Umbhali: Gregory Harris
Umhla Wokudalwa: 15 Utshazimpuzi 2021
Hlaziya Umhla: 25 Isilimela 2024
Anonim
Dr. Lyman on the Epoetin Alfa Biosimilar
Ividiyo: Dr. Lyman on the Epoetin Alfa Biosimilar

Umxholo

Inaliti ye-epoetin alfa kunye nenaliti ye-epoetin alfa-epbx ngamayeza e-biologic (amayeza enziwe ngezinto eziphilayo). Inaliti ye-Biosimilar epoetin alfa-epbx ifana kakhulu ne-epoetin alfa injection kwaye isebenza ngendlela efanayo ne-epoetin alfa injection emzimbeni. Ke ngoko, igama elithi epoetin inaliti iimveliso ziya kusetyenziswa ukumela la mayeza kule ngxoxo.

Zonke izigulana:

Sebenzisa iimveliso zenaliti ye-epoetin alfa yonyusa umngcipheko wokuba amahlwili egazi aya kungena okanye ahambe emilenzeni, emiphungeni, okanye kwingqondo. Tshela ugqirha wakho ukuba unesifo sentliziyo, ukubetha, i-venous thrombosis (i-DVT; igazi eligubungele umlenze wakho), i-pulmonary embolus (PE; i-clot yegazi kwimiphunga yakho), okanye ukuba uza kwenziwa utyando . Ngaphambi kokuba wenze utyando, nditsho notyando lwamazinyo, xelela ugqirha wakho okanye ugqirha wamazinyo ukuba uphathwa nge-epoetin alfa injection product, ngakumbi ukuba une-coronary artery bypass graft (CABG) yotyando okanye utyando lwamathambo. Ugqirha wakho unokukunika i-anticoagulant ('igazi elincinci') ukunqanda amahlwili ekubumbeni ngexesha lotyando. Biza ugqirha wakho kwangoko okanye ufumane uncedo lonyango olungxamisekileyo ukuba ufumana naziphi na kwezi mpawu zilandelayo: iintlungu, ukuthamba, ukuba bomvu, ukufudumala, kunye / okanye ukudumba emilenzeni; ukuphola okanye ukuphaphatheka engalweni okanye emlenzeni; ubunzima bokuphefumla okanye ukuphefumla okufutshane; iintlungu zesifuba; Ingxaki ekhawulezileyo yokuthetha okanye intetho eqondayo; ukudideka ngesiquphe; ubuthathaka ngequbuliso okanye ukuba ndindisholo kwengalo okanye umlenze (ngakumbi kwicala elinye lomzimba) okanye kobuso; ingxaki yokuhamba ngesiquphe, isiyezi, okanye ilahleko eseleyo okanye yokulungelelanisa; okanye isiqaqa. Ukuba uphathwa nge-hemodialysis (unyango lokususa inkunkuma egazini xa izintso zingasebenzi), iqokobhe legazi lingenza ufikelelo lwakho lwe-vascular (indawo apho i-hemodialysis tubing idibanisa nomzimba wakho). Tshela ugqirha wakho ukuba ukufikelela kwakho kwe-vascular akusebenzi njengesiqhelo.


Ugqirha wakho uya kuyilungisa idosi yakho ye-epoetin alfa yenaliti imveliso ukuze inqanaba lakho le-hemoglobin (isixa seprotein efumaneka kwiiseli ezibomvu zegazi) liphezulu ngokwaneleyo ukuba awudingi kutofelwa iiseli ezibomvu zegazi (ukuhanjiswa kweeseli ezibomvu zegazi lomntu komnye umzimba ukunyanga i-anemia). Ukuba ufumana ngokwaneleyo imveliso ye-epoetin alfa ukunyusa i-hemoglobin yakho ukuya kwinqanaba eliqhelekileyo okanye elikufutshane, kukho umngcipheko omkhulu wokuba uya kuba ne-stroke okanye uhlakulele iingxaki ezinzulu okanye ezisongela ubomi ezibandakanya ukuhlaselwa yintliziyo okanye ukuhluleka kwentliziyo. Biza ugqirha wakho kwangoko okanye ufumane uncedo lonyango olungxamisekileyo ukuba ufumana naziphi na kwezi mpawu zilandelayo: iintlungu esifubeni, uxinzelelo lokucinezela, okanye ukuqina; ukuqhawukelwa ngumphefumlo; isicaphucaphu, iintloko, ukubila, kunye neminye imiqondiso yokuqala yesifo sentliziyo; ukungonwabi okanye iintlungu ezingalweni, egxalabeni, entanyeni, emhlathini, okanye emqolo; okanye ukudumba kwezandla, iinyawo, okanye amaqatha.

