Tus Sau: Clyde Lopez
Hnub Kev Tsim: 20 Lub Xya Hli Ntuj 2021
Hloov Hnub: 17 Lub Kaum Ib Hli Ntuj 2024
Anonim
Abemaciclib for HR-Positive Metastatic Breast Cancer
Daim Duab: Abemaciclib for HR-Positive Metastatic Breast Cancer

Zoo Siab

[Tshaj tawm 09/13/2019]

Kev tuaj koom: Tus Neeg Mob, Kev Noj Qab Haus Huv Kev Noj Qab Haus Huv, Oncology

ISSUE: FDA tau ceeb toom tias palbociclib (Ibrance®), ribociclib (Kisqali®), thiab abemaciclib (Verzenio®) siv los kho qee tus neeg mob uas muaj mob qog mis ntau dua tuaj yeem ua rau mob ntsws tab sis muaj mob ntsws ua rau ntau heev. FDA tau pom zoo cov lus ceeb toom tshiab txog qhov kev pheej hmoo no rau kev muab tshuaj thiab Cov Ntawv Kho Mob Ntim rau tag nrho cov chav kawm ntawm cov cyclin-dependant kinase 4/6 (CDK 4/6) inhibitor tshuaj. Tag nrho cov txiaj ntsig ntawm CDK 4/6 inhibitors tseem muaj ntau dua li qhov kev pheej hmoo thaum siv raws li tau hais tseg.

ROV QAB ZIB: CDK 4/6 inhibitors yog ib chav kawm ntawm cov tshuaj uas siv los ua ke nrog cov tshuaj kho mob los kho cov neeg laus uas muaj cov tshuaj hormones receptor (HR) -positive, tib neeg kev loj hlob los ntawm qhov muaj feem 2 (HER2)-ua ntej los sis mob cancer mis hloov uas tau kis mus lwm qhov ntawm lub cev. CDK 4/6 inhibitors thaiv qee cov lwg me uas koom rau hauv kev txhawb nqa kev loj hlob ntawm cov qog nqaij hlav cancer. FDA pom zoo palbociclib hauv 2015, thiab ob qho tib si ribociclib thiab abemaciclib hauv 2017. CDK 4/6 inhibitors tau pom tias yuav txhim kho lub sijhawm tom qab pib kev kho mob cancer tsis loj hlob thiab tus neeg mob tseem muaj sia, hu ua kev vam meej-tsis muaj sia nyob (Saib Daim Ntawv Teev Qhia FDA-Pom Zoo CDK 4/6 Cov Tshuaj Tiv Thaiv hauv qab no).


LUS:Cov neeg mob yuav tsum qhia rau koj tus kws saib xyuas kev noj qab haus huv tam sim yog tias koj muaj cov tsos mob tshiab lossis mob hnyav ntxiv uas cuam tshuam txog koj lub ntsws, vim tias lawv yuav qhia qhov tsawg tab sis muaj kev phom sij uas tuaj yeem ua rau tuag taus. Cov tsos mob uas yuav tau saib yog:

  • Nyuaj lossis tsis xis nyob nrog kev ua pa
  • Ua tsis taus pa thaum so lossis nrog qes

Tsis txhob tsum tsis txhob noj koj cov tshuaj yam tsis tau tham ua ntej nrog koj tus kws kho mob. Tag nrho cov tshuaj muaj cov kev mob tshwm sim txawm tias siv raws li qhov raug, tab sis feem ntau cov txiaj ntsig ntawm kev noj cov tshuaj no ntau dua cov kev pheej hmoo.Nws yog ib qho tseem ceeb kom paub tias tib neeg teb rau txhua hom tshuaj sib txawv raws lawv kev noj qab haus huv, cov kab mob uas lawv muaj, yam caj ces, lwm yam tshuaj uas lawv tau noj, thiab ntau lwm yam. Cov kev pheej hmoo tshwj xeeb los txiav txim siab yuav ua li cas tus tib neeg thiaj li yuav muaj mob ntsws nrawm heev thaum noj palbociclib, ribociclib, lossis abemaciclib tseem tsis tau pom tias yog leej twg.


Cov kws kho mob nkeeg yuav tsum saib xyuas cov neeg mob tsis tu ncua ntawm cov ntsws ntsws uas qhia pom tias mob ntsws interstitial ntsws (ILD) thiab / lossis mob ntsws. Cov cim thiab tsos mob tuaj yeem suav nrog:

  • hypoxia
  • hnoos
  • dyspnea
  • interstitial infiltrates ntawm kev kuaj mob radiologic hauv cov neeg mob uas sib kis, neoplastic, thiab lwm yam ua rau raug cais tawm.

Kev cuam tshuam los ntawm CDK 4/6 inhibitor kev kho mob hauv cov neeg mob uas muaj cov tsos mob tshiab lossis ua pa nyuaj, thiab tsum tsis kho rau cov neeg mob uas muaj ILD loj thiab / lossis mob ntsws.

Yog xav paub ntaub ntawv ntau ntxiv mus saib FDA tus vev xaib ntawm: http://www.fda.gov/Safety/MedWatch/SafetyInformation thiab http://www.fda.gov/Drugs/DrugSafety.

Abemaciclib yog siv nrog rau kev ua kom zoo tag nrho (Faslodex) los kho qee yam ntawm cov tshuaj hormone receptor-positive, mob cancer ntawm lub mis (mob cancer mis uas nyob ntawm cov tshuaj hormones xws li estrogen kom loj hlob) lossis mob cancer mis uas tau kis mus rau lwm qhov ntawm lub cev tom qab kho nrog rau kev siv tshuaj tiv thaiv kab mob xws li tamoxifen (Nolvadex). Abemaciclib kuj tseem siv nrog rau anastrozole (Arimidex), exemestane (Aromasin), lossis letrozole (Femara) yog thawj qhov kev kho mob los ntawm hormone receptor-zoo, dhau mus ua mob cancer mis lossis mob cancer mis uas tau kis mus rau lwm qhov ntawm lub cev. Abemaciclib kuj tseem siv ib leeg los kho qee yam ntawm cov tshuaj hormone receptor-positive, advanced cancer mis lossis mob cancer mis uas tau kis mus rau lwm qhov ntawm lub cev hauv cov neeg uas twb tau siv tshuaj kho mob antestrogen thiab tshuaj kho mob. Abemaciclib nyob hauv chav kawm ntawm cov tshuaj hu ua kinase inhibitors. Nws ua haujlwm los ntawm kev thaiv qhov kev txiav txim ntawm cov protein tsis txaus uas ua rau muaj hlwb hlav hlav. Qhov no yuav pab kom qeeb los yog txwv tsis pub kis mob hlwb.


Abemaciclib los ua ib ntsiav tshuaj noj ntawm qhov ncauj. Nws feem ntau yog noj ob zaug ib hnub nrog lossis tsis muaj zaub mov. Noj tshuaj abemaciclib nyob ib ncig ntawm tib lub sijhawm txhua hnub. Ua raws li cov lus qhia ntawm koj daim ntawv sau tshuaj noj kom zoo, thiab nug koj tus kws kho mob lossis kws muag tshuaj kom piav qhia ib feem uas koj tsis nkag siab. Noj abemaciclib raws nraim li qhia. Tsis txhob noj ntau dua lossis tsawg dua lossis siv ntau dua li uas koj tus kws khomob tau qhia.

Nqos cov ntsiav tshuaj tag nrho; tsis txhob sib faib, zom, lossis tsoo lawv. Tsis txhob noj cov ntsiav tshuaj uas tawg, tawg, lossis puas tsuaj rau txhua txoj kev.

Yog tias koj ntuav tom qab noj abemaciclib, tsis txhob noj ib qho tshuaj ntxiv. Ua koj cov tshuaj noj tas li.

Koj tus kws kho mob tuaj yeem txo koj cov koob tshuaj lossis ib ntus lossis txiav tawm koj txoj kev kho mob yog tias koj muaj tej kev mob tshwm sim. Qhov no nws nyob ntawm seb cov tshuaj ua hauj lwm zoo npaum li cas rau koj thiab kev phiv uas koj ntsib. Nco ntsoov qhia koj tus kws kho mob seb koj xav li cas thaum kho koj nrog abemaciclib.

Cov tshuaj no tuaj yeem tsim tawm rau lwm txoj kev siv; nug koj tus kws kho mob lossis kws muag tshuaj kom paub ntaub ntawv ntau ntxiv.

