Inaliti yeNivolumab

Umxholo

• Ngaphambi kokufumana inaliti ye-nivolumab,

Inaliti yeNivolumab isetyenziswa:

• yedwa okanye ngokudibanisa ne-ipilimumab (Yervoy) ukunyanga iintlobo ezithile ze-melanoma (uhlobo lomhlaza wolusu) oluye lwasasazeka kwamanye amalungu omzimba okanye alunakususwa ngotyando,
• ukunyanga nokukhusela ukubuya kohlobo oluthile lwe-melanoma emva kotyando ukuyisusa kunye naziphi na izicubu ezichaphazelekayo kunye ne-lymph node,
• ngokudibeneyo ne-ipilimumab (Yervoy) ukunyanga uhlobo oluthile lomhlaza wemiphunga (non-encinci umhlaza wesifo somhlaza wemiphunga; i-NSCLC) ethe yanwenwela kwamanye amalungu omzimba,
• ngokudibeneyo ne-ipilimumab (Yervoy) kunye neplatinum chemotherapy ukunyanga uhlobo oluthile lwe-NSCLC ebuyileyo okanye ethe yasasazeka kwamanye amalungu omzimba,
• ndedwa ukunyanga uhlobo oluthile lwe-NSCLC ethe yasasazeka kwamanye amalungu omzimba kwaye iye yanzima nokuba kungexesha okanye emva konyango ngamayeza e-platinum chemotherapy,
• ukunyanga olunye uhlobo lomhlaza wemiphunga (umhlaza wamangqamuzana amancinci emiphunga, i-SCLC) ethe yasasazeka kwamanye amalungu omzimba athe kratya emva konyango emva kweplatinamotherapy kwaye ubuncinci iyeza elinye lonyango,
• ukunyanga i-renal cell carcinoma (RCC, uhlobo lomhlaza oqala kwiiseli zezintso) eziye zonyuka emva konyango ngamanye amayeza e-chemotherapy,
• ngokudibeneyo ne-ipilimumab (Yervoy) ukunyanga i-RCC ephambili kubantu abangakhange banyangwe ngamanye amayeza e-chemotherapy,
• ukunyanga i-Hodgkin's lymphoma (isifo sika-Hodgkin) kubantu abadala abaye baba mandundu okanye bangaphendula kwi-autologous stem cell transplant (inkqubo apho iiseli ezithile zegazi zisuswe emzimbeni zaze zabuyela emzimbeni emva konyango lwe-chemotherapy kunye / okanye unyango lwe-radiation) kunye ne-brentuximab vedotin (Adcetris) unyango okanye ubuncinci ezinye iindlela zonyango ezintathu kubandakanya ukufakelwa kweseli ye-stem,
• Ukunyanga uhlobo oluthile lomhlaza wentloko nentamo oqhubeka ubuya okanye osasazeke kwamanye amalungu omzimba okanye ubi kakhulu ngexesha okanye emva konyango ngamanye amayeza e-chemotherapy,
• ukunyanga umhlaza we-urothelial (umhlaza welinen yesinyi kunye nezinye iinxalenye zendlela yokuchama) ethe yasasazeka kwamanye amalungu omzimba kwaye iye yanzima ngexesha okanye emva konyango ngamanye amayeza e-chemotherapy,
• ndedwa okanye ngokudibeneyo ne-ipilimumab ukunyanga uhlobo oluthile lomhlaza obomvu (umhlaza oqala emathunjini amakhulu) kubantu abadala nakubantwana abaneminyaka eli-12 ubudala nangaphezulu osasazeke kwamanye amalungu omzimba kwaye uye wanda emva konyango nezinye i-chemotherapy amayeza,
• ndedwa okanye ngokudibeneyo ne-ipilimumab ukunyanga i-hepatocellular carcinoma (HCC; uhlobo lomhlaza wesibindi) kubantu ababekhe baphathwa nge-sorafenib (Nexafar),
• ukunyanga umhlaza wesifo somhlaza wesifo somhlaza (umhlaza webhubhu odibanisa umqala wakho nesisu sakho) osasazeke kwamanye amalungu omzimba, uye wanda emva konyango ngamanye amayeza e-chemotherapy, okanye awunakunyangwa ngoqhaqho,
• Kwaye ngokudibanisa ne-ipilimumab ukunyanga i-mesothelioma enobungozi (uhlobo lomhlaza oluchaphazela ulusu lwangaphakathi lwemiphunga kunye nesifuba) kubantu abadala abangenakususwa ngotyando.

I-Nivolumab ikwiklasi yamayeza abizwa ngokuba zii-antibodies ze-monoclonal. Isebenza ngokunceda amajoni akho omzimba ukuba acothise okanye ayeke ukukhula kweeseli zomhlaza.

