Eculizumab Txhaj Tshuaj

Zoo Siab

• Ua ntej tau txais kev txhaj tshuaj eculizumab,
• Eculizumab txhaj tshuaj tuaj yeem tsim cov kev mob tshwm sim. Qhia rau koj tus kws kho mob yog tias ib qho ntawm cov tsos mob no hnyav lossis tsis ploj mus:
• Qee qhov kev mob tshwm sim tuaj yeem loj heev. Yog tias koj muaj cov tsos mob no lossis cov uas teev rau hauv seem ceeb toom ceeb toom, hu rau koj tus kws kho mob tam sim ntawd lossis tau txais kev kho mob kub ceev:

Tau txais kev txhaj tshuaj eculizumab tuaj yeem ua rau muaj kev pheej hmoo ntxiv tias koj yuav kis mob meningococcal (ib qho mob uas yuav cuam tshuam rau npog ntawm lub hlwb thiab tus txha caj qaum thiab / lossis yuav kis tau los ntawm cov hlab ntshav) thaum lub sijhawm koj kho lossis qee lub sijhawm tom qab. Meningococcal mob yuav ua rau tuag taus nyob rau ib lub sijhawm luv luv. Koj yuav tsum tau txhaj tshuaj tiv thaiv mob meningococcal tsawg kawg 2 lub lis piam ua ntej koj pib kev kho mob nrog kev txhaj tshuaj eculizumab kom txo qis kev phom sij uas koj yuav tsim tus mob no. Yog tias koj tau txais cov tshuaj tiv thaiv no yav dhau los, koj yuav tsum tau txais koob tshuaj tiv thaiv ua ntej koj pib kho. Yog tias koj tus kws kho mob xav tias koj yuav tsum pib txhaj tshuaj eculizumab sai li sai tau, koj yuav tau txais tshuaj tiv thaiv mob meningococcal sai li sai tau.

Txawm hais tias koj tau txais koob tshuaj txhaj tiv thaiv meningococcal los, nws tseem muaj feem yuav ua rau koj muaj mob meningococcal thaum lossis tom qab koj siv tshuaj kho eculizumab. Yog tias koj muaj cov tsos mob li hais hauv qab no, hu rau koj tus kws kho mob tam sim ntawd lossis nrhiav kev pab kho mob kub ntxhov: mob taub hau uas ua nrog rau xeev siab lossis ntuav, kub ib ce, caj dab txhav, lossis txhav txhav; kub cev ntawm 103 ° F (39.4 ° C) lossis siab dua; pob thiab ua npaws; tsis meej pem; mob nqaij thiab lwm cov tsos mob ua npaws; los yog yog koj lub qhov muag rhiab rau pom kev.

Qhia rau koj tus kws kho mob yog tias koj mob kub taub hau lossis lwm yam cim ntawm kev kis mob ua ntej koj pib kho nrog eculizumab txhaj. Koj tus kws kho mob yuav tsis muab kev txhaj tshuaj rau koj eculizumab yog tias koj twb muaj mob meningococcal lawm.

Koj tus kws kho mob yuav muab daim npav qhia txog kev nyab xeeb rau cov neeg mob nrog cov ntaub ntawv ntsig txog kev pheej hmoo ntawm kev muaj mob rau cov mob meningococcal thaum lossis rau ib lub sijhawm tom qab koj kho. Nqa daim npav no nrog koj txhua lub sijhawm thaum kho koj tus mob thiab rau 3 hlis tom qab kho koj tus mob. Muab daim npav rau txhua tus kws saib xyuas kev noj qab haus huv uas kho koj kom lawv paub txog koj qhov kev pheej hmoo.

Ib qho kev pab hu ua Soliris REMS tau teeb tsa txhawm rau txo cov kev pheej hmoo ntawm kev tau txais eculizumab txhaj tshuaj. Koj tsuas tuaj yeem tau txais kev txhaj tshuaj mob eculizumab los ntawm tus kws kho mob uas tau sau npe rau hauv txoj haujlwm no, tau tham nrog koj txog cov kev pheej hmoo ntawm tus mob meningococcal, tau muab daim npav qhia txog kev nyab xeeb rau cov neeg mob, thiab tau ua kom koj tau txais tshuaj tiv thaiv mob meningococcal.

