Inaliti ye-Alemtuzumab (Multiple Sclerosis)

Umxholo

• Inaliti ye-Alemtuzumab isetyenziselwa ukunyanga abantu abadala ngeendlela ezahlukeneyo ze-multiple sclerosis (MS; isifo apho imithambo-luvo ingasebenzi kakuhle kwaye abantu banokufumana ubuthathaka, ukuba ndindisholo, ukuphulukana nokulungelelaniswa kwemisipha, kunye neengxaki zombono, intetho, kunye nolawulo lwesinyi) abangakhange baphucule ubuncinci ngamayeza amabini e-MS kubandakanya:
• Ngaphambi kokufumana inaliti ye-alemtuzumab,
• Inaliti ye-Alemtuzumab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:
• Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Iinkcukacha ziyafumaneka kwi-Intanethi apha. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Inaliti ye-Alemtuzumab inokubangela ukuphazamiseka komzimba okanye izifo ezisongela ubomi (iimeko apho amajoni omzimba ahlasela amalungu asempilweni kwaye abangele iintlungu, ukudumba kunye nomonakalo), kubandakanya i-thrombocytopenia (inani eliphantsi leeplatelets [uhlobo lweseli yegazi efunekayo ukuze ukujiya kwegazi]) kunye neengxaki zezintso. Xelela ugqirha wakho ukuba unengxaki zokopha okanye isifo sezintso. Ukuba unazo naziphi na kwezi mpawu zilandelayo, tsalela umnxeba kwangoko: ukopha okungaqhelekanga, ukudumba kwemilenze okanye iinyawo, ukukhwehlela igazi, ukopha kunqumle ekunzima ukuyeka, ukuphuma kwegazi okunzima okanye okungaqhelekanga, amabala kulusu lwakho. bomvu, pinki, okanye mfusa, ukopha kwiintsini okanye empumlweni, igazi kumchamo, iintlungu esifubeni, ukwehla kwenani lomchamo nokudinwa.

Unokufumana ukusabela okunganyangekiyo okanye okusongela ubomi ngelixa ufumana idosi yenaliti ye-alemtuzumab okanye ukuya kuthi ga kwiintsuku ezi-3 emva koko. Uya kufumana idosi nganye yamayeza kwindawo yonyango, kwaye ugqirha wakho uya kukujonga ngononophelo ngexesha lokufakwa kunye nasemva kokuba ufumene iyeza. Kubalulekile ukuba uhlale kwiziko lokumiliselwa ubuncinci iiyure ezi-2 emva kokugqitywa kokufakwa kwakho. Ukuba ufumana naziphi na kwezi mpawu zilandelayo ngexesha okanye emva kokufakwa, xelela ugqirha ngoko nangoko: umkhuhlane; Ukugodola; isicaphucaphu; intloko ebuhlungu; ukugabha; imihlathi irhashalala; ukurhawuzelela; ukugungxula; isilungulela; isiyezi; ukuqhawukelwa ngumphefumlo; ubunzima bokuphefumla okanye ukugwinya; ukuphefumla okucothayo; ukuqina komqala; ukudumba kwamehlo, ubuso, umlomo, imilebe, ulwimi okanye umqala; ukudakumba; isiyezi; intloko emhlophe; isiqaqa; ukukhawuleza kwentliziyo okanye okungaqhelekanga; okanye iintlungu esifubeni.

Inaliti ye-Alemtuzumab inokubangela ukubetha okanye iinyembezi kwimithambo yakho ehambisa igazi kwingqondo yakho, ngakumbi kwiintsuku ezintathu zokuqala emva konyango. Ukuba unazo naziphi na kwezi mpawu zilandelayo ngexesha okanye emva kokumfakelwa, xelela ugqirha ngoko nangoko: ukugoba kwelinye icala lobuso, intloko ebuhlungu, iintlungu zentamo, ubuthathaka ngequbuliso okanye ukuba ndindisholo kwengalo okanye umlenze, ngakumbi kwelinye icala lomzimba , okanye kunzima ukuthetha, okanye ukuqonda.

Inaliti ye-Alemtuzumab inokunyusa umngcipheko wokuba ube nomhlaza othile, kubandakanya umhlaza wedlala lengqula, imelanoma (uhlobo lomhlaza wolusu), kunye nomhlaza othile wegazi. Kuya kufuneka ukuba ulusu lwakho luhlolwe ngugqirha iimpawu zomhlaza ngaphambi kokuba uqale unyango kunye nonyaka emva koko. Biza ugqirha wakho ukuba unempawu ezilandelayo ezinokuba luphawu lomhlaza wedlala lengqula: iqhuma elitsha okanye ukudumba entanyeni yakho; iintlungu phambi kwentamo; ukwehla kobunzima obungachazwanga; intlungu okanye ithambo; amaqhuma okanye ukudumba kulusu lwakho, entanyeni, entloko, emhlubulweni okanye esiswini; utshintsho kwimilo yemole, ubungakanani, okanye umbala okanye ukopha; isilonda esincinci esinomda ongagunyaziswanga kunye neenxalenye ezibonakala zibomvu, mhlophe, luhlaza okwesibhakabhaka okanye luhlaza-mnyama; ukududuzela okanye olunye utshintsho lwezwi olungapheliyo; ubunzima bokuginya okanye ukuphefumla; okanye ukukhohlela.