I-Nivolumab iza njengolwelo oluza kungeniswa emthanjeni ngaphezulu kwemizuzu engama-30 ngugqirha okanye umongikazi esibhedlele okanye kwiziko lonyango. Xa i-nivolumab inikwa yodwa ukunyanga i-melanoma, umhlaza wamangqamuzana ongekho mncinci (i-NSCLC), iHodgkin lymphoma, umhlaza wentloko nentamo, umhlaza we-urothelial, i-RCC ephambili, umhlaza we-colorectal, umhlaza wesifo somhlaza, okanye i-hepatocellular carcinoma, ihlala inikwa kube kanye zonke iiveki ezi-2 okanye ezi-4 kuxhomekeke kumyinge wakho okoko ugqirha ekucebisa ukuba ufumane unyango. Xa i-nivolumab inikwa yodwa ukunyanga umhlaza omncinci wesifo somhlaza (i-SCLC), ihlala inikwa kube kanye kwiiveki ezi-2 ukuba ugqirha ucebisa ukuba ufumane unyango. Xa i-nivolumab inikwa ngokudibeneyo ne-ipilimumab ukunyanga i-melanoma, i-hepatocellular carcinoma, i-colorectal cancer, okanye i-RCC, ihlala inikwa kube kanye kwiiveki ezi-3 ngeedosi ezi-4 ezine-ipilimumab, kwaye ibe iyodwa kube kanye kwiiveki ezi-2 okanye ezi-4 kuxhomekeke kumthamo wakho ukuba ugqirha ucebisa ukuba ufumane unyango. Xa i-nivolumab inikwa ngokudibeneyo ne-ipilimumab ukunyanga i-NSCLC, ihlala inikwa kube kanye kwiiveki ezi-2 ukuba ugqirha ucebisa ukuba ufumane unyango. Xa i-nivolumab inikezelwa ngokudibanisa ne-ipilimumab ukunyanga i-mesothelioma enobungozi, ihlala inikwa kube kanye kwiiveki ezi-3 okoko ugqirha ekucebisa ukuba ufumane unyango. Xa i-nivolumab inikwa ngokudibeneyo ne-ipilimumab kunye neplatinum chemotherapy ukunyanga i-NSCLC, ihlala inikwa kube kanye kwiiveki ezi-3 ukuba ugqirha ucebisa ukuba ufumane unyango.

I-Nivolumab inokubangela ukusabela okunobungozi okanye okusongela ubomi ngexesha lokufakwa. Ugqirha okanye umongikazi uya kukujonga ngokusondeleyo ngelixa ufumana ukumiliselwa kwaye kungekudala emva kokufakwa ukuze uqiniseke ukuba awunampendulo imbi kunyango. Xelela ugqirha wakho okanye umongikazi kwangoko ukuba unazo naziphi na kwezi mpawu zilandelayo ezinokuthi zenzeke ngexesha lokufakwa ngaphakathi: ukugodola okanye ukungcangcazela, ukurhawuzelela, irhashalala, ukugungxula, ukuphefumla nzima, isiyezi, umkhuhlane kunye nokuziva utyhafile.

Ugqirha wakho unokunciphisa ukunyuswa kwakho, ukulibazisa, okanye ukuyeka unyango lwakho ngenaliti ye-nivolumab, okanye ukunyanga ngamayeza angaphezulu kuxhomekeke kwimpendulo yakho kunyango kunye naziphi na iziphumo ebezingalindelekanga ohlangabezana nazo. Thetha nogqirha wakho malunga nendlela oziva ngayo ngexesha lonyango lwakho.

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwezigulana lomenzi (Isikhokelo seyeza) xa uqala unyango ngenaliti ye-nivolumab. Funda ulwazi ngononophelo kwaye ubuze ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo.

Eli yeza linokumiselwa ezinye izinto; buza ugqirha wakho okanye usokhemesti ngolwazi oluthe kratya.