Koj tus kws kho mob lossis kws muag tshuaj yuav muab daim ntawv qhia txog cov neeg mob rau koj (phau Ntawv Qhia Txog Tshuaj Kho Mob) thaum koj pib txhaj tshuaj nrog eculizumab txhaj tshuaj thiab txhua zaus koj tau txhaj tshuaj. Nyeem cov ntaub ntawv kom zoo thiab nug koj tus kws kho mob lossis kws muag tshuaj yog tias koj muaj lus nug. Koj kuj tuaj yeem mus saib tau Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) lub vev xaib (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) lossis cov chaw tsim tshuaj paus lub vev xaib kom tau txais Kev Qhia Tshuaj.

Tham nrog koj tus kws kho mob txog cov kev pheej hmoo ntawm kev txhaj tshuaj eculizumab.

Eculizumab txhaj tshuaj yog siv los kho paroxysmal nocturnal hemoglobinuria (PNH: ib hom ntshav uas cov ntshav liab ntau dhau hauv lub cev, yog li tsis muaj cov hlwb noj qab haus huv txaus los nqa oxygen mus rau txhua qhov ntawm lub cev). Kev txhaj tshuaj Eculizumab kuj tseem siv los kho tus mob atypical hemolytic uremic syndrome (aHUS; ib qho mob uas muaj los ntawm cov ntshav txhaws me me hauv lub cev thiab yuav ua rau cov hlab ntshav, ntshav ntshav, raum, thiab lwm qhov hauv lub cev). Eculizumab txhaj tshuaj kuj tseem siv los kho qee hom mob myasthenia gravis (MG; kev tsis meej ntawm cov leeg hlwb uas ua rau cov leeg tsis muaj zog). Nws kuj tseem siv los kho neuromyelitis optica spectrum tsis meej (NMOSD; kev kho mob tsis ua haujlwm ntawm lub hlwb tsis zoo uas cuam tshuam rau lub qhov muag thiab tus txha caj qaum) hauv qee cov neeg laus. Eculizumab txhaj tshuaj yog nyob hauv ib pawg ntawm cov tshuaj noj hu ua monoclonal tiv thaiv kab mob. Nws ua haujlwm los ntawm kev thaiv cov haujlwm ntawm feem ntawm cov kab mob tiv thaiv kab mob uas ua rau cov ntshav hauv cov neeg muaj PNH thiab uas ua rau cov ntshav txhaws ua rau cov neeg mob aHUS. Nws tseem ua haujlwm los ntawm kev thaiv cov haujlwm ntawm feem ntawm cov tsis muaj zog tiv thaiv kab mob uas yuav ua rau qee qhov chaw hauv nruab nrab cov hlab ntsha hauv cov neeg uas muaj NMOSD lossis cuam tshuam kev sib txuas lus ntawm cov leeg thiab cov leeg hauv MG.

Eculizumab txhaj tshuaj tuaj ua kev daws teeb meem (ua kua) los txhaj tshuaj (tso rau hauv leeg ntshav) tsawg dua 35 feeb los ntawm tus kws kho mob lossis kws saib xyuas mob hauv chaw ua haujlwm kho mob. Feem ntau nws muab rau cov neeg laus ib hlis ib zaug rau 5 lub lis piam thiab tom qab ntawd ib zaug txhua lwm lub lim tiam. Cov menyuam yaus tuaj yeem tau txhaj tshuaj eculizumab rau txawv sijhawm, raws li lawv hnub nyoog thiab qhov hnyav. Kev txhaj tshuaj ntxiv rau eculizumab kuj tau muab ua ntej lossis tom qab qee yam kev kho mob rau PNH, aHUS, MG, lossis NMOSD.

Koj tus kws kho mob tej zaum yuav pib koj rau kev txhaj tshuaj eculizumab qis thiab nce ntxiv rau koj cov koob tshuaj tom qab 4 lub lis piam.