Ngenxa yomngcipheko ngeli chiza, inaliti ye-alemtuzumab ifumaneka kuphela ngenkqubo ekhethekileyo yokuhanjiswa. Inkqubo ebizwa ngokuba yiNkqubo ebizwa ngokuba yiLimtrada Risk Evaluation and Mitigation Strategy (REMS). Buza ugqirha wakho ukuba unemibuzo malunga nokuba uza kuwafumana njani amayeza akho.

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho uya kuyalela iimvavanyo ezithile ukujonga impendulo yomzimba wakho kwisitofu se-alemtuzumab ngaphambi kwaye ngexesha lonyango lwakho kunye neminyaka emi-4 emva kokufumana idosi yakho yokugqibela.

Thetha nogqirha wakho malunga neengozi zokufumana inaliti ye-alemtuzumab.

Inaliti ye-Alemtuzumab isetyenziselwa ukunyanga abantu abadala ngeendlela ezahlukeneyo ze-multiple sclerosis (MS; isifo apho imithambo-luvo ingasebenzi kakuhle kwaye abantu banokufumana ubuthathaka, ukuba ndindisholo, ukuphulukana nokulungelelaniswa kwemisipha, kunye neengxaki zombono, intetho, kunye nolawulo lwesinyi) abangakhange baphucule ubuncinci ngamayeza amabini e-MS kubandakanya:

• Iifom zokuphinda zibuyele kwakhona (ikhosi yesifo apho iimpawu zivela khona amaxesha ngamaxesha) okanye
• iifomati zesekondari eziqhubekayo (ikhosi yesifo apho ukubuyela umva kwenzeka rhoqo).

I-Alemtuzumab ikwiklasi yamayeza abizwa ngokuba ngamachiza omzimba. Isebenza ngokunciphisa isenzo samaseli omzimba anokubangela ukonakala kwentliziyo.

I-Alemtuzumab ikwafumaneka njengenaliti (Campath) esetyenziselwa ukunyanga i-lempemia ye-lymphocytic leukemia (umhlaza okhula kancinci kancinci apho uhlobo oluninzi lweeseli ezimhlophe zegazi luqokelela emzimbeni). Le monograph inika kuphela ulwazi malunga nenaliti ye-alemtuzumab (Lemtrada) yesifo se-sclerosis. Ukuba ufumana i-alemtuzumab ye-lymphocytic leukemia engapheliyo, funda i-monograph enesihloko esithi Alemtuzumab Injection (Chronic Lymphocytic Leukemia).

Inaliti ye-Alemtuzumab iza njengesisombululo (ulwelo) esiza kufakwa ngaphakathi (emthanjeni) ngaphezulu kweeyure ezi-4 ngugqirha okanye umongikazi esibhedlele okanye kwiofisi yezonyango. Ihlala inikwa kube kanye yonke imihla kwiintsuku ezintlanu kumjikelo wokuqala wonyango. Umjikelo wesibini wonyango uhlala unikwa kube kanye yonke imihla kwiintsuku ezintathu, iinyanga ezili-12 emva komjikelo wokuqala wonyango. Ugqirha wakho unokumisela umjikelo wonyango owongezelelweyo iintsuku ezi-3 ubuncinci iinyanga ezili-12 emva konyango lwangaphambili.

Inaliti ye-Alemtuzumab inceda ukulawula i-multiple sclerosis, kodwa ayiyinyangi.

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

Ngaphambi kokufumana inaliti ye-alemtuzumab,

• xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabana ne-alemtuzumab, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ye-alemtuzumab. 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, othabathayo okanye oceba ukuthatha Qiniseka ukuba ukhankanya oku kulandelayo: alemtuzumab (Campath; igama lebrendi yemveliso esetyenziselwa ukunyanga i-leukemia); amayeza omhlaza; okanye amayeza okunyanga umzimba njenge-cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (Cellcept), prednisone, kunye ne-tacrolimus (Astagraf, Envarsus, Prograf). Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba unentsholongwane okanye intsholongwane kaGawulayo. Ugqirha wakho uya kukuxelela ukuba ungayifumani inaliti ye-alemtuzumab.
• xelela ugqirha wakho ukuba unesifo sephepha (isifo sephepha; isifo esosulelayo esichaphazela imiphunga kwaye ngamanye amaxesha namanye amalungu omzimba), iherpes zoster (ukurhawuzelela; irhashalala enokuthi ibekho kubantu abanenkuku ngaphambili) , i-herpes yelungu lobufazi (usuleleko lwe-herpes virus olwenza ukuba izilonda zibumbe zijikeleze amalungu esini kunye ne-rectum amaxesha ngamaxesha), i-varicella (irhashalala), isifo sesibindi kubandakanya i-hepatitis B okanye i-hepatitis C, okanye idlala lengqula, intliziyo, umphunga, okanye isifo senyongo.
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ungumfazi, kuya kufuneka uthathe uvavanyo lokukhulelwa ngaphambi kokuba uqale unyango kwaye usebenzise ulawulo lokuzalwa ngexesha lonyango lwakho kunye neenyanga ezi-4 emva kwedosi yakho yokugqibela. Thetha nogqirha wakho malunga neentlobo zolawulo lokuzalwa onokuzisebenzisa ukuthintela ukukhulelwa ngeli xesha. Ukuba ukhulelwa ngelixa ufumana inalitizumab inaliti, tsalela umnxeba kwangoko. I-Alemtuzumab inokwenzakalisa umntwana ongekazalwa.
• jongana nogqirha wakho ukubona ukuba ufuna ukufumana naluphi na ugonyo ngaphambi kokufumana i-alemtuzumab. Xelela ugqirha wakho ukuba ufumene isitofu sokugonya kwezi veki zintandathu zidlulileyo. Awunalo ugonyo ngaphandle kokuthetha nogqirha wakho ngexesha lonyango lwakho.

