Ngo-2011, xa i-United States Yokutya kunye noLawulo lweeDrug (FDA) yamkela iBenlysta (belimumab) yayiyinto enkulu! UBenlysta wayeyilungu lokuqala leziyobisi ezivunyelwe i-lupus kwiminyaka engaphezu kwama-50. Ngaphambi koko, izidakamizwa kuphela ezivunyiweyo yi-FDA ukuphatha i-lupus zaziyi-Plaquenil (i-hydroxychloroquine), i-prednisone (1955) kunye ne-aspirin (1948). Kodwa i-Plaquenil ayidalwanga kwaye ayisetyenziswanga kuphela i-lupus. Kubizwa ngokuba yi-anti- malaria ngenxa yokuba isetyenziswe ukukhusela i-malariya, kwaye isetyenziselwa ukuphatha isifo se-rheumatoid arthritis.
Xa uva ngo-Benlysta, uya kudla ukuva igama elithi biologic . Ngokungafani neziyobisi ezidalwe kwiinkqubo zeekhemikhali, i-biologic isilwanyana esivela kwimithombo yendalo njengezilwanyana, abantu okanye i-microorganism. UBenlysta uyingqayizivele ngenxa yokuba ezinye i-biologics zifikile phambi kwayo kwaye zahluleka njengonyango lwe-lupus.
Ukongeza, iBenlysta yonyango olujoliswe ku-lupus. Ezinye iziyobisi eziqhelekileyo ezisetyenziswa ukuphatha i-lupus-like hydroxychloroquine, i-corticosteroids, i-methotrexate, i-azathioprine, i-cyclophosphamide, kunye ne-mycophenolate mofetil-yenzelwe ezinye iinjongo zokukhusela isistim somzimba ngokubanzi. Kodwa ngenxa yokuba iBenlysta i-biologic, eyenziwe ngamaprotheni abantu, abaphandi bakwazi ukuvelisa isicatshulwa esinokujolisa kwinqanaba elithile le-immune system edlala indima ekubangela iimpawu ze-lupus.
Njengoko lokuqala unyango lwe-biologic lupus, alukho kuphela u-Benlysta onika olunye unyango, kodwa lukhuthaze uphando olutsha kunye nolutsha olutsha lwe-lupus. Ngenxa yezi zizathu, ukuvunyelwa kwe-FDA kwemvume yimbonakalo ebalulekileyo kwimbali yophando lwe-lupus!
Ngokwemvelo, umntu ofunda ngoBenlysta okokuqala unokufuna ukwazi kabanzi malunga neziyobisi. Ngezantsi ziphendula iimbuzo eziqhelekileyo malunga noBenlysta.
UBenlysta Usebenza njani?
Ngokutsho kweLupus Research Alliance, iBenlysta "isebenza ngokuthobisa i-immune system echaphazelekayo ye-lupus ngokuvimbela iprotheni ebizwa ngokuthi 'i-B lymphocyte stimulator (BLyS)' ikholelwa ukuba ikhulise iimpawu ezivukelayo ezihlasela nokulimaza izicubu zomzimba."
Ngamanye amagama, i-BLyS yinxalenye yesistim somzimba sokuzikhusela komzimba ukuba iithagethi zamachiza. UBenlysta inenjongo yokukhusela i-BLyS ekusebenziseni ukuvuvukala okubangela ukuba isistim somzimba sihlasele umzimba womntu.
UBenlysta isetyenziselwa ukudibanisa namanye amayeza e-lupus (unyango oluqhelekileyo). Intlangano iboniswe ukuba iphumelele ngakumbi ekunciphiseni iimpawu ze-lupus kuneyonyango kuphela. Iimpawu ezincitshiswayo zihlala zihambelana nolusu, umlomo, amaqabane kunye nezihlunu, kunye nesistim somzimba.
Enye inzuzo enokwenzeka yeziyobisi kukunciphisa ukusetshenziswa kwe-corticosteroid. Oku kubalulekile kuba njengonyango lwexesha elide, i-corticosteroids iyaziwa ukuba ibangele imiphumo echaphazelekayo njengokulahlekelwa kwethambo kunye nomonakalo wembutho.
I-Benylsta ilawulwa njani?
Ngokungafani neminye inkatho ye-lupus, uBenlysta akayiyo ipilisi. Ilawulwa yi-intravenous (IV) ukumnika okanye nge-self-injection.
