma kathathu noma ngaphezulu okwedlule obekubandakanya i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni. Kulesi simo, iDarzalex isetshenziswa yodwa.
• Kubantu abadala abazame i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni kepha akukho muthi osebenzele i-myeloma eminingi. Kulesi simo, iDarzalex isetshenziswa yodwa.

I-Empliciti ivunyelwe ukusetshenziswa:

• Kubantu abadala abathole ukwelashwa okukodwa kokuthathu kwangaphambilini nge-myeloma yabo eminingi. I-Empliciti isetshenziswa ne-lenalidomide (Revlimid) ne-dexamethasone.
• Kubantu abadala abathole okungenani imishanguzo emibili edlule ebifaka i-lenalidomide ne-proteasome inhibitor. I-Empliciti isetshenziswa ne-pomalidomide (Pomalyst) ne-dexamethasone.

Imvamisa, i-Empliciti inikezwa uma i-myeloma yakho eminingi ibuyile ngemuva kokunye ukwelashwa.

Amafomu wezidakamizwa nokuphathwa

Kokubili iDarzalex ne-Empliciti zinikezwa njenge-infravenous (IV) infusion. Lo ngumjovo ofakwa kancane ngokuhamba kwesikhathi ngenaliti efakwa emthanjeni wakho.

OkweDarzalex

I-Darzalex iza njengesisombululo (ingxube ye-liquid) oyothola ngesimo somjovo. Isixazululo singabi nombala ophuzi ophuzi. Umuthi utholakala ngosayizi ababili:

• 100 mg / 5 mL esitsheni esisodwa somthamo owodwa
• 400 mg / 20 mL esitsheni esisodwa somthamo owodwa

Ukwehlisa ithuba lokuphendula ukumnika, udokotela wakho uzokunika inhlanganisela yezidakamizwa. Ihora elilodwa kuya kwamathathu ngaphambi kokufakwa komunye nomunye kwe-Darzalex, uzothola:

• i-corticosteroid yokunciphisa ukuvuvukala
• i-antipyretic ukuvimbela noma ukunciphisa umkhuhlane
• i-antihistamine ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba

Ungase futhi uthole usuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze ugweme ukusabela okubambezelekile. Kepha uma usuvele uthatha i-steroid efana ne-dexamethasone noma i-prednisone, cishe ngeke udinge ukukhushulwa okwengeziwe kwe-steroid.

Okwe-Empliciti

IMpliciti iza njengempuphu emhlophe qwa. Umhlinzeki wezokunakekelwa kwempilo uzohlanganisa lokhu nesixazululo sokukunika umjovo. I-Empliciti itholakala ngamandla amabili:

• 300 mg esitsheni esisodwa sethamo elilodwa
• 400 mg esitsheni esisodwa sethamo elilodwa

Ukwehlisa ithuba lokuphendula ukumnika, udokotela wakho uzokunika inhlanganisela yezidakamizwa. Cishe imizuzu engama-45 kuye kwengu-90 ngaphambi kokufakwa kwe-Empliciti, uzothola:

• i-acetaminophen ukuvimbela noma ukunciphisa umkhuhlane
• diphenhydramine (Benadryl) ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba
• ranitidine ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba
• i-dexamethasone ukunciphisa ukuvuvukala

Imiphumela emibi kanye nezingozi

IDarzalex ne-Empliciti zombili ziqukethe izidakamizwa ezisebenza ngokufanayo. Ngakho-ke, yomibili le mithi ingadala imiphumela emibi efanayo. Ngezansi kunezibonelo zale miphumela emibi.

Imiphumela emibi ejwayelekile

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi ejwayelekile engenzeka ngeDarzalex, ne-Empliciti, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeDarzalex:
  • ubuthakathaka
  • Ubuhlungu bomzimba noma ubuhlungu bamalunga
  • isicanucanu
  • inkathazo yokulala
  • i-bronchitis, uhlobo lokutheleleka kwamaphaphu
  • isiyezi
• Kungenzeka nge-Empliciti:
  • ushukela ophakeme wegazi *
  • ubuhlungu obuvuthayo ezingalweni noma emilenzeni yakho * *
• Kungenzeka ngeDarzalex ne-Empliciti:
  • ukuzizwa ukhathele noma ukungabi namandla
  • isisu esithukuthele kubandakanya uhudo noma ukuqunjelwa
  • ukuncipha kokudla
  • imfiva
  • Ukugodola
  • ukuphefumula noma ukukhwehlela
  • ukutheleleka okuphezulu kokuphefumula okufana nomkhuhlane
  • ukuphazamiseka kwemisipha (ukudikiza)
  • ukuhlanza
  • i-peripheral edema, okuwukuvuvukala kwezandla nezinyawo

** Lapho i-Empliciti isetshenziswa neleneralomide plus dexamethasone

Imiphumela emibi kakhulu

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi kakhulu engenzeka ngeDarzalex, ne-Empliciti, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeDarzalex:
  • i-thrombocytopenia, izinga eliphansi lama-platelets, okuluhlobo lweseli legazi elisiza amahlule egazi
  • i-neutropenia, izinga eliphansi lama-neutrophils, okuluhlobo lwamaseli amhlophe egazi asiza ukulwa nezifo
  • ama-shingles (ukutheleleka kwe-herpes zoster)
• Kungenzeka nge-Empliciti:
  • umdlavuza omusha
  • izinkinga zesibindi
• Kungenzeka ngeDarzalex ne-Empliciti:
  • ukumnika ukusabela
  • inyumoniya, uhlobo lokutheleleka kwamaphaphu
  • i-peripheral sensory neuropathy, uhlobo lokulimala kwezinzwa okubangela ukuqaqamba, ukuba ndikindiki, noma ubuhlungu

Ukusebenza ngempumelelo

I-Darzalex ne-Empliciti zinokusetshenziswa okwehlukile okuvunyelwe yi-FDA, kodwa zombili zisetshenziselwa ukwelapha i-myeloma eminingi kubantu abadala.

