Kuvomerezedwa kwa Mitundu Yina ya Matenda a Nyamakazi, Nawonso
Erelzi (etanercept-szzs), biosimilar kwa Enbrel (etanercept) , inavomerezedwa ndi FDA pa August 30, 2016 kuti awonetsere zomwezo zomwe Enbrel anavomerezedwa poyamba. Enbrel ndiyo mankhwala oyambirira a biologic omwe amavomereza matenda a nyamakazi ndi nyamakazi zina zotupa zamatenda mu 1998.
Biosimilar ndi mankhwala omwe ali ofanana kwambiri ndi chipangizo choyambirira cha FDA chovomerezeka (chomwe chimatchedwa reference product), ndipo sichiwonetsa kusiyana kwapadera kwapadera kuchokera ku bukhuli ponena za chitetezo ndi mphamvu.
Pangakhale kusiyana kwakukulu m'magulu osagwira ntchito. Zosakaniza zosafunika ku Erelzi zikuphatikizapo sodium citrate, sucrose, sodium chloride, lysine, ndi citric asidi.
Erelzi amapangidwa ndi Sandoz, kampani yomwe inali ndi biosimilar yoyamba yovomerezedwa ndi FDA, (Zarxio [filgrastim-sndz] - biosimilar ku white white booster Neupogen (filgrastim). Njira yoyamba yokhudzana ndi kutupa kwa nyamakazi inali Inflectra (infliximab-dyyb) yomwe imayambira ku Remicade (infliximab) . Chivomerezo cha Erelzi chinayambira pa chisankho cha 20-0 chimodzimodzi ndi Komiti Yowonongeka ya Arthritis ya FDA kuti avomereze mankhwalawa chifukwa cha zizindikiro zonse za mankhwala omwe amatchulidwa.
Zisonyezo
Erelzi ndi chojambulira chotupa cha necrosis (TNF) chomwe chikuwonetsedwa kwa:
- nyamakazi ya nyamakazi
- psoriatic nyamakazi
- ankylosing spondylitis
- phala psoriasis
- ana aamuna odwala matenda a nyamakazi , azimayi, azimayi, a zaka ziwiri kapena kuposerapo
Mlingo ndi Utsogoleri
Erelzi imayendetsedwa ndi jekeseni ya subcutaneous. Lilipo monga 25 mg / 0.5mL ndi 50 mg / mL yankho mu mlingo umodzi wokhayo wodula sitiroko. Erelzi imabweranso pakamwa la 50mg / mL mu cholembera cha prefens Sensoready.
Mlingo wovomerezeka kwa anthu omwe ali ndi nyamakazi yaikulu ya mafupa kapena psoriatic nyamakazi ndi 50 mg kamodzi pamlungu, kaya ndi kapena popanda methotrexate .
Mlingo wovomerezeka wa anthu okhala ndi ankylosing spondylitis ndi 50 mg kamodzi pamlungu. Kwa akuluakulu a psoriasis plaque, mlingo woyenera wa Erelzi ndi 50 mg kawiri mlungu uliwonse kwa miyezi itatu ndikutsatiridwa ndi 50 mg mlungu uliwonse. Mankhwalawa amathandiza kuti ana azilemera kwambiri kuposa makilogalamu 63, mlingo wake ndi 0.8mg / kg mlungu uliwonse ndi mlingo wokwanira wa mlungu wa 50 mg.
Zotsatira Zotsatira
Monga ndi mankhwala alionse, pali zotsatira ndi zovuta zomwe zikuchitika ndi Erelzi. Zochitika zovuta kwambiri zomwe zimagwirizanitsidwa ndi etanercept ndizopatsirana komanso zomwe zimachitika pa siteji . Malinga ndi maphunziro azachipatala ndi zochitika zokhudzana ndi postmarketing, zochitika zovuta kwambiri zogwirizana ndi etanercept zikuphatikizapo matenda, matenda a neurologic, congestive mtima kulephera, ndi matenda a hematologic (mwachitsanzo, matenda a magazi).
