Inaliti ye-Eculizumab

-Delile

• Ngaphambi kokuthola umjovo we-eculizumab,
• Umjovo we-Eculizumab 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:

Ukuthola umjovo we-eculizumab kungakhuphula ubungozi bokuthi uzoba nokutheleleka nge-meningococcal (ukutheleleka okungathinta ukumbozwa kobuchopho nomgogodla kanye / noma kungasakazeka egazini) ngesikhathi sokwelashwa kwakho noma isikhashana ngemuva kwalokho. Izifo ze-Meningococcal zingadala ukufa esikhathini esifushane. Uzodinga ukuthola umuthi wokugoma i-meningococcal okungenani amasonto ama-2 ngaphambi kokuba uqale ukwelashwa kwakho ngomjovo we-eculizumab ukunciphisa ubungozi bokuthi uzohlakulela lolu hlobo lokutheleleka. Uma uke wawuthola lo muthi wokugoma esikhathini esedlule, kungadingeka ukuthi uthole i-booster dose ngaphambi kokuba uqale ukwelashwa kwakho. Uma udokotela wakho ezwa ukuthi udinga ukuqala ukwelashwa ngomjovo we-eculizumab khona manjalo, uzothola umuthi wokugoma we-meningococcal ngokushesha okukhulu.

Noma uthola umuthi wokugoma i-meningococcal, kusesengcupheni yokuthi ungahlaselwa yisifo se-meningococcal ngesikhathi noma ngemuva kokwelashwa kwakho ngomjovo we-eculizumab. Uma uhlangabezana nanoma yiziphi zalezi zimpawu ezilandelayo, shayela udokotela wakho ngokushesha noma uthole usizo oluphuthumayo lwezokwelapha: ikhanda eliza kanye nesicanucanu noma ukuhlanza, umkhuhlane, intamo eqinile, noma umqolo oqinile; umkhuhlane ka-103 ° F (39.4 ° C) noma ngaphezulu; ukuqubuka nomkhuhlane; ukudideka; ubuhlungu bemisipha nezinye izimpawu ezinjengomkhuhlane; noma uma amehlo akho ezwela ukukhanya.

Tshela udokotela wakho uma unemfiva noma ezinye izimpawu zokutheleleka ngaphambi kokuqala ukwelashwa kwakho ngomjovo we-eculizumab. Udokotela wakho ngeke akunikeze umjovo we-eculizumab uma usuvele unesifo se-meningococcal.

Udokotela wakho uzokunikeza ikhadi lokuphepha lesiguli elinolwazi mayelana nobungozi bokuhlaselwa yisifo se-meningococcal ngesikhathi noma isikhathi esithile ngemuva kokwelashwa kwakho. Phatha leli khadi njalo ngezikhathi zokwelashwa kwakho nezinyanga ezi-3 ngemuva kokwelashwa kwakho. Khombisa ikhadi kubo bonke abahlinzeki bezempilo abakwelapha ukuze bazi ngobungozi bakho.

Uhlelo olubizwa ngeSoliris REMS lubekiwe ukunciphisa ubungozi bokuthola umjovo we-eculizumab. Ungathola umjovo we-eculizumab kuphela kudokotela obhalise kulolu hlelo, okhulume nawe ngobungozi besifo i-meningococcal, wakunikeza ikhadi lokuphepha lesiguli, futhi waqinisekisa ukuthi uthole umuthi wokugoma i-meningococcal.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomjovo we-eculizumab futhi isikhathi ngasinye lapho uthola umjovo. 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.

Khuluma nodokotela wakho ngezingozi zokuthola umjovo we-eculizumab.

Umjovo we-Eculizumab usetshenziselwa ukwelapha i-paroxysmal nocturnal hemoglobinuria (i-PNH: uhlobo lwe-anemia lapho amaseli egazi abomvu amaningi ehla emzimbeni, ngakho awekho amaseli anempilo anele okuletha umoya-mpilo kuzo zonke izingxenye zomzimba). Umjovo we-Eculizumab nawo usetshenziselwa ukwelapha i-atypical hemolytic uremic syndrome (aHUS; isimo esizuzwe njengefa lapho amahlule amancane egazi akha khona emzimbeni futhi angadala ukulimala emithanjeni yegazi, kumaseli egazi, ezinso nakwezinye izingxenye zomzimba). Umjovo we-Eculizumab nawo usetshenziselwa ukwelapha uhlobo oluthile lwe-myasthenia gravis (MG; ukuphazamiseka kwesistimu yezinzwa okubangela ubuthakathaka bemisipha). Ibuye isetshenziselwe ukwelapha i-neuromyelitis optica spectrum disorder (i-NMOSD; i-autoimmune disorder yesistimu yezinzwa ethinta izinzwa zamehlo nentambo yomgogodla) kubantu abadala abathile. Umjovo we-Eculizumab useqenjini lemithi ebizwa ngama-antibody monoclonal. Isebenza ngokuvimba ukusebenza kwengxenye yamasosha omzimba engalimaza amangqamuzana egazi kubantu abane-PNH futhi abangele ukuthi kwakheke amahlule kubantu abane-AHUS. Isebenza futhi ngokuvimba ukusebenza kwengxenye yesistimu yomzimba engalimaza izingxenye ezithile zesistimu yezinzwa emaphakathi kubantu abane-NMOSD noma ngokuphazamisa ukuxhumana phakathi kwezinzwa nemisipha kubantu abane-MG.

