Mankhwala Osakaniza a Psoriasis ndi Psoriatic Arthritis
Stelara (ustekinumab), mankhwala ojambulidwa ndi jekeseni, adavomerezedwa ndi US Food and Drug Administration (FDA) pa September 25, 2009, pofuna kuchiza psoriasis yapamwamba kwambiri. Chomera chotchedwa plaque psoriasis, chomwe chimakhudza anthu pafupifupi 6 miliyoni ku US, ndicho chitetezo cha mthupi chomwe chimayambitsa kuchulukanso kwa maselo a khungu.
Masamba a psoriasis amakhala ndi zikopa zofiira za khungu lofiira, lomwe limaphimbidwa ndi mamba omwe amaoneka ngati silvery. Maphunziro atatu okhudza odwala 2,266 anazindikira kuti Stelara ndi wotetezeka komanso wogwira mtima, ndipo pamapeto pake amachititsa kuti azivomerezedwa ndi psoriasis.
Patatha zaka zinayi, pa September 23, 2013, adalengezedwa kuti FDA inavomereza Stelara, yekha kapena kuphatikizapo methotrexate , pofuna kuchiza odwala achikulire omwe ali ndi nyamakazi ya psoriatic . Anthu oposa 2 miliyoni ku US ali ndi nyamakazi ya psoriatic, matenda omwe amadziwika ndi kutukudzidwa pamodzi ndi kuwonongeka kwa mgwirizano, komanso zilonda zakhungu zomwe zimapezeka ndi psoriasis. Mayesero awiri ofunika kwambiri omwe amachititsa kuti azimayi azikhala ndi maulendo awiri, omwe amachititsa kuti asamangidwe, omwe amatha kuyendetsa malo awo (PSUMMIT I ndi PSUMMIT II). Odwala 927 omwe ali ndi matenda a psoriatic anazindikira kuti Stelara anali wotetezeka komanso wogwira mtima.
Janssen Biotrech, Inc. anapeza ndikukula Stelara. Wopanga mankhwalawa amagwiritsa ntchito ufulu wokonda malonda ku mankhwalawa ku US The Janssen Pharmaceutical Companies ali ndi ufulu wopezera malonda padziko lonse.
Kodi Stelara N'chiyani?
Stelara ndi anti-monoclonal antibody . Zowonjezerapo, Stelara ndi mdani wa interleukin wotsutsana ndi IL-12 ndi IL-23, mapuloteni awiri omwe amalingaliridwa kuti amathandiza pazifukwa zina zotupa, kuphatikizapo psoriasis ndi psoriatic nyamakazi.
Momwe Mankhwala Amagwiritsidwira
Stelara imayendetsedwa ngati jekeseni ya subcutaneous (mwachitsanzo, pansi pa khungu). Odwala psoriasis omwe amalemera masentimita 220. (Makilogalamu 100) kapena osachepera, mlingo woyenera komanso mlingo wotsatira pakatha masabata 4 ndi 45 mg., Wotsatira 45 mg. masabata khumi ndi awiri. Kwa odwala omwe amalemera zoposa 220 lbs. (Makilogalamu 100), mlingo woyenera wa mlingo woyenera ndi mlingo wotsatira pamasabata 4 ndi 90 mg., Wotsatira 90 mg. masabata khumi ndi awiri.
Kwa odwala psematic arthritis, mlingo woyenera wa Stelara ndi 45 mg. poyamba komanso pamasabata 4, kenako 45 mg. masabata khumi ndi awiri. Kwa odwala omwe ali ndi psoriasis komanso psoriatic nyamakazi ndipo amatha kupitirira 220 lbs., Mlingo woyenera komanso mlingo wa masabata 4 pambuyo pake ndi 90 mg., Wotsatira 90 mg. masabata khumi ndi awiri.