Kev txhaj tshuaj Eculizumab tuaj yeem ua rau muaj kev tsis haum tshuaj loj. Koj tus kws kho mob yuav saib xyuas koj zoo thaum koj tau txais kev txhaj tshuaj eculizumab thiab rau 1 teev tom qab koj tau txais kev noj tshuaj. Koj tus kws kho mob tuaj yeem qeeb lossis tso tseg koj txoj kev hla yog tias koj muaj qhov ua xua. Yog tias koj muaj cov tsos mob nram qab no, qhia koj tus kws kho mob tam sim ntawd: mob hauv siab; hnov tsaus muag; ua pob; khaus; o ntawm lub qhov muag, ntsej muag, daim di ncauj, tus nplaig lossis lub caj pas; txhaws qa; lossis ua pa nyuaj lossis nqos khoom.

Cov tshuaj no tuaj yeem tsim tawm rau lwm txoj kev siv; nug koj tus kws kho mob lossis kws muag tshuaj kom paub ntaub ntawv ntau ntxiv.

Ua ntej tau txais kev txhaj tshuaj eculizumab,

• qhia rau koj tus kws kho mob thiab tus kws muag tshuaj yog tias koj muaj kev fab tshuaj rau eculizumab txhaj tshuaj, lwm yam tshuaj noj, lossis ib qho twg hauv kev txhaj tshuaj eculizumab. Nug koj tus kws muag tshuaj lossis tshawb xyuas Phau Ntawv Qhia Tshuaj Kho Mob rau cov npe ntawm cov khoom siv.
• qhia rau koj tus kws kho mob thiab kws muag tshuaj uas siv tshuaj thiab cov tshuaj uas tsis yog kws kho mob, cov vitamins, khoom noj khoom haus zoo, thiab tshuaj ntsuab koj tau noj lossis npaj yuav noj. Koj tus kws kho mob tej zaum yuav tau hloov qhov tshuaj ntawm koj cov tshuaj lossis saib xyuas koj kom zoo rau kev phiv.
• qhia rau koj tus kws kho mob yog tias koj muaj lossis tau muaj dua lwm yam kev mob.
• qhia koj tus kws kho mob yog tias koj cev xeeb tub, npaj yuav cev xeeb tub, lossis pub mis niam. Yog tias koj xeeb tub thaum tau txais kev txhaj tshuaj eculizumab, hu rau koj tus kws kho mob.
• yog tias koj tus menyuam yuav tau txais kev kho mob eculizumab, koj tus menyuam yuav tsum tau txhaj tshuaj tiv thaiv tus mob Streptococcus pneumoniae thiab Haemophilus khaub thuas hom b (Hib) ua ntej pib kho. Tham nrog koj tus menyuam tus kws kho mob txog kev txhaj tshuaj tiv thaiv kab mob thiab lwm yam kev txhaj tshuaj uas koj tus menyuam xav tau.
• yog tias koj raug kho rau PNH, koj yuav tsum paub tias koj tus mob yuav ua rau cov ntshav liab ntau heev kom tawg tom qab koj tsum tsis txhaj tshuaj mob eculizumab. Koj tus kws kho mob yuav soj ntsuam koj kom zoo thiab tej zaum yuav xaj kuaj nyob hauv thawj 8 lub lis piam tom qab koj tau txais kev kho mob tas. Hu rau koj tus kws kho mob tam sim ntawd yog tias koj muaj qee cov tsos mob hauv qab no: tsis meej pem, mob hauv siab, ua pa nyuaj, lossis lwm yam tsos mob txawv txawv.
• yog tias koj raug kho los ntawm aHUS, koj yuav tsum paub tias koj tus mob yuav ua rau cov ntshav txhaws hauv koj lub cev tom qab koj tsum tsis txhaj tshuaj mob eculizumab. Koj tus kws kho mob yuav soj ntsuam koj kom zoo thiab tej zaum yuav xaj kuaj nyob hauv thawj 12 lub lis piam tom qab koj tau txais kev kho mob tas. Hu rau koj tus kws kho mob tam sim ntawd yog tias koj muaj ib qho ntawm cov tsos mob hauv qab no: hais lus tsis meej lossis tsis nkag siab hais lus; tsis meej pem; cia li tsis muaj zog lossis plam ntawm ib sab caj npab lossis ceg (tshwj xeeb ntawm ib sab ntawm lub cev) lossis ntawm lub ntsej muag; kev ntxhov siab ceev ceev thaum taug kev, kiv taub hau, ploj ntawm qhov sib npaug los yog sib haum; tsaus muag; qaug dab peg; mob hauv siab; ua pa nyuaj; o rau sab caj npab lossis ceg; lossis lwm cov tsos mob txawv txawv.