Ua ntej noj cov tshuaj abemaciclib,

  • qhia rau koj tus kws kho mob thiab tus kws muag tshuaj yog tias koj muaj kev fab tshuaj rau abemaciclib, lwm yam tshuaj, lossis ib qho tshuaj twg hauv cov ntsiav tshuaj abemaciclib. Nug koj tus kws muag tshuaj rau cov npe ntawm cov khoom xyaw.
  • qhia rau koj tus kws kho mob thiab kws muag tshuaj tias lwm yam tshuaj uas tsis yog kws kho mob thiab cov tshuaj uas tsis yog kws kho mob sau, tshuaj vitamins, khoom noj khoom haus zoo, thiab tshuaj ntsuab koj tau noj lossis npaj yuav noj. Nco ntsoov hais txog ib qho ntawm cov hauv qab no: clarithromycin (Biaxin, hauv Prevpac), diltiazem (Cardizem, Tiazac, lwm tus), itraconazole (Sporanox), ketoconazole (Nizoral), rifampin (Rifadin, Rimactane, hauv Rifater), thiab verapamil (Calan) , Verelan, lwm tus). Koj tus kws kho mob tej zaum yuav tau hloov qhov tshuaj ntawm koj cov tshuaj lossis saib xyuas koj kom zoo rau kev phiv. Ntau lwm yam tshuaj kuj tseem tuaj yeem cuam tshuam nrog abemaciclib, yog li nco ntsoov qhia koj tus kws kho mob txog txhua yam tshuaj uas koj siv, txawm tias tsis tshwm nyob hauv daim ntawv no.
  • qhia rau koj tus kws kho mob yog tias koj kub taub hau, ua daus no, lossis muaj lwm yam tsos mob ntawm tus mob lossis yog koj muaj lossis muaj kab mob siab lossis mob raum.
  • qhia rau koj tus kws kho mob yog tias koj cev xeeb tub los yog npaj yuav cev xeeb tub. Koj yuav tsum tau kuaj cev xeeb tub ua ntej koj pib kev kho mob thiab yuav tsum siv kev tswj tsis pub muaj menyuam kom tiv thaiv kev xeeb tub thaum koj kho thiab tsawg kawg 3 lub lis piam tom qab koj cov tshuaj zaum kawg. Yog tias koj xeeb tub thaum noj cov tshuaj abemaciclib, hu rau koj tus kws kho mob tam sim ntawd. Abemaciclib tuaj yeem tsim kev puas tsuaj rau lub menyuam.
  • qhia rau koj tus kws kho mob yog tias koj pub mis niam lossis npaj yuav pub mis. Koj yuav tsum tsis txhob pub niam mis thaum noj abemaciclib thiab tsawg kawg 3 lub lis piam tom qab koj cov tshuaj zaum kawg.
  • koj yuav tsum paub tias cov tshuaj no tuaj yeem txo qis kev muaj menyuam hauv cov txiv neej. Tham nrog koj tus kws kho mob txog cov kev pheej hmoo ntawm kev noj abemaciclib.
  • koj yuav tsum paub tias abemaciclib feem ntau ua rau mob raws plab, uas tuaj yeem mob hnyav tau. Tej zaum koj tus kws kho mob yuav qhia koj kom haus dej kom ntau thiab noj tshuaj rau lub plab kom tiv thaiv tsis txhob ua kom lub cev qhuav dej (tsis muaj dej ntau hauv koj lub cev) thaum koj nyuam qhuav pib raws plab lossis tso quav. Hu rau koj tus kws kho mob tam sim ntawd yog tias koj pom cov tsos mob ntawm lub cev qhuav dej: nqhis dej heev, qhov ncauj qhuav lossis tawv nqaij, tso zis tsawg, lossis lub plawv dhia ceev.

Tsis txhob noj txiv kab ntxwv qaub lossis haus cov txiv kab ntxwv kua txiv thaum noj cov tshuaj no.

Hla lub tshuaj uas tsis nco qab noj thiab txuas ntxiv koj lub sijhawm noj tshuaj. Tsis txhob noj tshuaj rau ob zaug kom ua rau qhov ploj lawm ib zaug.

Abemaciclib tuaj yeem ua phiv. Qhia rau koj tus kws kho mob yog tias ib qho ntawm cov tsos mob no hnyav lossis tsis ploj mus:

  • xeev siab
  • ntuav
  • mob plab
  • cem quav
  • mob ntawm daim di ncauj, qhov ncauj, lossis caj pas
  • tsis qab los
  • poob phaus
  • plaub hau poob
  • khaus
  • ua pob
  • mob taub hau
  • hloov pauv hauv saj
  • kiv taub hau
  • mob tej pob txha

Qee qhov kev mob tshwm sim tuaj yeem loj heev. Yog koj muaj cov tsos mob no los yog nyob hauv cov nqe lus tshwj xeeb tshaj plaws, hu rau koj tus kws kho mob tam sim ntawd:

  • nkees nkees
  • mob hauv sab saud hauv plab
  • daj ntawm daim tawv nqaij lossis qhov muag
  • tsis qab los noj mov
  • los ntshav lossis doog ntshav yooj yim
  • mob mob ntawm caj npab lossis txhais ceg
  • o ntawm tes, taw, ceg lossis pob taws
  • txog siav
  • mob hauv siab
  • pa ceev heev
  • lub plawv dhia nrawm, tsis xwm yeem, lossis sib dhia
  • kub taub hau, ua daus no, hnoos lossis lwm yam cim ntawm tus kab mob
  • daj ntseg tawv nqaij

Abemaciclib tuaj yeem ua lwm cov kev mob tshwm sim. Hu rau koj tus kws kho mob yog tias koj muaj teeb meem txawv txawv thaum noj cov tshuaj no.

Yog tias koj muaj kev mob tshwm sim loj, koj lossis koj tus kws kho mob tuaj yeem xa ntawv ceeb toom rau Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) lossis hauv xov tooj ( 1-800-332-1088).

Khaws cov tshuaj no rau hauv lub khob uas nws nkag los, kaw kom nruj, thiab ncav tsis cuag ntawm cov menyuam. Khaws nws ntawm chav sov thiab deb ntawm qhov kub thiab noo noo (tsis nyob hauv chav dej).

Nws yog ib qho tseem ceeb kom tsis txhob muaj txhua yam tshuaj rau qhov tsis pom thiab ncav cuag ntawm cov menyuam yaus ntau li ntau ntim (xws li tshuaj ntsiav tshuaj txhua lub limtiam thiab cov tshuaj rau qhov muag, tshuaj pleev, pleev xim, thiab nqus tshuaj) tsis tiv thaiv menyuam yaus thiab cov menyuam yaus tuaj yeem qhib lawv tau yooj yim. Txhawm rau tiv thaiv cov menyuam yaus me los ntawm kev lom, ib txwm kaw lub kaus mom kev nyab xeeb thiab muab cov tshuaj tso rau qhov chaw nyab xeeb - ib qho chaw nyob thiab deb thiab tawm ntawm lawv pom thiab ncav cuag. http://www.upandaway.org

Cov tshuaj tsis siv tshuaj yuav tsum tau muab pov tseg hauv txoj kev tshwj xeeb kom ntseeg tau tias cov tsiaj, menyuam yaus, thiab lwm tus neeg tsis tuaj yeem haus lawv. Txawm li cas los xij, koj yuav tsum tsis txhob yaug cov tshuaj no hauv lub qhov viv. Hloov chaw, txoj hauv kev zoo tshaj plaws hauv kev muab koj cov tshuaj tshem tawm yog los ntawm kev siv tshuaj rov qab. Tham nrog koj tus kws muag tshuaj lossis tiv tauj koj lub chaw khaws khib nyiab / chaw khaws khoom ubno hauv ib cheeb tsam kom paub txog cov haujlwm thim rov qab hauv koj lub zej zog. Saib ntawm FDA's Kev Nyab Xeeb Kev Nyab Xeeb Kev Siv Tshuaj lub vev xaib (http://goo.gl/c4Rm4p) kom paub cov ntaub ntawv ntau ntxiv yog tias koj tsis muaj kev nkag mus saib rov qab.

Yog hais tias noj ntau dhau, hu rau kem tus xov tooj kev pab tswj kev lom ntawm 1-800-222-1222. Cov ntaub ntawv tseem muaj nyob online ntawm https://www.poisonhelp.org/help. Yog tus neeg raug tsim txom, tsaus muag, ua tsis taus pa, lossis sawv tsis taus, hu rau 911 tus neeg pab thaum muaj xwm ceev.

Khaws tag nrho cov kev teem caij mus ntsib koj tus kws kho mob thiab chav kuaj mob. Koj tus kws khomob yuav xaj kuaj qee yam kev kuaj sim ua ntej thiab thaum kho koj lub cev kom kuaj xyuas koj lub cev cov lus teb rau abemaciclib.

Tsis txhob cia lwm tus noj koj cov tshuaj. Nug koj tus kws muag tshuaj cov lus nug uas koj muaj txog kev rov ntxiv tshuaj rau koj.

Nws yog ib qho tseem ceeb rau koj kom koj muaj ib daim ntawv sau tag nrho cov tshuaj noj thiab cov tshuaj uas tsis yog kws kho mob sau ntawv (tsis yuav khoom) uas koj tab tom noj, nrog rau txhua yam khoom xws li cov vitamins, minerals, lossis lwm yam tshuaj noj rau lub cev. Koj yuav tsum nqa cov ntawv no nrog koj txhua zaus koj mus ntsib kws kho mob lossis yog tias koj tuaj nyob hauv tsev kho mob. Nws tseem yog cov ntaub ntawv tseem ceeb los nqa nrog koj thaum muaj xwm txheej ceev.

  • Verzenio®
Kawg Kho - 04/15/2018

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