An jera Opdivo a cikin Amurka don maganin ciwon huhu. Yawancin masu fama da cutar kansa ba za su iya fita waje neman magani ba saboda wasu dalilai. Tuntubi Opdivo kan yadda ake amfani da shi da fatan samun damar siyan magani daga kasashen waje.
FDA ta Amurka ta faɗaɗa yarda don amfani da Opdivo don magance ciwon huhu
Richard Pazdur, MD, Director of the Hematology and Oncology Products Division at the FDA ’s Center for Drug Evaluation and Research, said: “When the results of this clinical trial were first available in December 2014, FDA ’s active work with the company facilitated this early submission and review. , “” This approval will provide patients and health care providers with the knowledge that accompanies the survival benefits of Opdivo and will help guide patient care and future kwayar cutar huhu trials. “Priority review
Waɗannan mahimman bayanai ba su haɗa da duk bayanan da ake buƙata don amfani da OPDIVO lafiya da inganci ba. Da fatan za a koma OPDIVO don cikakkun bayanan likitancin magani.
OPDIVO (nivolumab) allura don amfani a cikin jijiya
Izinin farko a Amurka: 2014
Alamomi da amfani
Manyan canje-canje na kwanan nan (ja shine sabon sigar)
Alamu da amfani (1.2) 3/2015
Gargaɗi da taka tsantsan (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2015
Alamomi da amfani
OPDIVO ɗan adam ne mai karɓar mai karɓar mutuwa-1 (PD-1) wanda ya dace da toshe maganin rigakafi a cikin marasa lafiya masu zuwa:
(1) Maganin marasa lafiya tare da metastatic maras kyau melanoma da ipilimumab [ipilimumab] da, alal misali, BRAF V600 maye gurbi-tabbatacce, ci gaban cuta bayan mai hana BRAF. (1.1) An yarda da wannan alamar a ƙarƙashin ingantacciyar amincewa bisa ga tumo Yawan amsawa da dorewar amsa. Ci gaba da yarda da wannan alamar na iya dogara da tabbaci da bayanin fa'idar asibiti a cikin gwajin tabbatarwa. (1.1, 14)
⑵ Yi amfani da chemotherapy na tushen platinum ko squamous metastatic cututtukan daji na kansa marasa kansar. (1.2)
Sashi da hanyar gudanarwa
An ba da 3 mg / kg ta hanyar jiko na cikin jini sama da mintuna 60 kowane mako biyu. (2)
Formulations da bayani dalla -dalla
Allura: 40 mg / 4 ml da 100 mg / 10 ml mafita a cikin gwangwani da za a iya zubarwa (3)
contraindications
Gargadi da kiyayewa
Maganganun rigakafi-matsakaici: Ana ba da Glucocorticoids gwargwadon girman halayen. (5.1, 5.2, 5.3, 5.4, 5.6)
⑴ Ciwon huhu mai tsaka-tsaki na rigakafi: ba a ba shi matsakaici da kuma ƙarewa na dindindin don ciwon huhu mai tsanani ko barazanar rai. (5.1)
⑵ colitis mai tsaka-tsaki na rigakafi: Kada a ba da ƙarewa ta dindindin zuwa matsakaici ko mai tsanani kuma mai barazanar rai. (5.2)
(3) Hepatitis na rigakafin rigakafi: lura da canje-canje a cikin aikin hanta. Matsakaicin rashin gudanarwa da ƙarewa na dindindin na transaminase mai haɗari ko haɗari ko jimlar haɓakar bilirubin. (5.3)
⑷ Nephritis mai tsaka-tsakin rigakafi da rashin wadatar koda: lura da canje-canje a cikin aikin koda. Don matsakaicin gazawar da kuma ƙarewar dindindin na hauhawar jini mai haɗari ko barazanar rayuwa. (5.4)
⑸ Maganin rigakafin rigakafi da hypothyroidism da hyperthyroidism: saka idanu canje-canje a cikin aikin thyroid. Fara maye gurbin hormone thyroid lokacin da ake bukata. (5.5)
⑹ Ciwon ciki da tayi: na iya haifar da lahani. Bayar da shawara akan yuwuwar haɗari ga tayin da kuma amfani da ingantaccen rigakafin hana haihuwa. (5.7, 8.1, 8.3)
Halin halayen halayen
Mafi yawan mummunan halayen (≥20%) a cikin marasa lafiya tare da melanoma shine kurji. (6.1)
Mafi yawan halayen rashin lafiya (≥20%) a cikin marasa lafiya da ke fama da ciwon huhu na huhu wanda ba ƙananan ƙwayar cuta ba shine gajiya, wahalar numfashi, ciwon tsoka, asarar ci, tari, tashin zuciya, da maƙarƙashiya.
Ana amfani dashi a cikin mutane na musamman
⑴ Shayarwa: Kashe shayarwa.