IV Infusion
Le ndlela ivumela ukuba isilwanyana singene ngqo kwigazi kwaye sihambe ngesisu. Ukuba igalelwe kwifomu yepilisi, yayiza kungena kwisisu kwaye kubalulekile ukuba iiprotheni ezenza izidakamizwa ziya kutshatyalaliswa.
Xa ulawulwa yi-IV ukumnika, awukwazi ukuyilawula ekhaya kwaye kufuneka uhambe kwindawo ethile yokungenisa iifisi njengeofisi yakho yegulana, isibhedlele okanye isikhungo sokungena ngaphakathi. Ukuxhamla kungathabatha malunga neyure, kodwa ixesha elide ukuba ixesha lokubamba kunye / okanye ixesha lokujonga liyimfuneko.
Kwiintlobo zokuqala ezintathu, ziqhelekile ukuba zenzeke kanye emva kweeveki ezimbini, emva koko emva kweeveki ezine emva koko.
UBenlysta uhloselwe njengelinye ixesha elide, kwaye ukuba wena kunye nodokotela wakho uyavuma ukuba kusebenza kakuhle kuwe, musa ukuyeka ukuxhamla xa uqala ukuziva ungcono. Kufuneka uqhubeke unyango nangemva kokuba uzive ungcono njengendlela yokugcina izibonelelo ezilungileyo.
Ukuzibulala
Kukho iinzame zokubonelela ngokhetho lokuzibulala, oku kuthetha ukuba unokhetho lokulawula uBenlysta, ekhaya. I-FDA ivunyiwe ukhetho lokuqala lokuzijova ngo-2017, ngokukodwa kwi-systemic lupus erythematosus, ifomu eqhelekileyo ye-lupus. Inketho yokonyango idinga uqeqesho oluthile kumgqirha wakho kwaye lunokuba lulula kune-IV ezininzi.
Ndivile ukuba Ayisebenzeli abantu base-Afrika baseMerika
Izifundo zangaphambili ezikhokelela ekuvunyweni kukaBenlysta azizange zibandakanye abathathi-nxaxheba base-Afrika nabamerika. Oku akuthethi ukuba isilwanyana asiyi kusebenza kuwe ukuba ungumAfrika-waseMerika. Ngokuchasene noko, inokusebenza kakuhle ekubeni wonke umntu one-lupus ehlukile.
Kukho okwangoku iilingo zecilini ziza kusinceda sifunde ngakumbi malunga nendlela eyiyo ngayo uBenstasta kuma-Afrika aseMerika. Ezi zilingo zibaluleke ngakumbi kuba abafazi base-Afrika nabama-America bangama-kathathu amathuba okuphuhlisa i-lupus kunabamhlophe abamhlophe.
Thetha nogqirha wakho ukuba unomdla wokuzama uBenlysta okanye ukuthatha inxaxheba kwisilingo se-clinical Benlysta.
Kuthekani ukuba Ndibe ne-Organ-Involvement?
Xa uBenlysta yavunywa okokuqala yi-FDA, kwakungacacanga ukuba le nkunkuma yayiza kubanceda abantu ngokubandakanyeka komzimba onjenge-lupus nephritis okanye inkqubo ye-nervous central (CNS) lupus. Nangona kunjalo, kolunye uhlalutyo lophando, kwafunyanwa ukuba kwiminyaka emihlanu yokuqala yonyango kunye noBenlysta, le mveliso ayizange ibangele okanye yenza umonakalo womzimba ube mbi ngakumbi, kwaye ingenokuphuculwa kwesifo sokuqhubela phambili okuhambelana nomonakalo komzimba. Ekubeni oku bekukho ulwazi olusekelwe kuhlalutyo oluphando oluye lwadibanisa izifundo ezimbini, uphando oluninzi luncedo. Uphando luyathembisa, ngoko ke ukuba unomdla kunye nokuba unomdla ekuzameni uBenlysta, thetha kunye ne-rheumatologist yakho ukuba ubone ukuba bacinga ukuba oku kuyindlela enhle kuwe.
Ziziphi iimpembelelo kunye neengozi?
Njengamachiza, uBenlysta unokubangela iziphumo zecala kwaye uza neengozi. Inkampani yeziyobisi kufuneka ilumkise ngazo zonke iziphumo ezichaphazelekayo, kodwa oku akuthethi ukuba uya kuba namava. Ukuba ukhathazeke ngemiphumo emibi, kubalulekile ukuthetha kunye neengcali ze-rheumatologists malunga neenkxalabo zakho. Kwiimeko apho abantu bafumana iziphumo ezinemiphumo emibi, banokugqiba isigqibo sokuqhubeka unyango ukuba iziphumo ezingekho mthethweni okanye ukuba kunye noogqirha bazo baziva ukuba izibonelelo zesilwanyana zigqithise iziphumo ezibi.
