Imibuzo ebuzwa rhoqo malunga ne-Sunitinib Malate 丨 AASraw
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I-Sunitinib Malate

 

  1. Amagqabantshintshi eSunitinib Malate
  2. Yintoni esinokuyisebenzisa ngeSunitinib Malate?
  3. Isebenza njani iSunitinib Malate?
  4. Uyithatha njani iMalate yeSunitinib?
  5. Ungayigcina njani iMalate yeSunitinib?
  6. Singazi kangakanani Iziphumo ezibi zeSunitinib Malate?
  7. Zeziphi ezinye iziyobisi ezichaphazela i-Sunitinib Malate?
  8. I-FDA ivuma i-Sunitinib Malate njengonyango olongezelelekileyo lwe-Renal Cell Carcinoma
  9. Ndingayithenga phi i-Sunitinib Malate kwi-Intanethi?

 

I-Sunitinib Malate (i-CAS:341031-54-7) yafunyanwa e-SUGEN, inkampani ye-biotechnology eyayiphayona ngeprotein kinase inhibitors. Kwakuyinto yesithathu kuthotho lweekhompawundi kubandakanya i-SU5416 kunye ne-SU6668. Umxholo wawungowokulinganisa kwe-ATP eyayiza kukhuphisana ne-ATP yokubopha kwindawo yokubambisa ye-receptor tyrosine kinases. Olu luvo lukhokelele ekuyileni uninzi lweemolekyuli ezincinci tyrosine kinase inhibitors, kubandakanya uGleevec, Sutent, Tarceva nabanye abaninzi.

 

Amagqabantshintshi eSunitinib Malate

I-Sunitinib Malate yityheli etyheli ukuya kwiorenji. ISunitinib Malate yimolekyuli encinci ekujolise kuyo I-receptor tyrosine kinase (RTK) isithintelo. NgoJanuwari 26, 2006, iarhente yamkelwa ngokusesikweni yi-US FDA ngokubonisa ukunyanga i-renal cell carcinoma (RCC) kunye ne-imatinib-resistant gastrointestinal stromal tumor (GIST). Ukulungiselela ezi njongo, iSunitinib Malate iyafumaneka ngokubanzi njengolawulo olulawulwa ngomlomo. I-Sunitinib Malate inqanda umqondiso weselfowuni ngokujolisa kwii-RTKs ezininzi. Oku kubandakanya zonke ii-receptors ezikhulayo ezivela kwiplatelet (PDGF-R) kunye ne-vascular endothelial factor factor receptors (VEGF-R). I-Sunitinib Malate ikwathintela i-KIT (CD117), i-RTK eqhuba uninzi lwee-GIST. Ukongeza, i-Sunitinib Malate inqanda ezinye ii-RTKs kubandakanya i-RET, CSF-1R, kunye ne-flt3.

 

Yintoni esinokuyisebenzisa ngeSunitinib Malate? 

I-Sunitinib Malate isetyenziselwa ukunyanga abantu abadala abanesifo somhlaza esingasasazwanga (sasekhaya) kwaye abasemngciphekweni omkhulu we-RCC ukubuya kwakhona emva kotyando lwezintso.

I-Sunitinib Malate isetyenziselwa ukunyanga umhlaza wezintso (i-renal cell carcinoma okanye i-RCC).

I-Sunitinib Malate isetyenziselwa ukunyanga umhlaza onqabileyo wesisu, isisu, okanye umqala obizwa ngokuba isisu esiswini somzimba (GIST) kwaye xa uthathe amayeza imatinib mesylate kwaye awuthintanga umhlaza ukuba ukhule okanye awunakuthatha imatinib mesylate. I-Gleevec luphawu lwentengiso olubhalisiweyo lweNovartis Pharmaceuticals Corporation.

I-Sunitinib Malate isetyenziselwa ukunyanga uhlobo lomhlaza wepancreatic obizwa ngokuba zii-pancreatic neuroendocrine tumors (pNET) esele iqhubekile kwaye ayinakunyangwa ngoqhaqho.

 

Isebenza njani iSunitinib Malate?

