Jiyya na maganganu ga Psithicist Arthritis da Psoriasis
Ranar 21 ga Maris, 2014, FDA ta sanar da amincewa da Otezla (apremilast) don maganin cututtuka na masu ilimin lissafi a cikin manya. Otezla mai kirki ne mai guba na phosphodiesterase-4 (PDE4). Otezla ne kawai FDA-yarda maganin magance musamman ga psoriatic arthritis. Ranar 23 ga watan Satumba, 2014, FDA ta amince da Otezla don ƙarin nuni, da kula da marasa lafiya da matsakaicin matsananciyar psoriasis wanda wanda ya fi dacewa da yin nazari ko tsarin likita.
Kafin amincewa da Otezla, yawancin maganin arthritis sunyi amfani da su tare da corticosteroids , masu tarin fuka na TNF , ko Stelara (ustekinumab ) , mai yarda da interleukin-12 / interleukin-23 a watan Satumba 2013.
Ta yaya ake sarrafa ta?
Otezla ta zo ne a matsayin nau'i na lu'u-lu'u, nau'i mai launi na fim a ƙarfin uku: 10 MG, 20 MG, da 30 MG. Na farko da aka ba da shawara na Otezla ya haɗa da tsaida daga ranar 1 zuwa 5 don zuwa jigilar maganin maganin 30 mg. sau biyu a kowace rana a ranar 6. Dangantakar da aka tsara a yau shine:
Ranar 1: 10 MG. da safe
Ranar 2: 10 MG. da safe da 10 MG. da yamma
Ranar 3: 10 MG. da safe da 20 MG. da yamma
Ranar 4: 20 MG. da safe da 20 MG. da yamma
Ranar 5: 20 MG. da safe da kuma 30 MG. da yamma
Ranar 6 da kuma bayan: 30 MG. da safe da kuma 30 MG. da yamma
(Lura: Magunguna masu fama da mummunan cututtuka suna buƙatar gyarawa zuwa jadawalin sashi).
Menene Ra'ayin Kayan Kasuwanci An Haɗu da Otezla?
A gwaji, cututtuka, ciwon kai, da kuma tashin hankali sune mafi yawan rahotanni masu dangantaka da Otezla. Yawancin abubuwan da suka faru sun faru a cikin makonni biyu na farko na jiyya kuma sun yi nasara a lokaci tare da ci gaba da amfani da Otezla.
Shin Akwai Kwayoyi ko Gargaɗi da Tsaro da Aka Haɗa tare da Otezla?
Otezla an saba wa wadanda suka kamu da cutar tare da sanannun sanadiyar zuwa apremilast. Game da gargadi da tsare-tsaren, Otezla yana haɗuwa da ƙananan haɗarin baƙin ciki. Har ila yau an lura da ƙimar nauyi a yayin gwaji na asibiti kamar yiwuwar mummunan yanayi. Marasa lafiya ya kamata a kula da asarar rashin asarar rashin lafiya da rashin asibiti.
Har ila yau, za'a iya yin hulɗar likita tsakanin Otezla da cytochrome P450 masu haɗarin enzyme, irin su rifampin, phenobarbital, carbamazepine, da phenytoin wanda zai rage tasirin Otezla. A hade ba da shawarar.
An yi nazari tare da Otezla a cikin mata masu juna biyu. Ya kamata a yi amfani da Otezla a lokacin haihuwa kawai a lokacin da amfanin da zai iya haɓakar da tayin. Har ila yau ba a sani ba idan Otezla ko Metabolites na Otezla suna cikin madarayar mutum, sabili da haka jaririyar mace dole ne mai hankali. A matsayin wani ɓangare na amincewa da FDA, za a yi rajista ga matan da suke da ciki da kuma kula da su tare da Otezla.
Yaya Yayi Otezla yayi a gwaji?
An kiyasta aminci da tasiri na Otezla a cikin gwaje-gwajen gwaji uku da suka shafi marasa lafiya 1,493 tare da maganin ƙwayar cutar.
A cikin gwaji, mai suna PALACE-1, PALACE-2, da PALACE-3, an ba da mahalarta masu nazari a wuri ba tare da izini ba, to 20 mg. ko 30 MG. sau biyu a kowace rana. An yarda marasa lafiya su ci gaba da DMARDs, ƙananan corticosteroids, ko NSAIDs yayin gwajin. Dalilin farko shi ne ACR20 a mako 16. Otezla da DMARDs idan aka kwatanta da placebo da DMARDs da aka haɓaka tare da ingantaccen cigaba a cikin alamomi da alamun cututtuka na cututtuka na psoriatic. Har ila yau, akwai tabbaci na ingantaccen aiki na jiki tare da Otezla (30 mg sau biyu a kowace rana) fiye da placebo.
Menene Kudin Otezla?
Magungunan ƙwayoyi, Celgene, ya sanya farashi mai yawa na $ 22,500 kowace shekara don Otezla.
Sources:
Otezla (apremilast). Bayyana Bayani. Maris 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Ɗaukaka ta 2 - FDA ta amince da yarda da Celgene Drug for Arthritis Psoriatic. Bill Berkrot. Reuters. Maris 21, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
Otezla ya amince da FDA don Plaque Psoriasis. BusinessWire. Satumba 23, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Approved-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8