*nebadarTulia FDA-s mier

mabtera (rituqsimabi) pirveli da erTaderTi nebadarTuli* B-ujreduli Terapia granulomatozuri (vegeneris granulomatozi) da mikroskopuli poliangiitebis samkurnalod

broSura gankuTvnilia jandacvis personalisTvis

mabtera (rituqsimabi) –

pirveli da erTaderTi nebadarTuli B-ujreduli

Terapia granulomatozuri (vegeneris granulomatozi, GPA)

da mikroskopuli poliangiitis (MPA) samkurnalod

iwvevs srul remisias mkurnalobis me-6 Tveze

GPA da MPA-is mkurnalobis dros mabtera:

aranakleb efeqturia ciklofosfamidze4

seleqtiurad moqmedebs mxolod

CD20 + B-ujredebze

remisiis misaRwevad miiReba kviraSi erTxel

4 kviris manZilze5

2

granulomatozuri (vegeneris granulomatozi)

da mikroskopuli poliangiiti

granulomatozuri (GPA) da mikroskopuli poliangiitis (MPA) dros xdeba mcire zomis sisxlZarRvebis pirveladi dazianeba1

n GPA da MPA warmoadgenen antineitrofilur

citoplazmur antisxeulebTan (ANCA) asocirebuli

vaskulitis (AAV) or tips1,6

n es daavadebebi azianeben Tirkmlebs, filtvebs, kans da

zogierT sxva organos, Tumca daavadebaTa gamovlinebebi

sxvadasxvagvaria7

n AAV aris anTebiTi mdgomareobebis jgufi, romelic

dakavSirebulia autoantisxeulebis erT-erT tipTan -

ANCA-sTan. aRniSnuli antisxeulebi sxvadasxva organosa

da qsovilis sisxlZarRvTa kedlebSi anTebiT procesebs

iwveven8

3

4

1

3 4

2

2

1

ICAMANCA

TNF

neitrofili

MPO/PR3

proanTebiTi citokiebi

CD20

B-ujredebi

diferencirebaANCA

plazmuri ujredebi

granulomatozuri da mikroskopuli

poliangiitis paTogenezi

B ujredebi warmoqmnian ANCA antisxeulebs, romlebic mniSvnelovan rols TamaSoben GPA da MPA-is paTogenezSi.

ANCA-inducirebuli nekrozuli vaskuliti GPA da MPA dros

GPA/MPA dros autoimun-ur pasuxSi CarTulia mravali sxvadasxva tipis ujredi, B ujredebis CaTvliT. am ujredebis urTierTqmede-ba srulad Seswavlili ar aris.

ANCA - warmomqmneli ujredebi gamoyofen ANCA-ebs, romlebicsisxlSi cirkulireben.

TNF αreceptori

β2 integrini

Fcγ receptori

superoqsidisgamoyofa

ANCA-Ti gaaqtiurebuli neitrofilebi aRZraven anTebiT process, romlis Sedegad viTardeba vaskuliti.

neitrofilebis stimulireba iwvevs maT zedapirze PR3 da MPO urTierTqmedebas ANCA-Tan.

am urTierTqmedebis Sedegad neitrofilebi mWidrod ekvrian endoTelur ujredebs.

neitrofilebis Semdgomma stimulirebam SesaZloa aseve gamoiwvios proteolizu-ri fermentebis da reaqtiuli Jangbadis naerTebis gamoyofa.

es procesi SeiZleba ganviTardes organizmis yvela mcire sisxlZarRvSi da farTod gavrcelebuli

dazianeba gamoiwvios. aRniSnuli procesi gansakuTrebul zians ayenebs iseT uxvad vaskularizebul

organoebs, rogoricaa Tirkmlebi da filtvebi.

4

pro-B pre-B umwifari B zrdasruli B

CD20+

aqtivirebuli B mexsierebis B plazmoblasti plazmuriujredi

mabtera (rituqsimabi) – pirveli da erTaderTi nebadarTuli B-ujreduli Terapia granulomatozuri (GPA) da mikroskopuli poliangiitis (MPA) samkurnalod

mabtera granulomatozuri (GPA) da mikroskopuli poliangiitebis(MPA) samkurnalo preparatia, romelic zemoqmedebas axdens B ujredebze.

ciklofosfamidisgan gansxvavebiT, mabtera amorCeviTad moqmedebs B-ujredeb-ze, romlebic ZiriTad rols asruleben GPA da MPA-is paTogenezSi.3

mabtera ukavSirdeba CD20 antigens, romelic lokalizebulia pre-B da zrdasrul B limfocitebze.3

rituqsimabi seleqtiurad ukavSirdeba CD20 + B ujredebs3

CD20 + B ujredebi

mabtera ar moqmedebs Rerovan da plazmur ujredebze, vinaidan maTze ar aris CD203.