Ngenxa yemingcipheko ehambelana noBenlysta, ngaphambi kokuba uqale isilwanyana, xelela i-rheumatologist ukuba:
- baneempawu okanye baye bafumanisa ukuba banesifo, isifo senhliziyo, okanye isifo sengqondo
- kufuneka okanye ufumene ukugonya, ngokukodwa ukugonya okuphilayo
- zonyango
- bathatha enye imveliso ye-biologic, i-monoclonal antibodies okanye i-IV infusions ye-cyclophosphamide (i-Cytoxan®)
- kukho nawuphi na uhlobo lwamayeza, isongezelelo semfuyo, okanye i-vitamin
- baye okanye banakho nawuphi na umhlaza
- nezinye iimeko zonyango
- ukhulelwe okanye uceba ukukhulelwa, okanye ukuba uncelisa
Le ngcaciso iza kunceda ugqirha wakho acinge ukuba u-Benlysta uyilungiso olufanelekileyo kuwe kunye nexesha elifanelekileyo lokuqala unyango. Ngokomzekelo, ukuba unesifo, kuzakufuneka uhlehlise unyango ekubeni isichengululo sandisa ingozi yokusuleleka.
Ukuba kukho na kwezi zimo zenzeka ngelixa sele usele kwisibisi, kufuneka uxelele i-rheumatologist yakho.
Ngexesha lokuvavanywa kweekliniki, abantu bafumana imiphumo emibi, kodwa akusoloko icacile ukuba iziphumo zecala zibangelwa ngqo yiziyobisi. Nangona kunjalo, abaphandi-kwaye kule ngxaki uGlaxoSmithKiline (GSK), abenzi beziyobisi-kufuneka bahlule naziphi na iimpawu ezimbi abantu abajamelana nazo kwiimvavanyo zeclini.
Imiphumo echaphazelekayo yeBenlysta
- isicaphulelo
- isifo sohudo
- umkhuhlane
- impumlo okanye impumlo
- umqala obuhkungu
- ukukhwehlela (bronchitis)
- i ngxaki yokulala
- intlungu yomlenze okanye ingalo
- ukuxinezeleka
- intloko (migraine)
- usulelo lwezonyango
- ukunciphisa inani legazi lamhlophe (i-leukopenia)
- ukuhlanza
- intlungu yesisu
Ukuba ufumana ezi ziphumo ezibi kakhulu, kubalulekile ukuxelela i-rheumatologist kwangoko. Ukuba unobungozi obunobungozi bokuphila, njengempembelelo yokuphefumula, thintela 9-1-1 ngokukhawuleza.
Kukho ezinye izinto ezinokwenzeka, ezingaqhelekanga, ezichaphazelayo. Zizobhengezwa kwiwebhsayithi ye-GSK, kodwa kubalulekile ukuthetha kunye ne-rheumatologist malunga nefuthe lezommandla zeBenlysta kunye nobungozi, ngokubanzi.
Ungaphinda ubhengeze nemiphumo emibi yecala nayiphi na imithi egunyazisiweyo, kungekhona nje uBenlysta, kwi-FDA. Tyelela i-www.fda.gov/medwatch, okanye ufonele ku-1-800-FDA-1088.
Ngaba Ndiyakwazi Ukukhathazeka Benlysta?
Nangona iBenlysta yindlela ekhethileyo yokonyango, i-GSK inika inkxaso ngenkxaso. I-rheumatologist yakho inokusebenza kunye ne-inshurensi yakho kunye ne-GSK ukufumana uncedo lwezemali oluya kulufuna.
Ngaba uBenstasta Usebenzela Abantwana AbanoLupus?
Akukaziwa ukuba iBenlysta ikhuselekile kwaye isebenza kubantwana abane-lupus. Kukhona uphando oluqhubekayo lwe-lupus lwengqondo olulinganisa ukusebenza nokukhuseleko kwaBenlysta kubantwana abane-lupus phakathi kweminyaka eyi-5-17 ubudala. Ukuba umntwana wakho une-lupus, ungathetha nogqirha wakho malunga nokuba kufanelekile ukubhalisa olu phofu.
