::{rfcgh!:ndg°esed°ofs:r:s5,:fs: … · liraglutlde did r\ot change the overall exposure of...
TRANSCRIPT
ulvin following administration ofr\ot change the overall exposure of griseofLiraglutlde did
Name of the medicinal product
Victoza®6 mg/mlSolution for injection in pre-filled pen
Qualitative and quantitative composition
lffi|;fasno|#::gcoonn.|i#epmtid:.fT"{%#|d)ea*nai:;u%rep-:!'3:c%anbcyorneE:nib't:amniBr#:::he|:,:gT'in Saccharomyces cerevi5iae.
For the i ull list of excipients, see f'harmaceufi.ca/ part/cu/are.
Pha rmaceutica I formSolution for injection,
Clear, colourless or almost colourless, isotonic solution; pH=8.15,
Clin ical particularsTherapeuti( indicationsVictoza® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes
re";tsHLaosn::hae#pnyc#h°e:'ejeat::r:::r::S:ons[dered|nappropnLateduetointoleranceorcontraindications
• in addition to other medicinal products for the treatment of diabetes.
;n:t:e;a:uad#:ij:e:Po#t:i:;i:P£:t#i#d!u:;as:;°;;6:e;:i;:fis:i;#;y}C7a;:ti;:ac%n;:::c::pi%C#::r:;;%';r,cproperties.
Posology and method of administrationPosology
;:e:::;pr:¥:::n:ltd:§a:en:;:§jjn::;i;:::r:t;T;d;i;;2€rtu#:i::ten;;#:6¥g{;r§::,::#ug:,;:#e;::I;;;::a;ns;drf;::t:e;%thigher than 1.8 mg are not recommended.
¥igr:gy:Fhnebceu#e#ddto°s:X¢#'mnoeffmoerffm:r:in::£rti?a%ffinb:nd::::::nm£::;#nauneddt:%#;ne#.lone
:lr[!§i;|®:o%ia|:i:hr:d%¢oe;:1o:fs:u{:it;n#:e:!fa%#n:s:ui,;Srsath3od::i°tbge:c:!f%|:y|#:£da:toehtr:e9:r:in::otra|n::r*6fhypoglycaemia(see5pec/'a/wan/ng5anc/precaut/on5rorL/5e).
#:-:m±3:tl:t;i:rfg:;r°£f:}[°;f#i:v:;ctjsoe#:::eese%d;%n:#;twtii:aid:s:u!{:tf:{|u:I:s;i#}Vi#:a:§iot#°:::::
{g;;;#m3::uog;/(;?f:csf,ao:e°#i!s)N0doseadJustmentlsrequiredbasedonageflena/ /.mpa/rrnenf.. No dose adjustment is required for patients with m}ld, moderate or Severe
:enndaJ'j:%!:r®m,:nttheTr:f%:e'Sn::rtehceQr#':eedxi:[`::::|nt#east:e::St,;i:?(es::-;thaagr;:ecnoa#:ema/Sce`properties and Pharmacokinetie properfues).
##:t;'C:I/e#i#:#ar%°:c:o:;/i:St:!uo:t::ep:e:rfi|#nc:emdl:::::|fn°rpgt::I:tnstsw#seT::e°hreTa°t¢cerate
?%ei;avte".#g#if/€s?;:;sehsff:styeeap#::##°;::;:rfc,,:I)irFo::iaa:r%'easvca:,natj,:.e'°Wage
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to the actjve substance or to any Of the excipients "sted in i/5f of exc/Pt'ents,
precautions i or use
diabetic kctoacidosis.
12S{sedinpatientswithtypeldiabetesmeHitusorforthetreatmentof
LiraglutLdeisnotasubstitutai6rinsuh-- - ~- `
kefj:st,#R,rfi#::se,#;:r:3n,:r:;nfu3:::sn;;e#f:r:onngte:tIVoemh:::df:¢%¥seeTnytohr:seH;aa#entsThere is limited experience in patients with inflammatory bowel disease and diabetic
graasnt::epn:r:;I;{r:,Snete°!,'ira9:#j:::Sf::i::Cn°sr,Tci:gjendg':atuhseesae,%t+e,:,tnsgs'annc3:t,:Srrahso¥:'.atedw'th
A:#a::::::i:;§hasbeenobservedwiththeu5eofGLP-1receptorago"stspatientsshould
i:e:#:rime(:s:he:#dfe:C,%;;:ct::;£:5d#d:;#£:f::;e;:n:;t;;:C;r;o#r£:i),P|:rnacgfuati:I:S;i::igenc:;8`eThyrold dlsease
::i;re°hga#rsperee.:ex|stt:'n;utchhyraos.d#sr:;sheavL:r:::unt.|eep:hrtoeuid'nthc:'rn::::etriae'Sua£§#,tphar:Cu:I:rn'|nthese patients.
REt:hag:,::a:#:dse##:;:,:a;,#ncs#T;es:,,sf::#;epao:,y,cnaseu+:amc:#:V,eo:nerr::r:;Sed
REit#;i,a;t:fiaii,:tii;;rij;oo#;:,:#,:nt::::anti;tl:t:tas;r!:ete::;nat,:d(:icai:::gr:ula#!uo;#iaa:keection withj)ther medicinal products and other forms of interaction
be involved in pharmacokinetic interactions
with other active substances relat-ed_to cytochrome P450 and plasma protein binding.
ir§a!oir:!ti;;i:;S;a;:::ri!;f!i!*§:i:::;i;:;#:;EEg;5o;i:ia!;:i;;i;i;§ri:in;e:id;:e;;:rief:iuuir:ea::e:iF!e#:t#!i:t:t§{:::°`:|!.:n:t(y
REa;£:itc#csi;#ee#it:?::;ias:rhi:,c:o:;:in::h#et:d%;u::e:,t:slcesParacetamol
;I:::*:lad:€,!dc::::haasnd¥ctT::s:Vderba)':xp%:Sau:%°j5j,raa:et#af:!|°e%'y¥daus;ntg:e.gffinof|3°d°osmeg.adjustment for concomitant use of paracetamol is required.
Atorvastatin
i;:!o;;{!t§§j:;dn;;d':e;iti:::x:ai;a#!'!d}:ei;v:i:r:fiji#Xai;;:#j:;§fina§;ih#;:;I::in:::a::;,nwlc;s'!:oers:e;:a:ij:u:tdb;y8;eteof
/n vtfro, liraglutide has shown very low potential to
::{rfcgh!:ndg°eseD°ofs:r:S5,:fs:-#[:n5ts°:fmg:,;eGor;i#fnu:VIE:rharerccor:a;::nbdys3w7,:%h%*':oTqebii',:JatH8;permeabinty are not required.
#edoseadministrationofdigoxinlmgwithliraglutlderesultedinareductlonofdlgoxl
A::d;:s'ti°:°jtcoTa5,::;1:a§::eb,I:eTq°(°r.reDjgb°ax:fomoend:i:stem%swuifdelayedfromlhtol.5h
#doseadministratlonofllsinopnl20mgwlthliraglutideresultedlnareductlonof
!S'hn%r:'A*fthb|rTa;%°t',dcemafr8edc:::Saeddjubsyt;:;X{oi'i;s|:8;i,H:::aqnu:r:adxIraasse§e!:ytehde::°rTsuits
RE!na;;ij:;,:i:!dti;;#:i:;o:::nei,;e,::ii::,::;i::;:i;;o:;::!n;itii::::ir;a#:a;:t3io!oiie:;i;h;ecr!;i!ali::rmsife
}n:uP#a:ta::g°::}e!t::nt:ar#p::r:i::n::n#:s:jg:;n!eo:s::ctft:n:s#:nred:i::Treod5beu%:e£,{|ii[:ugt,I::daen'Fer[inty, preg nancy and lactation
#wnn°r:#e,vdeafoxf,rc?t?({she:#:c:/fn):r:/gj:i:d;Mar)egTnhaen;ovy:n|:a|„§tkufd::Sh'unmaan:T:unknown.
!n:rso#:dt:d:e#;o:gin:w:,3bhee:St:db:::#epprreeggnnaann?'oarn#:::au::y°j::::;;ntr`:arte;:#tmwe,|#ctoztBreast-feeding
lt is not known whether liraglutide is excrcted in human milk Animal studies have shown thetff.ii;n;:,:;i:;i:u:!j#;::;e::a:o;w,::t:t,:eo;iti;eu:s`e-#s,I:ecikt,f:ux:pi;ri::af::i:;i:ap:f8orso#!sn::o#:,nu:
#[°e#eacts!'gwh,:hd:ecsr#::{:i::,|#mberofllvelmplants,anlmalstudiesdidrotindicate
ifidg%,,;t,#,k#n,!|:;#!j;i#:s:e;::o;n;n:aiigo,is:;:#;#f,!ena#r:ia;eoar#:u:i,::egsmp:ctlhe,::s:,no,undesirable effects
±t,g:a#t:ai:a:r°#r,2ai::opnayt[':met:(h;:t:ro:#o:rteamtFti:rtmvy:1metformin plus rosiglitazone.
E[s%rE:rsst.f;::;::t:%:e£,:Fr:i:advwe:::#:o###:::caas,;:a+;t#cg::t::;:;:::,:i,dom
i!ii;:;;:i:;i!jsc!o;i:;S::gui{::;r;#:#r;e;!vi!j;iy;;i:ii;d:n;:S#C#::#n:i;iaa!j;ijii;io§i;i;tin;;t;i:a;dcombined with a sulfonylurea.
RE;rt%:::%#:o:n¢hstg:##:e::n:cse3t:%o::I:g::,:;#§jj:I,:rft#re#E;£re=R;;Frequencies are defined as: Very common (21/10); common (21/100 to <1/10); uncommon
(=a'(`n'o°t°£et:s{L/:t°e°d);f::I:(ti:/i;;#|:°d:t'a/)T'frj3{|nv:¥Ja;:e(q<u`e/:&°g°rg)jpni:;,k:8vwenrsereactions are presented in order of decreasing seriousness.
:#fo:asAc:raerr::t:oafi°t::if:fEmAi°EnR%;t::TsC;nnt:['#uEi#:::#a::jrntgh)e##erm
lnfections and
infestations
Vomiting
Dyspepsia
Abdominal pain
upper
Constipation
Gastritis
Flatulence
Abdominal
distension
Gastroesophageal
reflux disease .
Abdominal
discomfort
Toothache
Cholelithiasis
Cholecystltls
General
disorders and
administration
site conditions
Investigations
* From controlled phase 3b and 4 clinical trials only where they were measured.
RErh:e:a:::,::intt;s:t:##(ei:p,#e:i:(;nTs#p#;!:i#ot:gst
%:::t,eRatst,::ta::3rsj,3:t;#:i,rnastue,,mat::bo;;e:,[oe`:,njoa:,::j\{soeret#:ffoa;fndgy2:mj:ep#::,r:5t,:Of severe hypoglycaemia for both liraglutide and placeb_o was 2.2 events per 1.00 patient years.
Gastrointestinal adverse reactions
ia;uiiii;ii:!n;ii;{c:!rri{°;f!uia;iinijt;::iEj:n:;;;;p::i!eiiet;:t:ri;ii:°#:ii:i;n!:;a#sioi':#h;8if:ei:I:ji;::¥n°:severity decreased in most patients who initially experienced nausea.
#{,henmf,a7aon£;r;dine::teexp:nnae,n,c;p::£egn¥{;::natt:#,i::,c:#aergncT;ELt;3aLejmvy[tha,:rag:ud:g:.#;,#respectively) may expenence more gastroi ntestinal effects when treated with liragliitide.
i;:#:i:C;i:j;i:;:;:'i!;;::i;§i;i#:a§s`;i:nt;iia°#;i;;;!#t/i;;;:Lr):::D::,Rdbeet:}jeiph°i#aq:u:er;:;o;;f::rterm`Withdrawal
io:ni#:::rci9¢:h:e;:#;:s#t:h::2::8!:jog::::i:i:i:e|i§nj:rie:ail:;i;t-i;aSt};:ir{Ot;o:[e;!rr:ir:i:i:eti:ie.:;:k:t::t'ents
i,:::c::o;:s{;t;e;ef:T§`:o:hs;QV;gbe:,e:or:tpr:ifeeddt,rTa:sppTr:::::::%,:#Vpeatj:::;,;eE::v:n#:ctoza®mPancreatitis
!r::)|n;i;i,i;ia!.:.:;i;h,ij;;oi:a:!:;ja(.n;:::i;i;;:s,;;:js::in:s:;::;f;o#£d:ui:|i:io::;f:!5r;ain:din;;i:I,'i#ii:Pharmacodynamic properties).
AIIergic reactions
€!:;gzL:®reactlonslncludlngurtlcaria,rashandpruntushavebeenreportedfrommarketeduseof
!i:Pn:g;S:e:Sda:taa:;i;;#;;#;ea£:;nenjei#ne:dda#[§::.:t;elr¥g:d::in:c:a;outf:#S#hgi:e:n:S;:a:;e!a(5`!a5t:;|S`
ffi±#n:;,#\tshko:,::at::::i:::#::],:,,n##,sH:mag::aar:Iprofessionalsareaskedtoreportanysuspectedadversereactionsviathenationalreportingsystem
Overdose
:#dT:;irn#\C;:e:nr:aN:#:%?m{ir:ka:Pta:t:ed:i;ire:G:e:dead:!Ii,h:a::eehp;ai:engn,:y:cP:gm#e°&f,iue:va:t:::nt°::;:Tc:::::e2T#:iwithout com plications.
In the event of overdose, appropriate supportive treatment should be inltiated accordin-g to the -
patient's clinical signs and symptoms,
Pharmacologi€al proper(iesPharmacodynamic propertiesPharmacotherapeutic group Drugs used in diabetes, glucagon-llke peptide-1 (GLP-1 ) analogiie5
ATC code. A10BJ02
Mechanism Of action
in:;i;!r:ai;;Si;ih:::;n;§i;:e:h;i:i:i:i;ii;§j:#i;i¥iji{ie!n;;§!k;;::§ii:::c;;;:i:€iia;r:;:i::£ijy:i;a;a;i;::.;c!::ji:;;;t:::;andiDb;8.rz;I::ibn'::I:ai::::bpueT{|aaas:d(Nh#:rn;n#e?,a}:::#:!'i:ta°#;,tahsem%'Phea##y:Pept'dase4
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iy;is::::jcoi#:ata:°nii::iy;,:!i°d:e[iii:in::i##{{;#:i:::t:ir:°ip#qi!di!s!u;::d:i}a;aij:;tiia;te:d:aei°:a#ei;a::c:;:¢ues
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#+;fg;:%eanntdoiajiytcyaem|ccontro|andreductionofcardiovascularmorbldityandmortalltyare an integral part Of the treatment Of type 2 diabetes.
Five double-blind, randomised, controlled clinical phase 3a trials were conducted to evaluate the
:#C£:;f#::!#'%i§::#;:niij\;;C#;;Bell:n:a#%:ao;:y|:|j:d:Tpa::nc|e#j',rna#Tuct'(dHebE|°):uf::tinc;'n'Ca"y
;h:terh:::t:'§l';#:s):odie3:;:°%::in:e:n::3:#ep:t:s%j:#6Sot¥e:a:;i¥7,t:ha:i'ir%a#iido:;e#::e:i;;:;1:aEi:§e!::t;d::jatedAdditional trials were conducted wlth IIraglutlde that included 1,901 patients ln four unblinded
randomlsed, controlled clinical trlals (Includlng 464, 658, 323 and 177 patlents per trlal) and
one double-blind, randomised, controlled clinical trlal ln patients with type 2 dlabetes melhtus
and moderate renal lmpairment (279 patients).
A large cardiovascular outcomes trial (the LEADER® trial) was also conducted wth liraglutide in
9,340 patients with type 2 cliabetes mellitus at high cardiovascular risk
§!;5iTijji;:r;}§H;i:p;jea!a:;#:::rp::;t:#t[:!e!i:ei*:#;!a#b(;;#:':S:fgeo:r':i,Ce:n;n:dn:1xse}r§:i:n::dr8ABDmgvI
Combination with oral aatidiabetieLiraglutide in combination therapy, for 26 weeks, wth metformin, glimepiride or metformin and
::S#'ai:8nwe,tr:SpU:tt:ednE::::;i,':;";,:'cgen:i:C(aT:tb(ep€iooo1)andsustalnedreductlonsmHbA,c
::#:fl:a:i:angLujtt!#eo::
(n=836) and patients with mild (n=3,907}, moderate (n=1,934) or severe (n=224) renalimpairment The mean age was 64 years and the mean BMl was 32.5 kg/m2. The mean durationof diabetes was 12.8 years.
The prmary endpomt was the time from randomisatien to first occurrence of any maj.or adverse
;:rara::i:V{n¥§:;a:rts:y;:gi#,#f:p:r):f3¥t;ne#a!#:°infiie:nc£#(aF;:|aje'nif)arTcth':ne£:inn:tn#:i:rL°}aet,o
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_` -P€,\-at'G
---I-` J-Vl/ctf IHRl`,~~-~.'--,,-,,`.,-,,.`,~'~p~4HR;O.87
95g/o a [o.78; o.97|- p<o. co 1 for nori-irrferiorify
-~' p=0,005 for superiority
0 ` 6 12 18 24 30 36 42 48 54
Time from randomlsation (months)
Patients at riskP!acebo4672 4587 4473 4352 4237 4123 401Q 3914 1543 407Victoza®4668 4593 4496 4400 42cO 4172 4072 3982 1562 424
FAS. full analys'is set
Figure 1 : Kaplan Meier plot of time to first MACE -FAS population
5'#urefa:,:ofn°restpIotofanalysesoflndividualcardiovasculareventtypes.FAsAsignlficantandsustalnedrec!u{ttonlnHbAit~frombasellnetomonth36wasobservedwith
I;a:!ruet:::#TP#8:4°6iji.%:#Toto3`£i;nTdhaerdn8:5afi:er(t-r]e.a`t6m%n\S,;:e?:,:i°c'a:,Sothm;itehd,i:ua,inm:hatsreducedby48%wrthliraglnddeusplaceboininsulin-naivepatientsatbaselme(HRo.52[048,057n.
i;v:e#ge!i2%j?one;3#:m#a#.;mi:REe:p#:¥o.iEueefi;-e:-:: -was 1.9 to 4.5 mmHg.
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Paediatric Dooulation
}{t:hE££;§i;:%#t:;in;o::,:?#h::i:s5:or:aft:h;:nei:t:h#oirr;gp:i'§:nl;tiosguaien:ifet:hce2ur;#:I:sf#IleiOther clinical data
iir:it;#;id;i:'ft;4:o{°2aa:nd#4;ij%Tgve!;oe8Ei,a:'s;P;fe:::o#ai;gtt#io¥o#i€)#ly:T£S##i:::e:doff::[control group was not avalleble.
:e¥pee¥teove#tse#::;a#:':±tso{2e:;#LuslnoexenatldeTherewasnoconsistentpatternwith
i:€j:i;i;;ii{ji:;;:i;i;i;y;aii:i:i::%;:igi;i;i::;ii€iiii§i:i!io;°§si!rrv;i;€i;:i;i::i:¥j;;%:)i#!:;:d;;e:iPharmacokinetic properties
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Absolute bioavailabilfty Of hrag[uttde foll6wing subcutaneous administration is approximately 55°/a
Distribution
%,euipep:;edn,tstvr#:#oenQ:i;gt,r|iruat£:oadftse:S#::|s{:ant:&usoii,ra'g)i:i;3:I?sn6So'7'#L,:ahge,umi,i:n,sextensively bound to plasma proteins (>98%).
BietramsformationDuring 24 hours followlng administration of a single radiolabelled [3H]-IIraglutide dose to
;e:a#!ii:u:!:ey:es!e:;£:|i:d:(;<:9:?t;#fe;n;yo:;i::o:tat,i!a:snuiaaactrs:;5e::#,,i:e?a?n:;g,:i#ra:sgTuat,de,sidentified as maior route of elimination.
Elimination
i;{jg:;aa:rt::0:f](:6[;;8a!j#!:fx:;r:e:*:t£:;):V:T#|:Wd:e;,;;:ar:iet#::;tare:d:j§a¥,I;e:#:;!aas:je:;#[:sinexcreted during the flrst 6-8 days, and corresponded to three minor metabolltes, respectlvely.
The mean clearance following subcutaneous administration of a single dose liraglutide isapproximately 1-2 Vh with an elimination half-life Of approximately 13 hours
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!!iii;i:?iisg:::n;,;cii:i,p:,oijin,a;f;:jejri:nie#!;:#i;:Ri:,#:!r:tv;:i;i:pi::;elnjairtiiai::,::i£:,sng
ii,#:2:#ot;:a#i,!ii#;'#;::e::Si;c;t!ri::i!i(##!i:i;r!::i#ig,£n;tir;ijn#1;8m:;gg¥jein::#£:roaAt6
i:iee;;!r:#:h::e;i!:di!i§ii::i#iv:i#x§!#;;:'}§:reii;3;i;!mrc:ii}iiji,rg3Ej;:g{::ity:::|r+;ngPre{lini{al safety dataWon-clinical data reveal no special hazards for humans based on conventional studies Of safety
pharmacology, repeat-dose toxicity or genotoxicity.
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Animal studies did not indicate dlrect harmful effects with respect to fertilrty but slightlynereased`eadyembryorwcdeatheatihehighest-dosereosmgw±P-Viapma+ang`ENd----=
i§Liii::i:!i:#:i'ii:I:rvii:P;:;:;§;intfi!a!ii#;i:i!|§e;::::i;i;3tri°;:iijea¥:Suiit{irikci{jti:i;!a;i:u#g:sod:rec
:°#°h:#8::t:as-::i}*tl:i:#}::g:,::'dweetr:roabbsbel#;&IIghttomoderatehaemorrhage,Pharmaceutical particularsList of excipientsDisodium phosphate dihydrate, propylene glycol, pheno), water for Injections.
Incompatibilities
::;S;::i:,;;ds:#:;Y|:°#,T:g,C;ruos:udcteg+#t:::::'#:xg::t#:tthheeramb::|c::a?fproducts.Shelf lifeAfter #rsf use,. t month,
§t¥r::in'g#gii:tnosr{2!c¥r€?eDonotfreeze.storeawayfromthefreezercompertment.
A#er //'rst use.. Store below 30°C or store in a refrigerator (2°Cno°C), Do not freeze.
Keep the cap on the pen in order to protect i rom light.
Nature and contents of containerCpea,?,r;g8:}#)P:oTn£'i:Ses!Yn'tahpar£}||e%eL(u#s°eb#)o:E9iea#'#:tdeer:#lyso|:f:i(abnr8#%{ai
Each pen contains 3 ml solutron, delivermg 30 doses Of 0 6 mg, 15 doses Of 1 2 mg or 10 doses
Of 1.8 mg.
Pack sires of 1, 2 or 3 pFe-filled pens. Not all pack sizes may be marketed. _
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Victoza® should not be used if it has b'een frozen,
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Needles are not included.
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RToav'ok#d:sfu#°|!:::j&fl6r3'Kd.:r88oBageveerdLDenmark
Victoza®, NovoFine® and NovoTwist® are trademarksowned by Novo Nordisk AIS, Denmark.
© 2017Novo Nordisk AVS
8-9695-00-022-1