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I-FDA ivuma unyango lwe-sclerosis e-Ocrevus

I-FDA ivuma unyango lwe-sclerosis e-OcrevusIindaba

Kude kube ngo-1993, xa i-interferon beta-1b yamkelwa njengonyango lokuqala, kwakungekho nyango lwe-multiple sclerosis (MS). Ngo-Matshi ka-2017, i-United States yokutya kunye noLawulo lweeMithi (i-FDA) yamkelwe Ocrevus (ocrelizumab), ezise ithemba elihlaziyiweyo kubantu abane-MS. Ukusukela ukuvunywa kwe-FDA, u-Ocrevus ubonise izithembiso ezininzi.

Yintoni i-multiple sclerosis?

Nantsi lapho Akukho sizathu saziwayo se-multiple sclerosis . Kukho inkolelo exhaphakileyo yokuba i-MS ayinanto inye ebangela oko, kodwa sisiphumo sezinto ezininzi. Okwangoku, i-MS ithathwa njengesifo esingazenzisiyo, esithetha ukuba umzimba awuqapheli indawo eqhelekileyo yomzimba kwaye uyihlasele, ucinga ukuba ngowangaphandle. I-MS ichaphazela abasetyhini kakhulu kunamadoda ngokomyinge we-3 okanye u-4 ukuya ku-1. Nangona inokufunyanwa nakweyiphi na iminyaka, i-MS ifunyaniswa ifunyaniswa iphakathi kweminyaka engama-20 nama-40 ubudala.



Yintoni u-Ocrevus?

Ngaphandle konyango, ukhetho lwangoku lwe-MS lujolise ekukhawuleziseni ukubuyela kuhlaselo, kunciphise ukuqhubela phambili kwesi sifo, kunye nokulawula iimpawu. Nazi Iindidi ezine ze-MS , Kodwa ezi ndidi zimbini zixhaphakileyo yiRelapse-Remitting MS (RRMS) kunye nePrimary-Progressive MS (PPMS), ethi yona idibanise ama-95% oxilongo lwe-MS. I-Ocrevus kuphela kwonyango olunyangayo Zombini i-RRMS kunye ne-PPMS, oko kuthetha ukuba i-95% yabantu abane-MS banokulijonga eli nyango.



I-Ocrevus isebenza njenge-monoclonal antibody ebophelela kwiiseli ezithile ze-B. Uninzi lwee-B-cell luphethe i-antibody ebizwa ngokuba yi-CD20. I-CD20 icingelwa ukuba ibangela ukuba amajoni omzimba aphume emzimbeni, ibangele ukuba ihlasele amalungu omzimba. Xa ubophelela kwiiseli ze-B ezithwala i-CD20 antibody, i-Ocrevus ithintela ukuphendula kwamajoni omzimba kwaye ke kuthintela ukonakala kwenkqubo yeemvakalelo ekugqibeleni ekhokelela kukhubazeko lwabantu abane-MS. I-Ocrevus ibophelela kuphela kwezi seli, hayi kwiiseli ze-plasma kunye neeseli ezinesiqu, ukuze amajoni omzimba jikelele angachaphazeleki.

Ulawulwa njani u-Ocrevus?

I-Ocrevus ilawulwa ngemithambo rhoqo kwiinyanga ezintandathu. Idosi yokuqala ye-600 mg inikwa njengeedosi ezimbini ezahlukileyo ezingama-300 mg, ezinikwe ngaphezulu kweeyure ezingama-2.5, iiveki ezimbini ngokwahlukana. Emva kwethamo lokuqala, idosi nganye yethamo elinye le-600 mg, elawulwa ngaphezulu kweeyure ezintathu. Oku kwenza ukuba unyango lube lula kwizigulana ezisebenzisa i-Ocrevus. Ukungena kwiinaliti rhoqo ngonyaka kukungabikho koxinzelelo oluncinci kunolunye unyango. Amaxesha amaninzi amayeza (anjenge-antihistamine kunye / okanye i-steroid) aya kwenziwa phambi kwe-Ocrevus ukukhusela impendulo kumayeza.



Zithini iziphumo ebezingalindelekanga ze-Ocrevus?

Inokwenzeka iziphumo ebezingalindelekanga ze-Ocrevus Ngexesha lolawulo kubandakanya:

  • Iziphumo ezinxulumene nokufakwa ngaphakathi
  • Uxinzelelo lwegazi oluphantsi
  • Ifiva
  • Isicaphucaphu
  • Irhashalala
  • Ukuba nesiyezi
  • Usulelo oluphezulu nolusezantsi lokuphefumla
  • Usulelo lolusu
  • Uxinzelelo
  • Umqolo obuhlungu
  • Ubuhlungu kwimida

Phakathi kwama-34% -40% ezigulana ziye zaphucula ukumnika ngexesha lokuvavanywa kweklinikhi. Ezi mpawu zibonakala ngathi ziyenzeka ikakhulu ngexesha lokufakwa kancinci kwaye umngcipheko wokuphendula ngokunyuka emva koko uyancipha emva koko. Izigulana kufuneka zijongwe ubuncinci iyure enye emva kokumiliselwa nangona impendulo yokungeniswa ingenzeka ngaphakathi kweeyure ezingama-24 emva kokufakwa.

Ixabisa malini i-Ocrevus?

I-Ocrevus yamkelwa yi-FDA ngoMatshi 28, 2017 , kwaye yafumaneka kwakamsinya emva koko. Unyango lwe-MS lwenziwa yi IGenentech . Uluhlu lonyaka lwamaxabiso onyango lwe-Ocrevus lwaluyi- $ 65,000. Ukufakwa kweinshurensi kuya kwahluka kumnikezeli ngenkonzo, kodwa ungasoloko usebenzisa ikhadi lakho le-SingleCare ukuligcina Ocrevus amayeza .