Ọgwụgwọ Oral maka Arthritis Psoriatic na Psoriasis
Na March 21, 2014, FDA kwupụtara nkwenye nke Otezla (apremilast) maka ịgwọ ọrịa arthritis na-arụ ọrụ na ndị okenye. Otezla bụ onye na-emechi ọgwụ nke phosphodiesterase-4 (PDE4). Otezla bụ nanị ụdị ọgwụgwọ agwa ndị FDA na-akwado maka kpọmkwem maka ọrịa arthritis. Na September 23, 2014, FDA kwadoro Otezla maka ihe ngosi ọzọ, ịgwọ ndị ọrịa na-eji ihe dị egwu na psoriasis bụ ndị phototherapy ma ọ bụ usoro ọgwụgwọ usoro kwesịrị ekwesị.
Tupu okwenye nke Otezla, a na-ejikarị ọrịa corticosteroids , TNF block , ma ọ bụ stelara (ustekinumab ) na-eme ihe banyere ọrịa psoriatic , onye a na-akwado interleukin-12 / interleukin-23 na September 2013.
Kedu ka esi debe Otezla?
Otezla na-abịa dị ka diamond, ihe mbadamba ihe nkiri na-emepụta ihe nkiri atọ: 10 mg., 20 mg, na 30 mg. Ngwá ọgwụ mbụ a tụrụ aro nke Otezla gụnyere nhazi site na ụbọchị 1 ruo ụbọchị 5 iji nweta ọgwụ ngwọta akwadoro 30 mg. ugboro abụọ kwa ụbọchị na-amalite na ụbọchị 6. Nhazi oge nhazi oge bụ:
Ụbọchị 1: 10 mg. n'ụtụtụ
Ụbọchị 2: 10 mg. ke usenubọk ye 10 mg. na mgbede
Ụbọchị 3: 10 mg. ke usenubọk ye 20 mg. na mgbede
Ụbọchị 4: 20 mg. ke usenubọk ye 20 mg. na mgbede
Ụbọchị 5: 20 mg. ke usenubọk ye 30 mg. na mgbede
Ụbọchị 6 na karịa: 30 mg. ke usenubọk ye 30 mg. na mgbede
(Rịba ama: Ndị ọrịa nwere nkwarụ siri ike buru ibu ga-achọ mgbanwe maka usoro nhazi usoro).
Kedu ihe na-emekarị ka ọ bụrụ enyi na Otezla?
N'ọnwụnwa ahụike, afọ ọsịsa, isi ọwụwa, na ọgbụgbọ bụ ihe mmetụta kachasị emetụta metụtara Otezla. Ihe ka ọtụtụ n'ime ihe ọjọọ ahụ mere n'ime izu abụọ mbụ nke ọgwụgwọ ma dozie oge na iji iji Otezla eme ihe.
Enwere ihe ọ bụla ma ọ bụ ịdọ aka ná ntị na nchebe metụtara Otezla?
Otezla na-emegiderịta onwe ya na ndị ọrịa nwere hypersensitivity mara ọkwa na apremilast. N'ihe banyere ịdọ aka ná ntị na nlezianya, Otezla na-ejikọta nsogbu nke ịda mbà n'obi. A na-ahụkwa ọnụ ọgụgụ dị arọ n'oge ọnwụnwa na-adakarị dị ka ihe omume nwere ike ime. Ndị ọrịa kwesịrị ile anya maka ọnwụ na-enweghị atụ.
Ọzọkwa, enwere ike ịmekọrịta ọgwụ ọjọọ n'etiti Otezla na cytochrome P450 enzyme inducers, dị ka rifampin, phenobarbital, carbamazepine, na phenytoin nke ga-eme ka ọrụ Otezla dị irè. Nchikota ejighi akwadoro.
Ọ bụghị ụmụ nwanyị dị ime ka a na-eduzi ọmụmụ ihe nke ọma na Otezla. Otezla kwesịrị iji ya n'oge ime ime naanị mgbe uru ndị nwere ike ịba uru karịa nwa ebu n'afọ. A maghị ma ọ bụrụ na Otezla ma ọ bụ metabolites nke Otezla nọ na mmiri ara ehi mmadu, ya mere nwayi nọọsụ aghaghị ịkpachara anya. Dị ka akụkụ nke nkwado FDA, a ga-enwe ndekọ maka ndị inyom dị ime ma na-emeso Otezla.
Kedu ka Otezla si mee ihe nlele ahụ?
Echere nchekwa na irè nke Otezla na nyocha atọ nke ụlọ ọgwụ ndị metụtara mmadụ 1,493 nwere ọrịa arthritis.
N'ọnwụnwa, aha ya bụ PALACE-1, PALACE-2, na PALACE-3, a na-etinye ndị na-amụ ihe na random, placebe, Otezla 20 mg. ma ọ bụ 30 mg. ugboro abụọ kwa ụbọchị. A na-ekwe ka ndị ọrịa nọgide na DMARD, obere corticosteroids, ma ọ bụ NSAID n'oge ikpe ahụ. Ihe kachasị mkpa bụ ACR20 site n'izu 16. Otezla na DMARD jiri ya tụnyere placebo tinyere DMARDs dị mma na ihe ịrịba ama na mgbaàmà nke ọrịa arthritis. Enwerekwa ihe akaebe nke mmawanye na ọrụ Otezla (30 mg ugboro abụọ kwa ụbọchị) karịa placebo.
Kedu ihe bụ Otezla?
Onye na-aṅụ ọgwụ ọjọọ, bụ Celgene, emeela ihe dị ka $ 22,500 kwa afọ maka Otezla.
Isi mmalite:
Otezla (apremilast). Na-edepụta Ozi. March 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Nwelite 2 - FDA United States na-akwado Celgene Drug for Arthritis Psoriatic. Bill Berkrot. Reuters. March 21, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
Otezla Kwadoro FDA maka Plaque Psoriasis. BusinessWire. September 23, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Approved-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8