Inotuzumab Ozogamicin Injection

-Delile

• Ngaphambi kokusebenzisa umjovo we-inotuzumab ozogamicin,
• Inotuzumab ozogamicin injection 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 lezo ezisohlwini LWEZEXWAYISO EZIBALULEKILE noma INDLELA, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Inotuzumab ozogamicin injection ingadala ukulimala kwesibindi okunzima noma okusongela ukuphila, kufaka phakathi isifo se-hepatic veno-occlusive (VOD; imithambo yegazi evinjiwe ngaphakathi kwesibindi). Tshela udokotela wakho uma uke waba nesifo sesibindi noma wake wafakelwa i-hematopoietic stem-cell transplant (HSCT; inqubo lapho kususwa khona amangqamuzana athile egazi emzimbeni bese ebuyiselwa emzimbeni). Uma uhlangabezana nanoma yiziphi kulezi zimpawu ezilandelayo, shayela udokotela wakho ngokushesha: ukuzuza ngokushesha kwesisindo, ubuhlungu noma ukuvuvukala engxenyeni engenhla kwesokudla yesisu, ukuphuzi kwesikhumba noma kwamehlo, isicanucanu, ukuhlanza, umchamo onombala omnyama, noma ukukhathala okukhulu.

Umjovo we-Inotuzumab ozogamicin ungadala ingozi enkulu yokufa, hhayi ngenxa yokubuya kwe-leukemia, ngemuva kokuthola i-HSCT. Uma uhlangabezana nanoma yiziphi kulezi zimpawu ezilandelayo ngemuva kwe-HSCT ngenkathi uthola umjovo we-inotuzumab ozogamicin, shayela udokotela wakho ngokushesha: umkhuhlane, ukukhwehlela, umphimbo obuhlungu, ukubanda, noma ezinye izimpawu zokutheleleka; ukuthola isisindo esisheshayo, noma ubuhlungu noma ukuvuvukala engxenyeni engaphezulu kwesokudla yesisu.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile ngaphambi, ngesikhathi, nangemva kokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho ku-inotuzumab ozogamicin.

Umjovo we-Inotuzumab ozogamicin usetshenziselwa ukwelapha i-acute lymphoblastic leukemia (BONKE; uhlobo lomdlavuza oqala kumaseli amhlophe egazi) kubantu abadala abangaphendulanga ekwelashweni komdlavuza wangaphambilini. Inotuzumab ozogamicin injection usekilasini lemithi ebizwa ngama-antibody monoclonal. Isebenza ngokwenza amasosha omzimba abulale amaseli omdlavuza.

Umjovo we-Inotuzumab ozogamicin uza njengempuphu ezohlanganiswa noketshezi oluzofakwa ngaphakathi (emthanjeni) ngudokotela noma umhlengikazi esibhedlela noma esikhungweni sezokwelapha. Imvamisa ijovwa ngezinsuku 1, 8, no-15 zomjikelezo wamaviki amathathu kuya kwayi-4. Umjikelezo ungaphindwa njalo emavikini e-4 njengoba kunconywe udokotela wakho. Ubude bokwelashwa kwakho buncike ekutheni umzimba wakho uphendula kahle kanjani emithini nasemiphumeleni oyitholayo.

Udokotela wakho angadinga ukuphazamisa noma ukumisa ukwelashwa kwakho, ukwehlisa umthamo wakho, noma ukukuphatha ngemithi eyengeziwe, ngokuya ngempendulo yakho ku-inotuzumab ozogamicin neminye imiphumela emibi ohlangabezana nayo. Uzothola imithi ethile yokusiza ukuvimbela ukusabela ngaphambi kokuthola umthamo ngamunye we-inotuzumab ozogamicin. Tshela udokotela noma umhlengikazi wakho uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi okungenani sehora elilodwa ngemuva kokuphela kokumnika: umkhuhlane, ukubanda, ukuqubuka, ukuphefumula kanzima, noma ukuphefumula kanzima. Khuluma nodokotela wakho mayelana nokuthi uzizwa kanjani ngesikhathi nangemva kokwelashwa kwakho.

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

Ngaphambi kokusebenzisa umjovo we-inotuzumab ozogamicin,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-inotuzumab ozogamicin, noma imuphi omunye umuthi, noma yiziphi izithako zomjovo we-inotuzumab ozogamicin. 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: amiodarone (Pacerone, Nexterone); i-chloroquine (Aralen); i-clarithromycin (i-Biaxin, ku-Prevpac); i-disopyramide (iNorpace); i-erythromycin (E.E.S., E-Mycin, PCE, abanye); i-haloperidol; i-methadone (i-Dolophine, i-Methadose); nefazodone; ipimozide (i-Orap); procainamide; i-quinidine (ku-Nuedexta); i-sotalol (iBetapace, iBetapace AF, iSorine); futhi thioridazine. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imishanguzo eminingi ingaxhumana ne-inotuzumab ozogamicin, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho naleyo engabonakali kulolu hlu.
• Tshela udokotela wakho uma wena noma omunye emndenini wakho enesikhathi eside se-QT (inkinga engavamile yenhliziyo engadala ukushaya kwenhliziyo okungajwayelekile, ukuquleka, noma ukufa okungazelelwe). Futhi, tshela udokotela wakho uma uke waba nezinga eliphansi le-potassium noma i-magnesium egazini lakho noma isifo sezinso.
• utshele udokotela wakho uma ukhulelwe noma uhlela ukukhulelwa. Uma ungowesifazane, akufanele ukhulelwe ngenkathi uthola i-inotuzumab ozogamicin futhi okungenani izinyanga eziyi-8 ngemuva komthamo wakho wokugcina. Khuluma nodokotela wakho ngezindlela zokulawula ukubeletha ezizokusebenzela. Uma ungowesilisa, wena nomlingani wakho wesifazane kufanele nisebenzise ukulawulwa kokubeletha ngesikhathi sokwelashwa futhi niqhubeke nokusebenzisa ukubeletha okungenani izinyanga ezinhlanu ngemuva komthamo wakho wokugcina. Uma wena noma umlingani wakho ukhulelwa ngenkathi uthola i-inotuzumab ozogamicin, shayela udokotela wakho. I-Inotuzumab ozogamicin ingalimaza umbungu.
• tshela udokotela wakho uma uncelisa. Udokotela wakho angakutshela ukuthi ungancelisi ngesikhathi sokwelashwa kwakho ngomjovo we-inotuzumab ozogamicin futhi okungenani izinyanga ezimbili ngemuva komthamo wakho wokugcina.
• kufanele wazi ukuthi lo muthi unganciphisa ukuzala kwabesilisa nabesifazane. Khuluma nodokotela wakho ngezingozi zokuthola i-inotuzumab ozogamicin.

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

Inotuzumab ozogamicin injection ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• isiyezi
• ubumhlophe

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:

• umkhuhlane, ukubanda, ukukhwehlela, noma ezinye izimpawu zokutheleleka
• ukopha okungajwayelekile noma ukulinyazwa
• indle emnyama neyokulinda
• igazi elibomvu endle
• isikhumba esiphaphathekile
• ukukhathala

Inotuzumab ozogamicin injection ingadala 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 mayelana nomjovo we-inotuzumab ozogamicin.

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.

• Besponsa^®