Le mithi ayikaze iqhathaniswe ngqo ezifundweni zomtholampilo (ezibizwa ngezifundo ezenziwa ngekhanda). Kodwa-ke, ukubuyekezwa kwezifundo zokwelashwa eziyi-13 zeDarzalex ne-Empliciti kutholakale ukuthi zombili lezi zidakamizwa ziphumelele ekubambezeleni ukuqhubeka (okuba kubi kakhulu) kwe-myeloma eminingi.

Kubantu abane-myeloma eminingi ebuyile noma eqhubeka ikhula ngisho nangemva kokwelashwa okuningi, imihlahlandlela yeNational Comprehensive Cancer Network incoma iDarzalex kuqala. Uma iDarzalex ingasebenzi, ukwelashwa nge-Empliciti kungenye indlela.

Izindleko

I-Darzalex ne-Empliciti zombili izidakamizwa ezinamagama. Okwamanje azikho izinhlobo ezijwayelekile zomuthi. Imithi enegama lomkhiqizo ivame ukubiza ngaphezu kwama-generic.

Ngokuya ngokulinganiselwa ku-WellRx.com, iDarzalex ngokuvamile ibiza ngaphansi kuka-Empliciti. Inani langempela ozolikhokhela noma yimuphi umuthi lincike ohlelweni lwakho lomshuwalense nasendaweni okuyo.

IDarzalex vs. Kyprolis

Njengo-Empliciti (ngenhla), isidakamizwa iKyprolis sisebenzisa okufana nalezo zeDarzalex. Manje ake sibheke ukuthi iDarzalex neKyprolis zifana kanjani futhi zehlukene kanjani.

Mayelana

IDarzalex iqukethe i-daratumumab, kanti iKyprolis iqukethe i-carfilzomib. Zombili lezi zidakamizwa zibhekwa njengokwelapha okuhlosiwe kwe-myeloma eminingi. Kodwa-ke, izidakamizwa zisezigabeni ezahlukahlukene zezidakamizwa. (Isigaba semithi siyiqembu lemithi esebenza ngendlela efanayo.) I-Darzalex uhlobo lomuthi obizwa ngokuthi i-monoclonal antibody. I-Kyprolis uhlobo lomuthi obizwa nge-proteasome inhibitor.

Isebenzisa

Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvume ukuthi iDarzalex isetshenziswe:

• Kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.) Kulesi simo:
  • IDarzalex ingasetshenziswa nemithi lenalidomide (Revlimid) ne-dexamethasone.
  • I-Darzalex nayo ingasetshenziswa nemithi bortezomib (Velcade), melphalan, ne-prednisone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile. Kulesi simo, iDarzalex isetshenziswa ne-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma. Kulesi simo, iDarzalex isetshenziswa ne-bortezomib ne-dexamethasone.
• Kubantu abadala abathole imishanguzo emibili noma ngaphezulu yokwelashwa kwe-myeloma eyedlule ebandakanya i-lenalidomide ne-proteasome inhibitor, okuwuhlobo lomuthi. Kulesi simo, iDarzalex isetshenziswa nemithi pomalidomide (Pomalyst) ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa kwe-myeloma kathathu noma ngaphezulu okwedlule obekubandakanya i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni. Kulesi simo, iDarzalex isetshenziswa yodwa.
• Kubantu abadala abazame i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni kepha akukho muthi osebenzele i-myeloma eminingi. Kulesi simo, iDarzalex isetshenziswa yodwa.

I-Kyprolis ivunyiwe yi-FDA ukuthi isetshenziswe:

• Kubantu abadala abathole ukwelashwa okukodwa kokuthathu kwangaphambilini nge-myeloma yabo eminingi. I-Kyprolis isetshenziswa ne-dexamethasone noma nge-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma ngaphezulu kwe-myeloma yabo eminingi. I-Kyprolis isetshenziswa yodwa.

Amafomu wezidakamizwa nokuphathwa

Kokubili iDarzalex neKyprolis zinikezwa njengokufakwa emthanjeni (IV). Lo ngumjovo ofakwa kancane ngokuhamba kwesikhathi ngenaliti efakwa emthanjeni wakho.

OkweDarzalex

I-Darzalex iza njengesisombululo (ingxube ye-liquid) oyothola ngesimo somjovo. Isixazululo singabi nombala ophuzi ophuzi. Umuthi utholakala ngosayizi ababili:

• 100 mg / 5 mL esitsheni esisodwa somthamo owodwa
• 400 mg / 20 mL esitsheni esisodwa somthamo owodwa

Ukwehlisa ithuba lokuphendula ukumnika, udokotela wakho uzokunika inhlanganisela ye-. izidakamizwa. Ihora elilodwa kuya kwamathathu ngaphambi kokufakwa komunye nomunye kwe-Darzalex, uzothola:

• i-corticosteroid yokunciphisa ukuvuvukala
• i-antipyretic ukuvimbela noma ukunciphisa umkhuhlane
• i-antihistamine ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba

Ungase futhi uthole usuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze ugweme ukusabela okubambezelekile. Kepha uma usuvele uthatha i-steroid efana ne-dexamethasone noma i-prednisone, cishe ngeke udinge ukukhushulwa okwengeziwe kwe-steroid.

OkweKyprolis

I-Kyprolis iza ngefomu lekhekhe noma le-powder esitsheni esisodwa somthamo. Iza ngamandla amathathu: i-10 mg, i-30 mg, ne-60 mg.

