natgillin/translations-raw huggingface dataset:
Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive.
Zdravilo Oncaspar vsebuje pegaspargazo, encim (asparaginazo), ki razgrajuje asparagin, pomemben gradnik beljakovin, brez katerih celice ne morejo preživeti.
Based on its pharmacological properties, any risk to the breast-fed newborns/infants cannot be excluded.
Zaradi farmakoloških lastnosti zdravila tveganja za dojenega novorojenca/otroka ne moremo izključiti.
- medicines which require cell division for their effect, for example, methotrexate (a medicine used for cancer as well as arthritis treatment) may have a decrease in its effect.
- zdravila, ki za svoje delovanje zahtevajo celično delitev, npr. metotreksat (zdravilo, ki se uporablja za zdravljenje raka in artritisa), imajo lahko manjši učinek;
Grade 3 or higher febrile neutropenia was 15.4%.
Febrilne nevtropenije 3. stopnje ali višje je bilo 15,4 %.
When there is a marked decrease in fibrinogen or antithrombin III (ATIII) deficiency, consider appropriate replacement therapy.
V primeru izrazitega znižanja ravni fibrinogena ali pomanjkanja antitrombina III (ATIII) moramo razmisliti o ustreznem nadomestnem zdravljenju.
AUC0-t (mUday/mL)* AUC0-∞ (mUday/mL)
AUC0-t (me.dan/ml)* AUC0-∞ (me.dan/ml)
Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase.
Zdravljenje se lahko spremlja na podlagi aktivnosti serumske asparaginaze, izmerjene pred naslednjim dajanjem pegaspargaze.
Neutralising antibodies reducing clinical efficacy were also recorded.
Zaznali so tudi nevtralizirajoča protitelesa, ki so zmanjšala klinično učinkovitost.
The protocol-specified goal was achievement of asparagine depletion to a serum concentration of ≤1 µM.
Cilj, opredeljen v protokolu, je bil doseči upad ravni asparagina na serumsko koncentracijo ≤ 1 µM.
Arithmetic Mean (SD)
Aritmetična sredina (SD)
Days After First Dose of L-Asparaginase
Dni po prvem odmerku L-asparaginaze
The decrease in serum proteins caused by pegaspargase can increase the toxicity of other medicinal products that are protein bound.
Znižanje ravni serumskih beljakovin, ki jih povzroči pegaspargaza, lahko poveča toksičnost drugih zdravil, ki se vežejo na beljakovine.
A pilot study was conducted for newly diagnosed patients from 1 to <31 years of age with high risk B-precursor ALL (Study AALL07P4).
Opravljena je bila pilotna študija pri bolnikih, starih od 1 do < 31 let, z novo diagnozo ALL B-prekurzorjev z visokim tveganjem (študija AALL07P4).
It is not known whether pegaspargase is excreted into the breast milk.
Ni znano, ali se pegaspargaza izloča v materino mleko.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega in razredčenega zdravila glejte poglavje 6.3.
Treatment was administered during Induction (Day 7), and then every 2 weeks for a total of 30 weeks post-Induction therapy.
Zdravljenje so dali med indukcijo (7. dan) in nato vsake 2 tedna skupno 30 tednov po indukcijskem zdravljenju.
This medicine can lead to fluctuations in clotting factors and may increase the risk of bleeding and/or clotting.
To zdravilo lahko povzroči nihanja ravni faktorjev strjevanja krvi in poveča tveganje za krvavitve in/ali strjevanje krvi.
The decrease in the number of circulating lymphoblasts is often quite marked, and normal or too low leukocyte counts are often seen in the first days after the start of therapy.
Zmanjšanje števila limfoblastov v obtoku je zelo izrazito in v prvih dneh po začetku zdravljenja je pogosto opaziti normalno ali prenizko število levkocitov.
Therefore, use of Oncaspar could increase the risk of infections.
Zato lahko uporaba zdravila Oncaspar poveča tveganje za okužbe.
A rise in serum urea occurs regularly, is dose-independent and nearly always a sign of pre-renal metabolic imbalance.
Zvišanje ravni sečnine v serumu se pojavlja redno, je neodvisno od odmerka in skoraj vedno znak predledvičnega presnovnega neravnovesja.
The vial should be gently swirled until the powder is reconstituted.
Vialo je treba narahlo vrteti, dokler se prašek ne raztopi.
Not known: Confusional state
Neznana: stanje zmedenosti
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik.
In such cases, a switch to a different asparaginase preparation should be considered.
V takšnih primerih je treba razmisliti o prehodu na drugo zdravilo z asparaginazo.
Asparagine concentration fell to <3 µM when asparaginase activity was >0.1 U/mL.
Raven asparagina je upadla za < 3 µM, če je bila aktivnost asparaginaze > 0,1 e./ml.