Rerovaniujredi

1997 20062001 2008 2009 2010 2011

mabtera – xangrZlivi klinikuri gamocdileba5

mabteras istoriuli TariRebi

nebadarTulia granulomatozuri da mikroskopuli poliangiitebis samkurnalod

nebadarTulia folikuluri limfomis SemanarCunebeli TerapiisTvis

pirveli monoklonuri antisxeulis gamoyeneba nebadarTulia kibos dros*

nebadarTulia gamoyeneba arahojkinis (NHL) limfomis dros

nebadarTulia mabteras gamoyeneba revmatoiduli arTritis (RA) dros maTTvis, visac TNF– inhibitorebze ar aReniSne- baT adeqvaturi pasuxi.

nebadarTulia rogorc pirveli xazis Terapia folikuluri arahjkinis limfomis, dabali diferencirebis arahojkinis limfomis da DLBCL-is dros.

nebadarTulia, rogorc revmatoiduli arTritis (RA) dros saxsrebis struqturuli dazianebis progresirebis Semaferxebeli agenti

nebadarTulia revmatoiduli arTritis ganmeorebiTi mkurnalobisaTvis 6 Tviani intervalebiT

nebadarTulia CD20+CLL samkurnalod

sxvadasxva CvenebebiT namkurnalebi 2.1 milionze meti pacienti, 200 kvleva da 4000 publikacia

NHL = arahojkinis limfoma; RA=revmatoiduli arTriti; DLBCL =difuzuri msxvili B-ujreduli limfoma CLL = qronikuli limfocituri leikemia. *sxva CvenebebisaTvis ixileT gamoyenebis sruli instruqcia TNF = simsivnis manekrozirebeli faqtori

6

klinikur kvlevaSi RAVE mabtera Seadares ciklofosfamids (CYC), romelsac mosdevda azaTiopriniT (AZA) SemanarCunebeli Terapia

n RAVE -multicentruli, randomizebuli, ormagi brma kvleva, romelSic mabteras adarebdnen ciklofosfamids, romelsac mohyveboda azaTiopriniT Terapia. kvlevas unda daedasturebina, rom mabteriT mkurnaloba aranakleb efeqturia ciklofosfamidiT Terapiaze

n monawileobda 197 pacienti granulomatozuri da mikroskopuli poliangiitis diagnoziT

n kvlevaSi CarTuli iyvnen, rogorc axlad diagnostirebuli pacientebi, ise - pacientebi morecidive daavadebiT

n mabteras jgufSi kreatininis saSualo maCvenebeli Seadgenda 76,51 ml/wT, xolo ciklofosfamidis jgufSi - 91,40 ml/wT

mabtera - granulomatozuri da mikroskopulipoliangiitebis dros

RAVE: kvlevis dizaini

N=1971-3 (1000 mg) i.v. puls-Terapia meTilprednizoloniT

RTX - rituqsimabiCYC - ciklofosfamidiAZA - azaTioprini

RTX jgufi (N=99) prednizoloni (dozis TandaTanobiTi Semcireba)*

RTX i.v. (375 mg/m2 kviraSi erTxel 4 kviris manZilze)

pacientebi remisiaSi

pacientebisTvis daSvebuli iyo jgufis cvlileba

CYC (sakontrolo) jgufi (N=98)prednizoloni (dozis TandaTanobiTi Semcireba)*

CYC peroralurad (2mg/kg) yoveldRiurad 3-6 Tve

pacientebi remisiaSiAZA

2mg/kg yoveldRiurad 18 Tvemde)

*remisiaSi myofi pacientebisTvis, doza TandaTanobiT mcirdeboda da mkurnaloba wydeboda 5 Tvis ganmavlobaSi, Tirkmlis ukmarisobis dros xdeboda dozis regulireba

pacientebisTvis, romelTac aReniSnebodaT mZime anTeba, 6 Tveze nakleb periodSi, SeiZleboda kvlevis jgufis Secvla

rituqsimabiT Terapias ar mosdevda imunosupresiuli, SemanarCunebeli Terapia, raTa ukeT SeefasebinaT erTxazovani Terapiis efeqturoba

kvlevis pirveladi saboloo wertili:sruli remisia = daavadebis aqtivobis ararseboba (BVAS/WG=0) da prednizolonis dozis TandaTanobiTi SemcirebiT moxsnis SesaZlebloba me-6 TvisTvis

