Pharmacy & Therapeutics- July 2008 - (Page 386) Infections laboratOfy Tests Inledo""e with <oloio cO<J!li/afon """IS Iros been delertol in IXJIienls treclol wof CIMlJA. Certo~lUlOOb pogO moy <IDle erroneoos/y.everted 01'lT I1M/ reso~ illXJlienl$ ",!hoot cO<J!li/afon obnOllOOI~es.Tho effertlros been rJJse Jgoostko ltogo, ond the ffenlOsilAPTl-5P ""id ond Hero"'l f(ophlzol ;~'" tests fum Instrurnentotion loborotories. Other aPTI assoys rmy be affected os well.lntooereme with thlOOIOO time (11) ond pmthlOOloo time (PI) """IS h~ "" been obse.oI. Th.e 0no eWlence !hot OMlIA therapy h~ 00 effect on in vMJcoogOOfion. USE IN SPKIFIC POPULATIONS The iKiIoKe of olediins 0coo, iTecrtoi IXJIienls.The inlec1illns cCJffiisloll'ioon~ of ulIl'r resfirolOl'( inlecloo (20% CIMlJA, 13% pIoceroJ.The in<idence of seIiws "'emoos dOOng the coo,oUoI cinko 51u<fIes was 3% IN OMlIA-,ecrtoi polenls ond 1% I. pIoc'" !rooted potien~. 5erioos infe<tions observed inckJded Ixxteriol ood viml infectioos, pne.Jmooi1, 000 pye\onfl\ilritis (see WARNINGS AND PliECAUnDNS, 5eJiJ<r; InfeilkJns oro TuiJemms). Tuberculosis and Opportunistic Infections In completed and ongoing {Iinicol studies thOI include over 4,650 patients, the overol1lOle of tuberculClSis is approximately 0.5 per 100 pOlienl-yeors. The role in (rohn's disease studies was 0.3 cases per 100 pofient-yeors. The reports include cases 01 pulmonary and dissemiooled tubercuklsis. (ases of opportunistic infection have also been lejlorted in dinicol trials. Some «(lSes of opportunistic infections and rubefrulosis have been '0101 (see WARNINGS AND PliECAUnDNS, TuiJemmsI. Malignancies In (~nkol stu&es of OMZIA, tOe overoll incideoce rote of mo~gnoocies was sim~or fIX C1MZlMreoted rod control 1XJIien15. For sane TNF blockers, mexe cases of morIQROOdes hove 0000 obseMld croong patients receivi~ those TNF 1M", cm'"ored to coo,," JXI1ien. (see WARNINGS AND PlECAunDNS, ilJJlgnoOOesl. Au1oanlibodies In (~nicol snxr.,0Croon's """'" 4% of I"tienls ,entol wof CIMlJA ond 2% of I"tienls ,ecrtol wnil pIocero thot ood negative baseline ANA ~Iers developed posmve titEl!S during the srudies. One of the 1,564 Cmhn's Osense polenIs ,ecrtol wof CIMlJA deveiotJed S\II1lIOO\l of° .JlI'i1ce"""'OO1e. The impoct of kx'f term treatment with (IMIIA on the developmeol of outornrnJllfl liseoses is unknown (see WARNINGS ANO PlfCAIITIONS, AllIrJimmuIitYJ. Immunogenicily Pregnan<y Pregooncy (ateglXY B- Becouse certolizumOO pegoI does oot crOSS1eoct with roouse or rot TNFa, reprOOJctioo studies were performed in lOts using 0rodeflt onli-murine TNFa peg~ated Fah' fro;jment (dN3 Pf) similcr to certoolUlOOb pogO. Repradrdioo stu<ies h",e been I"doonoI in mIs o! doses up lO 100 mgjkg ond hove reveoled no eWlen Ji,oIlemilv. honn 10 the fetus due to cIN3 Pf.Thera .e, """",, no IJieq.ote ond welk001TOled Sludies of (IMZIA in pregnant women. 