Uyewo Yakagamuchirwa nePororiatic Arthritis, Ankylosing Spondylitis, nezvimwe
Overview
Inflectra (infliximab-dyyb), biosimilar kuna Remicade (infliximab), yakagamuchirwa neU.S. Food and Drug Administration (FDA) musi waApril 5, 2016. Maererano neDFA, "Bhiosimilar chigadzirwa chigadzirwa chezvinyorwa chinogamuchirwa pane kuratidza kuti yakakodzana zvikuru neye FDA-inogamuchirwa chigadzirwa chemagetsi, inozivikanwa semutauro wekutarisa, uye haina magirisiro ezvakagadzirwa nehutano maererano nekuchengeteka uye kubudirira kubva pane zvinyorwa.
Kusiyana kwechidiki bedzi muzvipatara zvisingabatsiri zvinogamuchirwa mune zvigadzirwa zve biosimilar. "Remicade, iyo blocker yeTNF inogadzirwa naJanssen Biotech, Inc., ndiyo inotaura nezvemishonga ye Inflectra.
Inflectra inoumbwa naCaltrion, Inc (inowanikwa muYeonsu-gu, Incheon, Republic of Korea) yeHotpira yeLake Forest, Illinois. Inflectra ndiyo biosimilar yechipiri yakagamuchirwa muUnited States neCDA. Yokutanga, Zarxio, yakagamuchirwa musi waMarch 6, 2015 nekuda kwezviratidzo zvakanangana nekenza.
Zviratidzo
Inflectra inogamuchirwa uye inogona kunyorwa kune:
- varwere vane unyanzvi kuti vaite zvakanyanya rheumatoid arthritis .
- varwere vane ankylosing spondylitis inoshanda .
- varwere vane active psoriatic arthritis .
- vakuru varwere vane chirwere chisingaperi chine plaque psoriasis.
- varwere vakura kana vana vane makore matanhatu nekure uye vane mwero kusvika kune chirwere chakanyanya kurwara cha Crohn chakanga chisina kukwana kugadziriswa kwechirwere chinowanzoitika.
- vanhu vakuru vane mwero kuti vaite zvakakomba chironda chepachirwere chirwere chisina kukodzera kugadziriswa kwechirwere chinowanikwa.
Nokuda kwerheumatoid arthritis, Inflectra inoshandiswa kuderedza zviratidzo nezviratidzo zvine chokuita nechirwere, zvinodzivisa kufambira mberi kwekubatana kwekubatana, nekuvandudza basa remuviri. Mune varwere vane ankylosing spondylitis, Inflectra inoratidzwa kuderedza zviratidzo nezviratidzo.
Mune psoriatic arthritis, Inflectra inogona kurongerwa kuti kuderedze zviratidzo uye zviratidzo zvekushanda kweArthritis, zvinodzivisa kufambira mberi kwechimiro chekugadzirisa uye kunatsiridza basa remuviri.
Dosage uye Administration
Nokuda kwerheumatoid arthritis, Inflectra inoshandiswa seinopera inopisa (yakapiwa nguva inenge maawa maviri) pamutengo we 3mg / kg yakapiwa pa1, 2, uye 6 masvondo. Shure kwaizvozvo, chirwere chekuchengetedza che 3 mg / kg chinotarisirwa masvondo masere ose. Varwere vanorapwa ne Inflectra ye rheumatoid arthritis vanofanirawo kutora methotrexate . Varwere vasina kukwana mhinduro pamutengo wakataurwa pamusoro apa vanogona kunge vane chirwere chakashandurwa kusvika kusvika 10mg / kg kana nguva inenge iri pakati peiyo inogona kuderedzwa kumasvondo mana. Iko kugadziriswa kunogona kuwedzera njodzi yekukanganisa kwakaipa.
Pamusana peplondylitis ankylosing, chirongwa chinoridzirwa chinokwana 5mg / kg sechirwere chinoputika pa 0, 2, uye masvondo matanhatu akazotevera chirwere chekuchengetedza cha 5 mg / kg pamasvondo matanhatu. Nhamba yakakurudzirwa ihwohwo 5 mg / kg pa 0, 2, uye 6 masvondo ye psoriatic arthritis, asi chirwere chekuchengetedza cha 5 mg / kg chinopiwa mavhiki masere. Pamusoro pemapuroriyamu arthritis, inogona kushandiswa kana kuti isina methotrexate.