I-Sunitinib Malate yi-inhibitor encinci ye-molecule ye-receptor tyrosine kinases, ezinye zazo zibandakanyeka ekukhuleni kwethumba, i-angologenesis ye-pathologic kunye nokuqhubela phambili komhlaza. Iarhente inqanda ukukhula kweplatelet-derived factor receptors - (PDGFRα kunye ne-PDGFRβ), i-vascular endothelial growth factor receptors (VEGFR1, VEGFR2, kunye ne-VEGFR3), i-stem cell factor receptor (KIT), i-FMS-efana ne-tyrosine kinase 3, i-colony-stimulating factor receptor Uhlobo lwe-1, kunye ne-glial cell-line ethathwe kwi-neurotrophic factor receptor (RET). I-Sunitinib Malate inhibition yomsebenzi kunye nomsebenzi wale receptor tyrosine kinases ibonakalisiwe kwiimvavanyo zebhayoloji kunye neselfowuni kunye nokuvavanywa kweseli okwandayo. Imetabolite ephambili yeSunitinib Malate ibonisa amandla afanayo nekhompawundi yabazali kwiimvavanyo zebhayoloji kunye neselfowuni.

I-Sunitinib Malate inqanda i-phosphorylation ye-receptor eninzi ye-tyrosine kinases (PDGFRβ, VEGFR2, KIT) kwi-tumor xenograf ebonisa i-receptor tyrosine kinase ekujoliswe kuyo kwi-vivo kwaye inqanda ukukhula kwe-tumor kunye ne-metastasis kwezinye iimodeli zovavanyo. Iarhente inqanda ukukhula kweeseli zedlala ezibonisa ukudakumba okungafunekiyo kwe-receptor tyrosine kinases (PDGFR, RET, okanye KIT) kwi-vitro kunye ne-PDGFRβ-kunye ne-VEGFR2-exhomekeke kwisisu se-angiogenesis kwi-vivo.

 

I-Sunitinib Malate

 

Uyithatha njani iMalate yeSunitinib?

Umthamo weSunitinib Malate ugqirha wakho omiselweyo uya kuxhomekeka kwizinto ezininzi. Oku kubandakanya:

Uhlobo kunye nobukhali bemeko oyisebenzisayo ukuze uphathe i-Sunitinib Malate

❷ ezinye iimeko zonyango onokuba nazo

❸ amanye amayeza owasebenzisayo

Ugqirha wakho uya kuthi ekugqibeleni anike idosi encinci enika isiphumo esifunayo.

Olu lwazi lulandelayo luchaza iidosi eziqhelekileyo ezisetyenziselwa okanye ezicetyiswayo. Nangona kunjalo, qiniseka ukuthatha idosi ekumisela ugqirha wakho. Ugqirha wakho uya kumisela eyona idosi ilungele iimfuno zakho.

 

Iifom zamachiza kunye namandla

I-Sunitinib Malate iza njengephilisi oyiginyeyo. Iyafumaneka kula mandla: 12.5 milligrams (mg), 25 mg, 37.5 mg, kunye no-50 mg.

 

Os Umthamo womhlaza wamathumbu

Umthamo oqhelekileyo weSunitinib Malate yamathumbu esisu esiswini (GISTs) yi-50 mg kanye ngemini kangangeeveki ezi-4. Oku kulandelwa ziiveki ezimbini ngaphandle kwamayeza. Emva koko, uya kuphinda ujikeleze.

Uya kuqhubeka nokuthatha i-Sunitinib Malate de umhlaza ube mandundu okanye umzimba wakho unganyamezeli unyango kunye neziyobisi. Ugqirha wakho uya kugqiba xa kufuneka uyeke ukuthatha i-Sunitinib Malate. Ngolwazi malunga nendlela iSunitinib Malate esetyenziselwa ngayo ukunyanga ii-GISTs, jonga ikhonkco njengezantsi.

 

Os Umthamo womhlaza kwizintso

I-Sunitinib Malate ikwasetyenziselwa ukunyanga uhlobo lomhlaza wezintso obizwa ngokuba yi-renal cell carcinoma (RCC). Umthamo oqhelekileyo weSunitinib Malate ye-RCC ephambili yi-50 mg kanye ngemini kwiiveki ze-4. Oku kulandelwa ziiveki ezimbini ngaphandle kwamayeza. Emva koko, uya kuphinda ujikeleze.

Uya kuqhubeka nokuthatha i-Sunitinib Malate de umhlaza ube mandundu okanye umzimba wakho unganyamezeli unyango kunye neziyobisi. Ugqirha wakho uya kugqiba xa kufuneka uyeke ukuthatha i-Sunitinib Malate. Ngolwazi oluthe kratya malunga nendlela iSunitinib Malate esetyenziselwa ngayo ukunyanga i-RCC ephambili, jonga ikhonkco njengezantsi.

