Inaliti yeRavulizumab-cwvz

-Delile

• Ngaphambi kokuthola umjovo we-ravulizumab-cwvz,
• I-Ravulizumab-cwvz 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:

Ukuthola umjovo we-ravulizumab-cwvz kungakhuphula ubungozi bokuthi uzoba nokutheleleka nge-meningococcal (ukutheleleka okungathinta ukumbozwa kobuchopho nomgogodla kanye / noma kungasakazeka egazini) ngesikhathi sokwelashwa kwakho noma ngemuva kwesikhathi esithile. Izifo ze-Meningococcal zingadala ukufa esikhathini esifushane. Uzodinga ukuthola umuthi wokugoma i-meningococcal okungenani amasonto ama-2 ngaphambi kokuba uqale ukwelashwa kwakho ngomjovo we-ravulizumab-cwvz 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-ravulizumab-cwvz khona manjalo, uzothola umuthi wokugoma wakho we-meningococcal ngokushesha okukhulu futhi uthathe i-antibiotic amasonto ama-2.

Noma uthola umuthi wokugoma i-meningococcal, kusesengozini yokuthi ungahlaselwa yisifo se-meningococcal ngesikhathi noma ngemuva kokwelashwa kwakho ngomjovo we-ravulizumab-cwvz. 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; imfiva; ukuqubuka nomkhuhlane; ukudideka; ubuhlungu bemisipha nezinye izimpawu ezinjengomkhuhlane; noma uma amehlo akho ezwela ukukhanya.

Tshela udokotela wakho uma unemfiva noma ezinye izimpawu zokutheleleka ngaphambi kokuba uqale ukwelashwa ngomjovo we-ravulizumab-cwvz. Udokotela wakho ngeke akunikeze umjovo we-ravulizumab-cwvz 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 eziyi-8 ngemuva kokwelashwa kwakho. Khombisa ikhadi kubo bonke abahlinzeki bezempilo abakwelapha ukuze bazi ngobungozi bakho.

Uhlelo olubizwa nge-Ultomiris REMS selusungulwe ukunciphisa ubungozi bokuthola umjovo we-ravulizumab-cwvz. Ungathola umjovo we-ravulizumab-cwvz kuphela kusuka kudokotela obhalise kulolu hlelo, ukhulume 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 Wokwelashwa) lapho uqala ukwelashwa nge-ravulizumab-cwvz futhi isikhathi ngasinye lapho ugcwalisa khona incwadi kadokotela. 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-ravulizumab-cwvz.

Umjovo we-Ravulizumab-cwvz usetshenziselwa abantu abadala ukwelapha i-paroxysmal nocturnal hemoglobinuria (PNH: uhlobo lwe-anemia lapho amaseli egazi abomvu amaningi kakhulu ehla khona emzimbeni, ngakho-ke awekho amaseli anempilo anele okuletha umoya-mpilo kuzo zonke izingxenye zomzimba ). Umjovo weRavulizumab-cwvz uyasetshenziswa nakwabadala nasezinyangeni ezineminyaka engu-1 nangaphezulu ukwelapha i-atypical hemolytic uremic syndrome (aHUS; isimo esizuzwe njengefa lapho amahlule amancane egazi akha khona emzimbeni futhi angadala ukulimala emithanjeni yegazi, kumaseli egazi, izinso, nezinye izitho zomzimba). I-Ravulizumab-cwvz isekilasini 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.

Umjovo weRavulizumab-cwvz uza njengesisombululo (uketshezi) okufanele ujovwe ngemithambo yegazi (emthanjeni) ngaphezu kwamahora amabili nambili ngudokotela noma umhlengikazi ehhovisi lezokwelapha. Imvamisa inikezwa njalo emavikini ayisishiyagalombili ukuqala amasonto ama-2 ngemuva komthamo wakho wokuqala. Izingane zingathola umjovo we-ravulizumab-cwvz njalo emavikini ama-4 noma ama-8, kuya ngesisindo somzimba wazo, ukuqala amasonto ama-2 ngemuva komthamo wokuqala.