0

20

40

80

100

60

rituqsimabi

mTliani populacia

daavadebis qvejgufebi

granulomatozuri poliangiiti (GPA) mikroskopuli poliangiiti (MPA)

63.6%53.1%

63%

n=73N=99 N=98

50%

n=74

66.7%

n=24

62.5%

n=24

18 (18%) 20 (20%) 12 (12%) 11 (11%)

17 (17%) 12 (12%) 11 (11%) 6 (6%)

17 (17%) 19 (19%) 10 (10%) 11 (11%)

17 (17%) 15 (15%) 10 (10%) 26 (27%)

16 (16%) 20 (20%) 10 (10%) 17 (17%)

16 (16%) 6 (6%) 9 (9%) 18 (18%)

14 (14%) 12 (12%) 8 (8%) 13 (13%)

13 (13%) 9 (9%) 8 (8%) 13 (13%)

13 (13%) 11 (11%) 7 (7%) 13 (13%)

13 (13%) 21 (21%) 5 (5%) 11 (11%)

13 (13%) 15 (15%) 4 (4%) 19 (19%)

12 (12%) 5 (5%)

mabtera - sruli remisia mkurnalobis me-6 Tveze

yvela gverdiTi movlenis sixSire, romelic gamovlinda pacientTa ≥ 10%-Si 6 Tvis manZilze4-5,10

kvlevis pirveladi saboloo wertili miRweuli iqna mkurnalobis me-6 Tveze (P<0.001)4

sruli remisia mkurnalobis me-6 Tveze

pac

ient

ebi,

ro

mleb

sac

aRen

iSna

T s

ru

li

rem

isia

(%)

CYC da AZA

eqvsTviani, multicentruli, randomizebuli, ormagi-brma, arainferioruli kvleva, romelSic moxda rituqsimabisa da ciklofosfamidis remisiis mainducirebeli efeqtis Sedareba. kvlevaSi CarTulni iyvnen GPA da MPA-iT daavadebuli pacientebi. daavadebis aqtivobis gansazRvra xdeboda Birmingham Vasculitis Activity Score for Wegener’s granulomatosis (BVAS/WG), aseve anamnezisa da eqimis mier globaluri Sefasebis Tanaxmad. specifiuri arainferioruli zRurbli iyo -20 procentiani qula remisiis xarisxis gansxvavebisaTvis. pirveladi analizi ganxorcielda intent-to-treat meTodiT5.

remisia = daavadebis aqtivoba ar aRiniSnebasruli remisia = daavadebis aqtivoba ar aRiniSneba da prednizolonis TandaTanobiTi SemcirebiT moxsnis SesaZlebloba me-6 TvisaTvis.

pacientTa 38%-s, mabteris erTi kursis dasrulebidan 18 Tvis Semdegac SeunarCunda sruli remisia. mabtera aranakleb efeqturia ciklofosfamidze, romelsac mosdevs azatiopriniT mkurnaloba5

gverdiTi movlenebi mkurnalobis me-6 Tveze

kvlevis dizaini saSualebas iZleoda pacientebis gadanacvlebas jgufebs Soris. mabteraze myofma 5 pacientma da CYC-ze myofma 7 pacientma gadainacvles sxva jgufSi5. mabteras jgufSi dafiqsirebuli infuziasTan dakavSirebuli reaqciebi moicavda citokinebis gamoyofis sindroms, wamoxurebas, yelis gaRizianebas da tremors.

gverdiTimovlena (AEs)

mabtera(N=99) n(%)

CYC da Semdgom AZA(N=98) n(%)

gverdiTimovlena (AEs)

mabtera(N=99) n(%)

CYC da Semdgom AZA(N=98) n(%)

gulisreva

faRaraTi

Tavis tkivili

kunTebis spazmi

anemia

perif. SeSupeba

Zilis darRveva

saxsrebis tkivili

xvela

daRliloba

alt momateba

hipertenzia

infuz. dakavS. reaqciebi

cxviridan sisxldena

qoSini

leikopenia

gamonayari

alopecia

cxeleba

zemo sasunT. gzebis infeqcia

dabali hematokriti

ast donis momateba

sisxlSi leik. raod. Semcireba

8

P=0.673

axlad diagnostirebuli

60.4%

n=48 n=48

64.6%

P=0.013

morecidive

n=51 n=50

66.7%

42%

0

20

40

80

100

60

mabtera - sruli remisia mkurnalobis me-6 Tveze

sruli remisia mkurnalobis me-6 Tveze pacientTa qvejgufebis mixedviT5

pac

ient

ebi,

ro

mleb

sac

aRen

iSna

T s

ru

li

rem

isia

(%)