Ukwehlisa ithuba lokuba ne-infusion reaction, udokotela wakho uzokunika i-steroid. Uzothola i-steroid 30 imizuzu kuya kumahora angu-4 ngaphambi kokufakwa kwakho kwe-Kyprolis. Kodwa uma usuvele uthatha i-steroid efana ne-dexamethasone, udokotela wakho ngeke adinge ukukunikeza umthamo owengeziwe.

Imiphumela emibi kanye nezingozi

I-Darzalex ne-Kyprolis zingadala imiphumela efanayo efanayo. Ngezansi kunezibonelo zale miphumela emibi.

Imiphumela emibi ejwayelekile

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi ejwayelekile engenzeka nge-Darzalex, ne-Kyprolis, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeDarzalex:
  • ubuthakathaka noma ukungabi namandla
  • i-bronchitis, uhlobo lokutheleleka kwamaphaphu
  • Ubuhlungu bomzimba noma ubuhlungu bamalunga
• Kungenzeka nge-Kyprolis:
  • ukubalwa kwamangqamuzana egazi abomvu aphansi
  • ukubalwa kwamangqamuzana egazi amhlophe aphansi
  • inkinga yokuphefumula
  • kwehle amazinga e-potassium
• Kungenzeka ngamabili iDarzalex neKyprolis:
  • ukuphazamiseka kwemisipha (ukudikiza)
  • inkathazo yokulala
  • ngizizwe ngikhathele
  • isisu esithukuthele kubandakanya uhudo noma ukuqunjelwa
  • imfiva
  • Ukugodola
  • ukuphelelwa umoya
  • ukukhwehlela
  • ukutheleleka okuphezulu kokuphefumula, njengomkhuhlane
  • isicanucanu noma ukuhlanza
  • ukuncipha kokudla
  • i-peripheral edema, okuwukuvuvukala kwezandla nezinyawo
  • isiyezi

Imiphumela emibi kakhulu

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi engaba khona ne-Darzalex, ne-Kyprolis, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeDarzalex:
  • i-neutropenia, izinga eliphansi lama-neutrophils, okuluhlobo lwamaseli amhlophe egazi asiza ukulwa nezifo
  • ama-shingles (ukutheleleka kwe-herpes zoster)
  • i-peripheral sensory neuropathy, uhlobo lokulimala kwezinzwa okubangela ukuqaqamba, ukuba ndikindiki, noma ubuhlungu
• Kungenzeka nge-Kyprolis:
  • ukulimala kwamaphaphu njengokuphuma kwegazi, amahlule egazi, ukuvuvukala, noma ukutheleleka emaphashini
  • ukulimala kwenhliziyo noma ukwehluleka kwenhliziyo
  • izinkinga zesibindi, njengokunyuka kwezinga lamaprotheni wesibindi noma ukwehluleka kwesibindi
  • ukwehluleka kwezinso
  • i-tumor lysis syndrome, isimo lapho amangqamuzana omdlavuza efa ngokushesha futhi okuqukethwe kwawo kuchithela egazini lakho
  • i-posterior reversible encephalopathy syndrome, isifo sezinzwa ebuchosheni
  • umfutho wegazi ophakeme
  • umfutho wegazi ophakeme wamaphaphu, okuyi-high blood pressure emaphashini
  • amahlule egazi
  • izinkinga zokopha kakhulu njengokuphuma esiswini, emaphashini, noma ebuchosheni
• Kungenzeka ngamabili iDarzalex neKyprolis:
  • ukumnika ukusabela
  • i-thrombocytopenia, izinga eliphansi lama-platelets, okuluhlobo lweseli legazi elisiza amahlule egazi
  • inyumoniya, uhlobo lokutheleleka kwamaphaphu

Ukusebenza ngempumelelo

I-Darzalex ne-Kyprolis zinokusetshenziswa okwehlukile okuvunyelwe yi-FDA, kodwa zombili zisetshenziselwa ukwelapha i-myeloma eminingi.

Ukusetshenziswa kweDarzalex neKyprolis ye-myeloma eminingi akuzange kuqhathaniswe ngqo ezifundweni zokwelashwa. Kodwa-ke, ucwaningo luthole ukuthi iDarzalex neKyprolis zisebenza kahle ekwelapheni i-myeloma eminingi.

Abaphenyi manje bacwaninga ngokusetshenziswa kwale mithi emibili kanye ne-dexamethasone ukwelapha lolu hlobo lomdlavuza. Imiphumela ikhombisile ukuthi abantu asebevele belashelwe i-myeloma eminingi baphendule kahle ekwelashweni okuhlanganisiwe. Kepha kudingeka izivivinyo eziningi ngaphambi kokuthi i-FDA ivume ukwelashwa okuhlanganisiwe kweDarzalex neKyprolis ye-myeloma eminingi.

Izindleko

I-Darzalex ne-Kyprolis yizidakamizwa ezibizwa ngegama. Okwamanje azikho izinhlobo ezijwayelekile zomuthi. Imithi enegama lomkhiqizo ivame ukubiza ngaphezu kwama-generic.

Ngokuya ngokulinganiselwa ku-WellRx.com, iDarzalex ngokuvamile ibiza ngaphansi kukaKyprolis. Inani langempela ozolikhokhela noma yisiphi isidakamizwa lizoya ngohlelo lwakho lomshuwalense nendawo okuyo.

Isebenza kanjani iDarzalex

I-Multiple myeloma ngumdlavuza oqala ngohlobo lweseli elimhlophe elibizwa nge-plasma cell. Amaseli e-Plasma akha ingxenye yamasosha akho omzimba futhi asiza ukulwa nezifo emzimbeni wakho.