Zvinowanzovhiringidza Kuchinja
Kukanganisa kwakaipisisa kunowanzoitika, zvichibva pamakiriniki ekuedzwa kwezvigadzirwa zve infliximab, zvinosanganisira zvirwere (kumusoro kuputika, sinusitis, uye pharyngitis), kutaridzika kwehutachiona (kufema kufema, kuputika, kuputika), kurwadziwa musoro, uye kurwadziwa mumimba.
Contraindications
Inflectra, pamadhora makuru kupfuura 5 mg / kg, haafaniri kupiwa kuvarwere vane muongorori kusvika kune mwoyo wakaremara. Uyezve, Inflectra haifaniri kupiwa kuvarwere vane chirwere chakaipa chekuita remicade (infliximab). Inflectra haifaniri kutarisirwa kune ani naani anozivikanwa hypersensitivity kune chero zvisiri izvo zvinoshandiswa mumushonga kana kuti murine (rodent) mapuroteni.
Manyevero
Zvimwe nyevero uye matanho akachengetwa kuti ave nechokwadi chekushandiswa kwakachengeteka kweElectlectra. Izvo nyevero dzinosanganisira:
- Dambudziko rekukudziridza zvirwere zvakakomba - Inflectra haifaniri kutarisirwa panguva yehutachiona hwehutachiona. Uyezve, kana utachiona huchiri kuitika apo uchishandisa Inflectra, inofanira kuongororwa zvakanyatsonaka uye kana ikava yakakomba, Inflectra inofanira kumira. Zvirwere zvinopesana (zvirwere zvinowanzoitika zvakanyanya kana kuti kazhinji kune avo vane simba rekudzivirira zvirwere) zvakataurwa kune varwere vanobatwa neTNF blockers. Uyezve, kuiswazve kwechirwere chetachiona kana kuti hutachiona hwehutachiona hwakaitika nekushandiswa kwezvigadzirwa zve infliximab.
- Kuvhiringidzika kwezvirwere zvinokonzera - Kana murwere achikura chirwere chetsika paanenge achishandisa Inflectra, anti-fungal therapy inofanira kufungidzirwa kune avo vanogara munzvimbo dzinenge dzisina kufanira.
- Kunyadzisa - Chiitiko chezvakaipa, kusanganisira lymphoma, zvakawanikwa kuva mukuru kune varwere vanobatwa neTNF blockers kupfuura mukuraira. Iyo ngozi / kubatsirwa kwekushandisa Inflectra inofanira kuongororwa, kunyanya kune varwere vane zvimwe zviitiko mune zvakaitika mune zvehutano.
- Hepatitis B virus (HBV) kugadzirisa - Varwere vanofanira kuongororwa nehutachiona hweHepatitis B vasati vatanga Inflectra. Kutakura kweHBV kunofanira kuongororwa panguva uye kwemwedzi inoverengeka mushure mekushandisa Inflectra. Kana kugadziriswa kweHBV kuchiitika, Inflectra inofanira kuregwa uye kupesana kwehutachiona hwakatanga.
- Hepatotoxicity - Kazhinji zvakanyanya kuitika zvinogona kuitika. Zvimwe zvinogona kunge zvinouraya kana zvinoda kuwedzerwa kwechiropa. Nekuvandudzwa kwe jaundice kana kuti yakakura yakakura yevirumusi yeukitiri, Inflectra inofanira kumira.
- Kukundikana kwemoyo - Kusava nemwoyo wose kusakundikana kana kukura kwezviratidzo zvekushaya kwemoyo ikozvino kunogona kuitika nekushandiswa kwe Inflectra.
- Cytopenias - Pangangodaro kuve nekuderedza kuwanda kwemasero eropa ane kushandiswa kweAlectlectra. Varwere vanofanira kutsvaga kurapwa kana zviratidzo zvichiitika.
- Hypersensitivity - Kukanganisa kwakakomba kunogona kukura, kusanganisira anaphylaxis kana serum chirwere-shanduko yakafanana.
