`
`WARNINGS
`
`pre:,ellted:,eparztell'
`
`III pzllellt:'l',rtil exce:':'lveleukeITlIClTll'eIQld blz:,l:, III tire bUlle mzrrClJ', or perlpileral blood (",10°'0)
`
`1)
`LEUKINEr:,CQlllrzllldlcaled
`CONTRAINDICATIONS
`
`INDICATIONS AND USAGE
`
`2) pzllellt:,dr:,plzl'lIlgadelzl' III ellgrattlTlellt(ANC",100 cell:,/r TlITl'bl'dzI'21pu:'i-trzll:,plzlltztIQlI)Zlld\',IIQllzdevldellceQIZllnilvellltecllUlI arid
`1) pzllellt:,dr:,plzl'lIlgadelzl' III ellgrattlTlellt(ANC",100 cell:,/r TlITl'bl' dzl' 2Spu:,t-trzll:,plzlltztIQlI)
`
`:,ialr:,illZl:,rQllltlczllce
`
`LEUKINE(sargramostrm)
`
`CLINICAL EXPERIENCE
`
`CLINICAL PHARMACOLOGY
`
`DESCRIPTION
`
`III
`
`BERLEX"
`
`Rx only
`
`SARGRAMOSTIM
`LEUKINE®
`
`1:,:,ued05/02(5052400)
`REV 0230-3
`
`[~
`... '"=
`=-.....
`~ .
`t'I'j~
`=~ ~ .....
`rQ.
`-~ ... =
`
`.... OC
`....
`0
`O~
`00
`'C' ,0
`OC 0'\
`....
`0
`.... 0
`
`t'l'jrFl
`~
`N
`0
`
`~ = Q.
`
`rFl
`
`
`
`HBlI:,edJulle2002
`
`5052400
`Hl:V0230-03
`
`SerlexLabmatmle:, Illc HlclllllUild CA94804
`BERLEX
`lVIallutacturedbl'
`
`NlNartl:,CcrpcratlcrIUSPatelltNo:,5942221590875358955455891429alld5720952
`Serlex Labmatmle:, Illc US Patellt No:, 5391485 5393870 alld 5 229495 Llcell:,ed Ullder He:,tzrcll Cmpmatlml lecliliologle:, U S Patellt No 5502007 alld Ullder
`
`52002 Serlex 12bmatmle:' Illc All rlgllt:,re:,er,ed
`
`lJata mltlleSerlexLabmatmle:, Illc Hlclllllmid CA
`
`5 Ho,\,eJIVI Allder:,ellJWlVlazzaJJ
`5
`
`NalllallCf-PlllllJL
`
`232505-508
`
`IllductlUlI ot IIIZCfopllagetulllmlcldal actIVity by graIIUIOl)te-1il ZCfopllagecoIUlll'-:'illliulatlllgtactcr:'
`
`3 Grab:'ielllKH UrdallJL lu:,lllIl:,kIHJ
`
`2 ParkLS rrlelld lJ GIIII:'S UrdallJL Clwactematlml ot tile cell :,urtacereceptmtcr Ilulliall grallulocl'te/lllacropllagecolUlll' :,tllilulatlligtactm J explVIed 1985
`1
`REFERENCES
`Ll:UKINl: :,llQuld be retrlgerated at 2-8"C (35-45'l) lJo IIOt tree:ze m :,llake lJo IIOt u:,e beymld IIle explratlml date prilited ml tile VIal
`STORAGE
`
`lVIetlZltlJ Illelliolecular blologl'alldtullctlml:'ottilegrallulol)te-lilacropllagecoIUlIl'-:'ililiulatlligtactm:' Siood 198557(2)257-257
`
`154251-252
`
`cmltalll:,1I11Lotpre:,er,ed500Illcg/IIILLl:UKINl:lIquld (NlJC50419-050-30)
`
`Cartml ot5I11ultlple-do:,e\ilal:'
`Cartml ot5\i1al:,otll'oplllllzed Ll:UKINl: 250 IIIcg (NlJC50419-002-33)
`
`Ll'opllllized Ll:UKINl:I:,a,allableIII Vlal:'cmltalllllig 250lllcg
`
`HOW SUPPLIED
`
`lJl:,card ally relllalllllig :'olutlml alter 20 day:,
`
`2 Ll:UKINl: Liquid iliaI' be :,tmed tm up to 20 day:, at 2-8"C mice tile \ilallla:, beell elltered
