Amjevita (adalimumab-atto), biosimilar kwa Humira (adalimumab) , yavomerezedwa ndi FDA kwa matenda a nyamakazi ndi matenda osiyanasiyana kutupa. Amjevita anakhala biosimilar yachinayi kuti ivomerezedwe ndi FDA. Zosayansi, ndi tsiku lawo lovomerezeka la FDA, ndi:
- Zarxio (filgrastim-sndz) - March 6, 2015
- Inflectra (infliximab-dyyb) - April 5, 2016
- Erelzi (etanercept-szzs) - August 30, 2016
- Amjevita (adalimumab-atto) - September 23, 2016
Zarxio, mosiyana ndi enawo, satchulidwa chifukwa cha matenda a rheumatic , koma makamaka ndi kukula kwa leukocyte. Inflectra ndi biosimilar kwa Remicade (infliximab) . Erelzi ndi biosimilar kwa Enbrel (etanercept) . Enbrel, Remicade, ndi Humira ndi mankhwala osokoneza bongo , omwe amadziwika ngati TNF .
Zizindikiro za Amjevita
Amjevita amasonyezedwa kuti azisamalira:
- Matenda a Nyamakazi - Kuti athe kuchepetsa zizindikiro, amalepheretseratu kuwonongeka kwa chilengedwe, ndikupangitsanso kuti thupi likhale labwino kwa akuluakulu moyenera kuti azidwala nyamakazi.
- Nthano Yachiberekero ya Idiopathic Arthritis (JIA) - Kuchepetsa zizindikiro ndi zizindikiro zabwino kuti agwire mwamphamvu polyarticular JIA kwa ana a zaka 4 kapena kuposerapo.
- Psoriatic Arthritis - Pochepetsa zizindikiro, zimapangitsa kuti chiwonongeko chiwonongeke, ndikupangitsanso kuti thupi likhale labwino kwa akuluakulu omwe ali ndi nyamakazi ya psoriatic.
- Ankylosing Spondylitis - Kuchepetsa zizindikiro ndi zizindikiro kwa akuluakulu omwe ali ndi antkylosing spondylitis yogwira ntchito.
- Matenda a akulu a Crohn - Kuchepetsa zizindikiro ndi zizindikiro; Kuwongolera ndi kusunga chikhululukiro chachipatala kwa akuluakulu mwachangu kuti adwale matenda a Crohn omwe sanagwire ntchito yowonongeka, kapena ataya yankho lawo ku Remicade, kapena sangathe kulekerera Remicade.
- Ulcerative Colitis - Kupanga ndi kusunga chikhululukiro chachipatala kwa anthu akuluakulu omwe ali ndi matenda oopsa opatsirana ndi zilonda zam'mimba omwe sagwiritsidwe ntchito moyenera kwa ma immunosuppressants.
- Plaque Psoriasis - Kwa anthu akuluakulu omwe ali ndi vuto lachilendo lachilombo chachikulu la plaque psoriasis omwe ali oyenerera kuti athe kugwiritsa ntchito njira zochizira; Komanso, pamene njira zina zowonongeka zimayesedwa zosayenera.
Malingaliro Ovomerezedwa ndi Utsogoleri
Amjevita imayendetsedwa ndi subcutaneous jekeseni. Amapezeka ngati mlingo wa 40 mg / 0,8 mL pogwiritsira ntchito imodzi yogwiritsiridwa ntchito SureClick autoinjector, monga mlingo wa 40 mg / 0,8 mL mu siringi yomwe imagwiritsidwa ntchito imodzi yokha, ndi 20 mg / 0,4 mL mu galasi logwiritsidwa ntchito limodzi sirinji.
Mlingo woyenera wa Amjevita wodwala nyamakazi, nyamakazi ya psoriatic, ndi ankylosing spondylitis ndi 40 mg sabata iliyonse. Ngati muli ndi nyamakazi yambiri ndipo musatenge methotrexate , mlingo wochuluka wa 40 mg mlungu uliwonse ukhoza kuganiziridwa.
Kwa ana omwe amalemera pakati pa mapaundi 33 ndi mapaundi 65, mlingo woyenera wa Amjevita ndi 20 mg. sabata iliyonse. Mlingo wa ana omwe amalemera mapaundi 66 kapena kuposa ndi 40 mg. sabata iliyonse.
Kwa matenda a Crohn ndi ulcerative colitis, pa Tsiku 1 la mankhwala ndi Amjevita, mlingo ndi 160 mg.
(Zindikirani: zikhoza kugawidwa mu 80 mg pa masiku awiri otsatizana, tsiku la 15, mlingo ndi 80 mg, ndipo pa Tsiku 29, mumayamba mlingo woyenera wa 40 mg sabata iliyonse. Kwa anthu okhala ndi psoriasis , mlingo woyambira ndi 80 mg ndipo patatha mlungu umodzi kumayambiriro kwa mlingo, mlingo woyenera ndi 40 mg sabata iliyonse.
Zotsatira Zachimake, Zochitika Zoipa, ndi Contraindications
Zovuta zomwe zimachitika ndi Amjevita zimaphatikizapo matenda (monga sinusitis kapena matenda opuma kupuma), momwe amajambulira malo, kupweteka mutu, ndi kupweteka. Palibe zotsutsana zomwe zili muzinthu zofotokozera Amjevita.
Chenjezo ndi Kusamala
Amjevita amabwera ndi Chenjezo la Black Box, chenjezo lalikulu kwambiri lochokera kwa FDA.
