Injectable Drug for Plaque Psoriasis uye Psoriatic Arthritis
Stelara (ustekinumab), injectable biologic mishonga , yakagamuchirwa neU.S. Food and Drug Administration (FDA) musi waSeptember 25, 2009, kuitira kurapwa kwemaitiro echirwere psoriasis muvanhu vakuru. Plaque psoriasis, iyo inokanganisa vanhu vanosvika mamiriyoni matanhatu muU.S., ine maitiro ezvirwere zvemuviri zvinokonzera kukurumidza kudengenyeka kwemasero eganda.
Plaque psoriasis inoratidzirwa nechepamusoro-soro yeganda rakatsvuka, rakatsvuka, rinowanzovharwa nezviyero zvinoita sechirivha. Zvidzidzo zvitatu zvinosanganisira varwere 2 266 vakaongorora kuchengetedza nekubudirira kweStera, pakupedzisira zvichiita kuti zvibvumirwe nekapori psoriasis.
Makore mana gare gare, musi waSeptember 23, 2013, yakaziviswa kuti FDA yakabvumirawo Stelara, oga kana kuti pamwe chete ne methotrexate , pakurapa kwevakuru varwere vane active psoriatic arthritis . Vanhu vanopfuura mamiriyoni maviri muUnited States vane psoriatic arthritis, chirwere chinoputika chinoratidzwa nekubatana kwekubatana uye kuwirirana pamwe chete, pamwe chete nemaperembudzi eganda ane psoriasis. Zvikamu zviviri zvakakosha zvikamu zvitatu zvakasiyana-siyana, miviri-mapofu, randomized, placebo-controlled trials (PSUMMIT I uye PSUMMIT II) inosanganisira 927 varwere vane chirwere cheporiori inoronga kuchengetedzwa nekubudirira kwaStera uye vakatungamirira kugamuchirwa kwayo.
Janssen Biotrech, Inc. yakawana uye yakagadzira Stelara. Muiti wezvinodhaka ane kodzero dzekutengesa zvakakwana kune mishonga iri muU.S. The Janssen Pharmaceutical Companies inoshandisa kodzero dzekutengesa munyika yose.
Chii Chinonzi Stelara?
Stelara inonzi monoclonal antibody . Kunyanya kunyanya, Stelara munhu anopikisa interleukin anotarisa IL-12 uye IL-23, mapurotini maviri anofungidzirwa kuti anobatanidzwa mune zvimwe zviitiko zvinopesana, kusanganisira psoriasis uye psoriatic arthritis.
Kurapa Kwakaita Mishonga
Stelara inoshandiswa senzira inopinza (kureva, pasi peganda). Kune psoriasis varwere vanoyera masendi 220. (100 kg.) Kana zvishoma, chirongwa chekutanga chekutanga uye chiitiko chinotevera pane masvondo mana ndi 45 mg., Inotevera 45 mg. masvondo gumi nemaviri. Kune varwere vanoyera zvinopfuura 220 lbs. (100 kg.), Chirongwa chekutanga chekutanga uye chirwere chinotevera pane masvondo mana chinokwana 90 mg., Chinotevera 90 mg. masvondo gumi nemaviri.
Kune varwere vane psoriatic arthritis, chirongwa chakakurudzirwa cheSlara is 45 mg. pakutanga uye pamasvondo mana, inotevera 45 mg. masvondo gumi nemaviri. Kune varwere vane zvose plaque psoriasis uye psoriatic arthritis uye vanoyera kudarika 220 lbs., Chirongwa chekutanga chekutanga uye chirosi mavhiki mana gare gare 90 mg,, inotevera 90 mg. masvondo gumi nemaviri.
Stelara inowanikwa mune 45 mg / 0.5mL kushandiswa kusina kushandiswa, sendiza inotanga kuzadzwa uye mune 90 mg / mL kushandiswa kushandiswa kusati kwazadza seringiri. Stelara inowanikwawo mumvura isina kushandiswa imwe chete ine 45 mg / 0.5mL kana 90 mg / mL yaSlara.
