Kuvunyelwe Kwezinye Izinhlobo Zokwelashwa Kwe-Arthritis, Kakhulu
I-Erelzi (i-etanercept-szzs), i- biosimilar ku- Enbrel (etanercept) , yavunywa yi-FDA ngomhla ka-Agasti 30, 2016 ukuphatha izinkomba ezifanayo ukuthi i-Enbrel yavunywa kuqala. I-Enbrel yayiyisilwane sokuqala se- biologic esavunyelwe isifo samathambo kanye nezinye izinhlobo zokuvuvukala kwamathambo ngonyaka ka-1998.
I-biosimilar ngumkhiqizo wezinto eziphilayo ofana kakhulu nomkhiqizo wokuqala we-bio-approved of FDA (owaziwa ngokuthi umkhiqizo wokubhekisela), futhi awubonisi umehluko emtholampilo ovela kumkhiqizo wokubhekisisa ngokuphathelene nokuphepha nokusebenza.
Kungase kube khona umehluko omncane ezingxenyeni ezingasebenzi. Izithako ezingasebenziyo e-Erelzi zifaka i-citrate ye-sodium, i-sucrose, i-chloride ye-sodium, i-lysine, ne-citric acid.
I-Erelzi ikhiqizwa ngu-Sandoz, inkampani eyayine-biosimilar yokuqala evunywe yi-FDA, (i-Zarxio [filgrastim-sndz] - i-biosimilar ku-white cell booster Neupogen (filgrastim). I-biosimilar yokuqala yezinhlobo zokuphefumula zamathambo yi- Inflectra (infliximab-dyyb) okuyi-biosimilar ku- Remicade (infliximab) . Ukwamukelwa kuka-Erelzi kwavela ezithamelwaneni zokuncoma okungafani okungu-20 yi-FDA I-Advisory Committee eKomidi yokuVumelanisa izidakamizwa ukuze kuvunyelwe izidakamizwa kuzo zonke izibonakaliso zedokotela.
Izinkomba
I-Erelzi yisibhamu se-necrosis factor (TNF) esiboniswayo:
- i-arthritis ye-rheumatoid
- i-psoriatic arthritis
- i-spondylitis e-ankylosing
- i- psoriasis ye- plaque
- i-juvenile idiopathic arthritis , i-polyarticular, ezinganeni ezineminyaka emibili noma ngaphezulu
Isilinganiso Nokuphatha
I-Erelzi ilawulwa yi-injection encane. Itholakala njengesisombululo se-25 mg / 0.5mL nesilinganiso se-50 mg / mL ku-dose eyodwa ekhethiwe yensilinga. U-Erelzi uphinde afike nesisombululo se-50mg / mL ku-penenja ye-Sensoready ekhethiwe.
Umthamo ophakanyisiwe wabantu abane-arthritis yabantu abadala abadala noma i-psoriatic arthritis ingama-50 mg kanye ngesonto, kungaba ne- methotrexate noma ngaphandle.
Umthamo ophakanyisiwe wabantu abane-ankylosing spondylitis u-50 mg kanye ngesonto. I-psoriasis yama-adult plaque, umthamo ophakanyisiwe we-Erelzi u-50 mg kabili ngesonto izinyanga ezingu-3 ulandelwa ngu-50 mg ngesonto ngalinye. Umthamo we-arthritis wamantombazane we-idiopathic uncike kwisisindo-kubantwana ababa ngaphezu kuka-63 kg, umthamo u-0.8mg / kg ngesonto onke ngesilinganiso esiphezulu seviki lama-50 mg.
Okuqhamuka uma udla imishanguzo
Njenganoma imuphi umuthi, kunemiphumela emibi kanye nezenzakalo ezimbi ezihlobene no-Erelzi. Izenzakalo ezivame kakhulu ezihlobene ne-etanercept yizifo kanye nokuphendula kwesayithi lomjovo . Ngokususelwa kwizifundo zemitholampilo kanye nokuhlangenwe nakho kwe-postmarketing, izenzakalo ezimbi kakhulu ezihlobene ne-etanercept zihlanganisa izifo, izinkinga ze-neurologic, ukwehluleka kwe-heart congestive, nezenzakalo ze-hematologic (okungukuthi, ukuphazamiseka kwegazi).
