Inflectra - Remicade Biosimilar Yavomerezedwa ku Matenda a Matenda a Khunyu

by Chithunzi; Yofotokozedwa ndi Grant Hughes, MD

Komanso Yavomerezedwa ndi Matenda a Psoriatic, Ankylosing Spondylitis, ndi Zambiri

Mwachidule

Inflectra (infliximab-dyyb), biosimilar kwa Remicade (infliximab), inavomerezedwa ndi US Food and Drug Administration (FDA) pa April 5, 2016. Malinga ndi a FDA, "Chida cha biosimilar ndi mankhwala omwe amavomerezedwa powonetsa kuti ndi ofanana kwambiri ndi chipangizo cha bizinesi cha FDA-chovomerezeka, chomwe chimatchedwa kuti product product, ndipo alibe kusiyana kwakukulu pamagulu otetezeka ndi ogwira ntchito kuchokera ku bukhuli.

Kusiyana kwakukulu kochepa chabe m'zigawo zosavomerezeka za mankhwala ndizovomerezeka kuzinthu zosawerengeka. "Kukonzekera, mtengo wa TNF wopangidwa ndi Janssen Biotech, Inc., ndilo mankhwala otchedwa Inflectra.

Inflectra amapangidwa ndi Celltrion, Inc (yochokera ku Yeonsu-gu, Incheon, Republic of Korea) kwa Hospira Lake Lake, Illinois. Inflectra ndi biosimilar yachiwiri yomwe inavomerezedwa ku United States ndi FDA. Yoyamba, Zarxio, inavomerezedwa pa March 6, 2015 kuti izi ziwonetsedwe zokhudzana ndi khansa.

Zisonyezo

Inflectra imavomerezedwa ndipo ikhoza kulamulidwa kuti:

odwala mwakachetechete kuti azidwala kwambiri nyamakazi .
odwala okhala ndi ankylosing spondylitis .
odwala omwe ali ndi matenda a psoriatic .
Odwala achikulire omwe ali ndi psoriasis.
odwala achikulire kapena ana a zaka zisanu ndi chimodzi kapena kuposerapo mwakuya kuti adziwe matenda a Crohn's achulukira omwe sanachite bwino mankhwala ochiritsira.

achikulire omwe ali ndi mphamvu zolimbana ndi ulcerative colitis omwe sanagwiritse ntchito mankhwala oyenera.

Matenda a nyamakazi, Inflectra amagwiritsidwa ntchito kuchepetsa zizindikiro zomwe zimayambitsidwa ndi matendawa, kulepheretsa kuwonongeka kwa mgwirizano wokhudzana, ndi kupititsa patsogolo ntchito ya thupi. Odwala omwe ali ndi spondylitis ankylosing, Inflectra amasonyeza kuchepetsa zizindikiro.

M'maganizo a nyamakazi, matendawa angapangidwe kuti athe kuchepetsa zizindikiro ndi zizindikiro za nyamakazi yogwira mtima, kulepheretsa kuwonongeka kwa chilengedwe ndi kusintha ntchito ya thupi.

Mlingo ndi Utsogoleri

Chifukwa cha nyamakazi yotchedwa rheumatoid arthritis, Inflectra imatumizidwa ngati kulowetsedwa m'mimba (kuperekedwa kwa maola oposa 2) pa mlingo wa 3mg / kg woperekedwa pa 0, 2, ndi masabata asanu ndi limodzi. Pambuyo pake, mlingo wokwanira wa 3 mg / kg umaperekedwa milungu isanu ndi itatu. Odwala omwe amagwidwa ndi Inflectra chifukwa cha matenda a nyamakazi ayenera kutenga methotrexate . Odwala omwe alibe yankho lokwanira pa mlingo umene tanena kale akhoza kukhala ndi mlingo wokwana 10mg / kg kapena mlingo wokhala pakati pa mlingo wafupipafupi ukhoza kufupikitsidwa kwa milungu iwiri iliyonse. Kusintha kumeneku kungapangitse ngozi yovuta.

