Kukhona ukukhathazeka ngokubambisana okungenzeka phakathi kwe-Xolair imithi (omalizumab) nomdlavuza. Ngaphambi kokuba i-Xolair ivunyelwe ukusetshenziswa e-United States, umbiko we-FDA wokuqala wezokuphepha wawuhlanganisa le mininingwane elandelayo:
"Ukuqhathaniswa kwamazinga okuhlukunyezwa kubonisa (kepha angasunguli) inani elikhuphukile lezihloko eziveziwe ze-Omalizumab ... Ukuqhathaniswa kwedatha yokutadisha emtholampilo ku-database enkulu ye-epidemiological database ephakanyisiwe e-Omalizumab evezwe ngaphezulu kwezidakamizwa kunokuba kulindeleke ngenkathi iqembu lokulawula lihlangene kakhulu ukuhlukunyezwa. "
Ekuhlolweni kwemitholampilo, amakhemikhali abonakala kunoma yiziphi izivolontiya zokuhlolwa ezingu-200 ze-Xolair (iziguli ezingu-20 zazingu-4127) uma kuqhathaniswa nomunye wabavolontiya abangama-500 abangazange bathathe i-Xolair (iziguli ezingu-5 zazingu-2236). Amagciwane ayenamahlobo ahlukahlukene. Amanqamu okwenzeka kaningi kuleli qembu afaka:
- Umdlavuza wesibeletho
- Umdlavuza wesikhumba (i-melanoma ne-non-melanoma)
- Umdlavuza we-prostate
Kwakukhona amanye amahlanu emdlavuza okwenzeka ngayinye ngesikhathi esisodwa.
Kubalulekile ukuqaphela ukuthi uma umuntu enomdlavuza ngaphambi kokuba ahlanganyele ezifundweni ze-Xolair, awazange akhishwe ekutadisheni - eqinisweni, kucatshangwa ukuthi okungenani iziguli ezingu-5 zinezibonakaliso zomdlavuza ngaphambi kokujoyina isilingo somtholampilo. Ngenxa yalokho, ngeke kube lula ukuthi i-Xolair ibangele umdlavuza kulezi ziguli.
Iziguli nazo zazakhela umdlavuza esikhathini esifushane kakhulu emva kokuqala ukwelashwa nge-Xolair. Akungabazeki ukuthi ama-cancer angabe esekhulile ngesikhathi esincane esifanele - okusho ukuthi kungenzeka ukuthi kakade abe nomdlavuza ngaphambi kokuqala i-Xolair.
Ngokulandelayo, iphaneli le-oncologists liye lasho ukuthi ayizizwa ukuthi ukwelashwa kwe-Xolair kubangela umdlavuza ngokusekelwe kwedatha okwamanje etholakalayo.
Umthelela wokwehliswa isikhathi eside ku-Xolair noma ukusetshenziswa kwawo kubantu abasengozini enkulu yomdlavuza (njengababhemayo noma labo abanomlando womdlavuza womndeni) aziwa kodwa uyaqhubeka nokufunda.
I-Epidemiologic Study of Xolair (omalizumab): Ukuhlola Ukusebenza Kwemitholampilo nokuPhepha Kwesikhathi Eside Kuziguli Nge-Asthma Elinganiselwe Kuzohlola imiphumela yesikhathi eside ye-Xolair ehlobene nezinhlobonhlobo zamanqamu.
Ukubuyekezwa kuka-2014 kwedatha yokuphepha eneminyaka engu-5 ye-Xolair akutholanga umehluko emkhakheni wegciwane phakathi kweziguli ze-Xolair nalabo ababengaphathwa nge-Xolair. Isidakamizwa siye sahlotshaniswa nemivimbo emincane eyaziwa ngokuthi ukuhlaselwa kwe-ischemic okudlulayo . Ukuhlaselwa kwenhliziyo; ukuphuza okungazelelwe kwenzeke; umfutho wegazi ophezulu emithanjeni yamaphaphu okuthiwa i-pulmonary hypertension; kanye nama-blood clots emaphashini nasemithanjeni. Kodwa-ke, i-FDA ayikwazi ukusho noma ngabe i-Xolair ingenele kulezi zinkinga noma hhayi ngokususelwa ekuhloleni kwabo ubufakazi obukhona okwamanje. Ngenxa yokuthi i-FDA ayikwazi ukucacisa ukuthi kukhona ukungabikho kwenengozi ehlobene nalezi zinkinga nenhliziyo yobuchopho, i-FDA yabanezela ekufakweni kwephakheji kusigaba esingathandeki sokuphendula selebula lezidakamizwa. Ngokufanayo, i-FDA ayikwazi ukusho ngokucacile ukuthi akuyona ingozi yomdlavuza nge-Xolair, ngakho-ke ulwazi oluphathelene nalesi sihloko longezwe esigabeni sokuxwayisa nokuqapha kwelebula lezidakamizwa.
Uma uzocabangela i-Xolair njengokwelashwa kwesifo sakho se-asthma noma ingane yakho kufanele uxoxe ngalezi zinkinga nodokotela wakho.
I-FDA iphakamisa ukuthi odokotela bavuselela ngezikhathi ezithile isidingo sokuqhubeka nokuphathwa kwe-Xolair esekelwe ukugula kwesiguli nesimo sokulawula isifo se-asthma.
> Imithombo:
> Lanier B. Imibuzo yokutholwa engaphenduliwe kanye nokucabangela mayelana nendima ye > anti-immunoglobulin > E e-atopic ne-nonatopic. Isifo sofuzo soMthetho Wokuzibulala Ngomzimba Proc 27 >: S37 > -S42, 2006)
> Ukuvunyelwa Umlando, Izincwadi, Izibuyekezo, kanye Nemibhalo Ehlobene. I-XOLAIR (OMALIZUMAB) I-Document Review
> Katie Eder. I-Pharmacy TimesFDA Yengeza Izingozi Zezinhliziyo Nezinkinga Zebongo, I-Cancer ku-Label ye-Xolair.
> I-SA SA FDA Drug Safety Communication: I-FDA ivumela izinguquko zelebula nge-asthma izidakamizwa i-Xolair (omalizumab), kufaka phakathi ukuchaza> kancane > ingozi enkulu yenhliziyo nobuchopho obubi.