8e«Juse onrool reproduction stulies are not OMrays predictive of Imoo response, tho drug shoold be used wnng ~ngonncy no~ I cOody needol. Nursing Mothers It is 110t known whether this drug is excreted in human milk. Because many dlUgs are excreted in human milk and because of the potential for serious adverse reactions in nu~ing infants from (IMZIA, 0 decision should he mode whether to discontlnue nulSing or discontlnue the drug, toking inta occount the importance of the drug to the mother. Pediatric Use Potienls were tested o! roo~iJe lime I"inls I. ontibOOes lO certoolUroob pogO dunOJ Studies COl ond CO2. lie overall pellentoge of on~hcxly positive potlenlS was 8% in potiems conlinulXJS~ exposed to CIMZIA, of which approximately 80% were neutrolizilg in vitro. No oppmenl correlation of ontlbody development 10 odverse events or efficacy was observed. Patients trooled with Wl1cornitont immun051Jwressanls hod a lower rute 01 ontibody development thon patients 1'101 tokillll immooosuppressanlS of boselille (3% and 11%, ,espediveIyl. The following odvefSe events were reported in ontil>o<ttPJsilive patients {N=lOOl 01 on inciderKe ot Oost 3% b~ho ,,,,,,,red lO on'ixxtIflegotNe JXI1ienls (N:I,242): cixfOOlmci I"in, orthm~iJ, oIemo peripberol, erytheroo ncxlostJm, i1jection site erythema, injectioo site poin, pcjn in exfremity, and upper respiratory tmct ilfectioo. The duto reflect tile peI"Cenloge of patients wMse test r~1ts were wlIsklered positWe for onfibOOes 10 {ertoizooxt pegol in on ELISA ossoy, ond ore h~h~ dependent 00 the sensitivity ond spedficily of the 11M/. The observed oc"""e of on1lro<tf (mdi.<lng netrIIlizing on~b<xM posfIM~ in on I1M/O h~h~ dependenl 00 """I loci"', indtxf.g I1M/ sefIliIM~ ond 5IJ'Ci/id~, IJMf ""thrxfOtw, somple .,ndlng, liming of so~ collection, coocooihmt meoKotions, 000 undeft.{ing liseose. For these reasons, comparison of the incidence of ootilxxfleS to certobumoh peg~ with the f100ence of antDOOleS to other lX'ooucts may be misleOOllg. Hypersen~jtivily Readjon~ SoIety 000 effertiveonss in pecfKllric polenls 00ve nol been estobr,M Gerictric Use (linicol studies of C1MZIA did not include sufficient numbe~ of potients aged 65 and ove! to determine whether they respond differently from yoonger suhjerts. Othef reported clinical experience has nol identified differences in respooses betweefl the elder~ and yoongel plJlients. Apopulation phamlOcokinetic analysis of all pofients enrolled in C1MlfA clinicol studies concluded that there wos no opporent difference in drug concentlOtion regardless of age. Because there is a higher incidence of infections in the elderly population in generol, use ,"u'oo when •.,Iing Ihe eWeriy (see WARNINGS AND PRECAUTIDNS, 5errous Inf"lions!. OVERDOSAGE The foiowing S)lI'jJ!OOlS tho! (OOld be cOf\Xlli~e wof hwe""'siIM1y roodilffi hove been rellOlloi m.~ 1.0000g C1Ml~ _ _ to polen.: ongKJederm, _ ciIe~k, r1zliless (pos1IJof), rl!sl"en, 00t iISl, hvf'l-, injection site reactions, maloise, pyrexic, rosh, serum sickness, ond {vosovollOll syncope (see WARNINGS AND PlfCAIITIDNS, Hypeoe_~ ReocIioIJsI. Other Adverse Reactjon~ The most common~ occurring odverse reacfions in contl'Olied triak of Crohn's disease wele descrihed above. Other serious or significant adverse re<Jcfions reported in controlled ond uncontrolled studies in (rohn's disease and ather diseases under investigafion, occurring in pofients receiving (IMZIA at doses of 400 mg or othef doses include: 8kJod and Iymp/roli: ~ rfISOIrieIl: AnemiJ, ",kepenKJ, Wodenf\XJlby, I"ncytopeniJ, .. thlOOlh<\Jhir•. emdisorders:Mgina pecI<m, orrhythmias, COrDlOC foore, IrvTJertensr.oe heortliseose, lITy'OCOI'l/ial infarction, fll\ll{orOOl isdl.,." perK",,,,1 eIIusioo, 000 perk• . Eye disorders: Optic neuritis, refinal hemorriulge, ond uveitis. Genoal_ andadminisJrolian site (l)ndilials: B.oIing 000 inie<loo ~e reodions. HepatabirKNy _ Efelcted Ii'" enzymes 000 hepotitis. I"""" l'/S"m disonJeo: ~~ totor,. !