Inaliti ye-Alemtuzumab (Multiple Sclerosis)

-Delile

• Umjovo we-Alemtuzumab usetshenziselwa ukwelapha abantu abadala abanezinhlobo ezahlukahlukene ze-multiple sclerosis (MS; isifo lapho izinzwa zingasebenzi kahle futhi abantu bangathola ubuthakathaka, ukuba ndikindiki, ukulahleka kokuhlangana kwemisipha, nezinkinga ngombono, ukukhuluma, nokulawula isinye) abangazange bathuthuke okungenani ngemithi emibili noma ngaphezulu ye-MS kufaka phakathi:
• Ngaphambi kokuthola umjovo we-alemtuzumab,
• Umjovo we-Alemtuzumab ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezibalwe esigabeni ESIBALULEKILE SEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:
• Uma kwenzeka ukweqisa ngokweqile, shayela ucingo losizo lokulawula ubuthi ku-1-800-222-1222. Imininingwane iyatholakala naku-inthanethi ku-. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Umjovo we-Alemtuzumab ungadala ukuphazamiseka komzimba okunamandla noma okusongela impilo (izimo lapho amasosha omzimba ahlasela khona izingxenye ezinempilo zomzimba futhi abangele ubuhlungu, ukuvuvukala, nokulimala), kufaka phakathi i-thrombocytopenia (inani eliphansi lama-platelets [uhlobo lweseli legazi elidingekayo ukuvala igazi]) nezinkinga zezinso. Tshela udokotela wakho uma unenkinga yokopha noma isifo sezinso. Uma uhlangabezana nanoma yiziphi kulezi zimpawu ezilandelayo, shayela udokotela wakho ngokushesha: ukopha okungavamile, ukuvuvukala kwemilenze noma izinyawo zakho, ukukhwehlela igazi, ukopha okusikiwe okunzima ukukuyeka, ukuphuma kwegazi okunzima noma okungajwayelekile, amabala esikhunjeni sakho okubomvu, okupinki, noma okunsomi, ukuphuma ezinsinini noma emakhaleni, igazi emchameni, ubuhlungu besifuba, ukwehla kwenani lomchamo nokukhathala.

Ungahle uzwe ukuphendulwa okumuncayo noma okusongela ukuphila ngenkathi uthola umthamo womjovo we-alemtuzumab noma kuze kube yizinsuku ezi-3 ngemuva kwalokho. Uzothola umthamo ngamunye wemithi esikhungweni sezokwelapha, futhi udokotela wakho uzokuqapha ngokucophelela ngesikhathi sokumnika nangemva kokuthola umuthi. Kubalulekile ukuthi uhlale esikhungweni sokumnika okungenani amahora amabili ngemuva kokumnika ukumnika kwakho. Uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumnika noma ngemuva kokumnika, tshela udokotela wakho ngokushesha: umkhuhlane; Ukugodola; isicanucanu; ikhanda; ukuhlanza; isifuba; ukuqubuka; ukulunywa; ukuqhuma; isilungulela; isiyezi; ukuphelelwa umoya; ubunzima bokuphefumula noma ukugwinya; ukuphefumula kancane; ukuqina komphimbo; ukuvuvukala kwamehlo, ubuso, umlomo, izindebe, ulimi noma umphimbo; ukushaqeka; isiyezi; ikhanda elikhanyayo; ukuquleka; ukushaya kwenhliziyo okusheshayo noma okungajwayelekile; noma ubuhlungu besifuba.

Umjovo we-Alemtuzumab ungadala isifo sohlangothi noma izinyembezi emithanjeni yakho enikeza igazi ebuchosheni bakho, ikakhulukazi ezinsukwini ezintathu zokuqala ngemuva kokwelashwa. Uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumnika noma ngemuva kokumfakelwa, tshela udokotela wakho ngokushesha: ukwehla ohlangothini olulodwa lobuso, ikhanda elibuhlungu, ubuhlungu bentamo, ubuthakathaka obungazelelwe noma ukuphazamiseka kwengalo noma umlenze, ikakhulukazi ohlangothini olulodwa lomzimba , noma ubunzima bokukhuluma, noma ukuqonda.

Umjovo we-Alemtuzumab ungakhuphula ubungozi bokuthi uzoba nomdlavuza othile, kubandakanya umdlavuza we-thyroid, i-melanoma (uhlobo lomdlavuza wesikhumba), kanye nomdlavuza othile wegazi. Kufanele uhlolwe isikhumba sakho ngudokotela ukuthola izimpawu zomdlavuza ngaphambi kokuqala ukwelashwa nonyaka ngemuva kwalokho. Shayela udokotela wakho uma unalezi zimpawu ezilandelayo ezingaba uphawu lomdlavuza wegilo: isigaxa esisha noma ukuvuvukala entanyeni yakho; ubuhlungu phambi kwentamo; ukuncipha kwesisindo okungaqondakali; ubuhlungu bamathambo noma obuhlangene; izigaxa noma ukuvuvukala esikhunjeni sakho, entanyeni, ekhanda, emgodini noma esiswini; izinguquko ekubunjweni kwemvukuzane, usayizi, noma umbala noma ukopha; isilonda esincane esinomngcele ongajwayelekile kanye nezingxenye ezibonakala zibomvu, zimhlophe, ziluhlaza okwesibhakabhaka noma zimnyama okwesibhakabhaka; ukuduma noma okunye ukushintsha kwezwi okungapheli; ubunzima bokugwinya noma ukuphefumula; noma ukukhwehlela.