rituqsimabi

CYC da Semdgom AZA

klinikuri kvlevis RAVE-is CarTvis kriteriumebis Tanaxmad, kvlevaSi CarTuli iyvnen an axlad diagnostirebuli pacientebi, an pacientebi, romelTa mdgomareoba,akmayofilebda Semdeg krite-riumebs: ≥3 qula BVAS/WG Skalis mixedviT, rac Cveulebriv saWiroebs CYC mkurnalobas; aReniSnebodaT mZime, an sakmarisad mZime mdgomareoba imisaTvis, rom dasWirvebodaT mkurnaloba CYC-iT; an skriningis vizitze aReniSnebodaT proteinaza 3 (PR3)-ANCA pozitiuroba an mieloper-oqsidaza (MPO)-ANCA pozitiuroba5.

remisia = daavadebis aqtivoba ar aRiniSneba

sruli remisia= daavadebis aqtivoba ar aRiniSneba da prednizolonis TandaTanobiT SemcirebiT moxsnis SesaZlebloba me-6 TvisaTvis4

sxvadasxva CvenebiT rituqsimabis gamoyenebis sabaziso kvlevis Sedeged dafiqsire-buli gverdiTi movlenebisgan gansxvavebuli usafrTxoebis axali sakiTxebi ar wamoWrila3,5

kvirebi1 2 3 4

mabtera - dozireba da miRebis wesi

safexuri 1pacientis sxeulis zedapiris farTobis (BSA) gamoTvla misi simaRlis da wonis mixedviT5

n gamoTvlisaTvis saWiroa pacientis zusti wonisa da simaRlis codna, romlebic izomeba mabteris dawyebamde 14 dRis farglebSi

n klinikur kvlevebSi BSA gamosaTvlelad gamoiyeneboda Semdegi formula:

BSA m2 = (wona kg-Si)0.425 x (simaRle sm-Si)0.725 x 0.007184

safexuri 2pacientis BSA-s mixedviT gamoTvaleT mabteras kviris doza Semdegi formuliT3

n kviris doza =BSA (m2) x 375 mg

safexuri 3 mabteris infuzia unda ganxorcieldes yovelkvireulad 4 kviris manZilze

n meTilprednizolonis infuziebis Semdeg rekomendebulia peroraluri prednizoloni 1 mg/kg/dReSi (ara umetes 80 mg-isa dReSi da klinikuri saWiroebis mixedviT dozis TandaTan SemcirebiT).

pnevmocisturi pnevmoniis profilaqtika (PCP)GPA da MPA mqone pacientebisaTvis aseve rekomendebulia PCP profilaqtika, rogorc mabteris infuziebis dros, aseve mkurnalobis dasrulebidan sul mcire 6 Tvis ganmavlobaSi

mabteris infuziis dawyebamdemZime vaskulitis simptomebis samkurnalod rekomendebulia glukokortikoidebi, kerZod meTilprednizoloni, 1000 mg dReSi 1-3 dRis manZilze da Semdeg peroralurad - pred-nizoloni 1 mg/kg/dReSi (araumetes 80 mg-mde dReSi da klinikuri saWiroebis mixedviT dozis TandaTan SemcirebiT). es reJimi unda daiwyos mabteras miRebis dawyebamde 14 dRis farglebSi an mabteras dawyebasTan erTad da unda gagrZeldes mabteraTi mkurnalobis 4 kviriani kursis manZilze da mis Semdeg

dozirebamabtera (rituqsimabi) miiReba intravenuli (i.v.) infuziis saxiT doziT 375 mg /m2 (e.i dozireba xdeba sxeulis zedapiris farTobis mixedviT) , kviraSi erTxel 4 kviris manZilze3

dozirebis reJimi5

mabtera(375 mg/m2 ) +

yoveldRiurad prednizoloni peroralurad

10

n ar SeiyvanoT intravenuri nakadis saxiT an bolusurad

n yovelTvis daicaviT aseptikis teqnika

n infuziis xangrZlivoba damokidebulia mabteras dozaze, raomelic gamoTvlilia pacientis BSA-is mixedviT

n moamzadeT fiziologiuri xsnaris an 5%-iani glukozis paketi, romelic Seicavs sakmarisi raodenobiT xsnars mabteris saWiro koncentraciamde gansazaveblad

