I-Palbociclib

-Delile

• Ngaphambi kokuthatha i-palbociclib,
• I-Palbociclib ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

[Kuthunyelwe 09/13/2019]

Isithameli: Isiguli, Ochwepheshe Bezempilo, Oncology

ISIQEPHU: I-FDA ixwayisa ngokuthi i-palbociclib (Ibrance^®), i-ribociclib (Kisqali^®), kanye ne-abemaciclib (Verzenio^®) esetshenziselwa ukwelapha ezinye iziguli ezinomdlavuza webele osezingeni eliphakeme kungadala ukuvuvukala okungavamile kodwa okukhulu kwamaphaphu. I-FDA igunyaze izexwayiso ezintsha mayelana nale ngozi kulwazi olunqunyiwe kanye ne-Patient Package Insert yekilasi lonke lale mithi yokuvimbela i-cyclin-dependent kinase 4/6 (CDK 4/6). Inzuzo ephelele ye-CDK 4/6 inhibitors isenkulu kunezingozi lapho isetshenziswa njengoba kunqunyiwe.

ISENDLALELO: Ama-CDK 4/6 inhibitors ayisigaba semithi kadokotela esetshenziswa ngokuhlangana nezindlela zokwelapha ama-hormone ukwelapha abantu abadala abane-hormone receptor (HR) -positive, human epidermal growth factor 2 (HER2) - umdlavuza webele ophambili noma we-metastatic osabalalele ku ezinye izitho zomzimba. Ama-CDK 4/6 inhibitors avimba ama-molecule athile abandakanyeka ekukhuthazeni ukukhula kwamangqamuzana omdlavuza. I-FDA ivume i-palbociclib ngo-2015, futhi zombili i-ribociclib ne-abemaciclib ngo-2017. Ama-CDK 4/6 inhibitors akhonjisiwe ukuthi enza ngcono isikhathi ngemuva kokuqala kokwelashwa umdlavuza ungakhuli kakhulu kanti isiguli siyaphila, okubizwa ngokuthi yi-progression-free survival (Bheka Uhlu lwe-CDK 4/6 Inhibitors evunyelwe yi-FDA ngezansi).

Ukuncoma:Iziguli kufanele wazise uchwepheshe wakho wokunakekelwa kwezempilo ngokushesha uma unezimpawu ezintsha noma eziya ziba zimbi ezibandakanya amaphaphu akho, ngoba zingakhombisa isimo esingajwayelekile kodwa esisongela impilo esingaholela ekufeni. Izimpawu okufanele zibhekwe zifaka:

• Ubunzima noma ukungaphatheki kahle ngokuphefumula
• Ukuphefumula okuncane ngesikhathi sokuphumula noma ngomsebenzi ophansi

Ungayeki ukuthatha umuthi wakho ngaphandle kokuqala ukhulume nodokotela wakho wezempilo. Yonke imithi inemiphumela engemihle noma ngabe isetshenziswe kahle njengoba kunqunyiwe, kepha ngokuvamile izinzuzo zokuthatha le mithi zidlula lezi zingozi. Kubalulekile ukwazi ukuthi abantu baphendula ngokuhlukile kuyo yonke imithi kuye ngempilo yabo, izifo abanazo, izici zofuzo, eminye imithi abayisebenzisayo, nezinye izinto eziningi. Izici ezithile zobungozi zokunquma ukuthi kungenzeka kanjani ukuthi umuntu othile abhekane nokuvuvukala okukhulu kwamaphaphu lapho ethatha i-palbociclib, i-ribociclib, noma i-abemaciclib ayikaziwa.

Abasebenzi bezempilo kufanele iqaphe iziguli njalo ukuthola izimpawu zamaphaphu ezibonisa ukuthi i-interstitial lung disease (ILD) kanye / noma i-pneumonitis. Izimpawu nezimpawu zingafaka:

• hypoxia
• ukukhwehlela
• I-dyspnea
• ukungena ngaphakathi kwezivivinyo ze-radiologic ezigulini lapho kukhishwe khona izifo ezithathelwanayo, i-neoplastic nezinye izimbangela.

Ukuphazamisa ukwelashwa kwe-CDK 4/6 inhibitor ezigulini ezinezimpawu zokuphefumula ezintsha noma eziba zimbi, futhi uyeke unomphela ukwelashwa ezigulini ezine-ILD enamandla kanye / noma i-pneumonitis.

Ukuthola eminye imininingwane vakashela iwebhusayithi ye-FDA ku: http://www.fda.gov/Safety/MedWatch/SafetyInformation naku-http: //www.fda.gov/Drugs/DrugSafety.

I-Palbociclib isetshenziswa ngokuhlangana ne-anastrozole (Arimidex), i-exemestane (i-Aromasin), noma i-letrozole (i-Femara) ukwelapha uhlobo oluthile lwe-hormone receptor-positive, umdlavuza webele othuthukile (umdlavuza webele oncike kumahomoni afana ne-estrogen ukukhula) noma ibele umdlavuza osabalalele kwezinye izingxenye zomzimba kubantu besifazane asebeke babhekana nokunqamuka kokuya esikhathini (ushintsho lwempilo, ukuphela kokuya esikhathini njalo ngenyanga) noma kwabesilisa. I-Palbociclib iyasetshenziswa kanye ne-fulvestrant (Faslodex) ukwelapha uhlobo oluthile lwe-hormone receptor-positive, umdlavuza webele othuthukile (umdlavuza webele oncike kumahomoni afana ne-estrogen ukukhula) noma umdlavuza webele osabalalele kwezinye izingxenye zomzimba ku abantu abaphathwe ngemithi ye-antiestrogen efana ne-tamoxifen (Nolvadex). I-Palbociclib isekilasini lemithi ebizwa nge-kinase inhibitors. Isebenza ngokuvimba ukusebenza kweprotheni engavamile ekhombisa ukuthi amangqamuzana omdlavuza ayanda. Lokhu kusiza ukumisa noma ukubambezela ukusabalala kwamangqamuzana omdlavuza.

IPalbociclib iza njengephilisi elizothathwa ngomlomo. Imvamisa kuthathwa ngokudla kanye nsuku zonke ezinsukwini zokuqala ezingama-21 zomjikelezo wezinsuku ezingama-28. Udokotela wakho uzonquma ukuthi kufanele uwuphindaphinde kangaki lo mjikelezo. Thatha i-palbociclib ngasikhathi sinye nsuku zonke. Landela izinkomba ezikulebuli kadokotela wakho ngokucophelela, bese ubuza udokotela noma usokhemisi wakho ukuthi akuchaze nganoma iyiphi ingxenye ongayiqondi. Thatha i-palbociclib njengoba iqondisiwe. Ungayithathi kancane noma uyithathe kaningi kunokuyalelwa ngudokotela wakho.

Gwinya wonke amaphilisi; ungazivuli, uzihlafune noma uzichoboze. Ungathathi amaphilisi aphukile noma aqhekekile.

Uma uhlanza ngemuva kokuthatha i-palbociclib, ungathathi omunye umthamo. Qhubeka nesimiso sakho sokulinganisa okuvamile.

Udokotela wakho anganciphisa umthamo wakho noma ayeke ukwelashwa kwakho okwesikhashana noma unomphela uma uhlangabezana nemiphumela ethile emibi. Qiniseka ukuthi utshela udokotela wakho ukuthi uzizwa kanjani ngenkathi welashwa nge-palbociclib.