Ngenxa yobungozi balo muthi, umjovo we-alemtuzumab utholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe. Uhlelo olubizwa ngohlelo olubizwa ngeLemtrada Risk Evaluation and Mitigation Strategy (REMS) Programme. Buza udokotela wakho uma unemibuzo mayelana nokuthi uzowuthola kanjani umuthi wakho.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile ukuze ahlole impendulo yomzimba wakho kumjovo we-alemtuzumab ngaphambi nangesikhathi sokwelashwa kwakho kanye neminyaka engu-4 ngemuva kokuthola umthamo wakho wokugcina.

Khuluma nodokotela wakho ngezingozi zokuthola umjovo we-alemtuzumab.

Umjovo we-Alemtuzumab usetshenziselwa ukwelapha abantu abadala abanezinhlobo ezahlukahlukene ze-multiple sclerosis (MS; isifo lapho izinzwa zingasebenzi kahle futhi abantu bangathola ubuthakathaka, ukuba ndikindiki, ukulahleka kokuhlangana kwemisipha, nezinkinga ngombono, ukukhuluma, nokulawula isinye) abangazange bathuthuke okungenani ngemithi emibili noma ngaphezulu ye-MS kufaka phakathi:

• amafomu wokubuyisela emuva (inkambo yesifo lapho izimpawu zivela khona ngezikhathi ezithile) noma
• amafomu wesibili aqhubekayo (inkambo yesifo lapho ukubuyela emuva kwenzeka kaningi).

I-Alemtuzumab isekilasini lemithi ebizwa ngama-antibody monoclonal. Isebenza ngokunciphisa isenzo samaseli omzimba angadala ukulimala kwezinzwa.

I-Alemtuzumab iyatholakala futhi njengomjovo (iCampath) esetshenziselwa ukwelapha i-leukemia engamahlalakhona (umdlavuza okhula kancane lapho uhlobo oluningi lwamaseli amhlophe egazi luhlangana emzimbeni). Le monograph inika kuphela imininingwane mayelana nomjovo we-alemtuzumab (Lemtrada) we-multiple sclerosis. Uma uthola i-alemtuzumab ye-leukemia engapheli ye-lymphocytic, funda i-monograph enesihloko esithi Alemtuzumab Injection (Chronic Lymphocytic Leukemia).

Umjovo we-Alemtuzumab uza njengesisombululo (uketshezi) sokujova ngomjovo (emthanjeni) ngaphezu kwamahora ama-4 ngudokotela noma umhlengikazi esibhedlela noma ehhovisi lezokwelapha. Imvamisa inikezwa kanye ngosuku izinsuku ezi-5 kumjikelezo wokuqala wokwelashwa. Umjikelezo wesibili wokwelashwa uvame ukunikezwa kanye ngosuku izinsuku ezintathu, izinyanga eziyi-12 ngemuva komjikelezo wokuqala wokwelashwa. Udokotela wakho angakunikeza umjikelezo wokwelashwa owengeziwe izinsuku ezintathu okungenani izinyanga eziyi-12 ngemuva kokwelashwa kwangaphambilini.

Umjovo we-Alemtuzumab usiza ukulawula i-multiple sclerosis, kepha ayiyelaphi.

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

Ngaphambi kokuthola umjovo we-alemtuzumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-alemtuzumab, noma imuphi omunye umuthi, noma iziphi izithako zomjovo we-alemtuzumab. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithako zokudla okunomsoco, okwenzayo noma ohlela ukukuthatha. Qiniseka ukusho okulandelayo: alemtuzumab (Campath; igama lomkhiqizo lomkhiqizo osetshenziselwa ukwelapha i-leukemia); imithi yomdlavuza; noma imishanguzo yokuzivikela njenge-cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (Cellcept), prednisone, kanye ne-tacrolimus (Astagraf, Envarsus, Prograf). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• utshele udokotela wakho uma une-virus noma i-human immunodeficiency virus (HIV). Udokotela wakho mhlawumbe uzokutshela ukuthi ungawutholi umjovo we-alemtuzumab.
• Tshela udokotela wakho uma uke waba nesifo sofuba (i-TB; ukutheleleka okungathi sína okuthinta amaphaphu futhi ngezinye izikhathi nezinye izingxenye zomzimba), i-herpes zoster (ama-shingles; ukuqubuka okungenzeka kubantu abake baba nenkukhu ngaphambili) , i-herpes yesitho sangasese (ukutheleleka ngegciwane le-herpes elibangela ukwakheka kwezilonda ezungeze izitho zangasese kanye ne-rectum ngezikhathi ezithile), i-varicella (inkukhu), isifo sesibindi kubandakanya i-hepatitis B noma i-hepatitis C, noma i-thyroid, inhliziyo, iphaphu noma isifo se-gallbladder.
• utshele udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ungowesifazane, kuzodingeka uthathe ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa futhi usebenzise ukulawulwa kokubeletha ngesikhathi sokwelashwa kwakho nezinyanga ezi-4 ngemuva komthamo wakho wokugcina. Khuluma nodokotela wakho ngezinhlobo zokulawula ukubeletha ongazisebenzisa ukuvimbela ukukhulelwa ngalesi sikhathi. Uma ukhulelwa ngenkathi uthola umjovo we-alemtuzumab, shayela udokotela wakho ngokushesha. I-Alemtuzumab ingalimaza umbungu.
• buza nodokotela wakho ukuthi ngabe udinga ukuthola noma yimiphi imigomo ngaphambi kokuthola i-alemtuzumab. Tshela udokotela wakho uma ngabe uthole umuthi wokugoma emavikini ayisithupha edlule. Ungabi nayo imigomo ngaphandle kokukhuluma nodokotela wakho ngesikhathi sokwelashwa kwakho.

