Pharmacy & Therapeutics- July 2008 - (Page 385) PROFESSIONAL BRIEF SUMMARY-<ONSULT PACKAGE INSERT FOR FUll PRESCRIBING INFORMATION CIMIIA" (,erlolizumab pego!l WAiKING: R5K 01 SERIOUS IHflcnOHS T.erwlosis lfrequenl~ disseninated or exlra_ncry II tiniced presentationl, invasive "/llgal infections, and atber opportunistic infemollS, have been olIserved in patients receiving (IMZIA. Some of these medions have been fatal AntHubercuiosis treatment of patieIlts with latent tuberculosis infection redures the risk of reactivation in patients re<eiving treatment with TNf bIocien such as (!MIlA. However, mive iWercuiosis has doveloped iI potionts '••viI! OMZ~ whol< I.~ wo, "!"iv'. 1v'''I. pot;"I, I.tubor""sis ri~ 1,0.,II1II I.~ I. latent """<Ulosis itlartiaa prior I' iitialilg CIMZIA II1II dumg ther~y. 01"'. ''''''''1 .1 latent """alasi, moian prior I. ther.py will OMIIA. Moil. patients receivilg 0Ml1A lor signs lIIlI s'fIIlPIOIIIS of active tuber~s, iIduitg patients who tested negative I. latent """ , itIartiaa (.. WARNINGS AND fglCAUTlONS, I1IIADVERSE REAcnOHS, Iiic~ Uiis Ujerior<e). Soiots'" _sisI INDICATIONS AND USAGE itlcotol 10 rerlxilg ~ffi ond syrr1J!orrrs of Udvl's rf_ 000 momroinilg dilk. respoose iI oOOllIJfien' with moderolely 10 ""rely _ rf_ who 00ve hod on illlli""" r _ to ,ooventionol ~eropy. CONTRAINDICATIONS N WARNINGS AND PRECAUTIONS ClMl~ , Serious Infec:tiOfls s.oous mlectioos, """', Old 'ffiffi of IJIlIl"I1Jnis1k ml"""'. iocornng futormffi, hove b<en reporterl in poI<ms re<eiving lNF blockers, indudillQ C1MlIA. Many of the serious infe perieoce,,~ TNF block",. infedkJffi 00ve bren obIerved w~ V<Iious poihogens o,orlng wol. lxrtefiol, fungol, and protolool orgonisms, and inle<tions!Jove been noted 'rl ollll'gon systems.lnfectioos!me beefl rep:H1ed in lXJIienls receiving GMZIA oklne or in (oo~()(oon with mnuoosu~essive ogeflls. 00 not iliOOte treatment with aMllA il patients with octive ilfemJns, ndOOina chconic (X' Iocoflzed medioos. Mon~or ~n1S for 9Jns and symptoms of infe<tion wh~e on ood after treatmeIlt witlJ OMlIA. Patients who deVlllop anew oledion while unrlery.ng ,entment with [IMl~ ~ooIrI be moon doseIy. Oil<orrIinue orIminislrotioo ~ [L\Il~ ~ apofienl deveI~ 0serous infection. Exercise (ou!ion when {()nsideri~ the use of C1Ml1A in patients with 0histtxy of re<urrenl mection, {o1l(omitOfl! irvru10suwressive thernpy, (I urderlying (OOd'rliOffi that mav pre&:spose them 10 inl"""'•• polen. who hove resilerl mre rel. Tuberculosis As obIerved,,~ other TNF ~ocke •• tuborulosis ossorimerl w~ ~e oorrililtmlioo of [IMnA il ,nni,. stu&es hffi b<en r",,'erI. o,krdilg fotorm~. Before VlitiOtion of /hempy with C1MllA, evouole potielrts f(l Itberrulosis Iii foOlXS and test lor Ioleflt tubercultrn infe<fun.lnifute treolmef1t d Iolenl tubrro.*Jsis inlecOOns prior to /hemP'( with CIMZlA. When lI.tlerw~n still testing is ~ormed Ill' krtenl Iuoo-ctmsmw, on indlrotion size d 5rrm or greolef siJotjj be ronsijered positive, even ff voce'lUted previoos!y with Bocille Colmetle-&Jerin (BCG).I! Iotenl infection is diagnosed, instiMe opproprillle proph~oxis in occoroooce with the cooenl guidelines from the CenlefS for lAseose Coo!rrA and Prevention. ["",riel the possibldy of unrletederl.lent tubo<Ulosis. espe<ol~ o",ti.,. who hove illni!,'Oled froo1 ~ 'ovelerl to countries with 0 h~h prevalence of Iubefcti:Ns or hod dose mnlOd with 0 pe!SOI1 with octive ~rru\osr;. All possin. 