Buza usokhemisi noma udokotela wakho ikhophi lemininingwane yomkhiqizi yesiguli.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokuthatha i-palbociclib,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-palbociclib, noma imiphi eminye imithi, noma iziphi izithako ezikuma-palbociclib capsules. Buza usokhemisi wakho ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Qiniseka ukuthi usho noma yikuphi okulandelayo: ama-antifungal anjenge-itraconazole (i-Onmel, i-Sporanox, iTolsura), i-ketoconazole, i-posaconazole (i-Noxafil), ne-voriconazole (i-Vfend); imithi ethile yokwelapha ukuquleka okufana ne-carbamazepine (Carbatrol, Equetro, Epitol, Tegretol, abanye) kanye ne-phenytoin (Dilantin, Phenytek); i-clarithromycin; enzalutamide (Xtandi); ama-ergot alkaloids afana ne-dihydroergotamine (D.H.E 45, Migranal) kanye ne-ergotamine (Ergomar, eCafergot, eMigergot); imishanguzo ethile yegciwane lesandulela ngculazi (i-HIV) noma i-immunodeficiency syndrome (i-AIDS) efaka i-indinavir (Crixivan), lopinavir (e-Kaletra), i-nelfinavir (i-Viracept), i-ritonavir (i-Norvir, e-Kaletra, e-Viekira Pak), i-saquinavir (i-Invirase), ne- telaprevir (ayisatholakali e-US); i-fentanyl (Abstral, Fentora, Lazanda, Subsys, nabanye); ama-immunosuppressants afana ne-cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), kanye ne-tacrolimus (Astagraf XL, Envarsus XR, Prograf); i-midazolam; nefazodone; ipimozide (i-Orap); i-quinidine (ku-Nuedexta); i-rifampin (Rimactane, Rifadin, eRifater, eRifamate); kanye ne-telithromycin (Ketek). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imishanguzo eminingi ingaxhumana ne-palbociclib, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho nalawo angaveli kulolu hlu.
• utshele udokotela wakho kanye nosokhemisi ukuthi yimiphi imikhiqizo yamakhambi oyithathayo, ikakhulukazi iSort John's wort.
• Tshela udokotela wakho uma unesifo noma ngabe uke waba nesifo sesibindi noma sezinso.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uma uhlela ukuba ngubaba wengane. Uma ungowesifazane, kuzodingeka uthathe ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa futhi usebenzise izilawuli zokubeletha ukuvimbela ukukhulelwa ngesikhathi sokwelashwa kwakho futhi okungenani amasonto ama-3 ngemuva komthamo wakho wokugcina. Uma ungowesilisa, wena nomlingani wakho kufanele nisebenzise ukulawulwa kokubeletha ngesikhathi sokwelashwa nge-palbociclib nezinyanga ezintathu ngemuva komthamo wakho wokugcina. Khuluma nodokotela wakho ngezindlela zokulawula ukubeletha ongazisebenzisa ngesikhathi sokwelashwa kwakho. Uma wena noma umlingani wakho ukhulelwa ngenkathi uthatha i-palbociclib, shayela udokotela wakho ngokushesha. I-Palbociclib ingalimaza umbungu.
• tshela udokotela wakho uma uncelisa. Akufanele uncelise ibele ngenkathi uthatha i-palbociclib namasonto amathathu ngemuva komthamo wokugcina.
• uma uhlinzwa, kufaka phakathi ukuhlinzwa kwamazinyo, tshela udokotela noma udokotela wamazinyo ukuthi uthatha i-palbociclib.
• kufanele wazi ukuthi lo muthi unganciphisa ukuzala emadodeni. Khuluma nodokotela wakho ngezingozi zokuthatha i-palbociclib.

Ungadli isithelo samagilebhisi noma uphuze ijusi lamagilebhisi ngenkathi uthatha lo muthi.

Yeqa umthamo ophuthelwe bese uqhubeka nesimiso sakho sokulinganisa esivamile. Ungathathi umthamo ophindwe kabili ngosuku olufanayo ukwenzela okulahlekile.

I-Palbociclib ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• isicanucanu
• isifo sohudo
• ukuhlanza
• ukuncipha kokudla
• izinguquko ekunambithekeni
• ukukhathala
• ukuba ndikindiki noma ukuncinza ezingalweni, ezandleni, emilenzeni nasezinyaweni
• izilonda ezindebeni, emlonyeni, noma emphinjeni
• ukuncipha kwezinwele okungavamile noma ukulahleka kwezinwele
• isikhumba esomile
• ukuqubuka

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• umkhuhlane, ukubanda, noma izimpawu zokutheleleka
• ukuphelelwa umoya
• isiyezi
• ukushaya kwenhliziyo okusheshayo, okungajwayelekile, noma okushaya ngamandla
• ubuthakathaka
• ukopha okungajwayelekile noma ukulinyazwa
• ukuphuma kwamakhala

I-Palbociclib ingadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthatha lo muthi.

Uma uthola imiphumela emibi kakhulu, wena noma udokotela wakho ungathumela umbiko kuhlelo lwe-Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting online (http://www.fda.gov/Safety/MedWatch) noma ngocingo ( 1-800-332-1088).

Gcina le mithi esitsheni efike ngayo, ivalwe ngokuqinile, futhi lapho izingane zingafinyeleleki khona.Gcina ekamelweni lokushisa futhi kude nokushisa okweqile nomswakama (hhayi endlini yangasese).

Imithi engadingeki kufanele ilahlwe ngezindlela ezikhethekile zokuqinisekisa ukuthi izilwane ezifuywayo, izingane nabanye abantu abakwazi ukuzidla. Kodwa-ke, akufanele ukhiphe le mithi ethoyilethi. Esikhundleni salokho, indlela engcono kakhulu yokulahla imithi yakho ngohlelo lokubuyisa umuthi. Khuluma nosokhemisi wakho noma uthinte umnyango wangakini wokulahla udoti / wokusebenzisa kabusha ukuze ufunde ngezinhlelo zokubuyisa emphakathini wakho. Bheka iwebhusayithi yakwa-FDA's Safe Disposal of Medicines (http://goo.gl/c4Rm4p) ukuthola eminye imininingwane uma ungakwazi ukufinyelela kuhlelo lokubuyisa.

Kubalulekile ukugcina yonke imishanguzo ingabonakali futhi ifinyeleleke ezinganeni njengoba iziqukathi eziningi (njengezingqondo zamaphilisi zamasonto onke kanye nalawo amaconsi wamehlo, okhilimu, amabala, kanye nama-inhalers) azimeleki ezinganeni futhi izingane ezincane zingazivula kalula. Ukuvikela izingane ezisencane ekufakeni ubuthi, hlala uvala amakepisi okuphepha bese ubeka umuthi endaweni ephephile - eyodwa ephezulu futhi engekho futhi engabonakali kubo futhi efinyelela kuyo. http://www.upandaway.org

Uma kwenzeka ukweqisa ngokweqile, shayela ucingo losizo lokulawula ubuthi ku-1-800-222-1222. Imininingwane iyatholakala online ku-https: //www.poisonhelp.org/help. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho angalawula izivivinyo ezithile zebhu ngaphambi nangesikhathi sokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho ku-palbociclib.

Ungavumeli omunye umuntu ukuthi athathe imithi yakho. Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nokugcwalisa umuthi wakho.

Kubalulekile ukuthi ugcine uhlu olubhaliwe lwayo yonke imishanguzo oyisebenzisayo kadokotela kanye nokungabhaliswanga (ngaphezulu kokuthenga), kanye nanoma yimiphi imikhiqizo efana namavithamini, amaminerali, noma ezinye izithako zokudla. Kufanele uze nalolu hlu njalo uma uvakashela udokotela noma uma ungeniswa esibhedlela. Kubaluleke kakhulu futhi nemininingwane ebalulekile ukuthi uphathe uma kwenzeka kunezimo eziphuthumayo.

• Ibrance^®