I-Moxetumomab Pasudotox-tdfk Injection

-Delile

• Ngaphambi kokuthola umjovo we-moxetumomab pasudotox-tdfk,
• Umjovo we-Moxetumomab pasudotox-tdfk ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezisohlwini LWEZEXWAYISO EZIBALULEKILE noma INDLELA, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Umjovo we-Moxetumomab pasudotox-tdfk ungadala ukusabela okungathi sína noma okusongela ukuphila okubizwa nge-capillary leak syndrome (isimo esidala uketshezi oluningi emzimbeni, umfutho ophansi wegazi, kanye namazinga aphansi eprotheni [albumin] egazini). Uma uhlangabezana nalezi zimpawu ezilandelayo, shayela udokotela wakho ngokushesha: ukuvuvukala kobuso, izandla, izinyawo, amaqakala, noma imilenze engezansi; ukukhuluphala; ukuphelelwa umoya; ukukhwehlela; ukuquleka; isiyezi noma ikhanda elikhanyayo; noma ukushaya kwenhliziyo okusheshayo noma okungajwayelekile.

Umjovo we-Moxetumomab pasudotox-tdfk ungadala i-hemolytic uremic syndrome (isimo esisongela impilo esifaka ukulimala kwamangqamuzana egazi abomvu, okwenza izinkinga ze-anemia nezinso). Tshela udokotela wakho uma uke waba nesifo sezinso noma wake waba naso. Uma uhlangabezana nalezi zimpawu ezilandelayo, tshela udokotela wakho ngokushesha: indle ebomvu noma enegazi noma isifo sohudo; ukuncipha kokuchama; igazi emchameni; ushintsho esimweni sengqondo noma ekuziphatheni; ukuquleka; ukudideka; ukuphelelwa umoya; ukuvuvukala kobuso, izingalo, izandla, izinyawo, amaqakala, noma imilenze engezansi; ukopha okungavamile noma ukulimaza; ubuhlungu besisu; ukuhlanza; imfiva; isikhumba esiphaphathekile; ukukhathala okungajwayelekile noma ubuthakathaka.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho anga-oda izivivinyo ezithile ngaphambi, ngesikhathi, nangemva kokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho kumjovo we-moxetumomab pasudotox-tdfk.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomjovo we-moxetumomab pasudotox-tdfk futhi isikhathi ngasinye lapho ugcwalisa umuthi wakho. 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.

Umjovo weMoxetumomab pasudotox-tdfk usetshenziselwa ukwelapha i-hairy cell leukemia (umdlavuza wohlobo oluthile lwamaseli amhlophe egazi) obuyile noma ongaphendulanga ngemuva kokungenani eminye imithi emibili yokwelashwa komdlavuza. Umjovo we-Moxetumomab pasudotox-tdfk usesigabeni semithi ebizwa ngama-antibody monoclonal. Isebenza ngokusiza amasosha akho omzimba ukwehlisa noma ukumisa ukukhula kwamangqamuzana omdlavuza.

Umjovo weMoxetumomab pasudotox-tdfk uza njengempuphu ezoxutshwa noketshezi bese ufakwa emthanjeni ngudokotela noma ngumhlengikazi ehhovisi lezokwelapha noma esibhedlela. Imvamisa ijovwa kancane esikhathini esiyimizuzu engama-30 ngezinsuku 1, 3, no-5 zomjikelezo wokwelashwa wezinsuku ezingama-28. Lo mjikelezo ungaphindwa kuze kube yimijikelezo engu-6. Ubude bokwelashwa buxhomeke ekutheni umzimba wakho uphendula kanjani emithini nakunoma imiphi imiphumela emibi ohlangabezana nayo.

Ngesikhathi sokwelashwa kwakho, udokotela wakho uzokucela ukuthi uphuze izingilazi eziyishumi nambili ze-8-oz zeziphuzo ezinjengamanzi, ubisi noma ijusi njalo emahoreni angama-24 ngezinsuku 1 kuya kwezingu-8 emjikelezweni ngamunye wezinsuku ezingama-28.