n momdevno gverdze mocemulia ganzavebis cxrilebi. gamoiyeneT is cxrili, romelic Seesabameba mabteras sasurvel koncentracias (4 mg/ml, 2 mg/ml an 1 mg/ml)

n cxrilis mixedviT daadgenT ramdeni fiziologiuri xsnari an 5%-iani glukoza unda datovoT sainfuzio paketSi

n gamoiReT da gaanadgureT arasaWiro fiziologiuri xsnari an 5%-iani glukoza (SeniSvna: es raodenoba SesaZloa varirebdes TiToeuli pacientis BSA-s, mabteras dozis da sasurveli koncentraciis mixedviT)

n aseve cxrilis mixedviT gansazRvreT amosaRebi mabteras moculoba. frTxilad gamoiReT mabteras saWiro moculoba. mabteras gamoRebis gasaadvileblad SeiZleba haeris frTxili Seyvanis an moqaCva-miwolis meTodis gamoyeneba

n frTxilad daamateT mabtera sainfuzio paketSi. paketSi miRebuli xsnaris saboloo moculoba unda Seesabamebodes ganzavebis cxrilis saerTo sainfuzio moculobis svetSi mocemul odenobas

n Serevis mizniT frTxilad gadaabruneT sainfuzio parki. ar SeanjRrioT

n unda moxdes intravenur paketSi arsebuli mTeli xsnaris infuzia

mabteras xsnaris momzadeba

1.3 488 49 441 4901.4 525 53 477 5301.5 563 56 504 5601.6 600 60 540 6001.7 638 64 576 6401.8 675 68 612 6801.9 713 71 639 7102.0 750 75 675 7502.1 788 79 711 7902.2 825 83 747 830

1

1.3 488 49 196 2451.4 525 53 212 2651.5 563 56 224 2801.6 600 60 240 3001.7 638 64 256 3201.8 675 68 272 3401.9 713 71 284 3552.0 750 75 300 3752.1 788 79 316 3952.2 825 83 332 415

2

1.3 488 49 74 1231.4 525 53 80 1331.5 563 56 84 1401.6 600 60 90 1501.7 638 64 96 1601.8 675 68 102 1701.9 713 71 107 1782.0 750 75 113 1882.1 788 79 119 1982.2 825 83 125 208

4 mg/ml

mabtera GPA da MPA dros: ganzavebis cxrilebi

mg/ml

mg/ml

375 mg/m2 rituqsimabis gadasxmakoncentraciiT 4 mg/ml

375 mg/m2 rituqsimabis gadasxmakoncentraciiT 2 mg/ml

375 mg/m2 rituqsimabis gadasxmakoncentraciiT 1 mg/ml

BSA (m2) saerTosainfuziomoculoba

(ml)

rituqsi-mabis

doza (mg)

rituqsimabisamosaRebimoculoba

(ml)

ganmazave-blis

moculoba(ml)

BSA (m2) saerTosainfuziomoculoba

(ml)

ganmazave-blis

moculoba(ml)

BSA (m2) saerTosainfuziomoculoba

(ml)

ganmazave-blis

moculoba(ml)

*fiziologiuri xsnari an D5W†advili ganzavebisaTvis zogierTi cifri damrgvalebulia

rituqsi-mabis

doza (mg)

rituqsimabisamosaRebimoculoba

(ml)

rituqsi-mabis

doza (mg)

rituqsimabisamosaRebimoculoba

(ml)

12

mabtera- dozireba da miRebis wesi

premedikacia

mabteras infuziis dawyebamde premedikaciisTvis rekomendebulia acetaminofeni da antihistaminuri preparatebi.3

preparatis Seyvanaar SeiyvanoT mabtera intravenuri nakadis saxiT an bolusuradn mabteras infuzia sxva medikamentebTan erTad ar SeiZleba

n mabteras Seyvana SeiZleba wveTovnad, pompis gamoyenebiT an 1- an 2 sainfuzio sistemis meTodiT

n 2 sistemis meTodi: SeiyvaneT mabtera ori sainfuzio sistemis gamoyenebis Semdegi wesiT 1. daayeneT pirveladi i.v. xazi fiziologiuri xsnariT, medikamentis gareSe, raTa uzrunvelyofili iyos venaze midgoma. am xaziT SegiZliaT SeiyvanoT damatebiTi siTxe an preparetebi Tu es gaxdeba saWiro. 2. daayeneT meore, specialuri xazi mabteras xsnaris infuziisaTvis, infuziis pirvelad xazSi. porti unda iyos pacientTan SeZlebisdagvarad axlos. meoradi xazis praimingi moaxdineT mabteras xsnariT. 3. mabteras xsnaris Seyvanis dawyebisas gadaketeT pirveladi, fiziologiuri xsnaris xazi.