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho uya kuyalela iimvavanyo ezithile zelebhu ukujonga impendulo yomzimba wakho kwiimveliso zenaliti ye-epoetin alfa. Ugqirha wakho anganciphisa idosi okanye akuxelele ukuba uyeke ukusebenzisa inaliti ye-epoetin alfa kangangexesha elithile ukuba iimvavanyo zibonisa ukuba usemngciphekweni omkhulu wokufumana iziphumo ebezingalindelekanga ezimandundu. Landela izikhokelo zikagqirha wakho ngononophelo.


Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango ngemveliso yenaliti ye-epoetin alfa kwaye ngalo lonke ixesha uzalisa amayeza akho. Funda ulwazi ngononophelo kwaye ubuze ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo. Ungandwendwela noLawulo lwezoKutya noLawulo lweziyobisi (FDA) iwebhusayithi (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) okanye iwebhusayithi yomenzi ukufumana isiKhokelo seMithi.

Thetha nogqirha wakho malunga nomngcipheko wokusebenzisa imveliso yenaliti ye-epoetin alfa.

Izigulana ezinomhlaza:

Kwizifundo zeklinikhi, abantu abanomhlaza othile abafumene inaliti ye-epoetin alfa basweleke msinya okanye banamava okukhula kwethumba, ukubuya komhlaza wabo, okanye umhlaza osasazeke kwangoko kunabantu abangakhange bafumane iyeza. Kuya kufuneka ufumane iimveliso ze-epoetin alfa ngenaliti ukunyanga i-anemia ebangelwa yi-chemotherapy ukuba i-chemotherapy yakho kulindeleke ukuba iqhubeke ubuncinci iinyanga ezi-2 emva kokuba uqale unyango lwakho ngenaliti ye-epoetin alfa kwaye ukuba akukho thuba liphezulu lokuba umhlaza wakho uza kuphiliswa. Unyango nge-epoetin alfa iimveliso zenaliti kufuneka zinqandwe xa ikhosi yakho ye-chemotherapy iphela.


Izigulana zotyando:

Unokunikwa imveliso ye-epoetin alfa yenaliti ukunciphisa umngcipheko wokuba uphuhlise i-anemia kwaye ufune ukutofelwa igazi ngenxa yokulahleka kwegazi ngexesha leentlobo ezithile zotyando. Nangona kunjalo, ukufumana imveliso ye-epoetin alfa yenaliti ngaphambi nasemva kotyando kungonyusa umngcipheko wokuba ube negazi eliyingozi ngexesha okanye emva kotyando. Ugqirha wakho unokuyalela amayeza ukunceda ukuthintela amahlwili egazi.

Iimveliso zenaliti ye-Epoetin alfa zisetyenziselwa ukunyanga i-anemia (inani elingaphantsi kuneliqhelekileyo leeseli ezibomvu zegazi) kubantu abanesifo sezintso esinganyangekiyo (imeko apho izintso zithi chu ziyeke ukusebenza ixesha elide). Iimveliso zenaliti ye-Epoetin alfa zikwasetyenziselwa ukunyanga i-anemia ebangelwa yi-chemotherapy kubantu abaneentlobo ezithile zomhlaza okanye ezibangelwa yi-zidovudine (AZT, Retrovir, e-Trizivir, e-Combivir), iyeza elisetyenziselwa ukunyanga intsholongwane kaGawulayo. Iimveliso zenaliti ye-Epoetin alfa ziyasetyenziswa ngaphambi nasemva kweentlobo ezithile zotyando ukunciphisa ithuba lokuba utofelo-gazi (ukuhanjiswa kwegazi lomntu komnye umzimba womnye umntu) luya kufuneka ngenxa yokuphulukana kwegazi ngexesha lotyando. Iimveliso zenaliti ye-Epoetin alfa akufuneki isetyenziselwe ukunciphisa umngcipheko wokuba utofelo luya kufuneka kubantu abatyandwa iintliziyo zabo okanye imithambo yegazi. Iimveliso zenaliti ye-Epoetin alfa nayo akufuneki isetyenziselwe ukunyanga abantu abanakho nabakulungeleyo ukunikela ngegazi ngaphambi kotyando ukuze eli gazi litshintshwe kwimizimba yabo ngexesha okanye emva kotyando. Iimveliso zenaliti ye-Epoetin alfa ayinakusetyenziswa endaweni yegazi elibomvu ukunyanga i-anemia kwaye ayiboniswanga ukuphucula ukudinwa okanye impilo-ntle enokubangelwa yi-anemia. Iimveliso ze-epoetin alfa zikudidi lwamayeza abizwa ngokuba zii-erythropoiesis-stimulating agents (ESAs). Zisebenza ngokubangela umongo wethambo (izicwili ezithambileyo ngaphakathi kwamathambo apho igazi lenziwa khona) ukwenza iiseli ezibomvu zegazi.