 

♦ Umthamo wonyango lwe-adjuvant lomhlaza wezintso

I-Sunitinib Malate ikwasetyenziswa njengonyango oluncedisayo kuhlobo lomhlaza wezintso obizwa ngokuba yi-RCC emva kwe-nephrectomy (ukususwa kwezintso). Esiqhelekileyo idosi ye I-Sunitinib Malate oku kusetyenziswa ngama-50 mg kanye ngemini kangangeeveki ezi-4. Oku kulandelwa ziiveki ezimbini ngaphandle kwamayeza. Uya kuphinda ujikeleze lo mjikelo ukuya kwizihlandlo ezilithoba. Ngolwazi malunga nendlela iSunitinib Malate esetyenziswa ngayo njengonyango lwe-RCC, bona ikhonkco njengezantsi.

 

Os Inqanaba lomhlaza wepancreatic

Idosi yesiqhelo ye-Sunitinib Malate ye-pancreatic neuroendocrine tumors (pNETs) eyi-37.5 mg kanye ngemini.

Uya kuqhubeka nokuthatha i-Sunitinib Malate de umhlaza ube mandundu okanye umzimba wakho unganyamezeli unyango kunye neziyobisi. Ugqirha wakho uya kugqiba xa kufuneka uyeke ukuthatha i-Sunitinib Malate.

 

Qaphela: idosi ibhekisa kuphela, nceda uncede ukujonga ezinye iinkcukacha kule webhusayithi:www.fda.gov .

 

 

Ungayigcina njani iMalate yeSunitinib?

Gcina le nyilisi kwisitya, ivalwe ngokuqinileyo, kwaye ingafiki kubantwana. Yigcine kwiqondo lokushisa lokushisa kwaye kude nobushushu obuninzi kunye nobumanzi (kungekhona kwindawo yokuhlambela).

Kubalulekile ukugcina onke amayeza angabonakaliyo kunye nokufikelela kubantwana njengezikhonkwane ezininzi (ezifana neepilisi zeveki zeeveki kunye nezokwamahla, i-creams, i-patches, kunye ne-inhalers) abaxhomeki abantwana kunye nabantwana abancinci bangabavula ngokulula. Ukukhusela abantwana abancinci besetyhefu, soloko uvale iifake zokuphepha kwaye ubeke ngokukhawuleza loo mayeza kwindawo ekhuselekileyo - enye ephakanyisiwe kwaye ingabikho emehlweni abo kwaye ifinyelele.

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 kumachiza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga ukulahlwa ngokukhuselekileyo kwe-FDA Iwebsite yamaYeza ngolwazi oluthe kratya ukuba awunakho ukufikelela kwinkqubo yokubuyela umva.

 

Singazi kangakanani Iziphumo ezibi zeSunitinib Malate?

Iziganeko ezigwenxa zeSunitinib zithathwa njengezilawulwayo kunye neziganeko ezimbi ezimbi ezisezantsi.

Ezona ziganeko zixhaphakileyo zixhaphakileyo kunyango lwe-Sunitinib Malate kukudinwa, urhudo, isicaphucaphu, i-anorexia, uxinzelelo lwegazi, umbala omthubi wolusu, ukusabela kolusu lwenyawo, kunye ne-stomatitis. rhoqo nge-Sunitinib Malate kune-placebo ibandakanya urhudo, i-anorexia, ukuvela kolusu, i-mucositis / stomatitis, i-asthenia, inguqu eguqulweyo, kunye nokuqunjelwa. Ukuncitshiswa kwethamo kwakufuneka kwi-50% yezigulana ezifundwe kwi-RCC ukulungiselela ukulawula iityhefu ezibalulekileyo zeli arhente.

Imicimbi emibi (yebanga lesi-3 okanye lesi-4) yeziganeko ezigwenxa zenzeka kwi-10% yezigulana kwaye zibandakanya uxinzelelo lwegazi, ukudinwa, i-asthenia, isifo sorhudo, kunye ne-chemotherapy eyenziwe yi-acral erythema. Ukungaqheleki kwilebhu enxulunyaniswa nonyango lweSunitinib Malate kubandakanya lipase, amylase, neutrophils, lymphocyte, kunye neeplatelets. I-Hypothyroidism kunye ne-erythrocytosis eguqukayo ikwayanyaniswa ne-Sunitinib Malate. Uninzi lweziganeko ezimbi zinokulawulwa ngononophelo lwenkxaso, ukuphazamiseka kwethamo, okanye ukunciphisa idosi.