pirveli infuzia (dRe 1)n daiwyeT infuzia siCqariT 50 mg/sT

n Tu infuziasTan dakavSirebuli reaqcia ar ganvi Tarda, aaCqareT infuzia 50 mg/sT-iani inkrementiT yovel 30 wT-Si, maqsimum 400 mg/sT-mde.

n infuziis xangrZlivoba sxvadasxva pacientisaTvis SeiZleba iyos sxvadasxva. igi damokidebulia Sesayvani wamlis dozaze, romelic gamoTvlilia pacientis sxeulis zedapiris farTobis (BSA) mixedviT1

Semdgomi infuziebi (dRe 8, 15 da 22)n Tu pacients pirveli infuziis dros aReniSneboda infuziasTan dakavSirebuli reaqcia, daiwyeT imave siCqariT, rogorc pirveli infuzia (50 mg/sT) da zemoTaRweril instruqcias miyeviT1

n Tu pacients infuzia kargad gadaaqvs, daiwyeT 100 mg/sT siCqariT1

n Tu infuziasTan dakavSirebuli reaqciebi ar vlindeba, ganagrZeT infuziis siCqaris zrda yovel 30 wT-Si 100 mg/sT -iani inkrementiT, maqsimum 400 mg/sT-mde1

n infuziis xangrZlivoba sxvadasxva pacientisaTvis SeiZleba iyos sxvadasxva. igi damokidebulia Sesayvani wamlis dozaze, romelic gamoTvlilia pacientis sxeulis zedapiris farTobis (BSA) mixedviT1

infuziasTan dakavSirebuli reaqciebis marTva

n mabteram SeiZleba gamoiwvios mZime, zogjer fataluri, infuziasTan dakavSirebuli reaqciebi

n infuziasTan dakavSirebuli reaqciis gamovlinebisas SeaneleT an SewyviteT infuzia

n moaxdineT infuziis reaqciebis medikamenturi marTva (mag. glukokortikoidebi, adrenalini, bronqodilatatorebi an Jangbadi), protokolis mixedviT.

n infuziis reaqciis simZimisa da savaldebulo Carevis gaTvaliswinebiT, simptomebis gaqrobis Semdeg infuziis siCqare minimum 50%-iT unda SeamcireoT.

infuziis Semdegn auxseniT pacients da misi ojaxis wevrebs, Tu romeli simptomebis mimarT unda iyvnen yuradRebiT da ra unda gaakeTon, Tu gamovlinda infuziis Semdgomi iseTi simptomebi, rogoricaa: gamonayari, qavili, tuCebis, enis, yelis an saxis SeSupeba, uecari xvela, sunTqvis gaZneleba, qoSini an xrotini, sisuste, Tavbru da guliswasvlis SegrZneba, guliscemis aCqareba, tkivili gulmkerdSi.

gaafrTxileT pacienti da misi ojaxis wevrebi, rom am simptomTagan romelimes gamovlenis SemTxvevaSi dauy-ovnebliv mimarTon eqims.

GPA da MPA mqone pacientebSi mabteras ganmeorebiTi kursebis usafrTxoebis da efeqturobis Sesaxeb sakmarisi informacia ar aris. aqtiuri kontrolis, ormag brma kvlevaSi mabteras ganmeorebiTi kursebis Catareba daSvebuli iyo pacientebisaTvis, romlebsac aReniSnebodaT daavadebis gamwvaveba.mabteriT ganmeo-rebiTi mkurnalobis usafrTxoeba da efeqturoba dadgenili ar aris.

14

sxeulis zedapiris farTobis gamosaTvleli cxrili (m2)

mabtera®

rituqsimabiwamlis Terapiuli/farmakologiuri jgufi simsivnis sawinaaRmdego (antineoplaziuri) saSualeba aTq klasifikaciis kodi: L01XC02

gamoSvebis forma sainfuzio xsnarSi gasaxsneli koncentrati. miRebis gza intravenuri (i.v.) infuzia.