Contraindications
Erelzi sayenera kupatsidwa kwa aliyense yemwe ali ndi sepsis .
Machenjezo
Pali machenjezo ofunika okhudzana ndi kugwiritsa ntchito Erelzi zomwe siziyenera kunyalanyazidwa:
- Erelzi sayenera kuyambika pa matenda opatsirana. Ngati matenda opatsirana amayamba pakapita mankhwala, Erelzi angafunike kuimitsidwa.
- Kwa anthu omwe amapita kumadera omwe malo osokoneza bongo amapezeka, ngati matenda aakulu amayamba pamene akugwiritsidwa ntchito ndi Erelzi, mankhwala oletsa fungali ayenera kuganiziridwa.
- Kuwonetsa matenda othetsa matenda kungapangitse pamene akudwala Erelzi.
- Mankhwala a Lymphoma achitika mwa anthu omwe amachitira ndi TNF blockers.
- Kusintha mtima kwa mtima kungabwereke, mwina kuyamba kwatsopano kapena ngati vuto loipa.
- Anthu omwe ali ndi zizindikiro za pancytopenia kapena aplastic anemia ayenera kupita kuchipatala ndikuganiza kuti asiye Erelzi.
- Anthu omwe ali ndi mbiri ya Hepatitis B ayenera kuyang'aniridwa kuti ayambitsenso pamene akuchiritsidwa ndi Erelzi ndi miyezi yambiri.
- Anaphylaxis kapena zotsatira zowopsa zimatha kuchitika pamene akuchiritsidwa ndi Erelzi.
- Matenda a Lupus kapena matenda a chiwindi amatha kukhala. Ngati chinachitika, Erelzi ayenera kuimitsidwa.
Kuyanjana kwa Mankhwala
Panapanda maphunziro omwe anachitidwa pokhudzana ndi madandaulo okhudza mankhwala ndi etanercept. Kuchokera ku maphunziro ena adatsimikiziridwa kuti anthu ochiritsidwa ndi etanercept ayenera AVOID:
- katemera
- kugwiritsa ntchito mankhwala osokoneza bongo nthawi zonse
- Kugwiritsiridwa ntchito kotheratu kwa Cytoxan (cyclophosphamide)
- kugwiritsa ntchito nthawi zonse Azulfidine (sulfasalazine)
Mfundo Yofunika Kwambiri
Cholinga chothandizira kupanga zamoyo ndi kupereka odwala ndi madokotala njira zothandizira mankhwala pa mtengo wotsika mtengo kwambiri kuposa mtengo wa mankhwala osokoneza bongo. Ngakhale kuti izo zikumveka bwino powerenga koyamba, pali zodetsa nkhaŵa zomwe zafika poyera. Chodetsa nkhaŵa chachikulu chikadalibe ngati zamoyo ziri "zofanana" ndi mankhwala awo owonetsera. Akatswiri azinthu akhala akutchedwa "ofanana kwambiri" koma kodi ndi ofanana ndi ofanana? Kodi funsoli lapindula mokwanira? Mavalo ozungulira mawuwa amachoka ambiri omwe akukumanabe osasangalala.
Kuyambira mu 2016, mtengo wa mtengo sunayengezedwe mwina. Choncho, tiyenera kuyembekezera kuti tiwone momwe "zotsika mtengo" zimasinthira madola enieni. Mungaganize kuti muone momwe Inflectra, Remicade biosimilar yomwe inavomerezedwa mu April 2016, yachita mwa mtengo ndi mphamvu. Kuyambira mu 2016, sikunayambe ku United States.
Kuwonjezera pa chisokonezo, pali milandu ya milandu za nkhani za chivomezi. Ngakhale zamoyo zikhoza kukhala zenizeni m'tsogolomu, pakuti tsopano zikuwoneka kuti zili ndi mavuto. Lankhulani ndi dokotala wanu ngati mukufuna kusankha bwino kapena ayi.
> Chitsime:
> Erelzi. Kufotokozera mwatsatanetsatane Mauthenga ndi Mankhwala Amadzimadzi . Sandoz, Inc. Kukonzekera 08/2016.