Kunqande oku kulandelayo kokutya kunokubangela usulelo ubuncinci kwinyanga enye ngaphambi kokuba uqale ukufumana i-alemtuzumab kwaye ngexesha lonyango lwakho: inyama yokuhambisa, iimveliso zobisi ezenziwe ngobisi olungafakwanga, itshizi ethambileyo, okanye inyama engaphekwanga, ukutya kwaselwandle, okanye inkukhu.

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

• ubunzima bokulala okanye ukulala
• iintlungu emilenzeni, kwiingalo, kwiinzwane nasezandleni
• umqolo, ukudibana, okanye intlungu yentamo
• ukurhawuzelela, ukuhlaba, ukuphola, ukutshisa, okanye ukubindeka kwesikhumba
• bomvu, urhawuzelele, okanye isikhumba esinamaxolo
• isilungulela
• ukudumba kwempumlo nomqala

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:

• ukuphefumla okufutshane, iintlungu esifubeni okanye ukuqina, ukukhohlela, ukukhwehlela igazi, okanye ukuvutha
• umkhuhlane, ukugodola, urhudo, isicaphucaphu, ukugabha, intloko ebuhlungu, iintlungu ezihlangeneyo okanye izihlunu, ukuqina kwentamo, ukuhamba nzima, okanye utshintsho kwingqondo.
• ukutyumza okanye ukopha ngokulula, igazi kumchamo okanye ilindle, ukuphuma kwempumlo, ukugabha kwegazi, okanye iintlungu ezibuhlungu kunye / okanye ukudumba
• ukubila okugqithisileyo, ukudumba kwamehlo, ukwehla kobunzima, ukoyika, okanye ukubetha kwentliziyo okukhawulezayo
• ukutyeba okungachazwanga, ukudinwa, ukuziva ubanda, okanye ukuqhina
• ukudakumba
• ukucinga ngokuzenzakalisa okanye ukuzibulala okanye ukucwangcisa okanye ukuzama ukwenza njalo
• izilonda zokuzala, imvakalelo yezikhonkwane kunye neenaliti, okanye irhashalala kwilungu lobudoda okanye kwindawo yelungu lobufazi
• izilonda ezibandayo okanye ukudumba komkhuhlane emlonyeni okanye emlonyeni
• irhashalala ebuhlungu kwicala elinye lobuso okanye lomzimba, kunye namadyungudyungu, iintlungu, ukurhawuzelela, okanye ukurhawuzelela kwindawo erhabaxa
• (kwabasetyhini) ivumba lobufazi, ukuphuma okumhlophe okanye okumthubi (kusenokuba namathambo okanye kujongeka njengekhitshi), okanye ukurhawuzelela kwilungu lobufazi
• izilonda ezimhlophe kulwimi okanye izidlele zangaphakathi
• isisu esibuhlungu okanye ukuthamba, umkhuhlane, isicaphucaphu, okanye ukugabha
• isicaphucaphu, ukugabha, iintlungu zesisu, ukudinwa kakhulu, ukungabinamdla wokutya, amehlo atyheli okanye ulusu, ukudinwa kakhulu, umchamo omnyama, okanye ukopha okanye ukutyumka ngokulula kunesiqhelo
• ubuthathaka kwelinye icala lomzimba eliba mandundu ngokuhamba kwexesha; ukungxama kweengalo okanye imilenze; utshintsho kwindlela ocinga ngayo, inkumbulo, ukuhamba, ukulinganisela, intetho, ukubona kwamehlo, okanye amandla ahlala iintsuku ezininzi; intloko; ukuxhuzula; ukudideka; okanye utshintsho kubuntu
• umkhuhlane, ukuvuvukala kwamadlala, ukukhawuleza, ukuxhamla, utshintsho ekucingeni okanye ukuphaphama, okanye ukutshabalalisa okanye ukungazinzi

Inaliti ye-Alemtuzumab 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).

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Iinkcukacha ziyafumaneka kwi-Intanethi apha. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

• intloko ebuhlungu
• irhashalala
• isiyezi

Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nenaliti ye-alemtuzumab.

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.

• Lemtrada^®