Tshwj tsis yog koj tus kws kho mob hais rau koj lwm yam, txuas ntxiv koj li kev noj haus zoo.

Yog tias koj tsis tau teem caij mus txhaj tshuaj eculizumab, hu rau koj tus kws kho mob tam sim ntawd.

Eculizumab txhaj tshuaj tuaj yeem tsim cov kev mob tshwm sim. Qhia rau koj tus kws kho mob yog tias ib qho ntawm cov tsos mob no hnyav lossis tsis ploj mus:

• mob taub hau
• los ntswg
• mob lossis o hauv qhov ntswg lossis caj pas
• hnoos
• teeb meem tsis tsaug zog los yog pw tsaug zog
• nkees dhau heev lawm
• kiv taub hau
• leeg mob lossis mob pob qij txha
• rov qab mob
• mob mob ntawm caj npab lossis txhais ceg
• qhov ncauj tawm hauv lub qhov ncauj
• zawv plab
• xeev siab
• ntuav
• mob plab
• mob los sis tso zis nyuaj

Qee qhov kev mob tshwm sim tuaj yeem loj heev. Yog tias koj muaj cov tsos mob no lossis cov uas teev rau hauv seem ceeb toom ceeb toom, hu rau koj tus kws kho mob tam sim ntawd lossis tau txais kev kho mob kub ceev:

• ua npaws
• o ntawm caj npab, tes, taw, pob taws, lossis ceg qis
• lub plawv dhia ceev
• tsis muaj zog
• daj ntseg tawv nqaij
• txog siav

Eculizumab txhaj tshuaj tuaj yeem ua lwm cov phiv. Hu rau koj tus kws kho mob yog tias koj muaj teeb meem txawv txawv thaum tau txais cov tshuaj no.

Yog tias koj muaj kev mob tshwm sim loj, koj lossis koj tus kws kho mob tuaj yeem xa ntawv ceeb toom rau Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) lossis hauv xov tooj ( 1-800-332-1088).

Yog hais tias noj ntau dhau, hu rau kem tus xov tooj kev pab tswj kev lom ntawm 1-800-222-1222. Cov ntaub ntawv tseem muaj nyob online ntawm https://www.poisonhelp.org/help. Yog tus neeg raug tsim txom, tsaus muag, ua tsis taus pa, lossis sawv tsis taus, hu rau 911 tus neeg pab thaum muaj xwm ceev.

Khaws tag nrho cov kev teem caij mus ntsib koj tus kws kho mob thiab chav kuaj mob. Koj tus kws kho mob yuav xaj qee yam kev kuaj sim kuaj xyuas koj lub cev cov lus teb rau txoj kev txhaj tshuaj eculizumab.

Nug koj tus kws muag tshuaj yog tias koj muaj lus dab tsi txog kev txhaj tshuaj eculizumab.

Nws yog ib qho tseem ceeb rau koj kom koj muaj ib daim ntawv sau tag nrho cov tshuaj noj thiab cov tshuaj uas tsis yog kws kho mob sau ntawv (tsis yuav khoom) uas koj tab tom noj, nrog rau txhua yam khoom xws li cov vitamins, minerals, lossis lwm yam tshuaj noj rau lub cev. Koj yuav tsum nqa cov ntawv no nrog koj txhua zaus koj mus ntsib kws kho mob lossis yog tias koj tuaj nyob hauv tsev kho mob. Nws tseem yog cov ntaub ntawv tseem ceeb los nqa nrog koj thaum muaj xwm txheej ceev.

• Soliris^®