For instructions on reconstitution and dilution of this medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja tega zdravila pred dajanjem glejte poglavje 6.6.
There is no specific pharmacological treatment for the overdose.
Specifičnega farmakološkega zdravljenja za preveliko odmerjanje ni.
Simultaneous vaccination with live vaccines may increase the risk of severe infections attributable to the immunosuppressive activity of pegaspargase, the presence of the underlying disease and combination chemotherapy (see section 4.4).
Sočasno cepljenje z živimi cepivi lahko poveča tveganje za hude okužbe, kar je posledica imunosupresivne aktivnosti pegaspargaze, prisotnosti osnovne bolezni in kombinirane kemoterapije (glejte poglavje 4.4).
Common: Hypoxia
Pogosti: hipoksija
It should be explained to patients that Oncaspar should not be used at the same time as other medicines associated with an increased risk of bleeding (see section 2 “Other medicines and Oncaspar”).
Bolnikom moramo pojasniti, da se zdravilo Oncaspar ne sme uporabljati sočasno z drugimi zdravili, povezanimi s povečanim tveganjem za krvavitev (glejte poglavje 2 Druga zdravila in zdravilo Oncaspar).
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ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1070/001
Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962)
Preglednica 2: Preživetje brez dogodkov po 3, 5 in 7 letih (študija CCG-1962)
Asparaginase facilitates the rapid conversion of asparagine and glutamine to aspartic acid and glutamic acid, with ammonia as the shared by-product of both reactions (see section 5.1).
Asparaginaza pospešuje hitro pretvorbo asparagina in glutamina v asparaginsko kislino in glutaminsko kislino, stranski produkt obeh reakcij pa je amoniak (glejte poglavje 5.1).
In Study CCG-1962, the most common adverse reactions were infections, including two life-threatening infections (1 patient in each arm).
V študiji CCG-1962 so bili najpogostejši neželeni učinki okužbe, vključno z dvema življenjsko nevarnima okužbama (po 1 bolnik v vsaki skupini).
The powder must be reconstituted with 5.2 ml water for injections prior to administration (see section 4.2).
Prašek je treba pred dajanjem rekonstituirati s 5,2 ml vode za injekcije (glejte poglavje 4.2).
Both diabetic ketoacidosis and hyperosmolar hyperglycaemia have been described, which generally respond to administration of insulin.
Opisani sta bili diabetična ketoacidoza in hiperosmolarna hiperglikemija, ki se običajno odzoveta na uporabo insulina.
For intramuscular injection, the volume should not exceed 2 ml in children and adolescents and 3 ml in adults.
Pri intramuskularni injekciji volumen ne sme presegati 2 ml pri otrocih in mladostnikih ter 3 ml pri odraslih.
Since an indirect interaction between the oral contraceptives and pegaspargase cannot be ruled out, the use of oral contraception is not considered an acceptable method of contraception (see sections 4.5 and 4.6).
Ker posredne interakcije med peroralnimi kontraceptivi in pegaspargazo ni mogoče izključiti, uporabe peroralnih kontraceptivov ne štejemo za sprejemljivo metodo kontracepcije (glejte poglavji 4.5 in 4.6).
When glucocorticoids (e.g., prednisone) and pegaspargase are given at the same time, alterations in coagulation parameters (e.g., fall in fibrinogen and antithrombin III deficiency, ATIII) can be more pronounced.
Pri sočasni uporabi glukokortikoidov (npr. prednizona) in pegaspargaze lahko spremembe v koagulacijskih parametrih (npr. padec ravni fibrinogena in pomanjkanje antitrombina III, ATIII) postanejo bolj izrazite.
The medicine is given as a solution by injection into a muscle or, if more suitable, into a vein.
Zdravilo se daje kot raztopina z injiciranjem v mišico ali v veno, če je slednje primernejše.
Adverse reactions and their frequencies are reported in Table 1.
Neželeni učinki in njihove pogostnosti so navedeni v Preglednici 1.
In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) may occur.
V redkih primerih se lahko pojavi sindrom reverzibilne posteriorne levkoencefalopatije (RPLS).
Overall, from five studies analysed based on 65 ALL patients exposed to Oncaspar using the highest therapeutic response during the entire study, complete remission was observed in 30 patients (46%), partial remission in 7 patients (11%) and haematological improvement in 1 patient (2%).
Skupno so v 5 analiziranih študijah s 65 bolniki z ALL, ki so bili izpostavljeni zdravilu Oncaspar, na podlagi največjega terapevtskega odziva v celotni študiji ugotovili popolno remisijo pri 30 bolnikih (46 %), delno remisijo pri 7 bolnikih (11 %) in hematološko izboljšanje pri 1 bolniku (2 %).