Stelara ilipo mu 45 mg / 0.5mL osagwiritsidwa ntchito limodzi, seringiri yodzazidwa kale ndi 90 mg / mL osagwiritsiridwa ntchito sirinji yodzazidwa. Stelara imapezekanso m'magwiritsidwe osakwatira omwe ali ndi 45 mg / 0.5mL kapena 90 mg / mL ya Stelara.
Amene Sagwiritse Ntchito Stelara
Anthu omwe amadziwika kuti hypersensitivity kwa ustekinumab kapena zosakaniza zosafunikira ku Stelara sayenera kugwiritsa ntchito mankhwalawa. Zosakaniza zophatikizapo zikuphatikizapo L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, ndi sucrose.
Zotsatira Zogwirizana
Zotsatira zofanana zomwe zimagwirizanitsidwa ndi Stelara zikuphatikizapo nasopharyngitis, matenda opuma opuma, mutu, ndi kutopa. Zotsatira zina ndizotheka. Lankhulani ndi dokotala wanu ngati mukukumana ndi zotsatira zina zomwe zingagwirizane ndi Stelara.
Chenjezo ndi Kusamala
Stelara ingapangitse chiopsezo chotenga matenda ndi kubwezeretsanso matenda opatsirana (osagwira ntchito kapena othawa). M'mayesero a zachipatala, mabakiteriya aakulu, fungal, ndi mavairasi anawonedwa mwa odwala ena omwe ankachitidwa ndi Stelara. Mankhwalawa sayenera kuperekedwa kwa wodwalayo ndi matenda opatsirana ndipo ayenera kuganiziridwa mosamala kwa odwala omwe ali ndi matenda aakulu kapena mbiri ya matenda aakulu kapena obwerezabwereza.
Asanayambe kulandira chithandizo ndi Stelara, odwala ayenera kuyesedwa TB . Kuchiza kwa TB yoyenera kuyenera kuyambitsa chithandizo ndi Stelara.
Malingana ndi mayesero a kachipatala, chiopsezo choyipa chikhoza kuwonjezeka ndi kugwiritsidwa ntchito kwa Stelara. Palipanso mauthenga omwe amawabweretsera posakhalitsa omwe amawoneka ngati odwala matenda a khansa ya khungu . Odwala onse omwe amathandizidwa ndi Stelara ayenera kuyang'aniridwa chifukwa cha khansa ya khungu yopanda khansa ya khansa.
Zochita za Hypersensitivity (mwachitsanzo, anaphylaxis ndi angioedema ) zakhala zikudziwika mu malipoti apambuyo. Ngati izi zikuchitika, mankhwala oyenerera ayenera kuperekedwa pofuna kuthetsa vuto la hypersensitivity reaction ndipo Stelara ayenera kusiya.
Chitsanzo chimodzi cha Reversible Posterior Leukoencephalopathy Syndrome chinafotokozedwa mwa wodwala amene analandira mayeso 12 a Stelara zaka ziwiri. Wodwalayo anachira bwinobwino ndi mankhwala abwino komanso kusiya Stelara.
Odwala omwe amachiritsidwa ndi Stelara sayenera kulandira katemera wathanzi, komanso palibe aliyense m'banja lawo. Odwala sayenera kulandira katemera wa BCG (Bacille Calmette Guerin) chaka chimodzi asanayambe mankhwala ndi Stelara kapena kwa chaka chimodzi Stelara atayimitsidwa.
Sipanakhale maphunziro okwanira kapena olamuliridwa bwino a Stelara pogwiritsa ntchito amayi oyembekezera kapena oyamwitsa. Kuti ligwiritsidwe ntchito panthawi yomwe ali ndi mimba kapena akuyamwitsa, phinduli liyenera kuwonjezera pa chiopsezo cha mwanayo.
Zotsatira:
Stelara. Kufotokozera Information. Zosinthidwa 03/2014.
FDA imavomereza Stelara. Drugs.com. September 2009.
Stelara (ustekinumab) amalandira chivomerezo cha FDA kuti athetse nyamakazi yogwira mtima. September 2013.