Umjovo weRavulizumab-cwvz ungadala ukusabela okweqile komzimba. Udokotela wakho uzokubuka ngokucophelela ngenkathi uthola umjovo we-ravulizumab-cwvz kanye nehora elingu-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; ukuphefumula kanzima; ukuphelelwa umoya; ukuvuvukala kobuso bakho, ulimi, noma umphimbo; ubuhlungu obuphansi emuva; ubuhlungu ngokumnika; noma uzizwe uphela amandla.

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

Ngaphambi kokuthola umjovo we-ravulizumab-cwvz,

• Tshela udokotela kanye nosokhemisi wakho uma une-aleji ye-ravulizumab-cwvz, noma imiphi eminye imithi, noma yiziphi izithako zomjovo we-ravulizumab-cwvz. 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 noma uhlela ukukhulelwa. Uma ukhulelwa ngenkathi uthola umjovo we-ravulizumab-cwvz, shayela udokotela wakho.
• tshela udokotela wakho uma uncelisa. Akufanele uncelise ibele ngenkathi uthola i-ravulizumab-cwvz nezinyanga eziyi-8 ngemuva komthamo wakho wokugcina wokwelashwa.
• uma welashelwa i-PNH, kufanele wazi ukuthi isimo sakho singadala ukuthi amangqamuzana egazi abomvu amaningi kakhulu aqhekeke ngemuva kokuyeka ukuthola umjovo we-ravulizumab-cwvz. Udokotela wakho uzokuqapha ngokucophelela futhi angayalela ukuhlolwa kwelabhoratri okungenani amasonto ayi-16 ngemuva kokuqeda ukwelashwa kwakho. Shayela udokotela wakho ngokushesha uma uba nezimpawu ezilandelayo: ukukhathala ngokweqile; igazi emchameni; ubuhlungu besisu; ubunzima bokugwinya; ukwehluleka ukuthola noma ukugcina ukwakhiwa; ukuphelelwa umoya; ubuhlungu, ukuvuvukala, imfudumalo, ubomvu, noma isisa emlenzeni owodwa kuphela; inkulumo ehamba kancane noma enzima; ubuthakathaka noma ukuphazamiseka kwengalo noma umlenze; noma yiziphi ezinye izimpawu ezingavamile.
• uma welashelwa i-aHUS, kufanele wazi ukuthi isimo sakho singadala ukuthi amahlule egazi akhe emzimbeni wakho ngemuva kokuyeka ukuthola umjovo we-ravulizumab-cwvz. Udokotela wakho uzokuqapha ngokucophelela futhi anga-oda izivivinyo zaselebhu okungenani izinyanga eziyi-12 ngemuva kokuqeda ukwelashwa kwakho. Shayela udokotela wakho ngokushesha uma uba nezimpawu ezilandelayo: ukukhathazeka ngokuzumayo ukukhuluma noma ukuqonda inkulumo, ukudideka, ukuba buthakathaka okungazelelwe noma ukuba ndikindiki kwengalo noma umlenze (ikakhulukazi ohlangothini olulodwa lomzimba) noma kobuso, ukuhamba ngokungazelelwe okunenkinga isiyezi, ukulahlekelwa ibhalansi noma ukuxhumanisa, ukuquleka, ukuquleka, ubuhlungu besifuba, ukuphefumula kanzima, noma ezinye izimpawu ezingavamile.

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

Uma uphuthelwa i-aphoyintimenti yokwamukela umjovo we-ravulizumab-cwvz, shayela udokotela wakho ngokushesha.

I-Ravulizumab-cwvz ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• isifo sohudo
• isicanucanu
• ukuhlanza
• ukuqunjelwa
• ikhanda
• ubuhlungu bemisipha noma bamalunga
• ubuhlungu ezandleni noma emilenzeni
• ikhala eligijimayo
• ubuhlungu noma ukuvuvukala emakhaleni noma emphinjeni
• ukukhwehlela
• isiyezi
• ukuchama kabuhlungu noma okunzima
• ukulahleka kwezinwele
• isikhumba esomile
• ukuncipha kokudla
• ukukhathala

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 noma ezinye izimpawu zokutheleleka
• ubuhlungu besisu

I-Ravulizumab-cwvz 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).

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-ravulizumab-cwvz.

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

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.

• Ultomiris^®