Chochenjeza bokosi lakuda ndizo matenda akuluakulu komanso zoopsa. Kuwonjezera apo, Amjevita ikugwirizana ndi chiopsezo choopsa cha matenda omwe angabweretse kuchipatala kapena imfa, kuphatikizapo TB (chifuwa chachikulu cha TB), matenda opatsirana ndi mabakiteriya, matenda opatsirana (monga histoplasmosis), ndi matenda omwe amabwera chifukwa cha tizilombo toyambitsa matenda. Chenjezo limalangizanso kuleka kwa Amjevita ngati matenda aakulu kapena sepsis amayamba panthawi ya mankhwala. Chiyeso cha TB yofiira imalimbikitsidwa musanayambe mankhwala ndi Amjevita. Komanso, omwe amachizidwa ndi Amjevita ayenera kuyang'anitsitsa kuti agwiritse ntchito TB, ngakhale kuti chifuwa chawo cha TB choyipa ndi choipa.
Ponena za chenjezo la malignancy, pakhala pali malipoti a lymphoma ndi ziwanda zina (zina mwazo zinali zakupha) ana ndi achinyamata akuchitidwa ndi TNF blockers. Komanso, pakhala pali malonda a mtundu wa T-cell lymphoma, omwe amatchedwa HSTCL (hepatosplenic T-cell lymphoma), ali achinyamata komanso achinyamata omwe ali ndi matenda opatsirana omwe amachititsa opaleshoni ndi TNF.
Zochenjeza zowonjezereka zinaperekedwa mufotokozera mfundo:
- Musayambe Amjevita panthawi yogwira ntchito.
- Amjevita iyenera kuimitsidwa ngati kachilombo kamakhala koopsa.
- Mankhwala oletsa fungalidwe ayenera kuganiziridwa kwa anthu omwe amayamba matenda opatsirana pogwiritsidwa ntchito ndi Amjevita ndikukhala kapena kupita kumadera kumene matenda opatsirana amapezeka.
- Zomwe zimayambitsa matenda kapena anaphylaxis zingachitike ndi Amjevita.
- Kukhazikitsidwa kwa chiwindi cha B hepatitis B kungatheke pothandizidwa ndi Amjevita. Othandizira a HBV ayenera kuyang'aniridwa.
- Kuyambika kwatsopano kapena kuwonjezeka kwa matenda othetsa chiwonongeko kungachitike ndi Amjevita.
- Kuwonongeka kwa magazi kungachitike, kuphatikizapo cytopenias (kuchepa kwa maselo a magazi) ndi pancytopenia (chiwerengero chochepa cha maselo ofiira ofiira, maselo oyera a magazi, ndi mapuleti).
- Kuyambika kwatsopano kapena kupweteka kwa mtima kungapangidwe pamene akuchitiridwa ndi Amjevita.
- Matenda a Lupus angapangidwe pamene akuchiritsidwa ndi Amjevita, kufuna kuti asiye.
Kuyanjana kwa Mankhwala
Pali chiopsezo chowonjezereka cha matenda akuluakulu pogwiritsa ntchito TNF blockers ndi Kineret (anakinra) kapena Orencia (abatacept) . Choncho, Amjevita sayenera kugwiritsidwa ntchito ndi anakinra kapena abatacept. Komanso, katemera amafunika kupewa ndi kugwiritsa ntchito Amjevita.
Mfundo Yofunika Kwambiri
A biosimilar amavomereza kuvomereza umboni womwe umatsimikizira kuti mankhwalawa ndi "ofanana kwambiri" ndi mankhwala omwe amavomerezedwa kale, omwe amatchedwa mankhwala owonetsera. Chivomerezo chimanena kuti palibe kusiyana kwakukulu pakati pa biosimilar ndi mankhwala omwe amatchula mankhwala.
Izi zati, pakhala chisokonezo ndi mafunso ozunguliridwa ndi maganizo a zamoyo, ngakhale asanaloweredwe. Kodi pali umboni wokwanira wokwanira wakuti biosimilar ndi mankhwala otchulidwa mankhwala ndi ofanana? Pogwiritsa ntchito malingaliro, kodi biosimilar yosinthika ndi mankhwala ake otchulidwa? Kodi makampani a inshuwalansi adzakakamiza kugwiritsa ntchito zamoyo chifukwa cha kuchepa mtengo?
Izi ndi mafunso akulu kwambiri ndipo amakhalabe mafunso. Ngakhale kuti biosimilar ingathe kuwerengedwa kwa wodwala wodwala kumene, kodi ndibwino kuyembekezera wodwala amene akuchita bwino pa biologic kuti asinthe ku biosimilar yake?
Kumapeto kwa 2016, panali kulumikizidwa kofewa kwa Inflectra. Erelzi sichidzayambanso chisanafike chaka cha 2018 pamene ikugwirizana ndi amgen. Kusinthasintha kwenikweni kwa akatswiri a zamoyo ndi mankhwala awo othawiritsira ntchito sayenera kukhazikitsidwa mwa njira zomwe zimasiya odwala ndi madokotala kukhala ndi chidaliro chonse. Mwina patapita nthawi, izi zidzasintha. Pakalipano, kambiranani ndi dokotala kuti muone zomwe mungachite bwino.
> Zotsatira:
> Amjevita. Kufotokozera Information. Amgen. Revised 9/2016.
> Palmer, Eric. > Sandoz mutu: Enbrel biosimilar Erelzi sangayambitse mchaka cha 2018, kuchedwa ndi nkhondo . > FiercePharma. January 25, 2017.
> Shaw, Gina. Biosimilar Infliximab Imayesetsa Kuchita Zinthu Mogulitsa. Specialty Pharmacy Continuum. January 23, 2017.