FDA - Lagu Ogaaday Xeeladaha Spondyloarthropathies iyo Plaque Psoriasis
Cosentyx (secukinumab), oo ay soo saartay Novartis, ayaa waxaa ansixiyay FDA 15-Janaayo, 2016 si loogu daaweeyo dadka qaan-gaarka ah ee leh daawada isnadaamiska firfircoon ee firfircoon iyo neefsiga cudurka psoriasic arthritis . Waxaa horay loo ansixiyay January 2015-ka loogu talagalay cudurka psoriasis ee dhexdhexaad ah ama daran ee dadka qaangaarka ah kuwaas oo u sharaxan daaweynta nidaamsan ama daaweyn. Ankolosing spondylitis iyo psoriasis arthritis waa noocyada xanuunka arthritis-ka ee loo yaqaan ' spondyloarthropathies' .
Ogolaanshaha Cosentyx ee daawada ankylosing spondylitis iyo psoriatic arthritis waxay ku saleysneyd natiijooyinka laga helay labo anchylosing spondylitis iyo labo psoriatic arthritis-ka ah ee tijaabooyinka xakamaynta wajiga III ee kormeerka kaas oo qiimeeyey amniga iyo waxtarka. Dhibaatooyinka ayaa ku lug lahaa in ka badan 1,500 qaan-gaar ah kuwaas oo lahaa mid ka mid ah labada xaaladood.
Waa maxay Dhalinyarada?
Cosentyx waa dawo ka shaqeysa habka difaaca jirka si loo daaweeyo cudurada iyo xaaladaha la soo sheegay. Gaar ahaan, Cosentyx waa antagonisto-17A antagonist (IL-17A) -da monoclonal antoclonal ee ku xiran IL-17A iyo jumladaha isdhexgalka ee la qaato reseptor IL-17. Waa antagonistaha ugu horreeya interleukin-17A ee loo ogolaaday in lagu daaweeyo daawada ankylosing spondylitis, psoriasis arthritis, iyo psoriasis-da.
Sidee baa daawada loo maamulaa?
Cosentyx waxaa maamula cirbadeynta subcutaneous ee bowdada sare ama caloosha. Cosentyx ayaa loo heli karaa sidii xal lagu mudo (150 mg / mL) oo keliya hal qalab ee Sensoready.
Waxaa sidoo kale laga helayaa sirinjiraha hore loo isticmaalo (150 mg / mL). Waxaa jira foorno loo baahan yahay in dib loo habeeyo, lakiin taasi waa xirfadlayaasha caafimaadka kaliya.
Dadka qaba cudurka psoriasis ee arthritis-ka ama ankylosing spondylitis, qiyaasta lagu taliyey ee Cosentyx waxay ku jirtaa qiyaas qaadasho ah 150 mg toddobaadyada 0, 1, 2, 3 iyo 4, oo ay ku xigto 4 todobaad kasta.
Waxaa sidoo kale la siin karaa 4 asbuuc kasta iyada oo aan la qaadin qiyaasta. Haddii uu cudurku weli firfircoon yahay, qiyaasta 300 mg ayaa la tixgelin karaa. Cudurka psoriasis-ka, daawada lagu taliyey waa 300 mg toddobaadyada 0, 1, 2, 3, 4 iyo 4-kii asbuucba. Qiyaas yar oo ah 150 mg ayaa ku filan dadka qaarkood. Dadka qaba cudur-maskaxeed ee cudurka psoriasis iyo psoriasis-da, ayaa lagu talinayaa habka loogu talagalay cudurka psoriasis-ka (plaque psoriasis).
Yaa Yaa Loo Isticmaali Karin?
Dadka qaba dareen-celinta xasaasiyadda daran ee secukinumab waa inaysan isticmaalin daawada.
Saameynada Caadiga ah
Dhibaatooyinka ugu badan ee la xiriirta Cosentyx waxaa ka mid ah nasopharyngitis (calaamadaha qabowga), infekshannada neefta ee sare, iyo shuban. Dhibaatooyinka kale ee suurtagalka ah waa suurtagal, haddii aad dareento wax welwel ah, la xiriir dhakhtarkaaga.
Digniinta iyo Taxaddarrada
Digniinta iyo taxaddarrada qaarkood waxay la xiriiraan Cosentyx:
- Caabuqyo halis ah ayaa ka dhacay isticmaalka. Sababtoo ah Cosentyx waxuu ku shaqeeyaa habka difaaca jidhka, waxay yareeyn kartaa awooddaada inaad kula dagaallanto infekshannada waxayna kordhin kartaa halista infakshanka. Haddii infekshan halis ah uu ku dhaco intaad isticmaalayso Cosentyx, ka jooji daawada inta cudurka la daweynayo. Xaqiiqdii, dadka qaba infekshinka hadda, infekshanka joogtada ah, ama taariikhda cudurada soo noqnoqonaya waa inay taxadaraan oo ay ugala hadlaan taariikhdooda cudurka cudurka dhakhtarkooda ka hor inta aan la isticmaalin Cosentyx.
- Ka hor inta aan bilaabin daaweynta Cosentyx, waa in lagaa baaro qaaxada . Haddii dhakhtarkaagu dareemo inaad qatar ugu jirto qaaxada sababtoo ah waxaa lagugu daweynayaa qaaxo, ka hor inta aanad bilaabin Cosentyx iyo inta lagugu daaweynayo Cosentyx.
- Dhibaatooyinka kliinikada, kiisaska cusub ee kicinta cudurka calool-bararka ayaa la xusay, iyo sidoo kale ka sii darista kuwa haysta IBD. Digniinta waa in la isticmaalaa marka Cosentyx la qoro qof la yaqaan IBD.
- Dareen-celinta xasaasiyadeed ee anaphylactic ama mid culus ayaa suurtagal ah. Haddii ay dhacdo, Cosentyx waa in isla markiiba la joojiyaa waana inaad raadsataa caawinaad caafimaad.
- Tallaalka nool waa in aan lagu siinin, haddii aad isticmaasho Cosentyx.
- Dumarka uurka leh kuma jirin baadhitaan ku filan Cosentyx. Waxaa kale oo aan la ogeyn haddii Cosentyx uu ka baxo caanaha bani'aadamka ama si nidaamsan u nuugo ka dib marka la cunay. Digniinta waa in la isticmaalaa.
Ereyga
Sida aan ognahay, maandooriyayaasha ma aha mid si isku mid ah waxtar u leh dhammaan dadka isku dayaya. Taasi waa sababta ay muhiim u tahay in la helo fursado badan oo daaweyn ah. Tan iyo Cosentyx waa daroogada ugu horeysa ee lagu barto interleukin-17A, marinka daaweynta ayaa la heli karaa hadda taas oo aan la helin kahor oggolaanshaha daawada.
Si aad u isticmaasho Cosentyx si badbaado leh, waa inaad barataa sida si habboon loo duro, la soco waxyeelada iyo digniinaha saameyn kara, iyo ka warbixi wixii dhacdooyin ah dhibaatooyinka haddii ay dhacaan. Haddii aad xiiseyneyso inaad waxbadan ka barato xulashadan, u qaado xirfadlahaaga daryeelka caafimaadka. Isaga ama iyada ayaa ku socon doona ilaa go'aan fiican oo adiga kugu habboon.
Ilaha:
Cosentyx. Macluumaadka Qorista . Shirkadda Novartis Pharmaceuticals Corporation. Dib loo eegay Janaayo 2016.
Cosentyx. Tilmaamaha Dawooyinka . Shirkadda Novartis Pharmaceuticals Corporation. Dib loo eegay Janaayo 2016.