Kwa ankylosing spondylitis, mlingo woyenera ndi 5mg / makilogalamu monga kulowetsedwa m'mimba pa 0, 2, ndi masabata asanu ndi limodzi ndi mlingo wokwanira wa 5 mg / kg pamasabata asanu ndi limodzi. Mlingo womwe umalimbikitsidwa umakhalanso 5 mg / kg pa 0, 2, ndi masabata asanu ndi limodzi chifukwa cha nyamakazi ya psoriatic, koma mlingo wokonzanso wa 5 mg / kg umaperekedwa milungu isanu ndi itatu. Kwa nyamakazi yamaganizo, imatha kugwiritsidwa ntchito kapena popanda methotrexate.

Zochitika Zowonongeka Zowonongeka

Zomwe zimayambitsa mavuto ambiri, zokhudzana ndi mankhwala a infliximab, zimaphatikizapo matenda (chaputala cha kupuma, sinusitis, ndi pharyngitis), zomwe zimakhudzana ndi kulowetsedwa (kupuma pang'ono, kuthamanga, kupweteka), kupweteka mutu, ndi kupweteka m'mimba.

Contraindications

Mankhwalawa, oposa mlingo wa 5 mg / makilogalamu, sayenera kuperekedwa kwa odwala omwe ali ndi mtima wolephera kwambiri. Komanso, Inflectra sayenera kuperekedwa kwa odwala omwe ali ndi vuto la hypersensitivity reaction kwa Remicade (infliximab). Mafupawa sayenera kuperekedwa kwa aliyense amene amadziwika kuti ali ndi mankhwala osokoneza bongo.

Machenjezo

Pali machenjezo ndi zowonongeka zomwe zakhazikitsidwa pofuna kutsimikizira kuti ntchito ya Inflectra imakhala yotetezeka. Machenjezo awa ndi awa:

Kuopsa kokhala ndi matenda akuluakulu - Inflectra sayenera kuperekedwa pa nthawi yogwira ntchito. Komanso, ngati matenda akugwiritsidwa ntchito pogwiritsa ntchito Inflectra, ayenera kuyang'anitsitsa mosamala ndipo ngati yayamba kukhala yaikulu, Inflectra iyenera kuyimitsidwa. Matenda osadziwika (matenda omwe amapezeka mwamphamvu kapena kawirikawiri mwa iwo omwe ali ndi mphamvu zoteteza thupi lawo) akhala akudziwika kwa odwala omwe ali ndi TNF blockers. Komanso, kubwezeretsa chifuwa chachikulu cha TB kapena matenda atsopano a chifuwa chachikulu cha TB chimachitika ndi kugwiritsa ntchito mankhwala osokoneza bongo.

Matenda oopsa a fungus - Ngati wodwala akudwala matenda ochizira matenda pogwiritsa ntchito Inflectra, mankhwala ophera fungalidwe ayenera kuganiziridwa kwa anthu okhala m'madera omwe matendawa amawopsa.
Malignancies - Chiwerengero cha ziwanda, kuphatikizapo lymphoma, chinapezeka kuti chikukula kwambiri kwa odwala omwe ali ndi TNF blockers kusiyana ndi kulamulira. Mavuto / chithandizo cha Inflectra ayenera kufufuzidwa, makamaka kwa odwala omwe ali ndi zina mwa mbiri yawo yachipatala.
Matenda a hepatitis B (HBV) omwe angayambirenso - Odwala ayenera kuyesedwa kwa kachirombo ka Hepatitis B musanayambe Inflectra. Zonyamulira za HBV ziyenera kuyang'aniridwa nthawi ndi miyezi ingapo mutatha kugwiritsa ntchito Inflectra. Ngati kubwezeretsa kwa HBV kumachitika, Inflectra iyenera kuthetsedwa ndipo mankhwala opatsirana pogonana amayamba.
Hepatotoxicity - Kawirikawiri zochita zowopsya zimatha kuchitika. Ena angakhale opha kapena amafunika kuika chiwindi. Ndi chitukuko cha jaundice kapena kuchuluka kwa michere ya chiwindi , Inflectra iyenera kuyimitsidwa.
Kulephera kwa mtima - Kulephera kwa mtima kwatsopano kapena kuwonjezereka kwa mtima wosagonjetsedwa kungayambe kugwiritsidwa ntchito kwa Inflectra.
Cytopenias - Pangakhale kuchepetsa chiwerengero cha maselo a magazi pogwiritsa ntchito Inflectra. Odwala ayenera kupita kuchipatala ngati zizindikiro zikuyamba.
Hypersensitivity - Kutaya kwakukulu kwa kulowetsedwa kungawonjezeke, kuphatikizapo anaphylaxis kapena matenda a serum-monga momwe amachitira.
Kuwonetsa matenda - Kuyambika kwatsopano kapena kuwonjezeka kwa matenda othetsera matenda omwe alipo alipo angathe kugwiritsidwa ntchito pogwiritsa ntchito Inflectra.
Matenda a Lupus - Matenda okhudzana ndi lupus- monga zizindikiro angapangitse pogwiritsa ntchito Inflectra. Mankhwalawa ayenera kuimitsidwa ngati matenda akukula.
Katemera wathanzi kapena othandizira odwala opatsirana - Osaperekedwe ndi Inflectra. Ana ayenera kukhala ndi nthawi zonse katemera asanayambe Inflectra. Ngati mwana wakhanda akuwonekera ku Inflectra kapena infliximab, ayenera kukhala osachepera miyezi 6 kuchokera pamene akubadwa asanalandire chithandizo chilichonse chamoyo.