Kwesinye isikhathi ushintsho oluzumayo kuzakhi zakho zofuzo, olubizwa ngokuthi ukuguquka kwezakhi zofuzo, lungaguqula amaseli anempilo abe ngumdlavuza. (Izakhi zofuzo ziyisethi yemiyalo esiza ukulawula indlela amaseli akho akhula futhi aziphathe ngayo). Lapho amangqamuzana e-plasma eguquka abe amaseli amaningi e-myeloma, aqala ukwanda emnkantsheni wethambo (ingaphakathi lamathambo akho). Njengoba amangqamuzana amaningi e-myeloma ekhula futhi esakazeka, angagcwala amangqamuzana anempilo futhi alimaze amathambo nxazonke zawo.

I-Darzalex yisidakamizwa esenziwe ngumuntu esibizwa ngokuthi i-monoclonal antibody. (Ama-antibody eMonoclonal angamaprotheni kumasosha akho omzimba. Aklanyelwe ukukhomba nokuhlasela ingxenye ethile yeseli yomdlavuza.)

Lapho amangqamuzana e-plasma ephenduka amaseli amaningi e-myeloma, akhula inani elikhulu lamaprotheni abizwa nge-CD38 ebusweni bawo. I-anti-monoclonal antibody Darzalex isebenza ngokunamathisela kwiprotheni ye-CD38 esitokisini se-myeloma esiningi. Ngokwenza lokhu, iDarzalex ibulala ngqo noma isize amasosha akho omzimba abhubhise amaseli amaningi e-myeloma.

Kuthatha isikhathi esingakanani ukusebenza?

Ezifundweni zokwelashwa, isikhathi esimaphakathi esithathe iDarzalex ukuqala ukusebenza bekuyinyanga eyodwa. Kodwa-ke, unganikezwa imithamo yakho isikhathi eside. Lokhu kuya ngokuthi umzimba wakho uphendula kanjani kuDarzalex futhi uma i-myeloma yakho eminingi iqala ukuba yimbi. Ubude bokwelashwa buxhomeke nokuthi i-myeloma yakho eminingi isanda kutholakala noma ngabe usuvele unezokwelapha esikhathini esedlule.

UDarzalex notshwala

Akukho ukuxhumana okwaziwayo phakathi kweDarzalex notshwala. Kodwa kunconywa ukuthi ugweme ukuphuza utshwala ngenkathi uthatha iDarzalex. Lokhu kuhlobene nokuthi kuthatha isikhathi esingakanani ukuthola umuthi.

I-Darzalex inikezwa njenge-infravenous (IV) ukumnika. Lo ngumjovo emthanjeni wakho onikezwa isikhathi esithile. I-infusions ye-Darzalex ingahlala kusuka emahoreni amathathu kuya kwangu-7. Ngakho-ke kubalulekile ukuhlala unamanzi ngaphambi nangesikhathi sokufakwa kwakho. Iziphuzo ezidakayo zingakwenza ukuthi uphelelwe amanzi emzimbeni, ngakho-ke gwema utshwala ngenkathi uthatha iDarzalex.

Uma unemibuzo ngotshwala neDarzalex, buza udokotela wakho.

Ukusebenzisana kweDarzalex

Ngaphambi kokuthatha iDarzalex, qiniseka ukuthi utshela udokotela kanye nosokhemisi ngayo yonke imishanguzo kadokotela, i-counter-counter, nezinye izidakamizwa oziphuzayo. Batshele futhi nganoma yimaphi amavithamini, amakhambi, nezithako ozisebenzisayo. Ukwabelana ngalolu lwazi kungakusiza ugweme ukuhlangana okungenzeka.

Uma unemibuzo mayelana nokuhlangana kwezidakamizwa okungakuthinta, buza udokotela wakho noma usokhemisi.

Ukuhlolwa kweDarzalex nelabhorethri

Ukuthatha iDarzalex kungashintsha imiphumela yokuhlolwa okuthile kwelebhu.

Amaphutha ohlobo lwegazi

Uma uthatha iDarzalex futhi uhlolwa igazi ukufanisa nohlobo lwegazi lakho, imiphumela kungenzeka ingalungi. Amaphutha kulezi zivivinyo angahlala ezinyangeni eziyisithupha ngemuva komthamo wakho wokugcina weDarzalex.

I-Darzalex isebenza ngokunamathisela kwiprotheni ye-CD38 ebusweni beseli ye-myeloma eminingi futhi ilimaza amaprotheni. Kwesinye isikhathi amaseli abomvu egazi nawo angaba namaprotheni e-CD38 kuwo. IDarzalex ingazinamathisela ngephutha kwiprotheni ye-CD38 engqamuzaneni elibomvu legazi esikhundleni seseli le-myeloma eliningi. Uma lokhu kwenzeka, kuguqula indlela iseli elibomvu "elibukeka" ngayo ekuhlolweni kwegazi. Noma kunjalo, iDarzalex ngeke iluthinte uhlobo lwegazi lakho.

Ukugwema amaphutha wokuthayipha igazi, udokotela wakho uzohlola uhlobo lwegazi lakho ngaphambi komthamo wakho wokuqala weDarzalex. Bazokwenza lokhu uma kwenzeka udinga ukumpontshelwa igazi ngokuzayo.