`
`1
`PreparatIOn of LEU KINE
`
`25
`25
`
`49
`
`(11=47)
`
`17
`35
`49
`
`13
`
`34
`
`14
`14
`15
`13
`
`14
`
`15
`
`14
`
`15
`25
`42
`
`50
`
`13
`23
`25
`29
`
`19
`
`48
`
`25
`58
`
`(11=52)
`Ll:UKJNl:
`
`(11=52)
`LlUKINl:
`Percent of AML Patients Reportmg Events
`
`(11=47)
`Placebo
`
`17
`
`23
`27
`41
`
`11
`11
`11
`
`17
`19
`
`11
`15
`17
`23
`
`13
`13
`15
`15
`15
`
`Hlgllcllole:,terol
`UN, lZlclUIil
`HlgllSUN
`uN,albulIIlIl
`Hlgllgluco:,e
`Laboratory Abnormalities'
`
`32
`
`I Pdre:,tlle:'la
`
`45
`
`Leukopeilia
`Illrolllbol)topellia
`Hemic and Lymphatic System
`Hlililltl:'
`lJl':,pllea
`l:pl:,tm:,
`Pllarl'llgltl:'
`Respiratory System
`Illcrea:,edalkpllQ:,pllata:,e
`edellia
`
`Illcrea:,edcreatlllllle
`PBrlplleraledellia
`Hyperglycelilia
`Slllrublllelilla
`Metabollc/Nutnt
`bellt:,bl' Sodl' Sl':'ielll
`
`20
`57
`53
`57
`55
`55
`
`18
`
`20
`35
`20
`
`11
`34
`
`11
`
`11
`21
`
`45
`70
`
`11
`11
`13
`17
`51
`52
`70
`70
`81
`
`15
`17
`17
`25
`
`Placebo
`
`Ll:UKINl:
`
`ercent of Altogenelc BMT Patients Reportm!
`
`LEUKINE(sargramostlm)
`
`Hellurllage
`CardIOvascular System
`Cwgulatlml
`Hemic and Lymphatic System
`Pulilimlary
`Respiratory System
`edellia
`lVIetabollc
`MetaboliC/NutntlOnalDlsorder
`bellt:,bl'Sodl'Sl':'ielll
`
`Neuru-:,ell:,ml'
`Neuru-p:,)cll
`Neuru-lIIotm
`Neuru-cllllllZl
`Nervous System
`GU
`Urogenital System
`Hwaell:'lml
`
`45
`
`13
`
`43
`34
`53
`83
`55
`
`13
`
`25
`
`28
`58
`
`13
`42
`45
`52
`77
`58
`
`12
`19
`
`37
`55
`
`15
`
`10
`13
`
`30
`
`27
`
`14
`
`25
`
`20
`
`CNSdl:,mder
`Nervous System
`Kldlleytullctlcrlabllcrilial
`Urillarytractdl:'crder
`Urogenital System
`
`54
`85
`
`Ha:,11
`Alopecia
`Skm and Appendages
`1I,erdalliage
`Stmllatltl:'
`Giliellurilage
`GI dl:,mder
`
`placebo-trtztedpatlellt:,
`
`DOSAGE AND ADMINISTRATION
`
`It I:' IIOt kIIO,\,1I ,\,lletiler Ll:UKINl: I:' excreted III IlulliallIIIllk Secau:,e lIIalll' drug:, are excreted III Ilulliall IIIllk Ll:UKINl::,llQuld beadlllllll:,ieredtoa
`
`Nursmg Mothers
`
`ellect mitertillty
`Carcmogenesls, MutagenesIs, Impairment of Fertility Alllliial :,tudle:, Ila,e IIOt beell CQllducted ,\,1111 U,UKINl: to e,aluate tile lZrclllogellic potelltlal mille
`
`tile data are IIlcmlclu:'l,e
`:,ugge:,i tliattuilim cell:, iliaI' be relea:,ed arid reilltu:'ed IIltollle patlellt III tile leuk;[pllere:'l:' product
`
`PRECAUTIONS
`
`LEUKINE(sargramosllm)
`
`WARNINGS (continued)
`
`[~
`... '"=
`=-.....
`~ .
`t'I'j~
`=~ ~ .....
`rQ.
`-~ ... =
`
`NOC
`....
`0
`O~
`00
`'C' ,0
`OC 0'\
`....
`0
`.... 0
`
`t'l'jrFl
`~
`N
`0
`
`~ = Q.
`
`rFl