Ukungafani
U-Erelzi akufanele anikezwe kunoma ubani one- sepsis .
Izixwayiso
Kunezixwayiso ezibalulekile nezixwayiso ezihlobene nokusetshenziswa kwe-Erelzi okungafanele kunganakwa:
- I-Erelzi akufanele iqalwe ngesikhathi sokutheleleka okusebenzayo. Uma ukutheleleka okusebenzayo kuqhubeka ngenkathi ukwelashwa, i-Erelzi ingadinga ukumiswa.
- Kubantu abahambayo noma abahlala ezindaweni lapho amagciwane amancane khona, uma isifo esibucayi se-systemic siqala ngenkathi siphathwa nge-Erelzi, ukuphathwa kwe-anti-fungal kufanele kucatshangelwe.
- Ukuhlaziya izifo kungase kuthuthuke ngenkathi kuphathwa u-Erelzi.
- Amacala e- Lymphoma ayenzeka kubantu abaphathwa nge-TNF blockers.
- Ukuhluleka kwenhliziyo ekhulile kungase kwenzeke, kungaba ukuqala okusha noma njengesimo esibi kakhulu.
- Abantu abanezimpawu ze- pancytopenia noma i-anemia ye-plastiki kufanele bafune ukwelashwa futhi bacabange ukuma u-Erelzi.
- Abantu abanomlando we- Hepatitis B kufanele baqashwe ukuze baphinde baphinde baphathwe ngenkathi bephathwa nge-Erelzi nezinyanga ezimbalwa emva kwalokho.
- I-Anaphylaxis noma ukusabela okukhulu kwe-allergen kungenzeka uma kuphathwa nge-Erelzi.
- I-Lupus-like syndrome noma i-autoimmune hepatitis ingahlakulela. Uma kwenzeka noma kunjalo, i-Erelzi kufanele imiswe.
Ukusebenzisana kwezidakamizwa
Akubekho izifundo ezenziwe ngokuphathelene nokusebenzisana kwezidakamizwa ezithile ne-etanercept. Kusuka kwezinye izifundo kwakunqunywe ukuthi abantu abaphathwa nge-etanercept kumele AVOID:
- phila imigomo
- ukusetshenziswa okufanayo kwezinye izidakamizwa ze-biologic
- ukusetshenziswa okufanayo kwe- Cytoxan (cyclophosphamide)
- ukusetshenziswa okufanayo kwe- Azulfidine (sulfasalazine)
Okubalulekile
Umgomo oshiwo wokuthuthukisa ama-organic biosimilars ukunikeza iziguli nodokotela ukhetho oluningi oluthengisa ukwelashwa ngezindleko ezingabizi, ngokuphansi kakhulu kunezindleko zemithi yokubhekisela. Nakuba lokho kuzwakala kuhle ekufundeni kokuqala, kunokukhathazeka ngokucacile okuye kwavela. Ukukhathazeka okukhulu kusekhona noma ngabe izidakamizwa "zilingana" nezidakamizwa zabo zokubhekisela. Ama-Biosimilars abizwe ngokuthi "afana kakhulu" kodwa ingabe afana nokulinganayo? Ingabe lo mbuzo uphendule ngokugculisayo? Ukudansa okuzungeze lesi sigama sishiya abaningi beba nomuzwa wokuthi bajabule.
Kusukela ngo-2016, iphuzu lentengo alizange limemezelwe noma. Ngakho-ke, kumelwe silinde ukubona kahle ukuthi "okungabizi kangako" kufinyelela kanjani kudola langempela. Ungase ucabange ukuhlola ukuthi i-Inflectra, i-Remicade biosimilar evunyelwe ngo-Ephreli 2016, yenze kanjani ngokwezindleko nokusebenza. Kusukela ngo-2016, ayizange iqalise e-United States.
Ukwengeza ekudidekeni, kukhona amacala enkantolo mayelana nezindaba ze-patent. Ngenkathi ama-biosimilars angase abe yindlela yangempela esikhathini esizayo, ngoba manje kubonakala sengathi igcwele izinkinga. Xoxa nodokotela wakho ukuthi ngabe ukhethe yini ukuthi cha.
> Umthombo:
> Erelzi. Umhlahlandlela ophelele wokuThola ulwazi kanye nemithi . I-Sandoz, Inc. Ibuyekeziwe ngo-08/2016.