Inikezwa kanjani iDarzalex

Ukuze uthole imithamo yakho yeDarzalex, uzoya ehhovisi likadokotela wakho noma esikhungweni sokumnika. Umuthi uza njengesisombululo (ingxube ketshezi). Umhlinzeki wezokunakekelwa kwempilo uzoxuba iDarzalex ne-0.9% sodium chloride (uhlobo lwesixazululo samanzi anosawoti). Bese bezokunika lo muthi ngokuhamba kwesikhathi ngenaliti efakwe emthanjeni wakho. Lokhu kubizwa ukumnika okufakwa emthanjeni (IV). Ungathola iDarzalex ngokwayo noma ngezinye izindlela zokwelashwa.

Udokotela wakho uzonquma ukuthi ingakanani iDarzalex azokunikeza yona ngokuya ngesisindo sakho kanye nohlelo lwakho oluthile lokwelashwa. Umhlinzeki wezokunakekelwa kwempilo uyohlale ekuqapha ngesikhathi sokumnika.

Ukuthatha nini

Udokotela wakho uzonquma ngesikhathi esiphakathi kwamanani nokuthi uzodinga imishanguzo emingaki yokwelashwa. Lokhu kuzosuselwa ekutheni ngabe uthatha iDarzalex wedwa noma nezinye izindlela zokwelapha. Buza udokotela wakho ukuthi ancoma usuku nesikhathi esihle kakhulu sokuthola ukumnika kwakho ngokuya ngenkambiso yakho yansuku zonke.

Uthola kangaki iDarzalex futhi ubude besikhathi sokufakwa kuzoncipha ngokuhamba kwesikhathi. Ukufakwa kwakho kokuqala kweDarzalex kungathatha cishe amahora ayi-7. Lokhu kungenxa yokuthi udokotela wakho uzofaka imithi kancane kancane emthanjeni wakho. Ama-infusions ngokuzayo azothatha isikhathi esincane futhi agcine cishe amahora amathathu kuya kwama-5 ngoba uzobe ufaka umuthi ngokushesha.

Ukuthatha iDarzalex ngokudla

Izikhathi zokumnika zeDarzalex zingaba kusuka emahoreni amathathu kuya kwangu-7, kuya ngohlelo lwakho lokwelashwa. Yingakho kuwumqondo omuhle ukuza uzilungiselele ngokudla okulula okunempilo neziphuzo uma kulungile nodokotela wakho.

UDarzalex nokukhulelwa

I-Darzalex ayizange ifundwe kwabesifazane abakhulelwe noma ezilwaneni. Kepha iDarzalex iyi-antibody e-monoclonal, okuwuhlobo lomuthi ohlose amangqamuzana omdlavuza. Futhi ama-antibody monoclonal ayaziwa ukuthi awele i-placenta. (I-placenta isitho esingaphakathi kwesibeletho sakho esidlulisa izakhi emzimbeni wakho ziye enganeni yakho.)

Ngokuya ngendlela iDarzalex esebenza ngayo, umuthi ungadala ukuncipha kwamathambo enganeni engakazalwa. Kunganciphisa futhi inani lamangqamuzana egazi namasosha omzimba ingane ekhulayo eyenzayo.

Ngaphambi kokuba uqale ukuthatha iDarzalex, qiniseka ukuthi utshela udokotela wakho uma ukhulelwe, kungenzeka ukuthi ukhulelwe, noma uhlela ukukhulelwa.

I-Darzalex ene-lenalidomide noma i-pomalidomide

I-Darzalex kwesinye isikhathi ithathwa ngomuthi obizwa ngokuthi i-lenalidomide (Revlimid) noma i-pomalidomide (i-Pomalyst) ye-myeloma eminingi. I-Lenalidomide ne-pomalidomide zombili zinexwayiso elibhokisiwe ngezinkinga zokuzalwa ezinzima nezisongela impilo. Uma ungowesifazane futhi udokotela wakho ekunika i-Darzalex nge-lenalidomide noma i-pomalidomide, akumele ukhulelwe:

• okungenani amasonto amane ngaphambi kokuqala ukwelashwa
• ngenkathi uthatha ukwelashwa
• nganoma ikuphi ukwelashwa ekwelashweni
• okungenani amasonto ama-4 ngemuva kokumiswa kwe-lenalidomide noma i-pomalidomide

Uma unemibuzo mayelana nokuthatha iDarzalex, lenalidomide, noma i-pomalidomide ngenkathi ukhulelwe, khuluma nodokotela wakho.

I-Darzalex nokulawulwa kokuzalwa

Uma kunethuba lokuthi ungakhulelwa, kunconywa ukuthi usebenzise ukulawulwa kokubeletha ngenkathi uthatha iDarzalex. Kufanele uqhubeke nokulawula inzalo izinyanga ezintathu ngemuva kokuthi ukwelashwa kwakho kweDarzalex kuqediwe. Lokhu kungenxa yokuthi umuthi ungahlala kusistimu yakho isikhashana ngemuva kokuyeka ukuwuthatha.

Uma uyindoda futhi uhlanganyela ocansini nowesifazane, kunethuba lokuthi ukukhulelwa kwenzeke. Cabanga ukusebenzisa indlela yokuvimbela inzalo, njengekhondomu, noma ngabe umlingani wakho ocansini naye esebenzisa ukulawulwa kokuzalwa.

I-Darzalex ene-lenalidomide noma i-pomalidomide

Kwezinye izimo, ungathatha iDarzalex ngemithi ebizwa ngeleneralomide (Revlimid) noma pomalidomide (Pomalyst). Uma ungowesifazane futhi uthatha iDarzalex nge-lenalidomide noma i-pomalidomide, kufanele uvume ukusebenzisa izindlela ezimbili zokuvimbela inzalo. Uzodinga ukuqala ukusebenzisa ukulawulwa kokuzalwa okungenani amasonto ama-4 ngaphambi kokuqala ukwelashwa ngemithi. Qhubeka nokusebenzisa ukubeletha ngenkathi uthatha i-Darzalex ne-lenalidomide noma i-pomalidomide, futhi nganoma ikuphi ukwelashwa. Uzodinga futhi ukuqhubeka nokulawula inzalo okungenani amasonto ama-4 ngemuva kokuyeka ukuthatha i-lenalidomide noma i-pomalidomide.