Iimveliso zenaliti ye-Epoetin alfa iza njengesisombululo (ulwelo) sokufaka ngenaliti (nje phantsi kolusu) okanye ngaphakathi (ngaphakathi emthanjeni). Ihlala itofwe kathathu ukuya kathathu ngeveki. Xa iimveliso zenaliti ye-epoetin alfa zisetyenziselwa ukunciphisa umngcipheko wokuba utofelo-gazi luya kufuneka ngenxa yotyando, ngamanye amaxesha itofwa kanye yonke imihla kangangeentsuku ezili-10 ngaphambi kotyando, ngosuku lotyando kunye neentsuku ezi-4 emva kotyando. Ngenye indlela, iimveliso ze-epoetin alfa yenaliti ngamanye amaxesha itofwa kanye ngeveki, ukuqala kwiiveki ezi-3 ngaphambi kotyando nangomhla wotyando.

Ugqirha wakho uza kukuqala ngedosi esezantsi yemveliso yenaliti ye-epoetin alfa kwaye uhlengahlengise idosi yakho ngokuxhomekeke kwiziphumo zakho zebhu kunye nendlela oziva ngayo, ihlala ingekho ngaphezulu kwenyanga nganye. Ugqirha wakho usenokukuxelela ukuba uyeke ukusebenzisa imveliso ye-epoetin alfa okwexeshana. Landela le miyalelo ngononophelo.

Iimveliso zenaliti ye-Epoetin alfa ziya kunceda ukulawula i-anemia kuphela ukuba uqhubeka nokuyisebenzisa. Kungathatha iiveki ezi-2 ukuya kwezi-6 okanye ngaphezulu ngaphambi kokuba uve isibonelelo esipheleleyo semveliso yenaliti ye-epoetin alfa. Sukuyeka ukusebenzisa imveliso ye-epoetin alfa ngaphandle kokuthetha nogqirha wakho.

Iimveliso zenaliti ye-Epoetin alfa zinokunikwa ngugqirha okanye ngumongikazi, okanye usenokuxelelwa ukuba utofe iyeza ekhaya. Ukuba uza kutofa amayeza ekhaya, landela imigaqo kwileyibhile yakho kagqirha kwaye ubuze ugqirha wakho okanye usokhemesti ukuba achaze nayiphi na indawo ongayiqondiyo. Sebenzisa imveliso ye-epoetin alfa yenaliti kanye njengoko kuyalelwe. Ukukunceda ukhumbule ukusebenzisa i-epoetin alfainjection product, phawula ikhalenda ukugcina umkhondo xa uza kufumana idosi. Sukuyisebenzisa ngaphezulu okanye ngaphantsi okanye uyisebenzise rhoqo kunokuyalelwa ngugqirha.

Ukuba usebenzisa imveliso ye-epoetin alfa ekhaya, umboneleli wezempilo uya kukubonisa ukuba ungalitofa njani iyeza. Qiniseka ukuba uyayiqonda le ndlela. Ngaphambi kokuba usebenzise i-epoetin alfaproduct okokuqala, wena kunye nomntu oza kunika inaliti kufuneka nifunde ulwazi lomenzi wesigulana esiza nayo. Buza umboneleli wakho wezempilo ukuba unayo nayiphi na imibuzo malunga nokuba uphi emzimbeni wakho kufuneka ulitofe iyeza, indlela yokufaka inaliti, loluphi uhlobo lwesirinji oza kuyisebenzisa, okanye indlela yokulahla iinaliti kunye neesirinji ezisetyenzisiweyo emva kokuba utofile iyeza. Soloko ugcine isirinji kunye nenaliti ngesandla.

