Ravulizumab-cwvz (indlela ye-intravenous)
Imikhiqizo etholakalayo
Ultomiris
Mayelana naleli khambi
I-Ravulizumab-cwvz injection isetshenziswa ekwelapheni uhlobo lwesifo segazi oluthiwa yi-paroxysmal nocturnal hemoglobinuria (PNH). Le mishanguzo iyasiza ekunciphiseni ukubhujiswa kwamaseli egazi ebomvu noma ukuphazamiseka (hemolysis) kubantu abane-PNH. I-Ravulizumab-cwvz injection isetshenziswa futhi ekwelapheni i-atypical hemolytic uremic syndrome (aHUS) kubantu abadala nezingane. I-Ravulizumab-cwvz injection isetshenziswa futhi ekwelapheni inkinga yezinzwa nemisipha ethiwa yi-generalized myasthenia gravis (gMG) kubantu abane-anti-acetylcholine receptor (AChR) antibody positive. I-Ravulizumab-cwvz injection isetshenziswa futhi ekwelapheni i-neuromyelitis optica spectrum disorder (NMOSD), isifo esingavamile esibangela ukuvuvukala kwezinzwa zamehlo ne-spinal cord. Isetshenziswa kubantu abane-anti-aquaporin-4 (AQP4) antibody positive. I-Ravulizumab-cwvz injection iyilona i-antibody elilodwa elihlanganisiwe elisebenza ohlelweni lokuvikela umzimba. Lona umuthi utholakala kuphela ngaphansi kohlelo lokusabalalisa oluqediwe oluthiwa yi-Ultomiris® REMS (Risk Evaluation and Mitigation Strategy) Program. Lo mkhiqizo utholakala ngezindlela zokulinganisa ezilandelayo:
Ngaphambi kokusebenzisa leli khambi
Uma ukuthatha isinqumo sokusebenzisa imithi, kufanele kuqondiswe ubungozi bokuthatha imithi ngokumelene nezinzuzo ezizokwenzeka. Lo ngumqondo owenzayo wena nodokotela wakho. Ngale mithi, okulandelayo kufanele kucabangelwe: Tshela udokotela wakho uma uke waba nanoma yiluphi uhlobo oluqondile noma olukhulu lokuphazamiseka kule mithi noma kunoma iyiphi enye imithi. Tshela futhi ochwepheshe bakho bezempilo uma unezinye izinhlobo zokuphazamiseka, njengokudla, izibhebhe, izigcini, noma izilwane. Ngomkhiqizo ongenayo iresiphi, funda ilebula noma izithako zephakheji ngokucophelela. Izifundo ezifanele ezenziwe kuze kube manje azibonisi izinkinga ezikhethekile zezingane ezingakhawuleli ukusetshenziswa kokudubula kwe-ravulizumab-cwvz ukuze kuphathwe i-paroxysmal nocturnal hemoglobinuria (PNH) ne-atypical hemolytic uremic syndrome (aHUS) ezinganeni ezineminyaka engu-1 noma ngaphezulu. Kodwa-ke, ukuphepha nokuphumelela akukaqiniswa ukuze kuphathwe i-PNH ne-aHUS ezinganeni ezincane kunenyanga engu-1 ubudala, noma ukuze kuphathwe i-generalized myasthenia gravis (gMG) ne-neuromyelitis optica spectrum disorder (NMOSD) ezinganeni. Izifundo ezifanele ezenziwe kuze kube manje azibonisi izinkinga ezikhethekile zabantu abadala ezingakhawuleli ukusetshenziswa kokudubula kwe-ravulizumab-cwvz kubantu abadala. Ayikho izifundo ezifanele kubesifazane zokunquma ubungozi lwengane uma usebenzisa le mithi ngesikhathi sokuncelisa. Linganisa izinzuzo ezingaba khona ngokumelene nezingozi ezingaba khona ngaphambi kokuthatha le mithi ngesikhathi sokuncelisa. Nakuba ezinye izimithi kufanele zingasetshenziswa ndawonye nhlobo, kwezinye izimo imithi emibili ehlukene ingasetshenziswa ndawonye ngisho noma kungenzeka ukuthi kube khona ukusebenzisana. Kulezi zimo, udokotela wakho angafuna ukushintsha umthamo, noma ezinye izinyathelo zokuphepha zingadingeka. Uma uthola le mithi, kubalulekile kakhulu ukuthi ochwepheshe bakho bezempilo bazi uma uthatha noma iyiphi imithi ehlaliswe ngezansi. Ukusebenzisana okulandelayo kukhethwe ngesisekelo sokubaluleka kwabo okungenzeka futhi akuyona yonke into. Ukusebenzisa le mithi nanoma iyiphi imithi elandelayo ngokuvamile akunconywa, kodwa kungadingeka kwezinye izimo. Uma kokubili imithi ilotshwe ndawonye, udokotela wakho angashintsha umthamo noma ukuthi uyayisebenzisa kangcono nini imithi. Ezinye izimithi akufanele zisetshenziswe ngesikhathi sokudla noma eduze kwesikhathi sokudla noma ukudla izinhlobo ezithile zokudla ngoba ukusebenzisana kungase kwenzeke. Ukusebenzisa utshwala noma utshaba ngezimithi ezithile kungabangela ukusebenzisana. Xoxa nochwepheshe bakho bezempilo ngokusetshenziswa kwemithi yakho ngokudla, utshwala, noma utshaba. Ukuba khona kwezinye izinkinga zezokwelapha kungathinta ukusetshenziswa kwale mithi. Qiniseka ukuthi utshela udokotela wakho uma unezinye izinkinga zezokwelapha, ikakhulukazi:
Indlela yokusebenzisa leli khambi
Umsesi noma omunye ochwepheshe bezempilo oqeqeshwe uzohlinzeka wena noma ingane yakho le miyekezo esikhungweni sezempilo. Inikezwa nge-IV catheter ebekwe kwenye yezinsimbi zakho. Lolu lwemiyekezo kumele luphiwe kancane. I-IV ivame ukuhlala endaweni ihora elilodwa noma ngaphansi. Ezimweni ezithile, i-IV ingadinga ukuhlala endaweni kwaze kwaba amahora angu-4. Udokotela wakho uzokulandela okungenani ihora elilodwa ngemuva kokufakwa kwemiyekezo yanoma yimiphi imiphumela engathandeki. Kubalulekile kakhulu ukuqonda izidingo zenhlangano ye-Ultomiris® REMS, futhi uqonde isiqondiso somuthi we-Ultomiris® nemiyalo yabaguli. Funda futhi ulandele le miyalo ngokucophelela. Buza udokotela wakho uma unemibuzo. Cela umthengisi wemithi isiqondiso somuthi uma ungenaso. Uma ushintsha ukwelashwa kusuka ku-Soliris® uya ku-Ultomiris®, kufanele uthole umthamo wakho wokuqala we-Ultomiris® ngesikhathi sakho esilandelayo sokudla i-Soliris®. Shaya udokotela wakho noma umthengisi wemithi ukuze uthole imiyalo.
Umshwana wokuzihlangula: I-August iyinkundla yolwazi lwezempilo futhi izimpendulo zayo azihlanganisi iseluleko sezokwelapha. Njalo thintana nochwepheshe bezokwelapha onelayisensi eduze nawe ngaphambi kokwenza noma yiluphi ushintsho.