Har ila yau an yarda da cututtuka na Psoriatic, Ankylosing Spondylitis, da Ƙari
Bayani
Inflectra (infliximab-dyyb), mai siffar kwayar halitta zuwa Remicade (infliximab), ya amince da ita ta Cibiyar Abinci da Drugurma ta US (FDA) a ranar 5 ga Afrilu, 2016. A cewar FDA, "Wani samfurin halitta shine samfurin halitta wanda aka yarda da shi a kan nuna cewa yana da kama da samfurin samfurin halitta na FDA, wanda aka sani da samfurin samfurin, kuma ba shi da bambanci na asibiti game da aminci da tasiri daga samfurin ƙira.
Kadan ƙananan bambance-bambance a cikin kayan aiki na asibiti suna ba da izinin samfurori ne na kwayoyin halitta. "Rigayarwa, mai tsaro na TNF wadda Janssen Biotech, Inc., ke ginawa, ita ce magungunan magani don Inflectra.
Inflectra ne kewayar da Celltrion, Inc. (wanda ke tushen Yeonsu-gu, Incheon, Jamhuriyar Koriya) don Hospira na Lake Forest, Illinois. Inflectra shi ne na biyu da aka yarda da shi a Amurka ta hanyar FDA. Na farko, Zarxio, an amince da shi ga Maris 6 ga watan Maris na 2015 don takamaiman alamun da suka shafi ciwon daji.
Shaidawa
An amince da lasisi kuma ana iya tsara shi don:
- marasa lafiya tare da matsanancin aiki na rheumatoid arthritis .
- marasa lafiya tare da cikewar spondylitis .
- marasa lafiya tare da sinadarin ƙwayoyin cuta na psoriatic .
- adult marasa lafiya tare da mai tsanani mai tsanani plaque psoriasis.
- marasa lafiya marasa lafiya ko yara 6 da haihuwa da haihuwa da cutar mai tsanani na Crohn da ke da rashin dacewar maganin magani.
- manya da matsananciyar ciwon haɗari mai cututtuka wanda ke da rashin dacewar amsawa ga al'ada.
Don cututtuka na rheumatoid, Ana amfani da Inflectra don rage alamomi da bayyanar cututtuka da suka shafi cutar, hana ci gaban haɗuwa, da kuma inganta aikin jiki. A cikin marasa lafiya da spondylitis, an nuna Inflectra don rage alamu da bayyanar cututtuka.
A cikin rubutun cututtuka na psoriatic, za'a iya yin amfani da Inflectra don rage alamu da bayyanar cututtuka na arthritis, da hana ci gaba da lalata tsarin kuma inganta aikin jiki.
Dosage da Gudanarwa
Don maganin wutsiyar jini, an yi amfani da Inflectra a matsayin jigilar intravenous (aka ba a tsawon akalla sa'o'i 2) a kashi 3mg / kg da aka ba a 0, 2, da 6 makonni. Bayan haka, ana gudanar da nauyin gyara na 3 MG / kg kowane mako takwas. Magunguna da aka bi da su tare da Inflectra don cututtuka na rheumatoid ya kamata su dauki hanya . Marasa lafiya waɗanda basu da amsa mara dacewa a kan sashin da aka ambata a baya zai iya yin gyare-gyaren da aka gyara har zuwa 10mg / kg ko kuma lokaci tsakanin tsaka zai iya rage ta kowane makonni. Daidaitawa na iya kara haɗari na halayen halayen.
Don samfurin spondylitis, ƙwararriyar shawarar shine 5mg / kg a matsayin jiko na intravenous a 0, 2, da makonni 6 kuma biye da kashi 5 MG / kg kowane mako shida. Ƙwararren shawarar shine 5 MG / kg a 0, 2, da makonni 6 na cututtuka na psoriatic, amma ana bada kashi na 5 mg / kg kowane mako takwas. Ga psoriatic arthritis, ana iya amfani dasu tare da ko ba tare da wata hanya ba.
Hanyoyin Kasuwanci na Musamman
Hanyoyin halayen da suka fi dacewa, bisa ga gwaji na asibiti na samfurori, sun hada da cututtuka (numfashi na sama, sinusitis, da pharyngitis), halayen haɗuwa da jiko (gajeren numfashi, flushing, rash), ciwon kai, da kuma ciwon ciki.
Contraindications
Inflectra, a asurai fiye da 5 MG / kg, bai kamata a baiwa marasa lafiya da rashin daidaituwa ta zuciya ba. Har ila yau, ba za a ba Inflectra ga marasa lafiya waɗanda suka yi mummunar haɗakarwa ba zuwa Remicade (infliximab). Ba za a yi amfani da Intlectra ga kowa ba tare da sanannun sananne ga duk wani abu mai sinadirai a cikin miyagun ƙwayoyi ko kuma sunadarai na murine (rodent).
Gargaɗi
An kafa wasu gargadi da tsare-tsaren don tabbatar da amfani da Intlectra lafiya. Wadannan gargadi sun haɗa da:
- Rashin ƙaddamar da cututtuka mai tsanani - Ba za a yi amfani da Inflectra ba a yayin da yake kamuwa da cuta. Har ila yau, idan kamuwa da cuta ta tasowa yayin amfani da Inflectra, ya kamata a kula da hankali kuma idan ya zama mai tsanani, dole a dakatar da Inflectra. Abubuwa masu yiwuwa (cututtuka da ke faruwa a cikin wadanda suka raunana tsarin rigakafi) an ruwaito su a cikin marasa lafiya da aka bi da su tare da masu tarin TNF. Har ila yau, mayar da cutar tarin fuka ko sababbin cututtuka na tarin fuka sun faru ne tare da yin amfani da samfurori marasa galihu.
- Abun ciki mai cutarwa - Idan mai haƙuri ya taso da rashin lafiyar jiki yayin amfani da Inflectra, ya kamata a yi la'akari da farfadowa da magunguna ga waɗanda ke zaune a yankuna inda yanayin yanayin ya kasance na ƙarshe.
- Malignancies - An samu mummunar yanayin rashin lafiya, ciki har da lymphoma, wanda ya fi girma a cikin marasa lafiya da ke tare da masu tarin fuka TNF fiye da magunguna. Dole ne a yi la'akari da hadarin / amfani da amfani da Inflectra, musamman ma marasa lafiya tare da wasu dalilai a tarihin likita.
- Harkar cutar Hizab da B (HBV) - Dole ne a gwada marasa lafiya don cutar Harshen B kafin a fara Inflectra. Dole ne a kula da masu ɗaukan HBV a yayin da kuma da yawa watanni bayan amfani da Intlectra. Idan sake dawo da HBV yana faruwa, dole ne a dakatar da Intlectra kuma farautar maganin bidiyo.
- Rawanci - Rawanin halayen gaggawa mai tsanani zai iya faruwa. Wasu na iya zama mai fatalwa ko kuma suna buƙatar haɓaka hanta. Tare da ci gaba da jaundice ko ƙananan enzymes hawan hawan haɗari , Inflectra ya kamata a tsaya.
- Ƙarƙashin zuciya - Sabon zuciya na farko ko kuma ƙara haɓaka bayyanar cututtuka na zuciya zai iya faruwa tare da amfani da Inflectra.
- Cytopenias - Akwai yiwuwar rage yawan adadin jini tare da amfani da Inflectra. Dole ne marasa lafiya su nemi likita idan bayyanar cututtuka ta ci gaba.
- Hanyoyin kamuwa da cututtuka - Ayyukan haɗari mai zurfi za su iya ci gaba, ciki har da anaphylaxis ko ciwon cutar-kamar halayen.
- Sakamakon ƙwayar cuta - Sabuwar farawa ko kuma ƙara tsanantawa da cutar mai lalatawa zai iya faruwa tare da amfani da Inflectra.
- Lupus-like syndrome - A ciwon da ke hade da lupus- kamar bayyanar cututtuka iya ci gaba da amfani da Inflectra. Ya kamata a dakatar da miyagun ƙwayar idan ciwon ya fara.
- Kanada maganin alurar rigakafi ko magungunan ciwon magunguna - Kada a ba da su tare da Inflectra. Yara ya kamata ya kasance a kan dukkanin maganin rigakafin kafin ya fara Inflectra. Idan an bayyana jariri a cikin utero zuwa Inflectra ko kuma babba, ya kamata a yi aƙalla watanni 6 bayan jinkirin haihuwa kafin a ba duk wani maganin alurar riga kafi.
Inflectra yana ɗaukar akwatin gargadi na fata game da kara yawan hadarin kamuwa da cuta da lymphoma, da kuma umarni don gwada tarin tarin ciki kafin farawa da miyagun ƙwayoyi.
Drug Interactions
Haɗin haɗin Intlectra tare da anakin ko Orencia (abatacept) ba a bada shawara ba. Yin amfani da Actemra (tocilizumab) tare da Inflectra ya kamata a kauce masa saboda yiwuwar ƙara yawan ciwon maganin rigakafi da ƙari ga kamuwa da cuta. Ba za a haɗu da Inflectra tare da sauran kwayoyin kwayoyi ba .
Layin Ƙasa
Biosimilars sun kasance cikin ci gaban shekaru masu yawa don maganin cututtuka na rheumatoid. Don samun na farko da kwayoyin halitta a ƙarshe FDA-yarda shi ne babban yarjejeniya. Daga yanayin hangen nesa, biosimilars sun samar da ƙarin maganin kulawa (wannan abu ne mai kyau!) Kuma farashin ya kamata ya zama ƙasa da ƙananan kwayoyin halitta (wannan shine wani abu mai kyau!). Duk da haka, ba ya zo ba tare da jayayya ba. Akwai damuwa da wasu mutane ke nunawa game da ko biosimilars zasu kasance daidai. Yi la'akari da magungunan da ake amfani da su a cikin magungunan magungunan maganin magunguna - shin suke daidai? An yi ta muhawara a cikin shekarun da suka wuce. FDA ta bayyana cewa "marasa lafiya da masu kiwon lafiyar za su iya dogara da aminci da tasiri na samfurin halitta ko samfurori, kamar dai yadda suke so." A gaskiya ma, an yarda da kwayar cutar biosimlar bisa ga shaidar cewa yana da "kama sosai" ga miyagun ƙwayoyi. Shin maɗaukakiyar kama da kama da daidai?
Har yanzu akwai wani nau'in, wanda FDA ta kira wani magungunan ƙwayar cuta. Bisa ga FDA, "Wani samfurin nazarin halittu wanda ya dace da na'urar samfurin FDA ya yarda da shi kuma ya hadu da ƙarin ka'idodi don hulɗar juna.Ya yiwu a musanya samfurin nazarin halittu ta hanyar likitancin ba tare da shigar da mai kula da lafiyar wanda ya ba da umarnin ba. samfurin bincike. "
Watakila yana da rikice a wannan mataki. Kamar yadda koyaushe, shawarwarinmu shine muyi magana da biosimilars tare da likitan ku ko likitancin ku. Har ila yau yana da muhimmanci a gare ka ka fahimci kanka tare da amsa daga al'umman rheumatology game da amincewa da Inflectra da kuma masu nazarin halittu masu zuwa. Karanta wannan sanarwa daga Joan Von Feldt, MD, MSEd, Shugaban Cibiyar Rheumatology na Amirka.
> Sources:
Bayanin Bayanan Bayanan Intlectra. 04/2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
FDA ta amince da Inflectra, mai ladabi zuwa hanyar maida hankali. 04/05/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
Bayani akan Biosimilars. FDA. Updated 2/22/2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
FDA ta amince da samfur na farko na Zarxio. FDA. 03/06/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm