Kuyavunyelwa Kweminye Iintlobo Ze-Arthritis Ezivuthayo, Njalo
I-Erelzi (i-etanercept-szzs), i- biosimilar ku- Enbrel (etanercept) , yamkelwe yi-FDA ngomhla we-Agasti 30, 2016 ukunyanga iimpawu ezifanayo apho i-Enbrel yavunywa ngokusemthethweni. I-Enbrel yiyilisi yezilwanyana zokuqala ezivunywe kwi- rheumatoid arthritis kunye nezinye iintlobo zokuvuvukala kwe-arthritis ngo-1998.
I-biosimilar ngumkhiqizo we-biological ofana kakhulu nomkhiqizo we-biological (approved) njengemveliso yenkcazelo ye-FDA (eyayibizwa ngokuba yi-reference product), kwaye ibonisa ukuba akukho mvelaphi enokwakheka kwimizimba evela kwimveliso yenkcazelo ngokubhekiselele kokukhuseleko nokusebenza.
Kukho ukungafani kancinci kwizithako ezingasebenzi. Izithako ezingasebenziyo e-Erelzi ziquka i-citrate ye-sodium, i-sucrose, i-sodium chloride, i-lysine kunye ne-citric acid.
U-Erelzi wenziwa ngu-Sandoz, inkampani ene-biosimilar yokuqala evunyiweyo yi-FDA, (Zarxio [filgrastim-sndz]) - i-biosimilar kwi-white cell booster neupogen (filgrastim). I-biosimilar yokuqala yeentlobo ezivuthayo zesifo se-arthritis yi- Inflectra (infliximab-dyyb) okuyi-biosimilar kwi- Remicade (infliximab) . Ukuvunyelwa kuka-Erelzi kwavela kwizithende ze-20-0 ukucebisa ngokubambisana yi-FDA iKomiti yeNgcebiso yeArthritis ukuba ivume isicatshulwa kuzo zonke izibonakaliso zesichengiso seziyobisi.
Iinkcazo
I-Erelzi iyimpawu ye- tumor necrosis (TNF) eboniswa kuyo:
- irheumatoid arthritis
- i-psoriatic arthritis
- spondylitis engavumelekanga
- psoriasis
- i-idiopathic arthritis , i-polyarticular, kubantwana abaneminyaka emi-2 okanye ngaphezulu
Isistim nokuLawula
I-Erelzi ilawulwa yijoza engaphantsi. Itholakala njenge-25 mg / 0.5mL kunye ne-50 mg / mL isisombululo kwisirya esisodwa esisithandayo. U-Erelzi ufika kwisisombululo se-50mg / mL kwi-Penensady ipenethi ekhethiweyo.
I-dose ephakanyisiweyo kubantu abane-arthritis yabantu abadala okanye i-psoriatic arthritis ingama-50 mg kanye ngeveki, mhlawumbi okanye ngaphandle kwe- methotrexate .
I-dose ephakanyisiweyo kubantu abane-spondylitis ene-ankylosing i-50 mg kanye ngeveki. Kwi-psoriasis yomdala omdala, i-dose ephakanyisiweyo ye-Erelzi ingama-50 mg kabini ngeveki kwiinyanga ezi-3 zilandelwa ngama-50 mg ngeveki. I-dose ye-idiopathic arthritis yabantwana isekelwe kwisisindo-kubantwana abanomlinganiselo ongaphezulu kwama-63 kg, i dose yi-0.8mg / kg ngeveki nganye kunye neqondo eliphezulu lama-50 mg veki.
Imiphumela
Njengaye naziphi na iziyobisi, kukho imiphumo emibi kunye neziganeko ezimbi ezinxulumene no-Erelzi. Iziganeko eziqhelekileyo eziqhelekileyo ezinxulumene ne-etanercept izifo kunye neempendulo zendawo ye-injection . Ngokusekelwe kwizifundo zekliniki kunye namava ombonakaliso, iziganeko ezimbi kakhulu ezinxulumene ne-etanercept ziquka izifo, iingxaki ze-neurologic, ukungaphumeleli kwintliziyo ye-congestive kunye neziganeko ze-hematologic (oko kukuthi, ukuphazamiseka kwegazi).
Ukungqinelana
U-Erelzi akafanele anikwe umntu onomdla we-sepsis .
Izilumkiso
Kukho izixwayiso ezibalulekileyo kunye nokuqapha okuhambisana nokusetyenziswa kwe-Erelzi okungafanelekanga.
- U-Erelzi akafanele aqalwe ngexesha lokusuleleka. Ukuba intsholongwane echaphazelekayo iyaqhubeka ngexesha lotyando, u-Erelzi unokufuna ukumiswa.
- Kuye abantu abaya kwiindawo okanye abahlala kwiindawo apho i-mycoses ihlala khona, ukuba isifo esibuhlungu sikhulayo siqhubeka xa siphathwa nge-Erelzi, kufuneka unyathelwe ingonyango.
- Ukuxhatshazwa kwezifo kunokuhlakulela xa kuphathwa ngo-Erelzi.
- Iimeko ze- Lymphoma zenzeke kubantu abaphathwa nge-TNF blockers.
- Ukungaphumeleli kwintliziyo yesibhambano kungenzeka, nokuba kutsha ngokutsha okanye njengento ebandezelayo.
- Abantu abaneempawu ze- pancytopenia okanye i- apemia ye-anemia kufuneka bafune unyango kwaye bacinge ukuyeka u-Erelzi.
- Abantu abanembali ye- Hepatitis B kufuneka bahlolwe ukuba baphinde baphinde baphathwe ngo-Erelzi kunye neenyanga ezimbalwa emva koko.
- I-Anaphylaxis okanye iimeko ezinzima zokuphendula ziyakwenzeka xa ziphathwa nge-Erelzi.
- I-Lupus-like syndrome okanye isifo se-hepatitis esingazimele singakhula. Ukuba kwenzeka, i-Erelzi kufuneka imiswe.
Ukusebenzisana kweziyobisi
Akukho zifundo eziqhutywe malunga nokusebenzisana kwezidakamizwa ezithile kunye ne-etanercept. Ukusuka kwezinye iifundo kwakunqunywe ukuba abantu baphathwa nge-etanercept kufuneka VAMILE:
- baphila iigonti
- ukusetyenziswa ngokufanayo kwezinye iziyobisi ze-biologic
- Ukusetyenziswa ngokufanayo kweCytoxan (cyclophosphamide)
- Ukusetyenziswa ngokufanayo kweAzulfidine (sulfasalazine)
Ngaphantsi
Injongo ejoliswe ekuphuhliseni i-biosimilars kukunika izigulane kunye noogqirha ithuba lokukhetha ukonyango ngeendleko ezinokubakho, ezincinci kakhulu kuneendleko zokusetyenziswa kweziyobisi. Nangona oko kukuva kakuhle ekufundeni kokuqala, kukho ukukhathazeka ngokucacileyo okuye kwabonakala. Inkxalabo enkulu kakhulu kusekhona nokuba i-biosimilars "ilingana" kunye neziyobisi zabo. I-Biosimilars ibizwa ngokuba "yinto efanayo" kodwa ingangokufanayo? Ngaba lo mbuzo uphendululwe ngokwanelisayo? Umdaniso ojikeleze isigama-magama ushiya abaninzi banesiva.
Ukususela ngo-2016, ixabiso lentengo alizange lhengezwe. Ngoko, simele silinde ukuba sibone indlela "engabizi ngayo" iguqulela kwiidola zangempela. Unokucinga ukujonga indlela i-Inflectra, i-Remicade biosimilar eyavunywa ngo-Apreli 2016, eyenziwe ngokweendleko nokusebenza. Ukususela ngo-2016, ayizange iqalise e-United States.
Ukongeza kwidideko, kukho iimeko zamatyala malunga nemiba yeepententi. Nangona i-biosimilars ingaba yinto yokwenene kwixesha elizayo, kuba ngoku kubonakala ngathi kunengxaki. Thetha ugqirha wakho malunga nokuba ngaba akunjalo.
> Umthombo:
> Erelzi. Ukunyathelisa ngokupheleleyo iNgcaciso kunye neNkxaso yamayeza . Sandoz, Inc. Ukuhlaziywa ngo-08/2016.