- Kuderedza hutachiona - Kutanga mutsva kana kuwedzera kwezvirwere zvinokonzerwa nehutachiona zvinogona kuitika nekushandiswa kweElectlectra.
- Lupus-like syndrome - A syndrome inosangana ne lupus -sezviratidzo zvinogona kukura nekushandiswa kwe Inflectra. Mishonga inofanira kumira kana chirwere chichikura.
- Urarame zvirwere kana kurapwa kwehutachiona hwehutachiona - Hahufaniri kupiwa ne Inflectra. Vana vanofanirwa kunge vachikwanisa kupedza zvirwere zvose vasati vatanga Inflectra. Kana mwana mucheche akaonekwa muUtero kune Inflectra kana kuti infliximab, inofanira kunge iine mwedzi mwedzi mitanhatu yakamirira mushure mekuberekwa vasati vapiwa chirwere chekurarama.
Inflectra inotakura bhokisi rakasvibiswa maererano nehuwandu hwehutachiona hwehutachiona uye lymphoma, uyewo murairo kuti uongorore hutachiona hutachiona husati watanga usati watanga mishonga.
Kubatana Kwemishonga
Kusanganiswa kweChreera ne anakinra kana Orencia (abatacept) hakurudzirwi . Kushandiswa kweCamememra (tocilizumab) neApplectra kunofanira kudziviswa nekuda kwekuwedzera kwekudzivirirwa kwezvirwere uye kuwedzerwa njodzi yehutachiona. Inflectra haifaniri kuiswa pamwe nezvimwe zvinodhaka zvebiologic zvakare.
The Bottom Line
Biosimilars ave ari mukurudzirwa kwemakore ye rheumatoid arthritis. Kuve ne biosimilar yekupedzisira pakupedzisira FDA inogamuchirwa chinhu chikuru. Kubva pane maonero evarwere, biosimilars inopa zvimwe zvirongwa zvekurapa (icho chinhu chakanaka!) Uye mutengo unofanira kunge wakaenzana kupfuura wepakutanga biologic zvinodhaka (ndicho chimwe chinhu chakanaka!). Asi, haisi kuuya pasina gakava. Pakave nekushushikana kwakaratidzwa nevamwe vanhu pamusoro pekuti zvii biosimilars zvichave zvakaenzana zvechokwadi. Chimbofunga zvinowanzoenderana nezita rechirwere mishonga yemuromo - zvinoshanda zvakaenzana here? Izvo zvave zvakakumbiriswa kwemakumi emakore. IA FDA inotaura kuti "varwere uye vashandi vezvoutano vachakwanisa kuvimba nekuchengeteka uye kubudirira kwezvigadzirwa zve biosimilar kana kushandurana, sezvakangoita zvinotaurwa." Ichokwadi, chirwere che biossimlar chinogamuchirwa zvichienderana nehuchapupu "chakanyatsofanana" kune zvinotaurwa nemishonga. Izvo zvakafanana zvakafanana zvakafanana here?
Kune imwezve chikwata, icho FDA inoshevedza mishonga inoshandurudzwa. Maererano neDFA, "Chigadzirwa chinoshandurudzika chinonzi biosimilar kune FDA-inogamuchirwa chigadzirwa chekushandisa uye inosangana nemimwe mitemo yekushandurana. the reference product. "
Zvichida zvichinyanyisa panguva ino. Sezvo nguva dzose, zano redu nderokurukurirana mazvigadzirwa zvehupenyu newachiremba wako kana rheumatologist. Zvakakoshawo kuti iwe uzvizive nemhinduro kubva munharaunda ye rheumatology pamusoro pekugamuchirwa kwe Inflectra uye remangwana biosimiliars. Verenga iri mazwi kubva kuna Joan Von Feldt, MD, MSEd, Mutungamiri weAmerican College yeRheumatology.
> Sources:
Kunyora Kuzvinyora Mashoko. 04/2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
FDA Inobvumira Inflectra, Biosimilar kuRicidade. 04/05/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
Ruzivo pamusoro pezvinyorwa zveBhiosimilars. FDA. Yakavandudzwa 2/22/2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
FDA inobvumira kutanga Biosimilar Product Zarxio. FDA. 03/06/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm