Abemaciclib

-Delile

• Ngaphambi kokuthatha i-abemaciclib,
• I-Abemaciclib ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma yiziphi esigabeni esikhethekile SOKUQAPHA, shayela udokotela wakho ngokushesha:

[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-Abemaciclib isetshenziswa 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 ngemuva kokwelashwa ngemithi ye-antiestrogen efana ne-tamoxifen (i-Nolvadex). I-Abemaciclib nayo isetshenziswa kanye ne-anastrozole (Arimidex), i-exemestane (i-Aromasin), noma i-letrozole (i-Femara) njengokwelashwa kokuqala komdlavuza we-hormone receptor-positive, umdlavuza webele osezingeni eliphakeme noma umdlavuza webele osabalalele kwezinye izingxenye zomzimba. I-Abemaciclib isetshenziswa yodwa ukwelapha uhlobo oluthile lwe-hormone receptor-positive, umdlavuza webele othuthukile noma umdlavuza webele osabalalele kwezinye izingxenye zomzimba kubantu asebevele belashwa ngemithi ye-antiestrogen kanye ne-chemotherapy. I-Abemaciclib isekilasini lemithi ebizwa nge-kinase inhibitors. Isebenza ngokuvimba isenzo sephrotheni engavamile ekhombisa ukuthi amangqamuzana omdlavuza ayanda. Lokhu kusiza ukunciphisa noma ukumisa ukusabalala kwamangqamuzana omdlavuza.

I-Abemaciclib iza njengethebhulethi ezothathwa ngomlomo. Imvamisa kuthathwa kabili ngosuku noma ngaphandle kokudla. Thatha i-abemaciclib ngasikhathi sinye nsuku zonke. Landela izinkomba ezikulebuli kadokotela wakho ngokucophelela, bese ubuza udokotela noma usokhemisi wakho ukuthi akuchaze nganoma iyiphi ingxenye ongayiqondi. Thatha i-abemaciclib njengoba nje kuqondisiwe. Ungayithathi kancane noma uyithathe kaningi kunokuyalelwa ngudokotela wakho.

Gwinya wonke amaphilisi; ungawahlukanisi, ungawahlafune noma uwagxoze. Ungathathi amaphilisi aphukile, aqhekekile noma alimele nganoma iyiphi indlela.

Uma uhlanza ngemuva kokuthatha i-abemaciclib, 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. Lokhu kuncike ekutheni umuthi usebenza kanjani kuwe kanye nemiphumela emibi oyitholayo. Qiniseka ukuthi utshela udokotela wakho ukuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho nge-abemaciclib.

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

Ngaphambi kokuthatha i-abemaciclib,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-abemaciclib, noma imuphi omunye umuthi, noma iziphi izithako ezibhebheni ze-abemaciclib. 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: i-clarithromycin (i-Biaxin, e-Prevpac), i-diltiazem (i-Cardizem, i-Tiazac, abanye), i-itraconazole (i-Sporanox), i-ketoconazole (i-Nizoral), i-rifampin (i-Rifadin, i-Rimactane, i-Rifater), ne-verapamil (i-Calan , Verelan, abanye). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imishanguzo eminingi ingaxhumana ne-abemaciclib, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho naleyo engabonakali kulolu hlu.
• utshele udokotela wakho uma unemfiva, ukugodola, noma ezinye izimpawu zokutheleleka noma uma uke waba nesifo sesibindi noma sezinso.
• utshele udokotela wakho uma ukhulelwe noma uhlela ukukhulelwa. Uzodinga ukuthatha ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa futhi kufanele usebenzise ukulawulwa kokuzalwa ukuvimbela ukukhulelwa ngesikhathi sokwelashwa kwakho futhi okungenani amasonto ama-3 ngemuva komthamo wakho wokugcina. Uma ukhulelwa ngenkathi uthatha i-abemaciclib, shayela udokotela wakho ngokushesha. I-Abemaciclib ingalimaza umbungu.
• tshela udokotela wakho uma uncelisa noma uhlela ukuncelisa. Akufanele uncelise ngenkathi uthatha i-abemaciclib futhi okungenani amasonto ama-3 ngemuva komthamo wakho wokugcina.
• kufanele wazi ukuthi lo muthi unganciphisa ukuzala emadodeni. Khuluma nodokotela wakho ngezingozi zokuthatha i-abemaciclib.
• kufanele wazi ukuthi i-abemaciclib ivame ukudala isifo sohudo, esingaba nzima. Udokotela wakho mhlawumbe uzokutshela ukuthi uphuze iziphuzo eziningi futhi uphuze nemithi elwa nohudo ukuvimbela ukomisa (ukulahleka kwamanzi amaningi emzimbeni wakho) lapho uqala ukuhlangabezana nohudo noma indle engasebenzi. Shayela udokotela wakho ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo zokoma: ukoma ngokweqile, umlomo owomile noma isikhumba, ukuncipha kokuchama, noma ukushaya kwenhliziyo okusheshayo.

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

Yeqa umthamo ophuthelwe bese uqhubeka nesimiso sakho sokulinganisa esivamile. Ungathathi umthamo ophindwe kabili ukwenza okulahlekile.

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

• isicanucanu
• ukuhlanza
• ubuhlungu besisu
• ukuqunjelwa
• izilonda ezindebeni, emlonyeni, noma emphinjeni
• ukuncipha kokudla
• ukuncipha komzimba
• ukulahleka kwezinwele
• ukulunywa
• ukuqubuka
• ikhanda
• izinguquko ekunambithekeni
• isiyezi
• ubuhlungu obuhlangene

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma yiziphi esigabeni esikhethekile SOKUQAPHA, shayela udokotela wakho ngokushesha:

• ukukhathala
• ubuhlungu engxenyeni engenhla kwesokudla yesisu
• ukuphuzi kwesikhumba noma kwamehlo
• ukulahlekelwa isifiso sokudla
• ukopha noma ukulimaza kalula
• ubuhlungu ezingalweni noma emilenzeni
• ukuvuvukala kwezandla, izinyawo, imilenze noma amaqakala
• ukuphelelwa umoya
• ubuhlungu besifuba
• ukuphefumula okusheshayo
• ukushaya kwenhliziyo okusheshayo, okungajwayelekile, noma okushaya ngamandla
• umkhuhlane, amakhaza, ukukhwehlela noma ezinye izimpawu zokutheleleka
• isikhumba esiphaphathekile

I-Abemaciclib 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).

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

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.

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 anga-oda izivivinyo ezithile zelebhu ngaphambi nangesikhathi sokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho ku-abemaciclib.

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.

• I-Verzenio^®