Ungangcangcazelisi imveliso yenaliti ye-epoetin alfa. Ukuba uyashukumisa amayeza, anokujongeka njengamagwebu kwaye akufuneki asetyenziswe.

Ungayifaka inaliti ye-epoetin alfa ngaphantsi nje kolusu naphina kwindawo engaphandle yeengalo zakho ezingasentla, phakathi kwamathanga angaphambili, isisu (ngaphandle kwendawo eziisentimitha ezi-5 ububanzi ejikeleze inkaba [iqhosha lesisu]) , okanye indawo engaphandle yeempundu. Musa ukufaka inaliti epoetin alfa kwindawo yethenda, ebomvu, etyumkileyo, enzima, okanye enezikrelemnqa okanye yolule amanqaku. Khetha indawo entsha ngalo lonke ixesha utofa iyeza, njengoko kuyalelwa ngugqirha wakho.

Ukuba uphathwa nge-dialysis (unyango lokususa inkunkuma egazini xa izintso zingasebenzi), ugqirha unokukuxelela ukuba utofe iyeza kwizibuko lakho lokungena. Buza ugqirha wakho ukuba unemibuzo malunga nokuba ungalifaka njani iyeza lakho.

Soloko ujonga isisombululo ngaphambi kokuba usitofe. Qiniseka ukuba ibhotile ibhalwe igama elichanekileyo kunye namandla amayeza kunye nomhla wokuphelelwa kwayo ongadlulanga. Jonga ukuba isisombululo sicacile kwaye asinambala kwaye asiqulathanga amaqhuma, iiflakes, okanye amasuntswana. Ukuba kukho naziphi na iingxaki amayeza akho, tsalela usokhemisti wakho kwaye musa ukujova.

La mayeza angamiselwa ezinye izinto. Thetha nogqirha wakho malunga neengozi zokusebenzisa eli yeza kwimeko yakho.

Ngaphambi kokusebenzisa imveliso ye-epoetin alfa,

  • xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabisa i-epoetin alfa, i-epoetin alfa-epbx, i-darbepoetin alfa (i-Aranesp), nawaphi na amanye amayeza, okanye nasiphi na isithako semveliso ye-epoetin alfa. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
  • xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
  • xelela ugqirha wakho ukuba unayo okanye unayo uxinzelelo lwegazi oluphezulu kwaye ukuba ukhe waba ne-aplasia yeseli ebomvu (i-PRCA; uhlobo lwe-anemia ebukhali enokuthi ivele emva konyango nge-ESA enje nge-darbepoetin alfa injection okanye i-epoetin alfa injection).Ugqirha wakho angakuxelela ukuba ungayisebenzisi imveliso yenaliti ye-epoetin alfa.
  • xelela ugqirha wakho ukuba ukhe waxhuzula okanye wakha waxhuzula. Ukuba usebenzisa imveliso ye-epoetin alfa ngenaliti ukunyanga i-anemia ebangelwa sisifo sezintso esinganyangekiyo, xelela ugqirha wakho ukuba unawo okanye wakhe wanomhlaza.
  • xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwe ngelixa usebenzisa imveliso ye-epoetin alfa, biza ugqirha wakho.
  • ukuba wenza utyando, kubandakanya utyando lwamazinyo, xelela ugqirha okanye ugqirha wamazinyo ukuba usebenzisa imveliso ye-epoetin alfa.

Ugqirha wakho unokuyalela ukutya okhethekileyo ukukunceda ukulawula uxinzelelo lwegazi kunye nokunceda ukunyusa amanqanaba akho e-iron ukuze imveliso yenaliti ye-epoetin alfa isebenze kangangoko. Landela le miyalelo ngononophelo kwaye ubuze ugqirha wakho okanye ugqirha wezondlo ukuba unayo nayiphi na imibuzo.

Tsalela umnxeba ugqirha wakho akubuze ukuba wenzeni ukuba uphoswa yidosi yemveliso yenaliti ye-epoetin. Sukusebenzisa idosi ephindwe kabini ukwenza eyilahlekileyo.