I-Lenalidomide ne-pomalidomide zingadlula zibe isidoda somuntu. Ngakho-ke wonke amadoda kufanele asebenzise ikhondomu noma i-synthetic condom lapho enza ucansi nowesifazane ongakhulelwa. Abesilisa kufanele basebenzise le ndlela yokulawula ukubeletha ngesikhathi esifanayo lapho abalingani babo bezocansi bethatha ukulawulwa kokuzalwa.

Uma uhlanganyela ocansini futhi wena noma umuntu ohlanganyela naye ocansini ningakhulelwa, khuluma nodokotela wakho. Bangakusiza ukuthi unqume ngezidingo zakho zokulawulwa kokuzalwa ngenkathi usebenzisa iDarzalex.

UDarzalex nokuncelisa

Akwaziwa ukuthi iDarzalex ingadlula ibisi lwebele noma ukuthi umuthi ungaluthinta kanjani ubisi lwebele. Akukaziwa nokuthi iDarzalex ingathinta yini ingane encela ibele.

I-Darzalex ene-lenalidomide noma i-pomalidomide

Kwezinye izimo, ungathatha iDarzalex ngemithi ebizwa ngeleneralomide (Revlimid) noma pomalidomide (Pomalyst). Uma ungowesifazane oncelisa ibele, akufanele usebenzise i-lenalidomide noma i-pomalidomide. Akwaziwa ukuthi lo muthi ungadlula yini obisini lwebele ulimaze ingane yakho.

Uma ufuna ukuncelisa ingane yakho ibele futhi ucabanga ukuthatha iDarzalex, khuluma nodokotela wakho. Bangakutshela ngobuhle nobubi bokusebenzisa lo muthi ngenkathi uncelisa.

Imibuzo ejwayelekile ngeDarzalex

Nazi izimpendulo zemibuzo ebuzwa njalo ngeDarzalex.

Kungani ngidinga ukuthatha ama-steroids neminye imishanguzo lapho ngiqokelwe ukungena kwe-Darzalex infusions?

Uma uthola i-Darzalex, ungahle ube nokusabela okweqile. Ukusiza ukuvimbela lokhu, udokotela wakho angakunika imishanguzo ebizwa nge-corticosteroids nezinye izidakamizwa.

Umhlinzeki wezokunakekelwa kwezempilo uzokunika iDarzalex njenge-infravenous (IV) infusion ehhovisi likadokotela wakho noma emtholampilo. Lo ngumjovo emthanjeni wakho onikezwa isikhathi esithile. Ihora elilodwa kuya kwamathathu ngaphambi kokumunyelwa ngakunye kweDarzalex, uvame ukuthola le mithi elandelayo:

• i-corticosteroid (ukunciphisa ukuvuvukala)
• i-antipyretic (ukuvimbela noma ukunciphisa umkhuhlane)
• i-antihistamine (ukuvimbela noma ukunciphisa izimpawu zokungezwani komzimba)

Ungase futhi uthole usuku lwe-corticosteroid 1 ngemuva kokufakwa ukuze ugweme ukusabela okubambezelekile. Kepha uma usuvele uthatha i-steroid efana ne-dexamethasone noma i-prednisone, cishe ngeke udinge ukukhushulwa okwengeziwe kwe-steroid.

Uma unemibuzo mayelana nanoma imiphi imithi enikezwe nge-Darzalex infusions, buza udokotela wakho.

Ngabe ngizokwazi ukuzishayela ngiye ekhaya ngemuva kokufakwa kwami ​​eDarzalex?

Akunconyiwe. Lokhu kungenxa yokuthi kujwayelekile ukuthi uzizwe ukhathele ngemuva kokufakwa noma ube nokusabela kokumunyelwa. (Bona i- “Infusion reaction” esigabeni esithi “Side effect imininingwane” ngenhla ukuze ufunde kabanzi.) Ngakho-ke ukuze uphephe, yilungu lomndeni, umngane, noma umnakekeli akushayele aye noma abuye lapho ubuya khona.

Naka indlela ozizwa ngayo ngemuva kokungenwa kwakho bese ugcina idayari yezimpawu zakho. Lokhu kungakusiza unqume ukuthi ungakwazi yini ukuzishayela, uma kwenzeka udinga.

Uma kwenzeka ungeke ukwazi ukuthola umshayeli, uJanssen Biotech, Inc., umkhiqizi weDarzalex, angakwazi ukusiza. Ungaxoxa nomxhumanisi weJanssen CarePath ngokuya nokubuya ezikhundleni zakho nokuthola usizo ngezindleko zokuhamba. Ukuze ufunde kabanzi, shayela ku-844-553-2792 noma vakashela iwebhusayithi yeDarzalex.

Ngingayisebenzisa iDarzalex uma ngike ngaba nama-shingles?

Yebo, ungasebenzisa iDarzalex uma uke waba nokutheleleka okubizwa nge-shingles. Kodwa ngaphambi kokuba uthathe i-Darzalex, kubalulekile ukutshela udokotela wakho uma ngabe uke waba ne-shingles noma i-chickenpox. (Igciwane elifanayo elibangela ama-shingles lingadala nenkukhu.)

Uma uke waba ne-chickenpox esikhathini esedlule, igciwane alishiyi umzimba wakho ngemuva kokululama ekutheleleni. Esikhundleni salokho, igciwane "limane lilale" emithanjeni yakho.