Gwema lokhu kudla okulandelayo okungadala ukutheleleka okungenani inyanga e-1 ngaphambi kokuqala ukuthola i-alemtuzumab nangesikhathi sokwelashwa kwakho: inyama yedeli, imikhiqizo yobisi eyenziwe ngobisi olungafakwanga amanzi, ushizi othambile, noma inyama engaphekiwe, inhlanzi yasolwandle, noma inkukhu.

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

• ubunzima bokulala noma ukulala
• ubuhlungu emilenzeni, ezingalweni, ezinzwaneni nasezandleni
• ubuhlungu emuva, ngokuhlanganyela, noma entanyeni
• ukuncinza, ukubhoboza, ukubanda, ukushisa, noma ukuzwa isikhumba
• isikhumba esibomvu, esilumayo, noma esinamakhaza
• isilungulela
• ukuvuvukala kwekhala nomphimbo

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezibalwe esigabeni ESIBALULEKILE SEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• ukuphefumula, ubuhlungu besifuba noma ukuqina, ukukhwehlela, ukukhwehlela igazi, noma ukuphefumula
• umkhuhlane, ukugodola, isifo sohudo, isicanucanu, ukuhlanza, ikhanda elibuhlungu, ubuhlungu bamalunga noma besisipha, ukuqina kwentamo, ukuhamba kanzima, noma ukushintsha kwesimo sengqondo
• ukulimaza noma ukopha kalula, igazi emchameni noma esihlalweni, ukuphuma kwamakhala, ukugabha okunegazi, noma amalunga abuhlungu kanye / noma okuvuvukala
• ukujuluka okweqile, ukuvuvukala kwamehlo, ukwehla kwesisindo, uvalo, noma ukushaya kwenhliziyo okusheshayo
• ukuzuza kwesisindo okungaqondakali, ukukhathala, ukuzwa ukubanda, noma ukuqunjelwa
• ukudana
• ukucabanga ngokuzilimaza noma ukuzibulala noma ukuhlela noma ukuzama ukwenza kanjalo
• izilonda zangasese, ukuzwa kwezikhonkwane nezinaliti, noma ukuqubuka kumthondo noma endaweni yangasese
• izilonda ezibandayo noma imishanguzo yomkhuhlane emlonyeni noma emlonyeni
• ukuqubuka okubuhlungu ohlangothini olulodwa lobuso noma lomzimba, ngamabhamuza, ubuhlungu, ukulunywa, noma ukuhayiza endaweni enamaqubu
• (kwabesifazane) iphunga lesitho sangasese sowesifazane, ukuphuma okumhlophe noma okuphuzi kwesitho sangasese sowesifazane (kungaba nesigaxa noma kubukeke njenge-cottage shizi), noma ukulunywa kwesitho sangasese sowesifazane
• izilonda ezimhlophe olimini noma ezihlathini zangaphakathi
• ubuhlungu besisu noma isisa, umkhuhlane, isicanucanu, noma ukugabha
• isicanucanu, ukuhlanza, ubuhlungu besisu, ukukhathala ngokweqile, ukungathandi ukudla, amehlo aphuzi noma isikhumba, ukukhathala ngokweqile, umchamo omnyama, noma ukopha noma ukulimaza kalula kunokujwayelekile
• ubuthakathaka ohlangothini olulodwa lomzimba olubi ngokuhamba kwesikhathi; ubulukhuni bezingalo noma bemilenze; izinguquko ekucabangeni kwakho, kwimemori, ekuhambeni, ekulinganiseni, ekukhulumeni, ekubukeni kwamehlo, noma emandleni okuhlala izinsuku ezimbalwa; ikhanda; ukuquleka; ukudideka; noma izinguquko zobuntu
• umkhuhlane, izindlala ezivuvukele, ukuqubuka, ukuqubuka, ukuguquka kokucabanga noma ukuphaphama, noma okusha noma okweqile kokungazinzi noma ukuhamba kanzima

Umjovo we-Alemtuzumab 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 naku-inthanethi ku-. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

• ikhanda
• ukuqubuka
• isiyezi

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

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.

• Lemtrada^®