Uphononongo lwakutsha nje olwenziwe kwiZiko loMhlaza i-And Anderson Cancer Centre lithelekise iziphumo zezigulo zomhlaza wesifo sezintso ezifumene iSunitinib Malate kwishedyuli esemgangathweni (i-50 mg / iiveki ezi-4 ngeeveki ezi-2 zikhutshiwe) kunye nabo bafumana iSunitinib Malate ngeeholide zeziyobisi rhoqo kunye nezifutshane. (enye ishedyuli). Kwabonwa ukuba ukusinda ngokubanzi, ukuqhubela phambili kokuphila simahla kunye nokubambelela kunyango kwakuphezulu kakhulu kwizigulana ezafumana iSunitinib Malate kwishedyuli eyenye. Izigulana zikwanokunyamezelana okungcono kunye nokuqina okungaphantsi kweziganeko ezimbi ezihlala zikhokelela ekuphelisweni kwonyango lwezigulana ezinomhlaza wesifo se-metastatic renal.

 

I-Sunitinib Malate

 

Zeziphi ezinye iziyobisi ezichaphazela i-Sunitinib Malate?

I-Sunitinib Malate inokubangela ingxaki enkulu yentliziyo. Umngcipheko wakho ungangaphezulu ukuba usebenzisa amanye amayeza usulelo, isifuba, iingxaki zentliziyo, uxinzelelo lwegazi, uxinzelelo, ukugula ngengqondo, umhlaza, isifo seengcongconi, okanye i-HIV.

Ngamanye amaxesha akukhuselekanga ukusebenzisa amayeza athile ngaxeshanye. Amanye amachiza anokuwachaphazela amanqanaba akho egazi amanye amayeza owathathayo, anokunyusa iziphumo ebezingalindelekanga okanye enze amayeza angasebenzi kakuhle. Xelela ugqirha wakho ngawo onke amanye amayeza akho, ngakumbi: iyeza le-osteoporosis.

Olu luhlu aluphelelanga. Amanye amachiza anokuchaphazela i-Sunitinib Malate, kubandakanya amayeza kunye neyeza zokuthenga, iivithamini kunye neemveliso zamayeza. Ayizizo zonke iindlela zokunxibelelana kweziyobisi ezidweliswe apha.

 

I-FDA ivuma i-Sunitinib Malate njengonyango olongezelelekileyo lwe-Renal Cell Carcinoma

Nge-16 kaNovemba ka-2017, uLawulo lokuTya kunye neZiyobisi lwamkele iSunitinib Malate (iSunitinib Malate, Pfizer Inc.) kunyango olusebenzayo kwizigulana zabantu abadala abasemngciphekweni omkhulu wokuphindaphinda i-renal cell carcinoma elandelayo nephrectomy.

Ukuvunywa kwakusekwe kwiziko elinamazwe amaninzi, kumazwe aphesheya, ngamehlo amabini, ngolawulo lwe-placebo, ulingo (S-TRAC), kwizigulana ezingama-615 ezinomngcipheko omkhulu wokuphindaphinda i-RCC kulandela i-nephrectomy. Izigulana zalungiswa nge-1: 1 yokufumana i-50 mg i-Sunitinib Malate kanye yonke imihla, iiveki ze-4 kunyango olulandelwa ziiveki ezi-2, okanye i-placebo. Ukuphila okungenasifo seMedian kwizigulana ezithatha iSunitinib Malate yayiyiminyaka eyi-6.8 (95% CI: 5.8, ayifikelelwanga) xa kuthelekiswa neminyaka eyi-5.6 (95% CI: 3.8, 6.6) kwizigulana ezifumana i-placebo (HR = 0.76; 95% CI: 0.59 , Ipesenti = 0.98) Ngexesha lohlalutyo lwe-DFS, idatha yokusinda iyonke yayingakhuli.

Ezona mpembelelo zixhaphakileyo (≥25%) kwi-Sunitinib Malate kukudinwa / i-asthenia, isifo sohudo, isifo se-mucositis / i-stomatitis, isicaphucaphu, ukuncipha kokutya / i-anorexia, ukugabha, iintlungu zesisu, isifo seenyawo, uxinzelelo lwegazi, imicimbi yokopha, isifo sedysgeusia / incasa etshintshiweyo. , iDyspepsia, kunye ne-thrombocytopenia. Ileyibheli inesilumkiso esinebhokisi yokwazisa abaqeqeshi bezempilo kunye nezigulana malunga nomngcipheko we-hepatoxicity, enokubangela ukusilela kwesibindi okanye ukufa.