Ndiani Asingafaniri Kushandisa Stelara
Vanhu vane hypersensitivity vanozivikanwa kuti ustekinumab kana zvisingabatsiri zvigadzirwa muStera havafaniri kushandisa chigadzirwa. Mishonga isingabatsiri inosanganisira L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, uye sucrose.
Nharaunda Dzakabatana
Matambudziko anowanzobatanidzwa neSlara anosanganisira nasopharyngitis, kuputika kwepamusoro kwezvirwere, kushaya musoro, uye kuneta. Dzimwe mimwe migumisiro inobvira. Taura nachiremba wako kana iwe uchinetseka nemimwe migumisiro inogona kunge yakabatana naStelara.
Manyevero uye Kuchengetedza
Stelara inogona kuwedzera mungozi yehutachiwana nekuitazve kweiyo latent (kusashanda kana kurara) zvirwere. Mumakiriniki, miviri yakakura yebhakitiriya, fungal, uye utachiona yakaonekwa kune vamwe varwere vanobatwa naSterara. Mushonga wacho haufaniri kutarisirwa kumurwere ane utachiona hwehutachiona uye hunofanirwa kunyatsoongororwa nevarwere vane chirwere chisingagumi kana nhoroondo yehutachiwana hwehutachiwana kana hunoitika.
Vasati vatanga kurapa naSlara, varwere vanofanira kuongororwa nehutachiona (TB) . Kurapa kweTB yakabatwa inofanira kutungamira kurapwa na Stelara.
Kubva pamakiriniki ekuedzwa, dambudziko rekuvadza rinogona kuwedzerwa nekushandiswa kweSlarara. Ikoko kwave kuriwo magwaro ekumhanya kwepamusoro ekuonekwa kwechimbichimbi chezvikamu zvakawanda zvinokonzerwa squamous cell carcinoma kune varwere vanobatwa naStera avo vakanga vagara varipo zvinokonzerwa nehutachiona hwekusava nemaranoma yechirwere cheganda . Vose varwere vanobatwa ne Stelara vanofanira kuongororwa nokuda kwechirwere chisingaoneki chinonzi melanoma.
Kuita kwehupenzi (eg, anaphylaxis uye angioedema ) zvakave zvichiratidzwa mumishumo yekusimudzira. Kana izvi zvichiitika, kurapa kwakakodzera kunofanira kupiwa kugadzirisa hypersensitivity reaction uye Stelara inofanira kubviswa.
Chimwe chiitiko cheReversible Posterior Leukoencephalopathy Syndrome yakashumwa mumurwere akawana madhora gumi nemaviri aSlara makore maviri. Murwere akazorora zvakakwana nekurapa kwakanaka uye kubviswa kweSlara.
Varwere vanorapwa ne Stelara havafaniri kugamuchira zvirwere zvinorarama, uyewo havafaniri kuve mune imwe imba yavo. Varwere havafaniri kugamuchira vachengeti veBBCG (Bacille Calmette Guerin) kwegore rimwe vasati varapwa ne Stelara kana kwegore rimwe mushure mokunge Stelara amiswa.
Izvo hazvina kuve nekugadzirisa kwakakwana kana kuchengetedzwa zvakanaka kweStrara kushandiswa mumadzimai ane pamuviri kana mucheche. Kuti iyo inoshandiswa panguva yekuzvitakura kana mukuyamwisa, kubatsirwa kunofanira kupfuurira kune ngozi inogona kuitika kumucheche.
Sources:
Stelara. Kunyora Mashoko. Yakarongedzwa 03/2014.
FDA Inobvumira Stelara. Drugs.com. Svondo 2009.
Stelara (ustekinumab) Inogamuchira FDA Chibvumirano Kubata Active Psoriatic Arthritis. Svondo 2013.