I-JAK yokuqala ye-Inhibitor ye-Rheumatoid Arthritis evunyelwe yi-FDA
I-Xeljanz (tofacitinib citrate), i- DMARD yomlomo (izidakamizwa ezishintsha izidakamizwa), yamukelwa yi-US Food and Drug Administration (FDA) ngoNovemba 6, 2012. Lesi sidakamizwa senzelwe ukwelashwa kwabantu abadala ngokulinganisela- i- arthritis ehlukumezeka kakhulu ye- rheumatoid ye-arthritis esebenze ukungapheleli, noma ukubekezelelana, ukuze i- methotrexate . Ekhiqizwa yi-Pfizer, i-Xeljanz iyithebhulethi emhlophe, emhlophe, ekhishwa ngokushesha, elinefilimu ene-"Pfizer" ngakolunye uhlangothi, futhi "i-JKI5" ishicilelwe ngaphesheya.
I-Xeljanz yi-DMARD yomlomo yokuqala evunyelwe isifo samathambo eminyakeni eyishumi. Kubuye kube ngowokuqala ekilasini elisha lemithi eyaziwa ngokuthi i-JAK (Janus kinase) inhibitors. I-Xeljanz ingasetshenziswa njenge-monotherapy (yodwa), noma ihlanganiswe ne-methotrexate noma enye i-DMARD engewona i-biologic. I-Xeljanz akufanele isetshenziswe ngezidakamizwa ze-biologic noma ama-immunosuppressants anamandla, njenge-Imuran (azathioprine) noma i- cyclosporine .
Indlela Esebenza ngayo
Ngokuyisisekelo, i-Xeljanz isebenza ngokuvimbela indlela ye-JAK - indlela yokubonisa ngaphakathi kwamaseli adlala indima ebalulekile ekuvuvukala okuhlobene nesifo samathambo. Ama-JAK angama-enzyme angena-intracellular adlulisa izibonakaliso ezivela e- cytokine noma ekukhulumeni kwe-factor-receptor embranini yeseli.
I-Xeljanz ibhekwa njengamaphilisi amancane, hhayi isidakamizwa se-biologic. I-Biologics, njenge- Enbrel (etanercept), i- Remicade (infliximab), i- Humira (i-adalimumab), i- Cimzia (i-certolizumab pegol), i- Simponi (golimumab), i- Orencia (abatacept), i- Actemra (tocilizumab), ne- Rituxan (rituximab) i-cytokines ene- pro-inflammatory kusuka ngaphandle kweseli.
Ukuhlolwa koMtholampilo
Iziguli ezingaphezu kuka-5 000 ze-rheumatoid arthritis zihileleke ekuvivinyweni kwemitholampilo ye-Xeljanz, okhiqiza olunye ulwazi olusemtholampilo olukhulu kunoma yiluphi uhlobo lwe-arthritis lwe-rheumatoid oluye lafakwa ku-FDA ukuze lubuyekezwe, ngokusho kukaPfizer.
Kukhona izivivinyo ezimbili zemitholampilo ezihlolisisa uhla lwe-Xeljanz, kanye nezilinganiso ezinhlanu zokwelashwa ezihlolisisa impendulo ye- ACR 20 ku-Xeljanz, kanye nemiphumela ye-DAS28 kanye ne-Health Assessment Questionnaire.
Ukuhlolwa kwamagciwane kwabonisa ukuthi i-Xeljanz yanciphisa kakhulu izimpawu nezimpawu zesifo se-rheumatoid kanye nokusebenza ngokomzimba (ikhono lokwenza imisebenzi evamile yansuku zonke).
Isilinganiso
I-Xeljanz ithathwa ngomlomo, iphilisi le-5 mg ithathwe kabili nsuku zonke. Kungathathwa noma ngaphandle kokudla. I-11 mg once-daily dose nayo iyatholakala manje njenge-Xeljanz-XR (ukukhululwa okukhulisiwe).
Imiphumela Ejwayelekile Ejwayelekile
Imiphumela emibi kakhulu evame ukuhambisana ne-Xeljanz, eyenzeke phakathi nezinyanga zokuqala ezintathu zokusetshenziswa ekuhlolweni kwemitholampilo, yayiyizifo ezingaphezulu zokuphefumula, ukukhanda ikhanda, isifo sohudo, kanye ne-nasopharyngitis.
Ukuxwayiswa nokuqapha
I-Xeljanz ithwala isixwayiso sebhokisi : izifo ezimbi eziholela esibhedlela noma ekufeni, kuhlanganise nesifo sofuba kanye ne-bacteria, isikhunta esihlaselayo, amagciwane kanye nezinye izifo ezithandanayo, zenzeke kwiziguli ezithola i-Xeljanz; uma ukutheleleka okungathí sina kukhula, i-Xeljanz kumele imiswe kuze kube yilapho ukutheleleka kulawulwa; ukuhlolwa kwesifo sofuba kumele kunikezwe ngaphambi kokuqala i-Xeljanz; iziguli ezithatha i-Xeljanz kufanele zihlolwe ngenxa yesifo sofuba esisebenzayo ngisho noma ukuhlolwa kokuqala kungalungile; I-lymphoma nezinye izidakamizwa ziye zaphawula ezigulini ezithatha i-Xeljanz; "I-Epstein Barr Virus-associated associated lymphoproliferative disorder" ibonwe ezigulini zokuguqula izithutha eziphathwe nge-Xeljanz zihlangene nezidakamizwa zokuzivikela.
Ezinye izinyathelo zokuqapha: sebenzisa i-Xeljanz ngokucophelela ezigulini ezisengozini yokuphefumula kwamathumbu; I-Xeljanz ayikhuthazwa iziguli ezinezifo ezinzima zesibindi; Ukuhlolwa kwe-laboratory ngezikhathi ezithile kunconywa ngoba i-Xeljanz ingabangela ushintsho ezinhlotsheni ezithile zamangqamuzana egazi ezimhlophe, i-hemoglobin, i- enzyme yesibindi , ne-lipids; iziguli ezithatha i-Xeljanz akufanele zithole imithi ephilayo.
Ucwaningo olufanele lwe-Xeljanz kwabesifazane abakhulelwe alukwenziwanga. I-Xeljanz kufanele isetshenziswe kuphela ngesikhathi sokukhulelwa uma inzuzo yesidakamizwa idlula ingozi engaba khona enganeni.
Izindleko
I-Xeljanz izoba nezindleko zokuthenga jikelele zama $ 2,055.13 ngezinsuku ezingu-30 (noma $ 24,666 ngonyaka).
Izindleko zeziguli zizohluka kuye ngezivumelwano kanye nokufakwa komshuwalense.
> Imithombo:
> Xeljanz. Umhlahlandlela ophelele wokuThola ulwazi kanye nemithi. I-02/2016 ebuyekeziwe.
> Ukuphathwa kwe-US Food and Drug kuvumela i-XELJANZ ye-Pfizer ye-XELJANZ (tofacitinib citrate) yabantu abadala abakwenza kahle kakhulu ukuthi baphethwe yi-arthritis (RA) ababenemiphumela engafanele noma ukungabekezelelani ku-Methotrexate. 11/06/2012.
> I-Xeljanz, i-Philzer ye-$ 25,000-A-Year-A-Ebizayo kakhulu ye-Physium ye-Rheumatoid Arthritis, ithola i-FDA Green Light. UMatewu Herper. I-Forbes.com. 11/06/2012.