Idosi ekhuthazwayo ye-Sunitinib Malate yonyango lwe-RCC yi-50 mg ngomlomo kanye yonke imihla, kunye okanye ngaphandle kokutya, iiveki ezi-4 kunyango olulandelwa ziiveki ezi-2 zokuya kwimijikelo elithoba yeeveki ezi-6.

 

Qaphela: Ulwazi olupheleleyo lokumisela luyafumaneka kwi:ufikelelo.fda.gov  IPDF. 

 

Ndingayithenga phi i-Sunitinib Malate kwi-Intanethi? 

Baninzi abathengisi / abavelisi be-Sunitinib Malate powder kwimarike, ukufumana eyinyani kubaluleke kakhulu kubo bonke abantu abafuna le mveliso ngokungxamisekileyo. Xa sithatha isigqibo sokuthenga i-Sunitinib Malate powder kwimarike, kufuneka sifunde ulwazi malunga nayo, siyazi indlela yokuyisebenzisa kunye nendlela yokusebenza, nayiphi na ingozi xa sithatha i-Sunitinib Malate powder…. Ukongeza, ixabiso kunye nomgangatho kufuneka ibe yinkxalabo yethu ngaphambi kokuba uyithenge.

Emva kokuba sihlolisise ii-datas ezivela kwiimarike, xa kuthelekiswa nabanikezeli abaninzi, i-AASraw ibukeka kakuhle kubantu abafuna ukuthenga ezininzi I-Sunitinib Malate powder, imveliso yabo yayilawulwa ngokungqongqo phantsi kwemeko ye-cGMP, umgangatho unokulandelwa nangaliphi na ixesha kwaye banokubonelela ngazo zonke iingxelo zovavanyo xa uzi-odola. Ngokubhekisele kwi-Sunitinib Malate powder iindleko / ixabiso, kufanelekile, emehlweni am. Ngenxa yokuba ndinamaxabiso amaninzi avela kubathengisi abahlukeneyo beSunitinib Malate, xa kuthelekiswa nomgangatho, ndicinga ukuba i-aasraw ayizukukhetha kakubi.

 

isingqiniso

[1] Ukutya kunye noLawulo lweziyobisi. Sunitinib (Sutent) Ukuchaza ulwazi. 2015.

[2] CA Naranjo, U. Busto, kunye nabathengisi be-EM, "Indlela yokuqikelela ukubakho kweziphumo ezibi zeziyobisi," Clinical Pharmacology and Therapeutics, vol. 30, hayi. 2, iphepha 239-245, 1981.

[3] Z. Ansari kunye noMK George, "I-thrombocytopenia ekwi-immune-Mediated-mediated-thrombocytopenia yesibini ukuya kwi-sunitinib kwisigulana esine-metastatic renal cell carcinoma: ingxelo yetyala," Ijenali yeeNgxelo zezoNyango, vol. 7, inqaku 54, 2013.

[4] K. Sakai, K. Komai, D. Yanase, kunye noM. Yamada, "IPlasma VEGF njengophawu lokuchonga nokunyanga i-vasculitic neuropathy," Ijenali yeNeurology, Neurosurgery kunye nePsychiatry, ivol. 76, hayi. 2, inqaku 296, 2005.

[5] IArhente yamaYeza yaseYurophu. I-Sunitinib (SUTENT). Isishwankathelo seMpawu zeMveliso. 2015.

[6] IPajares B, uTorres E, uTrigo JM okqhubekayo. I-Tyrosine kinase inhibitors kunye nokunxibelelana kweziyobisi: uphononongo kunye neengcebiso ezisebenzayo. Iklinikhi Guqula i-Oncol 2012; 14: 94-101.

[7] I-Teo YL, i-Ho HK, i-Chan A.Imetabolism enxulumene nokusetyenziswa kweziyobisi ngamachiza kunye ne-tyrosine kinase inhibitors: ukuqonda kwangoku, imiceli mngeni kunye neengcebiso. Br J Clin Pharmacol 2015; 79: 241-253.

[8] UJamie Dlugosch (2009-03-13). "Ngaba i-biologics kunye ne-Sutent iya kugcina iPfizer?". Indawo yoTyalomali.

[9] BMJ 31-Jan-2009 “NICE nomceli mngeni weziyobisi zomhlaza” p271

[10] IBray JY, Reichardt P (Juni 2009). "I-Advanced gastrointestinal stromal tumor in Europe: uphononongo lweengcebiso zonyango ezihlaziyiweyo". Ingcali nge-Rev Anticancer Ther. 9 (6): 831-8. ikhonkco: 10.1586 / era.09.34. I-PMID 19496720. I-S2CID 23601578.

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