Akekho owazi kahle ukuthi kungani, kepha igciwane lingavuselela noma "livuke" ngezimbangela ezithile ezifana namasosha omzimba abuthakathaka. (Amasosha omzimba wakho avikela umzimba wakho ezifweni.)

Ukwelashwa komdlavuza njengeDarzalex kunganciphisa amasosha akho omzimba futhi kuvuselele igciwane. Lapho iphaphama, iziveza njengama-shingles esikhundleni senkukhu.

Ngakho-ke uma uke waba nezinsumpa noma ingxibongo, udokotela wakho uzokunika umuthi olwa namagciwane ukuvimbela ama-shingles ukuthi angakhuli futhi emzimbeni wakho. Uzodinga ukuthatha imishanguzo yegciwane lengculaza kungakapheli isonto elilodwa uqale ukuthatha iDarzalex. Ngemuva kwalokho uzoqhubeka uphuza i-antiviral izinyanga ezintathu ngemuva kokuqeda ukwelashwa ngeDarzalex.

Uma ungaqiniseki ukuthi ngabe uke waba nezinsumpa noma izinkukhu, khuluma nodokotela wakho.

Ingabe iDarzalex yelapha i-myeloma eminingi?

Njengamanje, alikho ikhambi le-myeloma eminingi. Kepha okwenziwa nguDarzalex ukuthuthukisa ikhwalithi nobude bempilo yakho, kuya ngokutholakala kwakho. Udokotela wakho angakutshela okuningi.

Izinyathelo zokuqapha zeDarzalex

Ngaphambi kokuthatha iDarzalex, khuluma nodokotela wakho ngomlando wakho wezempilo. IDarzalex kungenzeka ingakulungeli uma unezimo ezithile zezokwelapha noma ezinye izinto ezithinta impilo yakho. Lokhu kufaka phakathi:

• I-hepatitis B. Uma ungaba nesifo sokusha kwesibindi kohlobo B noma uke waba naso esikhathini esedlule, ukuthatha iDarzalex kungadala ukuthi sisebenze futhi. Ngaphambi kokuba uqale ukuthatha iDarzalex, udokotela wakho uzokuhlolela i-hepatitis B. Bazokuhlola futhi ngemuva kokuqeda ukwelashwa kwakho. Izimpawu zesifo sokusha kwesibindi kohlobo B zibandakanya ukukhathala okuba kubi kakhulu, nombala ophuzi wesikhumba sakho nokumhlophe kwamehlo akho. Uma ubona lezi zimpawu, tshela udokotela wakho.
• Amaswazi. Ngenkathi uthatha iDarzalex, ungahlakulela ukutheleleka okubizwa ngama-shingles. Igciwane elifanayo elibangela ama-shingles lingadala nenkukhu. Ngakho-ke uma uke waba ne-chickenpox noma i-shingles esikhathini esedlule futhi uthatha iDarzalex, udokotela wakho angakunikeza umuthi wokulwa namagciwane. Lolu hlobo lomuthi lungasiza ukuvimbela ama-shingles ukuthi akhule emzimbeni wakho.
• Isifo esingapheliyo se-pulmonary disease (COPD). Uma unomlando wesifo sokuphefumula esibizwa ngokuthi yi-chronic obstructive pulmonary disease (COPD), tshela udokotela wakho ngaphambi kokuba uqale ukuthatha iDarzalex. Bangakunika i-inhaler ukukusiza uphefumule kalula nama-corticosteroids ukusiza ukunciphisa ukuvuvukala emaphashini akho.
• Ukukhulelwa. UDarzalex akazange afundwe kwabesifazane abakhulelwe. Kodwa wuhlobo lomuthi olungase lweqe i-placenta. (I-placenta isitho esingaphakathi kwesibeletho sakho esidlulisa izakhamzimba zisuka emzimbeni wakho ziye enganeni yakho.) Ukuthola eminye imininingwane, sicela ubheke isigaba se- “Darzalex nokukhulelwa” ngenhla.
• Ukuncelisa ibele. Akwaziwa ukuthi kuphephile yini ukuncelisa ibele ngenkathi uthatha iDarzalex. Ngeminye imininingwane, sicela ubheke isigaba se- “Darzalex kanye nokuncelisa ibele” ngenhla.

Tshela umhlinzeki wakho wezokunakekelwa kwempilo uma uhlakulela noma iyiphi yalezi zimo ngesikhathi noma ngemuva kokwelashwa ngeDarzalex.

Qaphela: Ngeminye imininingwane ngemiphumela emibi engaba khona yeDarzalex, bheka isigaba se- "Darzalex Side Effects" ngenhla.

Imininingwane yobungcweti yeDarzalex

Imininingwane elandelayo inikezwa odokotela nabanye ochwepheshe bezempilo.

Izinkomba

Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvume futhi kwaveza iDarzalex ukuthi isetshenziswe:

• Kubantu abadala abane-myeloma eminingi esanda kutholakala abangakwazi ukuthola ukufakelwa kwe-stem cell autologous. (Ngokufakelwa kwe-autologous stem cell, kusetshenziswa ama-stem cells akho.) Kulesi simo:
  • IDarzalex ingasetshenziswa nemithi lenalidomide (Revlimid) ne-dexamethasone.
  • I-Darzalex nayo ingasetshenziswa nemithi bortezomib (Velcade), melphalan, ne-prednisone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okungasebenzanga kahle noma i-myeloma yabo eminingi ebuyile. Kulesi simo, iDarzalex isetshenziswa ne-lenalidomide ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa okukodwa noma okuningi okwedlule okuningi kwe-myeloma. Kulesi simo, iDarzalex isetshenziswa ne-bortezomib ne-dexamethasone.
• Kubantu abadala abathole imishanguzo emibili noma ngaphezulu yokwelashwa kwe-myeloma eyedlule ebandakanya i-lenalidomide ne-proteasome inhibitor, okuwuhlobo lomuthi. Kulesi simo, iDarzalex isetshenziswa nemithi pomalidomide (Pomalyst) ne-dexamethasone.
• Kubantu abadala abathole ukwelashwa kwe-myeloma kathathu noma ngaphezulu okwedlule obekubandakanya i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni. Kulesi simo, iDarzalex isetshenziswa yodwa.
• Kubantu abadala abazame i-proteasome inhibitor kanye nemithi yokuzivikela emzimbeni kepha akukho muthi osebenzele i-myeloma eminingi. Kulesi simo, iDarzalex isetshenziswa yodwa.

