Mai gabatarwa na farko na JAK ga Arthritis Rheumatoid da FDA ta amince
Xeljanz (tofacitinib citrate), DMARD na maganin maganin cututtuka na cutar, ya amince da ita ta Cibiyar Abinci da Druggun Amurka (FDA) a kan Nuwamba 6, 2012. An yi amfani da miyagun ƙwayoyi don kula da manya da matsakaici-zuwa masu fama da cututtuka masu tsanani wadanda ke da rashin amsa, ko rashin amincewa, don bin tafarkin . Kamfanin Pfizer, Xeljanz ne mai zagaye, fari, nan da nan-release, kwamfutar hannu mai lakabi tare da "Pfizer" a gefe guda, kuma "JKI5" an sa shi a gefe ɗaya.
Xeljanz shi ne na farko DMARD na kwakwalwa wanda ya yarda da cutar arthritis a shekaru 10. Har ila yau shine farkon a cikin sababbin magunguna da ake kira JAK (Janus kinase). Xeljanz za a iya amfani dashi kamar yadda ake iya yin amfani da kwayoyin halitta (kadai), ko kuma hade tare da methotrexate ko wasu DMARDs marasa ilimin halitta. Xeljanz ba za a yi amfani da shi ba tare da kwayoyin halitta ko magungunan immunosuppressants, irin su Imuran (azathioprine) ko cyclosporine .
Yadda Yake aiki
Mahimmanci, Xeljanz yana aiki ne ta hanyar hana hanya JAK - hanya ta alama a cikin kwayoyin da ke taka muhimmiyar rawa a cikin ƙonewa da ke hade da cutar arthritis. JAKs sunadaran enzymes ne wanda ke aikawa da siginonin da ke fitowa daga cytokine ko girma factor-receptor interactions a kan tantanin halitta membrane.
Xeljanz an dauke shi magani ne kawai, ba magani ba. Halitta (adalimumab), Cimzia (certolizumab pegol), Simponi (golimumab), Orencia (abatacept), Actemra (tocilizumab), da kuma Rituxan (rituximab) sunadarai na cytokines masu tsinkaya. daga waje da tantanin halitta.
Ayyukan Gwaji na Clinical
Fiye da marasa lafiya 5,000 marasa lafiya a cikin mahaifa sun shiga cikin gwaje-gwaje na gwaji don Xeljanz, suna samar da daya daga cikin manyan bayanan asibitoci na duk wani maganin ƙwayar cuta na jini wanda aka sallama zuwa FDA don nazari, a cewar Pfizer.
Akwai gwaje-gwajen gwaje-gwaje biyu da suka tantance jimlar Xeljanz mafi kyau, da kuma gwaje-gwaje 5 na asibiti da suka ƙaddamar da amsawar ACR 20 ga Xeljanz, da DAS28 da Sakamakon Bincike na Lafiya.
Gwajen gwaje-gwaje na nuna cewa Xeljanz ya rage alamun da alamun bayyanar cututtuka na rheumatoid da inganta aikin jiki (ikon yin ayyukan yau da kullum).
Yankewa
An dauki Xeljanz a cikin launi, kwaya 5 MG dauke sau biyu a kowace rana. Ana iya ɗauka tare da ko ba tare da abinci ba. An samu nauyin MU 11 a kowace rana kamar yadda Xeljanz-XR (ƙarin saki).
Hanyoyin Kasuwanci
Abubuwa masu lalacewa mafi yawa da suka shafi Xeljanz, wadanda suka faru a farkon watanni 3 na yin amfani da su a gwaji, sune cututtukan respiratory respiratory, ciwon kai, zawo, da kuma nasopharyngitis.
Gargaɗi da Tsaro
Xeljanz yana ɗauke da gargadi mai kwalliya : cututtuka masu tsanani da ke haifar da asibiti ko mutuwa, ciki har da tarin fuka da kwayan cuta, magungunan haɗari, maganin cututtuka, da kuma sauran cututtuka na opportunistic, sun faru a marasa lafiya masu karɓar Xeljanz; idan kamuwa da cuta mai tsanani, Xeljanz ya kamata a dakatar da shi har lokacin da aka sarrafa kamuwa da cuta; Dole ne a bai wa jarrabawar tuberculosis kafin fara Xeljanz; marasa lafiya da ke shan Xeljanz ya kamata a kula da cutar tarin fuka ko da idan gwaji na farko ya saba; lymphoma da sauran malignancies an lura a marasa lafiya shan Xeljanz; "Harkokin lymphoproliferative-related Epirus Barr-Virus" sun kasance a lura da marasa lafiya wanda aka yi da Xeljanz tare da kwayoyin immunosuppressive.
Sauran kariya: Yi amfani da Xeljanz tare da hankali a cikin marasa lafiya a hadari ga perforations gastrointestinal; Xeljanz ba da shawarar ga marasa lafiya da ciwon hanta mai haɗari ba; gwagwarmayar gwaje-gwajen lokaci nagari saboda Xeljanz na iya haifar da canje-canje ga wasu nau'in jini, jini, hanta enzymes , da lipids; marasa lafiya dauke Xeljanz basu karbi maganin alurar rigakafi ba.
An ba da cikakken nazarin Xeljanz a cikin mata masu ciki ba. Xeljanz kawai ya kamata a yi amfani da shi a lokacin daukar ciki idan amfani da miyagun ƙwayoyi ya fi iyakar hadarin gaske ga tayin.
Kudin
Xeljanz zai sami kudin saye da sayen kuɗin dalar Amurka 2,055.13 don tanadi na kwanaki 30 (ko $ 24,666 a kowace shekara).
Kudin marasa lafiya zai bambanta dangane da kwangila da inshora.
> Sources:
> Xeljanz. Cikakken Bayanan Bayani da Magunguna. Revised 02/2016.
> Cibiyar Abincin Amurka da Drugta ta amince da Xaran JANZ na Pfizer (gadacitinib citrate) ga Adult da Dattijai zuwa Arthritis Rheumatoid Rheumatoid (RA) Mai Girma wanda ke da rashin dacewar amsawa ko rashin jituwa ga Methotrexate. 11/06/2012.
> Xeljanz, Kwayar Pfizer-Dalar Miliyan Dubu 25,000-Kyauta-Kyauta-Kyauta-Kyauta-Kyauta-Kyauta-Kyauta-Kyauta-$ 25,000-A-Year Domin Rheumatoid Arthritis, Yana samar da FDA Green Light. Matiyu Herper. Forbes.com. 11/06/2012.