'enlerl with [IMl~ ~MI hove 0thoroogh h<tory ~ken prior to inmolng ~eropy. Soo1e lIJfien. who hove ~rMrxJSiy r~eiverT ,,,_I.lotent. _ tu""'ulosls hove developed ornve IllJerruiosis whi. being 'enlerl with TNF bIrxk",. C_onlftulrernJosis theropy prior to __ of ClMl~ ill"fo1' with 0post Iistory of krtent. ocIive lllrerrulosis il whorn on rxlrqxr!e ,rme of ITentment be 'oofumerl.lirlflllrerrulosis ~ pra to iliIiofurg ~ shooIrI riso be ,orrsidererl il",ti.,. who hove severo!,. h~h~ ~nif<oot. risk fort", I. tubo<Ulosis infectioo Old hove on~e testfor Iotenlluherrulosis, WI the decisKln to ililiote onli-Iuherculosis therapy in the IXllioots shouk! oo~ be mode ofter tolilg ilto o",urI 00th ~e risk 10krtent tuberrufosls ilIectioo IIld ~e risks 01 onlHuberruklsis thempy. ar"Iel:B'lOry, cOO9.J~ 0 ~ysicion with ID::peOence in the treatment of Iuherrulosis. Mooitlt ",,,,,,, ",eIW1g [[Ml~ I~ signs ond SjlI\Jtoms of _ tuberruklsis. ",rtiaJIorfv be<wse tesIs I. 01",' tuborulosls inlectioo moy be lolse~ negotive. tnSl1uo ",ren. to ",k m",,1 rtTvke i ;!/lS/symptoms le.g.• posistenl ,.,g,. wosIin~ wei9hl loss. krte grorle level) "llgeslive of 0tu~osIs infectioo ocrur. Hepatitis BVirus Reactivation Use 01 TNF block",. indurling [IMIIA. moy increase ~e risk 01 ren'livonon 01 hopolitis 0 virus IHOV) in ~nts who ore duook mrriefS of this virus. In some instooces, HBV reoctivotioo ocrurring in cOfljnctioo with TNF Ikcker thempy has beef! fotol. The mojority 01 reports hove occurred in patients concomitontly receiving other medicorons Ihat~pp"ess the imrn.me system, whkh may lisa {onfnbJte to HBV reodivution. Evolume lIJfienM risk I~ HOV infernoo I. pri. evirleoce of HOV mfectioo bef.e inmng ClMl~ ~aopy. "arise couOOn fllJescribing CIMZ!A lor potierJ!S identified os Cl100rs of HBV. Adequate dato l1e not aV{)ila~ on Ihe safety or efficocy 01 trooting patients who are colliecs 01 HBV with onlh1rnl thernpy in coo~ncOOn with TNF blocker Iheropy to prevenl HOV r_n. Polen. who ore ,,,ners of HOV Old "",ire 'entmefrt with [IMlIA ~oold be ,kiseIy mooilorerl '" rlnkol 000 klrorolory ~ffi of _ HOV inledioo 1hr00!/100t ~empy 000 I. sev..1moolhs1.I"""g tmation olthempy. In potients who develop HBV renetivotion, dismntinue CIMZIA and initiate effective anti-vilOllhelOpy with appfOpriate supportive trelltment. The safety of restlm~g TNF blocker therapy oftef HBV reoetivotion is controlled is nol known. TherefOfe, exerdse {aution when coosidering re~mption of C1MZIA thempy in this situation and monitar patients dosely. Ma6gnandes In the mntrolled portioos of dini{al studies 01 some TNF blockers, more coses of malignancies hove bl*ln observed among potients re<eiving TNF blockers compared ta control patients. During controlled and openlabeled portions 01 CIMZtA studies of Crohn's disease and other investigational uses, malignancies (excluding nOlHllelonoma skin mncer) were observed ot 0 rote (95% confidence intervall of 0.6 (0.4, 0.8) per 100 potienl'ye<lrs among 4,650 C1MZIA-treoted patients versus a rote of 0.6 to.2, 1.7) pet' 100 patienf-years among 1,319 placebo-treated potients. The size of the mnfwl groop and flmited duration of the <ootrolled portions of the studies Pfe{llIde the ability to draw firm conclusioos. 