Indlela yokusebenza

I-Darzalex i-anti-monoclonal antibody futhi ivimbela noma ibhubhise ukukhula kwesisu samangqamuzana amaningi e-myeloma. Lapho amangqamuzana e-plasma ephenduka amaseli amaningi e-myeloma, aba nezinombolo eziningi zamaprotheni angaphezulu abizwa nge-CD38. IDarzalex ihlose futhi izinamathele kula maprotheni e-CD38. Ngezenzo ezenziwa ngamaseli omzimba futhi ziqondiswe ngqo kwi-tumor, iDarzalex inqanda ukukhula kwamangqamuzana amaningi e-myeloma bese iqala inqubo ye-apoptosis (ukufa kweseli).

I-Pharmacokinetics ne-metabolism

Akukho mehluko obalulekile emtholampilo kuma-pharmacokinetics eDarzalex njenge-monotherapy noma njengokwelashwa okuhlanganisiwe okwabonwa ngokususelwa kubantu abathile.

Ukulandela ukumukelwa kwesilinganiso esinconyiwe seDarzalex sisodwa noma njengokwelashwa okuhlanganisiwe, ukugxila kwegazi kweDarzalex kwakuphakame cishe kathathu ekugcineni komthamo wamasonto onke ngokuqhathaniswa nomthamo wokuqala.

Ukwehlukanisa umthamo wokuqala weDarzalex kuholele ekugxileni kwegazi okuhlukile kunokuthi ngabe umuntu uthole umthamo wokuqala ogcwele. Kodwa-ke, iziqongo ezifanayo nemikhombe yokugxilwa kwegazi kwabonwa futhi kwabikezelwa ngemuva kokuthola umthamo wesibili wokuhlukaniswa ngeviki 1, usuku 2 lokwelashwa.

Lapho iDarzalex inikezwa yodwa, izinga lokuhlushwa kwegazi elingaguquguquki (isimo esingaguquguquki) lafinyelelwa ezinyangeni ezinhlanu esikhathini ngasinye sokuvota kwamasonto amane (ngokufakwa okungama-21). Esimeni esigxilile, iDarzalex isho ukuqoqwa kwesilinganiso sokuhlungwa kwegazi okuphezulu kwakungu-1.6.

Ukusabalalisa:

• i-monotherapy: 4.7 ± 1.3 L
• Inhlanganisela yokwelashwa: 4.4 ± 1.5 L

Ukuqedwa kwesigamu sempilo ye-monotherapy kanye nokwelashwa kokuhlanganiswa kwakuyizinsuku eziyi-18 ± 9. Ukususwa kweDarzalex kwehle ngomthamo owandayo nange-dosing eminingi. Ukususwa kwalinganiselwa ku-171.4 ± 95.3 ml / ngosuku. Njengoba isisindo somzimba sikhula, ivolumu yokusabalalisa kanye nezinga lapho i-Darzalex isuswe khona emzimbeni landa.

Izimo

I-Darzalex iyaphikiswa ezigulini ezinomlando wokusabela okunamandla kwe-anaphylactic ku-daratumumab noma enye yezinto ezixhunywe kwifomula yezidakamizwa. Izimo ezinzima ze-neutropenia, i-thrombocytopenia, noma ukusabela kokumnika ngenxa yokwelashwa kungadinga ukuthi iDarzalex imiswe noma imiswe unomphela.

Isitoreji

IDarzalex kufanele igcinwe esiqandisini ku-36 ° F kuye ku-46 ° F (2 ° C kuye ku-8 ° C).

Unganyakazisi noma uqandise iDarzalex. Isidakamizwa kufanele sivikelwe ekukhanyeni. IDarzalex ayiqukethe noma yiziphi izivimbelakuvunda.

Ukuzikhulula: IMedical News Namuhla yenze yonke imizamo yokuqinisekisa ukuthi yonke imininingwane iyiqiniso, iphelele futhi ihambisana nesikhathi. Kodwa-ke, le ndatshana akufanele isetshenziswe njengokungena esikhundleni solwazi nobungoti bochwepheshe bezokunakekelwa kwezempilo onelayisense. Kufanele uhlale uthintana nodokotela wakho noma omunye uchwepheshe wezokunakekelwa kwempilo ngaphambi kokuthatha noma imuphi umuthi. Imininingwane yezidakamizwa equkethwe lapha ingashintsha futhi ayihloselwe ukumboza konke ukusetshenziswa okungaba khona, izinkomba, izixwayiso, izexwayiso, ukuxhumana kwezidakamizwa, ukungezwani komzimba, noma imiphumela emibi. Ukungabikho kwezixwayiso noma olunye ulwazi lomuthi othile awukhombisi ukuthi inhlanganisela yezidakamizwa noma yezidakamizwa iphephile, iyasebenza, noma ilungele zonke iziguli noma konke ukusetshenziswa okuthile.