Ngaphambi kokufumana inaliti ye-nivolumab,

• xelela ugqirha wakho kunye nosokhemisti ukuba ngaba uxabisa i-nivolumab, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ze-nivolumab. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
• xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba ukhe wafakelwa ilungu. Xelela ugqirha wakho ukuba ukhe unesifo sokuzimela komzimba (imeko apho amajoni omzimba ahlasela indawo esempilweni yomzimba) njengesifo sikaCrohn (imeko apho amajoni omzimba ahlasela khona umgca wokugaya obangela iintlungu, urhudo, ukwehla kobunzima bomzimba, kunye nefiva), ulcerative colitis (imeko ebangela ukudumba kunye nezilonda kuludwe lwekholoni [amathumbu amakhulu] kunye ne-rectum), okanye i-lupus (imeko apho amajoni omzimba ahlasela izicwili kunye namalungu amaninzi kubandakanya ulusu amalungu, igazi kunye nezintso); naluphi na uhlobo lwesifo semiphunga okanye iingxaki zokuphefumla; okanye isifo sedlala lengqula, sezintso okanye sesibindi.
• xelela ugqirha wakho ukuba ukhulelwe okanye ucwangcise ukukhulelwa. Uya kudinga ukuthatha uvavanyo lokukhulelwa ngaphambi kokuba ufumane i-nivolumab. Akufanele ukhulelwe ngelixa ufumana inaliti ye-nivolumab. Kuya kufuneka usebenzise ulawulo lokuzalwa olusebenzayo ukuthintela ukukhulelwa ngexesha lonyango lwakho ngenaliti ye-nivolumab kwaye ubuncinci iinyanga ezintlanu emva kwedosi yakho yokugqibela. Thetha nogqirha wakho malunga neendlela zokulawula ukuzalwa eziza kukusebenzela. Ukuba ukhulelwa ngelixa ufumana inaliti ye-nivolumab, tsalela ugqirha ngokukhawuleza. Inaliti yeNivolumab inokwenzakalisa umntwana ongekazalwa.
• xelela ugqirha wakho ukuba uncelisa okanye ucwangcisa ukuncancisa. Akufanele uncelise ngelixa ufumana inaliti ye-nivolumab kunye neenyanga ezintlanu emva kwedosi yakho yokugqibela.

Ngaphandle kokuba ugqirha wakho akuxelele ngenye indlela, qhubeka nokutya okuqhelekileyo.

Ukuba uphoswa idinga lokufumana inaliti ye-nivolumab, tsalela ugqirha ngokukhawuleza.

Inaliti yeNivolumab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• ngokudibeneyo, umva, umhlathi, okanye iintlungu zethambo
• iintlungu zemisipha okanye ubuthathaka
• owomileyo, oqhekekileyo, ulusu olunamaxolo
• ububomvu, ukudumba, okanye iintlungu ezintendeni zesandla sakho okanye kwiinyawo zakho
• izilonda zomlomo
• amehlo owomileyo okanye umlomo

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo le-HOW, xelela ugqirha wakho kwangoko okanye ufumane unyango olungxamisekileyo:

• ukuqhawukelwa ngumphefumlo
• ukukhwehlela okutsha okanye okuya kusiba mandundu
• ukhohlela igazi
• iintlungu zesifuba
• urhudo
• indawo yesisu okanye iintlungu
• ilindle elimnyama, elilindileyo, elincangathiweyo, okanye eliqulathe igazi
• ukudinwa okanye ubuthathaka
• ndiziva ndibanda
• Ukujula kwelizwi okanye ukungxola
• utshintsho kubunzima (ukuzuza okanye ukulahleka)
• utshintsho kwiimvakalelo okanye ekuziphatheni (ukunciphisa ukuqhuba ngesondo, ukucaphuka, okanye ukulibala)
• ukuqina kwentamo
• iintlungu, ukutshisa, ukubetha, okanye ukuba ndindisholo ezandleni okanye ezinyaweni
• iintloko, kubandakanya ezo ezingaqhelekanga okanye ezingayi kuhamba
• ukubona izinto ezingekhoyo (ukubona izinto okanye ukuva amazwi angabikho)
• ukuxhuzula
• ukudideka
• ifiva
• ukulahleka kweenwele
• ukurhawuzelela, irhashalala, isifuba, okanye iblisters kulusu lwakho
• ukuqhina
• isicaphucaphu
• ukugabha
• ukozela
• isiyezi okanye isiqaqa
• ubumthubi besikhumba okanye amehlo, umchamo omnyama, ukuphuma kwegazi okanye ukugruzuka ngokulula kunesiqhelo, ukuphelelwa ngumdla, ukuncipha kwamandla, okanye iintlungu kwicala lasekunene lesisu
• ukwanda kokoma
• ukuncipha okanye ukwanda kokuchama
• ukudumba kobuso, iingalo, imilenze, iinyawo okanye amaqatha
• igazi kumchamo
• utshintsho kumbono
• umphefumlo onuka iziqhamo

Inaliti yeNivolumab inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unayo nayiphi na ingxaki engaqhelekanga ngelixa ufumana eliyeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho uya kuyalela iimvavanyo ezithile zebhu ukujonga impendulo yomzimba wakho kwinaliti ye-nivolumab. Kwezinye iimeko, ugqirha wakho uya kuyalela uvavanyo lwelebhu ngaphambi kokuba uqale unyango lwakho ukuze ubone ukuba umhlaza wakho unganyangwa nge-nivolumab.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

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