Ingaba kukho iimeko zonyango kwiBenlysta?
Ewe. Ukuba ungathanda ulwazi oluthe xaxa malunga novavanyo lukaBenlysta lwezonyango, ungathetha ne-rheumatologist okanye uqhagamshelane ne-GSK ngqo. Unokutyelela i-clinicaltrials.gov uze uthayiphe uBenlysta kwibhokisi lokukhangela.
Ngaba Kukhuselekile ukuthatha i-Benlysta ixesha elide?
Abaphandi bafunda iiphumo likaBenstasta kubantu abaye bathabatha le nkunkuma iminyaka emihlanu kwaye baye bafumanisa ukuba, ngoku kude, eli liza likhuselekile ukuthatha le mali. Abazange bafumane ukwanda kwimiba emibi eyaziwayo.
Kuthiwani Ukuba Ndikhulelwe okanye Ndifuna Ukunxila?
Ngelixa kukho kwabakho abafazi abaye bazala ngokuphumelelayo kwiintsana ezinempilo ngelixa besethatha uBenlysta, abaphandi baqhubeka befunda ukuba ukhuselekile ukuthatha uBenstasta ngelixa bekhulelwe-ngaba isilwanyana sidluliselwa kumntwana kwaye ukuba kunjalo, yintoni umphumo? Abaphandi baye baqokelela kwaye bahlalutya idatha ethile kodwa kudatha idatha efunekayo.
Ukuba uyakhulelwa ngeli xesha uthabatha uBenstasta okanye emva kweenyanga ezine emva kokuyeka isilwanyana, xelela i-rheumatologist yakho kanye nangoko, ubuze nabo nge-Belimumab (Benlysta ™) Registry Pregnancy.
Ngokuqwalasela kunye nokuqokelela idatha, irejistri yenzelwe ukunceda abaphandi baqonde kakuhle umphumo kaBenlysta xa ukhulelwa. Wena kunye nosana lwakho kuya kujongwa ngokukhawuleza ukuba unquma ukuhlala kwisibisi.
Kwezinye iimeko, abantu banokugqiba ekubeni bahlale eBenlysta xa bekhulelwa xa iinzuzo zokuhlala kwisibisi zikhulu kunefuthe elibi elingenalo kumntwana.
Ngaphandle koko, kucetyiswa ukuba usebenzise ukukhulelwa kwezilwanyana ukukhusela ukukhulelwa ngelixa uthatha uBenstasta, okanye emva kweenyanga ezine emva kokuyeka isilwanyana.
Ngokufanayo, akwaziwa ukuba isigqirha sidlula kumzali ukuya kwintsana ngokuncelisa. Umzali kufuneka akhethe phakathi kokuncelisa okanye ukuthatha uBenlysta. Ukuba ucinga ngokuncelisa, nceda uthethe kunye ne-rheumatologist yakho eya kukunceda ukuba ufumanise indlela enokukhetha ngayo.
Ndingayifumana Njani Iindaba Ezikhoyo Nge Benlysta?
Ukufumana malunga naluphina uphando olutsha okanye iindaba ezinxulumene noBenlysta, ungathetha nogqirha wakho. Unokwenza uphando lwe-intanethi, uqinisekise ukuba ufumana imithombo ethembekileyo .
Kwi-injini yakho yokukhangela, ungangena kwixesha lokucinga njengoBenlysta yophando 2016 (sebenzisa unyaka okhoyo).
Iziphumo ezimbalwa zokukhangela ziza kubandakanya izixhumanisi kwi-Lupus Research Alliance, okanye eminye imibutho ye-lupus ehloniphekileyo. Imizekelo ye-website ye-lupus yophando yewebhu i-MedPage namhlanje kunye neLupus News namhlanje. Ezi zinto zinokuza kuphando lwakho. (Funda kabanzi malunga nendlela yokufumana ulwazi lwezempilo oluthembekileyo kwi-intanethi.)
Unokufumana amaxwebhu athishwe yi-GSK. Kuhlala kusinceda ukuba uye ngqo kwiinkampani zonyango kwaye ubone ukuba yikuphi ukukhutshwa kogcino abasanda kutshicilela malunga nonyango oluthile.
Ukuba ufuna ukuhamba ngokukhawuleza kuphando, i-PubMed yiwebhusayithi yaseburhulumenteni yaseUnited States enika ukufikelela kwamahhala kwiziko leNgcaciso yeThala leNgcaciso yeMathala elibizwa ngokuthi iMedline. Ngamanye amaxesha kunika amanqaku apheleleyo. Ngamanye amaxesha kunika izibhengezo. Ingqiqo isishwankathelo salo nqaku.