Inflectra ali ndi bokosi lamdima lakuda ponena za chiopsezo chowonjezereka cha matenda akuluakulu ndi matenda a lymphoma, komanso chigamulo choyesera chifuwa chachikulu cha TB asanayambe kumwa mankhwala.

Kuyanjana kwa Mankhwala

Kuphatikiza kwa Inflectra ndi anakinra kapena Orencia (abatacept) sikunakonzedwe. Kugwiritsiridwa ntchito kwa Actemra (tocilizumab) ndi Inflectra kuyenera kupeŵedwa chifukwa cha kuwonjezeka kwa chiopsezo cha thupi komanso kuwonjezeka kwa chiopsezo. Inflectra sayenera kuphatikizidwa ndi mankhwala ena a biologic .

Mfundo Yofunika Kwambiri

Akatswiri a zamoyo akhala akukula kwa zaka zambiri chifukwa cha nyamakazi ya nyamakazi. Kukhala ndi biosimilar yoyamba kumapeto kwa FDA ndizofunika kwambiri. Kuchokera muwona wodwalayo, zolemba zamaphunziro zimapereka njira zowonjezereka za mankhwala (ndicho chinthu chabwino!) Ndipo mtengo uyenera kukhala wochepa kuposa mankhwala oyambirira a biologic (icho ndi chinthu china chabwino!). Komabe, sizibwera popanda kutsutsana. Anthu akhala akudandaula ndi momwe anthu ena amadziwira ngati zamoyo zidzakhala zofanana. Ganizirani za mankhwala omwe amachititsa kuti azitha kumwa mankhwala a m'kamwa - kodi ali othandizira mofanana? Izi zakhala zokambirana kwa zaka zambiri. A FDA akunena kuti "odwala komanso akatswiri azaumoyo adzatha kudalira chitetezo ndi kugwiritsira ntchito mankhwala osokoneza bongo, monga momwe angafunire mankhwala." Ndipotu, mankhwala osokoneza bongo amavomerezedwa malinga ndi umboni wakuti "ndi ofanana kwambiri" ndi mankhwala osokoneza bongo. Kodi ndi ofanana kwambiri ndi ofanana?

Palinso gulu lina, limene FDA limatchula mankhwala osinthasintha. Malinga ndi a FDA, "Chida chosinthika chosinthika chimagwiritsa ntchito mankhwala omwe amavomerezedwa ndi FDA ndipo amakumana ndi miyezo yowonjezereka yosinthana. bukulo. "

Mwina ndizosokoneza panthawiyi. Monga nthawi zonse, malangizo athu ndi kukambirana zadokotala ndi dokotala wanu kapena rheumatologist. Ndikofunikanso kuti mudzidziwe ndi mayankho ochokera ku bungwe la rheumatology pankhani ya chivomerezo cha Inflectra ndi biosimiliars. Werengani mawu awa kuchokera ku Joan Von Feldt, MD, MSEd, Purezidenti wa American College of Rheumatology.

> Zotsatira:

_{Mauthenga okhudza kufotokozera.} _04/2016. _{http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf}

_{FDA ikuvomereza Inflectra, Biosimilar to Remicade.} _04/05/2016. _{http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm}

_{Information on Biosimilars.} _FDA. _{Kusinthidwa 2/22/2016.} _{http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/}

_{FDA imavomereza zoyamba zogulitsa Zarxio.} _FDA. _03/06/2015. _{http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm}