`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