Ukuba wenza uphando kwi-PubMeb yeBeneststa, uya kufumana iziphumo ezininzi. Unokunciphisa iziphumo ngokungongeza kwixesha lakho lokukhangela. Endaweni yokufuna uBenlysta , khangela iziphumo zecala laseBenlysta , umzekelo.
Ngaba iBenlysta Ikhona ngaphandle kwe-US?
Ukongeza kokufumaneka kwiUnited States, iBenlysta iyafumaneka kumazwekazi amathandathu - eNyakatho naseMzantsi Melika, e-Afrika, e-Asia, eYurophu nase-Australia. Ukufumana ukuba iBenlysta ikhona kwilizwe lakho, thetha ne-rheumatologist yakho. Unako ukubiza ne-GSK. Ukuqhagamshelana nabo ukuba uhlala ngaphandle kwe-US, tyelela icandelo labo lewebhu kwilizwe lonke kwaye uphendule ngommandla.
Ngaba uBenlysta Uzamsebenzela?
Wonke umntu onomdla we-lupus uyingqayizivele, ngoko akukho mpendulo elula kulo mbuzo.
Thetha kunye ne-rheumatologist ukufumana ukuba bacinga ukuba ungumviwa ofanelekileyo kule nyango.
Ukuba wena kunye ne-rheumologist yakho ucinga ukuba yindlela efanelekileyo yokonyango, uya kufuneka uzame izilwanyana ukuze ubone indlela ekusebenzela ngayo. Gcina ukhumbule ukuba ayisebenzi ngokukhawuleza njengonyango olufana ne-corticosteroids. Kungathatha iiveki okanye iinyanga ukuqala ukubona iziphumo.
Ucinga ngoBenlysta? Thetha kunye neRheumatologist yakho
Ukuba ucinga ngoBenlysta, isinyathelo esilandelayo kukuba uthethe ne-rheumatologist yakho. Ngokuqinisekileyo uya kuba nemibuzo emininzi kwintetho yakho yokuqala ngonyango, kunye nakweyiphi na into emva koko, kubandakanywa ngelixa uthabatha ichiza. Bhala phantsi imibuzo yakho njengoko iphakama, kwaye ulethe uluhlu lwakho lwemibuzo ekuqeshweni kwakho okulandelayo. Ungakwazi ukubiza no-GSK ngqo kwi-BENLYSTA Gateway ngo-1-877-4-BENLYSTA (1-877-423-6597) ngoMvulo ukuya ngoLwesihlanu, ngo-8 ukuya kwe-8 ukuya kwe-8 kwexesha leMpuma. Xa kuziwa kwimpilo yakho, unelungelo lokuba nolwazi njengoko lunokwenzeka.
> Imithombo:
> Bruce I, Urowitz M, Vollenhoven R, et al. Umonakalo wexesha elide ukuvelisa kunye nokukhuselwa kwizigulane ezine-SLE eziphathwe nge-belimumab kunye nokunyamekela. Lupus. 2016; 0: 1-11. http://lup.sagepub.com/content/early/2016/02/18/0961203315625119.full.pdf+html.
> Dubey A, Handu S, Dubey S, Sharma P, Sharma K, Ahmed Q. Belimumab: Ukwelashwa kokuqala okujoliswe kwi-Biological Lupus Erythematosus. Umbhalo we-Pharmacology & Pharmacotherapeutics. 2011; Oktobha-Dec; 2 (4): 317-319. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3198539/.
> Landy H, Powell M, Hill D, Eudy A, Petri M. Belimumab IRejista yokukhulelwa: Isifundo soBuchule boPhulo lweziPhumo. I-Obstetrics & Gynecology. 2014; 123 (1). http://journals.lww.com/greenjournal/Abstract/2014/05001/Belimumab_Pregnancy_Registry__Prospective_Cohort.130.aspx.
> Vollenhoven R, Petri M, Wallace J, et al. I-Cticulative Corticosteroid Dose KwiiVeki ezingamashumi amahlanu anesibini kwizigulane ezine-Systemup Lupus Erythematosus: I-Analysis Pooled ukusuka kwi-Phase III Belimumab Trials. Arthritis & Rheumatology. 2016; 68 (9): 2184-2192. http://onlinelibrary.wiley.com/doi/10.1002/art.39682/abstract.