Terapiuli Cvenebebi ara-hojkinis limfoma - morecidive an qimiorezistentuli dabali xarisxis an folikuluri, CD20-dadebiTi, B-ujredovani ara-hojkinis limfomiT daavadebuli pacientebisTvis. - winaswar aranamkurnalebi, III-IV stadiis folikuluri limfomiT daavadebuli pacientebisTvis qimioTerapiasTan kombinaciaSi. - folikuluri limfomiT daavadebuli pacientebisTvis SemanarCunebeli Terapiis saxiT induqciur Terapiaze pasuxis Semdeg. - CD20-dadebiTi difuzuri B-msxvilujredovani ara-hojkinis limfomiT-daavadebuli pacientebisTvis CHOP (ciklofosfamidi, doqsorubicini, vinkristini da prednizoloni) qimioTerapiasTan kombinaciaSi. qronikuli limfocituri leikemia mabtera/rituqsani qimioTerapiasTan kombinaciaSi naCvenebia winaswar aranamkurnalevi da morecidive/refraqteruli qronikuli limfocituri leikemiiT (qll) daavadebuli pacientebisTvis. revmatoiduli arTriti - saSualo da mZime formis aqtiuri revmatoiduli arTritis samkurnalod, rodesacdaavadebis mamodificirebel antirevmatiul preparatebze, maT Soris metotreqsatze, pasuxi iyo araadekvaturi. - saSualo da mZime aqtiuri revmatoiduli arTritis mqone im pacientebis samkurnalod, romelTac hqondaT araadekvaturi pasuxi an autanloba simsivnis nekrozis faqtoris (snf) (TNF–tumor necrosis factor) inhibitoriT mkurnalobis erT an ramdenime reJimze.

anca-sTan asocirebuli vaskulitebi (aav): granulomatozuri poliangiiti (vegeneris poliangiiti) (gpa) da mikroskopuli poliangii-ti (mpa)mabtera/rituqsani glukokortikoidebTan kombinaciaSi naCvenebia im pacientebis samkurnalod, romlebsac aqvT Zalian aqtiurad mimdinare granulomatozuri poliangiiti (vegeneris poliangiiti) da mikroskopuli poliangiiti (mpa).

dozireba da miRebis wesi anca-sTan asocirebuli vaskulitebi(aav): granulomatozuri poliangii-ti (vegeneris poliangiiti) (gpa) da mikroskopuli poliangiiti (mpa)mabtera/rituqsanis yoveli infuziis win yovelTvis saWiroa premedikacia, romelic moicavs analgeziur/sicxis damwev saSualebas (mag., paracetamo-li) da antihistaminur preparats (mag., difenhidramini).

mabtera/rituqsanis rekomendebuli dozireba aav-is mkurnalobisTvis aris 375 mg/m2 sxeulis zedapiris farTobze i.v. infuziis gziT, kviraSi erTxel, 4 kviris ganmavlobaSi. vaskulitis mZime simptomebis samkurnalod mabtera/rituqsanTan kombinaciaSi rekomendebulia i.v. meTilprednizoloni dReSi 1000 mg 1-dan 3 dRemde, Semdgom perorulad misaRebi prednizoni 1 mg/kg/dReSi (ara umetes 80 mg/dReSi da dozis ramdenadac SeiZleba swrafi klebiT klinikuri saWiroebidan gamomdinare) mabtera/rituqsaniT

mkurnalobis periodSi da mis Semdeg.gafrTxilebebi da sifrTxilis zomebi infuziasTan dakavSirebuli reaqciebi zemgrZnobeloba / anafilaqsiakardiovaskuluri movlenebi (hipotenzia, stenokardia, riTmis darRvevebi)infeqciebi aRwerilia B heatitis reaqtivaciis SemTxvevebi, maT Soris fulmi-nanturi mimdinareobis hepatitebi, rig SemTxvevaSi fataluri gamosavliT. am SemTxvevebis umetesoba gamovlinda im pacientebSi, romlebic rituqsimabs Rebulobdnen citotoqsikur qimioTerapias-Tan. yvela pacients mabtera/rituqsanis mkurnalobis dawyebamde aucileblad unda Cautardes B hepatitis virusis (HBV)skriningi adgilobrivi gaidlainebis mixedviT. aqtiuri B hepatitis mqone pacientebs ar unda CautardeT mkurnaloba mabtera/rituqsaniT. mkurnalobis dawyebamde da B hepatitis reaqtivaciis prevenciis mizniT aucilebelia pacientebis mudmivi monitoringi da marTva adgilobrivi samedicino standartebis Sesabamisad. aRwerilia kanis mZime reaqciebi, rogoricaa toqsiuri epidermuli nekrolizi da stivens-jonsis sindromi zogierT SemTxvevaSi letaluri gamosavliT. aseT SemTxvevaSi unda Sewydeswamlis miReba damkur-nalobis ganaxlebamde yovel calkeul SemTxvevaSi zedmiwevniT unda Sefasdes riski/sargebelis Tanafardoba. progresirebadi multifokaluri leikoencefalopaTia Senaxva am medikamentis gamoyeneba ar SeiZleba SefuTvaze miTiTebuli vadis gasvlis (EXP) Semdeg. flakonebi SeinaxeT 2°C - 8°C temperaturaze (macivarSi). wamlis Semcveli WurWeli datoveT gareTa muyaos kolofSi sinaTlisgan dacvis mizniT. mikrobiologiuri Tvalsazrisidan gamomdinare, gamzadebuli sainfuzio xsnari dauyovnebliv unda iqnas gamoyenebuli. winaaRmdeg SemTxvevaSi, gamzadebuli xsnaris gamoyenebamde Senaxvis vadaze da pirobebze pasuxismgebelia momxmarebeli da rogorc wesi, 24 sT-s ar unda aRematebodes 2°C-dan 8°C-mde temperaturis pirobebSi, Tu xsnari gakontrolebul da validaciur aseptikur pirobebSi ar aris momzadebuli.