\ydriJrrk _ Anxiety, .1"1. rIsoder, Old soic_e ~1. Reool and rnirory disaIde.: Nephrotic syndroroo ond rend fuirnre. R~ l'/Stem orobreosl_:Me_I disonIo. Slin and SIixJJton<oos tisslIe rfISOIrieIl· Dermotilt, oy!het11O rrodooJm, ond urticok. 1tJsaJlu_:Vasrurms. Adverse Reoction Information from Otfler Sources (ases of sevele skin rmons, irKluding Stevens-Johnson syndrome, toxic epidermol necf~, ond efYIhefOO rooltilorme, mbeen K1entilied dJring JXISIilP\XOvol use of ather TNF Ihkers. BecllJse these reo:!ionscre reported voIuntori~ from 0~afun of uncertol1 ~ze, it is rIOt olwoys possible to estincrte reidlty their freqJeocy or estdJrlSh aC(I..ISQ reloti~ to drug explNXe. DRUG INTERACTIONS Anokill"o The maximum toleroted dose of certolizumoh pegol has not heen established. Oases af up to 800 109 subcutaneous ond 20 mgfkg intmvenoos have heen administered withoot serious adve~e reactions. In coses of overdosage, it is lecommended that patients be monitored closely for any adverse reactions or effects, ond owrOjlriote symptomatic tre<Jtment irlStituted immediote~. PATIENT COUN5EUNG INFORMATION Sen PAnEIIT CDUNSfUNG INiDlIMnON, MedioJlian Guide iJ ill tresaiTNrg Infarmolian. Patient Counseling AcMse IXJIienls of the I"lenIiolltb ond beenIits of CIMl~ thempy. ,we polenls the Moicolion Go_e 000 0""" them ~"" to rool ft pn. to s10rlilg CIMlJA therqry ood 10 ,.,;,. ft perioOcol~. f<r( """",s resolting from the IXJIienrs ''''ng of the Mecficolioo Go_e shoo_ be d5rusled. B~ouse confon ~oo_ be exer,,;ed 0 odmoisteriOJ CIMlJA to I"tienIs wof cr.ko~ UnpoIont CKtNe "'ediins, iJMse polenls of the impOOonce of infooning the< heOOl1 (Ore provKle~ aboot ~ ospects of their hedth 1II e<Jrn treotment \4siI. -Immunosuppression Infoon JXI1ienls thot CIMl~ 0lrI km. the obl~ of the immune sysIero to fii/ll inlediins.lestruct polenls of the """,,~e of (OO1nrnng tbefr rixto Ithev deveq, ooy S\II1lIOO\l of infecloo, iJdmg tubemJkrsis ond _ of hepotitis Bmrs .Iemens. Coonsel polenls ohoot the ~b' "'" of ~"'" ond othe, rooUgnooc", wili. ",eivilg OMlL\. - Allergic Reactions Advise IXJlients to seek immediote medicol ollentlon allergic reactions. athey experience ony symptoms of seVefe - Other Medicm Conditions AlMse potiefrts to repocl ony 9i]ns of new or wmefling medkc) (()l1lfJtions SlJ(h os heart OlSeOse, netKoI~icol disease, N""""""" rIsod",. AdvIse polenls10 """" ~lJIIltly Illy S)lI\JIOO\I soggestive of qJenio"'" os bruisilg, lkeding, or persr;tent fever. °cyl (lJOUIrent oorrilistmtioo of onokinm (on interlookirtl antagonistl ond onother TNF lhker has shown I1fl inueased risk of serilllS infections, all increased risk of net.Jlropooio, and no mxfed benefit wrrpored to these med"tdoollX'oducts ciNe. TherelNe, the nro wof ather IN! bkKk"', irdJcfmg CIMlJA, mpy ofso WI in ;ni!or to_ (see WARNINGS AND PliECAUnDNS, Use ",di Arokinrol. live Voccines 00 not give live (irKlldillg alterlluled) vlKdnes conrurrently with OMZIA {see WARNINGS AND fWfCAUnONS, Imroonizolionsl. (001._ofonoki . . .t~ n~ clmzlo° (certolizumob pegoD sustainable results with stable dosing (IMllAf) is aregislered rrooemork of UCB, hIt or i
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