Umjovo we-Eculizumab uza njengesisombululo (uketshezi) sokujova ngomjovo (emthanjeni) okungenani imizuzu engama-35 ngudokotela noma umhlengikazi ehhovisi lezokwelapha. Imvamisa inikezwa abantu abadala kanye ngesonto amasonto ama-5 bese inikezwa kanye njalo ngesonto. Izingane zingathola umjovo we-eculizumab kushejuli ehlukile, kuya ngeminyaka yazo nesisindo somzimba. Imithamo eyengeziwe yomjovo we-eculizumab nayo inikezwa ngaphambi noma ngemuva kokunye ukwelashwa kwe-PNH, aHUS, MG, noma i-NMOSD.

Udokotela wakho kungenzeka akuqale ngomthamo ophansi womjovo we-eculizumab futhi akhuphule umthamo wakho ngemuva kwamasonto amane.

Umjovo we-Eculizumab ungadala ukusabela okweqile komzimba. Udokotela wakho uzokubuka ngokucophelela ngenkathi uthola umjovo we-eculizumab kanye nehora eli-1 ngemuva kokuthola umuthi. Udokotela wakho anganciphisa noma ayeke ukumnika kwakho uma uthola ukusabela okweqile. Uma uhlangabezana nalezi zimpawu ezilandelayo, tshela udokotela wakho ngokushesha: ubuhlungu besifuba; ukuzizwa ngiphelile; ukuqubuka; isifuba; ukuvuvukala kwamehlo, ubuso, izindebe, ulimi, noma umphimbo; ukushaqeka; noma ukuphefumula kanzima noma ukugwinya.

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

Ngaphambi kokuthola umjovo we-eculizumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-eculizumab injection, noma imuphi omunye umuthi, noma iziphi izithako zomjovo we-eculizumab. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi imishanguzo kadokotela neyokungabhalisi, amavithamini, izithako zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma ngabe uke waba nanoma yiziphi ezinye izimo zezempilo.
• utshele udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi uthola umjovo we-eculizumab, shayela udokotela wakho.
• uma ingane yakho izokwelashwa ngomjovo we-eculizumab, ingane yakho kufanele igonyelwe iStreptococcus pneumoniae neHaemophilus influenza type b (Hib) ngaphambi kokuqala ukwelashwa. Khuluma nodokotela wengane yakho ngokunikeza ingane yakho le mithi yokugoma kanye neminye imishanguzo ingane yakho eyidingayo.
• uma welashelwa i-PNH, kufanele wazi ukuthi isimo sakho singadala ukuthi amangqamuzana egazi abomvu amaningi kakhulu aqhekeke ngemuva kokuyeka ukuthola umjovo we-eculizumab. Udokotela wakho uzokuqapha ngokucophelela futhi angayalela ukuhlolwa kwelabhoratri phakathi namasonto ayi-8 okuqala ngemuva kokuqeda ukwelashwa kwakho. Shayela udokotela wakho ngokushesha uma uba nezimpawu ezilandelayo: ukudideka, ubuhlungu besifuba, ukuphefumula kanzima, noma ezinye izimpawu ezingavamile.
• uma welashelwa i-AHUS, kufanele wazi ukuthi isimo sakho singadala ukuthi amahlule egazi akhe emzimbeni wakho ngemuva kokuyeka ukuthola umjovo we-eculizumab. Udokotela wakho uzokuqapha ngokucophelela futhi angayalela ukuhlolwa kwelabhoratri phakathi namasonto okuqala ayi-12 ngemuva kokuqeda ukwelashwa kwakho. Shayela udokotela wakho ngokushesha uma uba nezimpawu ezilandelayo: ukukhathazeka ngokuzumayo ukukhuluma noma ukuqonda inkulumo; ukudideka; ubuthakathaka obungazelelwe noma ukuba ndikindiki kwengalo noma umlenze (ikakhulukazi ohlangothini olulodwa lomzimba) noma kobuso; ukuhamba ngokuzumayo, isiyezi, ukulahlekelwa ibhalansi noma ukuxhumanisa; ukuquleka; ukuquleka; ubuhlungu besifuba; ukuphefumula kanzima; ukuvuvukala ezandleni noma emilenzeni; noma yiziphi ezinye izimpawu ezingavamile.

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

Uma uphuthelwa i-aphoyintimenti yokwamukela umjovo we-eculizumab, shayela udokotela wakho khona manjalo.

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

• ikhanda
• ikhala eligijimayo
• ubuhlungu noma ukuvuvukala emakhaleni noma emphinjeni
• ukukhwehlela
• ubunzima bokulala noma ukulala
• ukukhathala ngokweqile
• isiyezi
• ubuhlungu bemisipha noma bamalunga
• ukuhlungu obusemhlane
• ubuhlungu ezandleni noma emilenzeni
• izilonda emlonyeni
• isifo sohudo
• isicanucanu
• ukuhlanza
• ubuhlungu besisu
• ukuchama kabuhlungu noma okunzima

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

• imfiva
• ukuvuvukala kwezingalo, izandla, izinyawo, amaqakala, noma imilenze engezansi
• ukushaya kwenhliziyo okusheshayo
• ubuthakathaka
• isikhumba esiphaphathekile
• ukuphelelwa umoya

Umjovo we-Eculizumab 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 online ku-https: //www.poisonhelp.org/help. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile zelebhu ukuze ahlole impendulo yomzimba wakho kumjovo we-eculizumab.

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

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.

• Soliris^®