I-Moxetumomab ingadala ukusabela okungathi sína ngesikhathi noma ngemuva kokuthola ukumnika kwakho. Uzonikezwa imishanguzo imizuzu engama-30 kuya kwengu-90 ngaphambi kokufakwa kwakho nangemuva kokufakwa kwakho ukusiza ukuvimbela ukusabela ku-moxetumomab. Udokotela wakho kungadingeka ayeke ukwelashwa kwakho uma uhlangabezana nemiphumela ethile emibi. Tshela udokotela wakho uma uhlangabezana nalezi zimpawu ezilandelayo: isiyezi, ukuquleka, ukuphefumula kanzima noma ukuphefumula kanzima, ukuphefumula okuncane, ukushaya kwenhliziyo okusheshayo, ubuhlungu bemisipha, isicanucanu, ukuhlanza, ikhanda elibuhlungu, umkhuhlane, ukubanda, ukukhwehlela, ukuquleka, ukushisa okushisayo, noma ukuqhuma . Kubalulekile ukuthi utshele udokotela wakho ukuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho ngomjovo we-moxetumomab pasudotox-tdfk. Shayela udokotela wakho khona manjalo noma uthole usizo oluphuthumayo lwezokwelapha uma uhlangabezana nanoma yiziphi zalezi zimpawu ngemuva kokuphuma ehhovisi likadokotela noma esikhungweni sezokwelapha.

Udokotela wakho anganciphisa umthamo wakho, abambezele noma amise ukwelashwa kwakho ngomjovo we-moxetumomab pasudotox-tdfk, noma akuphathe ngemithi eyengeziwe ngokuya ngempendulo yakho emithini kanye neminye imiphumela emibi ohlangabezana nayo. Khuluma nodokotela wakho mayelana nokuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho.

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

Ngaphambi kokuthola umjovo we-moxetumomab pasudotox-tdfk,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-moxetumomab, noma imiphi eminye imithi, noma iziphi izithako zomjovo we-moxetumomab pasudotox-tdfk. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha 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 nezinkinga zokwelashwa noma wake waba nazo.
• utshele udokotela wakho uma ukhulelwe noma uhlela ukukhulelwa. Uzodinga ukuhlolwa kokukhulelwa ngaphambi kokuqala i-moxetumomab. Akufanele ukhulelwe ngenkathi uthola umjovo we-moxetumomab pasudotox-tdfk futhi okungenani izinsuku ezingama-30 ngemuva komthamo wakho wokugcina. Khuluma nodokotela wakho ngezindlela zokulawula ukubeletha ezizokusebenzela. Uma ukhulelwa ngenkathi uthola umjovo we-moxetumomab pasudotox-tdfk, shayela udokotela wakho ngokushesha. Umjovo we-Moxetumomab pasudotox-tdfk ungalimaza umbungu.
• tshela udokotela wakho uma uncelisa noma uhlela ukuncelisa.

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

Uma uphuthelwa i-aphoyintimenti yokuthola ukumnika, shayela udokotela wakho ngokushesha okukhulu ukuze ubeke kabusha ukuqokwa kwakho.

Umjovo we-Moxetumomab pasudotox-tdfk ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ukuqunjelwa
• isikhumba esiphaphathekile
• ukukhathala
• iso elomile noma ubuhlungu beso
• ukuvuvukala kweso noma ukutheleleka
• umbono uyashintsha

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezisohlwini LWEZEXWAYISO EZIBALULEKILE noma INDLELA, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• amajaqamba; ukuba ndikindiki noma ukuhayiza; ukushaya kwenhliziyo okungajwayelekile noma okusheshayo; isicanucanu; noma ukuquleka

Umjovo we-Moxetumomab pasudotox-tdfk 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).

Buza usokhemisi wakho noma imiphi imibuzo onayo ngomjovo we-moxetumomab pasudotox-tdfk.

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.

• Lumoxiti^®