Iimveliso zenaliti ye-epoetin alfa inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

  • intloko ebuhlungu
  • ukudibana kwamalungu okanye izihlunu, iintlungu, okanye iintlungu
  • isicaphucaphu
  • ukugabha
  • ukuhla ukusinda
  • izilonda emlonyeni
  • ubunzima bokulala okanye ukulala
  • ukudakumba
  • ukudumba kwezihlunu
  • impumlo egudileyo, ukuthimla, kunye nokudibana
  • umkhuhlane, ukukhohlela okanye ukugodola
  • ubomvu, ukudumba, iintlungu, okanye ukurhawuzelela kwindawo yenaliti

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu zilandelayo, okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

  • irhashalala
  • urhwebo
  • ukurhawuzelela
  • ukudumba kobuso, umqala, ulwimi, imilebe, okanye amehlo
  • iblisters okanye isikhumba esixobukayo
  • ukuvutha
  • ubunzima bokuphefumla okanye ukugwinya
  • ukudinwa okungaqhelekanga
  • ukunqongophala kwamandla
  • isiyezi
  • isiqaqa
  • ukuxhuzula

Iimveliso zenaliti ye-epoetin alfa inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unayo nayiphi na ingxaki engaqhelekanga ngelixa usebenzisa eli yeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Gcina eli yeza kwisikhongozeli elingene ukukhusela ekukhanyeni, livale ngci, kwaye lingenakufikelela ebantwaneni. Gcina i-epoetin alfa kunye ne-epoetin alfa-epbx kwisikhenkcisi, kodwa ungayisusi ngumkhenkce. Lahla naliphi na iyeza ebelikhenkcisiwe. Lahla igutyana le-epoetin alfa ngenaliti yeentsuku ezingama-21 emva kokuba uyisebenzisile.

Kubalulekile ukugcina onke amayeza ngaphandle kwamehlo kunye nokufikelela kwabantwana njengezikhongozeli ezininzi (ezinje ngeeveki zeepilisi zeveki kunye nezo zamehlo, iikhrim, iipatches, kunye ne-inhalers) azinyangeki kwaye abantwana abancinci banokuzivula ngokulula. Ukukhusela abantwana abancinci kwiityhefu, soloko ukhiya iminqwazi yokhuseleko kwaye ubeke amayeza kwindawo ekhuselekileyo-leyo iphakame kwaye iphakame kwaye ingabonakali kubo kwaye ifikelele kuyo. http://www.upandaway.org

Amayeza angafunekiyo kufuneka achithwe ngeendlela ezizodwa zokuqinisekisa ukuba izilwanyana zasekhaya, abantwana kunye nabanye abantu abanakuzisebenzisa. Nangona kunjalo, akufuneki uligungxule eli yeza kwindlu yangasese. Endaweni yoko, eyona ndlela yokulahla amayeza akho yinkqubo yokubuyisa amayeza. Thetha kumayeza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga i-FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) ngolwazi oluthe kratya ukuba awunakho ukufikelela kwinkqubo yokubuyisa.

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Ulwazi lukwafumaneka kwi-Intanethi kwi-https: //www.poisonhelp.org/help. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Iimpawu zokudlula ngaphezulu zinokubandakanya:

  • ngokukhawuleza okanye ukukhawuleza ukubetha kwentliziyo

Gcina lonke ixesha lokudibana nogqirha wakho. Ugqirha wakho uza kubeka esweni uxinzelelo lwegazi rhoqo xa unyangwa nge-epoetin alfa.

Phambi kokuba wenze uvavanyo lwaselebhu, xelela ugqirha wakho kunye nabasebenzi baselebhu ukuba usebenzisa imveliso ye-epoetin alfa.

Musa ukuvumela omnye umntu asebenzise amayeza akho. Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nokuzalisa amayeza akho.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

  • I-Epogen®(I-Epoetin Alpha)
  • Eprex®(I-Epoetin Alpha)
  • Ukuzithemba® (I-Epoetin Alpha)
  • Buyisela kwakhona®(I-Epoetin Alpha-epbx)
  • EPO
  • I-Erythropoietin yoLuntu yeGlycoform alpha (Recombinant)
  • rHuEPO-alpha

Le mveliso inophawu akusekho kwimarike. Ezinye iindlela ezinokubakho zinokubakho.

Ukuhlaziywa kokugqibela-09/15/2019

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