specialuri instruqciebi gamoyenebis, utilizaciis da gankargvis Sesaxeb amoiReT mabtera/rituqsanis saTanado raodenoba aseptikur pirobebSi da gaxseniT rituqsibamis 1 - 4 mg/ml winaswar gansazRvru-li koncentraciis misaRebad steriluri, apirogenuli 0.9%-iani natriumis qloridis wyalxsnaris an 5%-ian deqstrozis wyalxsnaris Semcvel sainfuzio paketebSi. xsnarebis urTierTSerevis mizniT da aqafebis Tavidan asacileblad, frTxilad gadmoabruneT paketi. parenteralurad Sesayvani medikamentebi gamoyenebamde vizualurad unda iqnas Sefasebuli Sewonili nawilakebis arsebobaze da feris Secvlaze. mabtera/rituqsanis gamzadebuli saineqcio xsnari fizikurad da qimiurad stabiluria 24 sT-is ganmavlobaSi 2°C-8°Ctemperaturazeda Semdgom 12 sT-is ganmavlobaSi oTaxis temperaturaze.

SefuTva 10 ml-iani flakoni (10 mg/ml) 250 ml-iani flakoni (10 mg/ml) 1medikamenti: SeinaxeT bavSvebisTvis xelmiuwvdomel adgilze

gamoyenebis win gaecaniT srul instruqcias

mokle informacia preparatis Sesaxeb

References:1. American College of Rheumatology. Vasculitis. http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/vasculitis.asp.Accessed March 15, 2011. 2. Gómez-Puerta JA, Bosch X. Anti-neutrophil cytoplasmic antibody pathogenesis in small-vessel vasculitis: an update. Am J Pathol. 2009;175(5):1790-1798. doi:10.2353/ajpath.2009.090533. 3. Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc and Genentech USA, Inc; April 2011.4. Stone JH, Merkel PA, Spiera R, et al; for RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232. 5. Data on file, Genentech USA/Biogen Idec. 6. Falk RJ, Gross WL, Guillevin L, et al; for American College of Rheumatology, American Society of Nephrology,and European League Against Rheumatism. Granulomatosis with polyangiitis (Wegener’s): an alternative name for Wegener’s granulomatosis. Arthritis Rheum.2011;63(4):863-864. doi:10.1002/art.30286. 7. National Heart Lung and Blood Institute. Vasculitis. http://www.nhlbi.nih.gov/health/dci/Diseases/vas/vas_whatis.html. Accessed December 12, 2010. 8. University of North Carolina Kidney Center. ANCA vasculitis. http://www.unckidneycenter.org/kidneyhealthlibrary/anca.html. Accessed January 18, 2011. 9. Vasculitis Foundation. Vasculitis facts. http://www.vasculitisfoundation.org/advocacy/facts. Accessed January 18, 2011.10. Stone JH, Hoffman GS, Merkel PA, et al; for International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Wegener’sgranulomatosis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum.2001;44(4):912-920.

დამატებითი ინფორმაციისთვის მოგვმართეთ:შპს როშ ჯორჯიახეთაგუროვის ქ .6, თბილისი 0102ტელ.: +995 322 433363ელ-ფოსტა: georgia.medinfo@roche.comwww.roche.ge

ძალაშია 2 წელიგაიცემა რეცეპტით

12.14-GE.MAB0

2