Inaliti ye-Avelumab

-Delile

• Ngaphambi kokuthola umjovo we-avelumab,
• I-Avelumab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezisohlwini lwe-HOW section, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Umjovo we-Avelumab usetshenziselwa ukwelapha iMerkel cell carcinoma (MCC; uhlobo lomdlavuza wesikhumba) osabalele kwezinye izingxenye zomzimba kubantu abadala nezingane ezineminyaka engu-12 nangaphezulu. Umjovo we-Avelumab ubuye usetshenziselwe ukwelapha umdlavuza we-urothelial (umdlavuza wendwangu yesinye nezinye izingxenye zomgudu womchamo) osabalale waya ezicutshini eziseduze noma kwezinye izingxenye zomzimba kubantu abanomdlavuza owanda phakathi noma ezinyangeni eziyi-12 ngemuva kokuthi welashwa ngemithi ye-platinum chemotherapy. Ibuye isetshenziswe njengokwelashwa okuqhubekayo komdlavuza we-urothelial osabalalele ezicutshini eziseduze noma kwezinye izingxenye zomzimba ukusiza ukugcina impendulo kwi-platinum chemotherapy. Umjovo we-Avelumab usetshenziswa futhi ngokuhlangana ne-axitinib (Inlyta) njengokwelashwa kokuqala kwe-renal cell carcinoma (RCC; umdlavuza oqala ezinso) osakazeke noma ongasuswa ngokuhlinzwa. Umjovo we-Avelumab usesigabeni semithi ebizwa ngama-antibody monoclonal. Isebenza ngokusiza umzimba ukuthi unciphise noma umise ukukhula kwamangqamuzana omdlavuza.

Umjovo we-Avelumab uza njengesisombululo (uketshezi) sokujova ngomjovo (emthanjeni) ngaphezu kwemizuzu engama-60 ngudokotela noma umhlengikazi esikhungweni sezokwelapha noma esikhungweni sokumnika. Imvamisa inikezwa kanye njalo emavikini ama-2. Udokotela wakho uzonquma ukuthi uzoyithola kangaki i-avelumab ngokuya ngempendulo yomzimba wakho kulo muthi.

Umjovo we-Avelumab ungadala ukusabela okukhulu ngesikhathi sokufakwa komuthi. Unganikezwa eminye imithi yokwelapha noma yokusiza ukuvimbela ukusabela ku-avelumab. Udokotela noma umhlengikazi uzokuqapha ngokucophelela ngenkathi uthola umuthi. Tshela udokotela wakho noma umhlengikazi ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokufakwa: ukugodola noma ukuqhaqhazela, isifuba, umkhuhlane, ukuqhuma, izinhlungu emuva, ukuphefumula, ukuphefumula, noma ubuhlungu besisu. Udokotela wakho kungadingeka ukuthi anciphise ukumnika noma ukubambezeleka kwakho noma ayeke unomphela ukwelashwa kwakho uma unale miphumela emibi.

Udokotela wakho futhi angakuyeka unomphela noma okwesikhashana ukwelashwa kwakho, noma akuphathe ngeminye imithi uma uhlangabezana neminye imiphumela emibi. Qiniseka ukuthi utshela udokotela wakho ukuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho ngomjovo we-avelumab.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomjovo we-avelumab futhi isikhathi ngasinye lapho uthola umuthi. Funda imininingwane ngokucophelela bese ubuza udokotela noma usokhemisi wakho uma unemibuzo. Ungavakashela futhi iwebhusayithi ye-Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

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

Ngaphambi kokuthola umjovo we-avelumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-avelumab, noma imiphi eminye imithi, noma yiziphi izithako zomjovo we-avelumab. 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. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma uke waba nesifo sikashukela noma sesike saba khona, isifo sikaCrohn (isimo lapho umzimba uhlasela ulwelwesi lomgudu wokugaya ukudla, ubangele ubuhlungu, isifo sohudo, ukuncipha komzimba nomkhuhlane), i-ulcerative colitis (isimo esidala ukuvuvukala kanye izilonda emgqeni wekholoni [amathumbu amakhulu] ne-rectum), ukufakelwa isitho somzimba, noma isibindi, amaphaphu noma isifo sezinso.
• utshele udokotela wakho uma ukhulelwe noma uhlela ukukhulelwa. Sebenzisa indlela ethembekile yokulawula ukubeletha ukuvimbela ukukhulelwa ngesikhathi sokwelashwa kwakho nenyanga engu-1 ngemuva komthamo wakho wokugcina we-avelumab. Khuluma nodokotela wakho ngezindlela zokulawula ukubeletha ezizokusebenzela. Uma ukhulelwa ngenkathi uthola i-avelumab, shayela udokotela wakho ngokushesha. I-Avelumab ingalimaza umbungu.
• tshela udokotela wakho uma uncelisa noma uhlela ukuncelisa. Akufanele uncelise ngenkathi uthola i-avelumab kanye nenyanga engu-1 ngemuva komthamo wakho wokugcina.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

Uma uphuthelwa isikhathi sokuthola i-avelumab, shayela udokotela wakho ngokushesha okukhulu.

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

• ubuhlungu bemisipha, bethambo, noma bamalunga
• ikhanda
• ukuqunjelwa
• isifo sohudo
• ubuhlungu besisu
• isicanucanu
• ukuhlanza
• ukulahlekelwa isifiso sokudla
• ukuncipha komzimba
• ukukhathala

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezisohlwini lwe-HOW section, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• ukukhwehlela okusha noma okukhulayo; ukuphelelwa umoya; noma ubuhlungu besifuba
• isicanucanu; ukuhlanza; ubuhlungu ohlangothini lwesokunene sesisu; umchamo omnyama (onetayi); ukukhathala ngokweqile; ukulinyazwa noma ukopha okungavamile
• ukushaya kwenhliziyo okusheshayo; ukuqunjelwa; ukujuluka okwandayo; ukushintsha kwezwi; izinguquko zesisindo; ukuzwa ukoma kakhulu kunokujwayelekile; isiyezi noma ukuquleka; ukulahleka kwezinwele; isicanucanu; ukuhlanza; ukushintsha kwemizwa; ubuhlungu besisu; noma uzizwa ubanda
• ubuhlungu engxenyeni engenhla kwesokudla yesisu; ukuphuzi kwesikhumba noma kwamehlo; isicanucanu; ukuhlanza, noma ukopha kalula noma ukulimaza
• isifo sohudo; igazi ezansi; amnyama, alindile, indle enamathelayo; noma ubuhlungu bendawo yesisu noma isisa
• ubuthakathaka bemisipha
• ukozela
• uzizwe unesiyezi noma uqulekile
• ukuvuvukala kwezinyawo nemilenze
• ubuhlungu besifuba nokuqina
• umkhuhlane noma ezinye izimpawu ezinjengomkhuhlane
• umbono uyashintsha
• ukushaya kwenhliziyo kuyashintsha
• ukuqubuka, ukushwabana noma ukuxebuka isikhumba
• ukuphefumula kanzima noma ukugwinya
• ukuncipha kokuchama; igazi emchameni; ukuvuvukala emaqakaleni; noma ukulahlekelwa isifiso sokudla
• ukopha okungajwayelekile noma ukulinyazwa
• ukuchama kaningi, okubuhlungu, noma okuphuthumayo

Umjovo we-Avelumab ungadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthola 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).

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-avelumab.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nomjovo we-avelumab.

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.

• Bavencio^®