10"'" In ~e ron'oUer! poctioos of wnkol trio. of 01 the TNF ~.k",. "'''ffiffi of ¥npllomo hove b<en observed omong patients re<eiving TNF b10ckefS {()rrpored to {()f1trol patients. In controlled studies rJ CIMZIA lor Crohn's dIseose aoo other invesf);jotiooal uses, there was roe case Ii ~hlml among 2,657 Cinzilttreated potioots aoo one case 01 HorIgkil ¥npOOmo omoog 1.3T 9jJocelro-'enterllIJfien.. Rotes in (finical shxfIes for C1MlIA ((I1oot be <OOlX!red to the rotes of ctlrv((i trioIs of other TNf blocker.; 000 may not ~erno the rotffi obIerved when [IMlIA , ffierlo 0bmorIalIJfienl popu\1Iioo. Polen. with CIohn's rIsense. other orseoses thot reqJire chronic exposure 10 immunosuppressant thernpies I1llY be 01 highef risk lOOn the generol ",,,,00 I. the devolJP""11 01 ~"1Jh""" even 0~e obseoce of TNF blrxker theropy. lie ",tenool role of TNF blocker lhernpy in the developmenl of mo6QnaoOOs is not koown. Hypersensitivity Reactions The 10lkMing syrr1J!orrrs thot 'oo~ be ,,"rlIltb. with hypersen;tivi1y rendions 00ve b :,). Neurologic Reodions Use of TNF bkid<e•• irlJong ClMl~ Iros b<en ossockrterl with mre roses of new orsel • exoc,rtJotioo of rllt. SjlI\Jtoms ond/. rorl<\i-jO, evirlenre of ~nolng rIsense. "enise 'ootion il 'OOIirIering the use of [IMl~ il IXJIioots with pre-exf;ting or receot-onset centrol rIeIVClJS system demyelinating mers. RlIe roses of r1€Uroklgiml rlsooT",. iiliilIl ""'"risocrIe<. optk ""'mis, IIlIi periphenI "",rOflOlhy "'" b<en repaterl in poI<ms treoterI with ClMn~ the ,owl reIolorrsh~ 10 CI~ rero :,1. Hematological Reactions Rore reporIs of pa>rytqlIirlio. ",Wng o~osIk onemo. hove b<en repa1er1 with TNF bkid<1lIS. Adve<se renOoos of the herrIJioIogk ""em. mng morlco~~nli,ontryIopenKJ le.g.• kiukf\lOlo.",ocytopeno. ~romlrocytfll'no) hove b<en mfr_1iy reporterl w~ CIMl~ lsee ADVfKSE RfACTlONS. CiniroI Tri<t fxpeJienre) .lie ,oM _ p of these events to OMZIA renrins oodeor. Althoogh no high risk gr"IJ hOI b<en Klenlifierl. exa," roufoo il polen. beillg 'enterl with CIMl~ who hove oogOng••0Iistory of, ~ni<ont 1JrJrnot'0!i< obeormorrties. ArMse <I",,,,,,, to "'" inmomote morn,. onenfioo I they d~ si,jffi ood I)ITIpioons "IIg lIlIi dysaoskrs. infectioo I,.g.• pe<sistenl r Irnisilg. ~ ",1Jr) while 00 CI~. ["",riel rf"ootirurnoo of [IMl~ ~pyillIJfien."~ 'oolinlerl ;gnif<on' hemotokJgi' OOnoomrmffi. Use with Anakinra Serious infecfuns were seen in <i1icol studies with C(OOJrroot use of anokiuo (an interleukin-l ontogonist) and rzrother TNF blrxka. with no rxkIerI breen!. O~oose of ~e noture of~, orIverse reocIiorrs seen with ~ ,";'ilotioo thempy, simiklf toxkilies may olso resuilirom <ombination 01 oookinra ond other TNF blockers. 'lMrelore, the 'ornbinolioo of ClMIIA Old oookilm , not "'oormenrlerl lsee DRUG INTfI/ACTlONS. Amlinm). Heart Fadure [ffiffi of wrzseni :e). Immunizations No dolo lie (llI(l~oole on the response to vocdnotions (X' the sec(ll(/ary tronsmission 01 ilfeetioo by live voccines il lXItients receiving ClMZIA. Do nol oominister rM! VQ«iles or oIIenuoted voccioes <oorurrenlty with CIMZIA. Immunosuppression Since TNF mediates inflammotion ond modulates cellular immune responses, the possibility exists lor TNF blockers, including CIMZIA, to offe ther.py py.lI unrlery.ng
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