Although they have not been specifically associated with the use of pegaspargase, they may occur with the use of Oncaspar:
Čeprav niso bili konkretno povezani z uporabo pegaspargaze, se lahko pojavijo med uporabo zdravila Oncaspar:
The patterns of serum asparagine depletion in the 2 delayed intensification phases are similar to the pattern of serum asparagine depletion in the induction phase.
Vzorci upada serumske ravni asparagina v obeh fazah pozne intenzifikacije so podobni vzorcem upada serumske ravni asparagina v indukcijski fazi.
The immediate cell death of leukaemic cells in vivo, measured by rhodamine fluorescence, was the same for all three L-asparaginase preparations.
Takojšnja celična smrt levkemičnih celic in vivo, izmerjena s fluorescenco rodamina, je bila enaka pri vseh treh zdravilih z L-asparaginazo.
The mean half-life after absorption from the injection site was 1.7 days and the elimination half-life was 5.5 days.
Povprečna razpolovna doba po absorpciji z mesta injiciranja je bila 1,7 dni, razpolovna doba izločanja pa 5,5 dni.
Pegaspargase may cause myelosuppression, either directly or indirectly (by altering myelosuppressive effects of other agents such as methotrexate or 6-mercaptopurine).
Pegaspargaza lahko povzroči mielosupresijo neposredno ali posredno (s spreminjanjem mielosupresivnih učinkov drugih zdravil, kot sta metotreksat in 6-merkaptopurin).
CSF asparagine concentrations were determined in 50 patients during the induction phase.
Ravni asparagina v likvorju so bile določene pri 50 bolnikih v fazi indukcije.
Figure 1: Mean (± standard error) serum asparagine during Study CCG-1962 induction phase
Slika 1: Povprečna vrednost (± standardna napaka) serumske ravni asparagina v indukcijski fazi študije CCG-1962
ǂ N= 46 evaluable subjects.
n = 46 ocenljivih oseb
No statistically significant differences in PK characteristics between male and female subjects were identified in this analysis.
V tej analizi razlike v farmakokinetičnih značilnostih med moškimi in ženskami niso bile statistično pomembne.
Serum amylase and/or lipase levels should be monitored frequently to identify early signs of pancreatic inflammation.
Pogosto moramo določati raven amilaze v serumu in/ali lipaze, da prepoznamo zgodnje znake vnetja trebušne slinavke.
Do not drive or use machines when using this medicine because it may make you feel drowsy, tired or confused.
Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte vozil in strojev, ko uporabljate to zdravilo, saj lahko postanete zaspani, utrujeni ali zmedeni.
Not known: Renal failure acute*
Neznana: akutna odpoved ledvic*
There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women.
Podatki o uporabi L-asparaginaze pri nosečnicah so omejeni, podatkov o uporabi zdravila Oncaspar pri nosečnicah ni.
There is a dose-independent decrease in serum albumin in the majority of patients during the treatment.
Pri večini bolnikov se med zdravljenjem pojavi od odmerka neodvisno znižanje ravni albumina v serumu.
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ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1070/002
No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity (see section 5.3).
Študije vpliva pegaspargaze na sposobnost razmnoževanja pri živalih niso bile opravljene, vendar so v študijah na živalih z L-asparaginazo ugotovili teratogenost (glejte poglavje 5.3).
Pegaspargase was not mutagenic in the Ames test using Salmonella typhimurium strains.
Pegaspergaza ni bila mutagena v Amesovem testu s sevi bakterije Salmonella typhimurium.
What Oncaspar is and what it is used for
Kaj je zdravilo Oncaspar in za kaj ga uporabljamo
Patients were not allowed prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine.
Bolniki niso smeli imeti predhodne citotoksične kemoterapije z izjemo steroidov in intratekalnega citarabina.
Normal cells, in contrast, are capable of synthesising L-asparagine and are less affected by its rapid depletion during treatment with the enzyme L-asparaginase.
V nasprotju z njimi so normalne celice sposobne sintetizirati L-asparagin in jih hiter upad ravni L-asparagina med zdravljenjem z encimom L-asparaginazo manj prizadene.
MedDRA standard system organ class
Organski sistem po standardu MedDRA
An alteration in serum lipid levels was observed and changes in serum lipid values, in most cases without clinical symptoms, are very common.
Opazili so spremembe ravni serumskih lipidov, ki so v večini primerov brez kliničnih simptomov in zelo pogoste.
Since an indirect interaction between oral contraceptives and pegaspargase cannot be ruled out , oral contraceptives are not considered sufficiently safe in such clinical situation.
Ker posredne interakcije med peroralnimi kontraceptivi in pegaspargazo ni mogoče izključiti, peroralnih kontraceptivov ne štejemo za dovolj varne v takšni klinični situaciji.
It is strongly recommended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product.
Zelo priporočljivo je, da vsakič ko bolniku damo zdravilo Oncaspar, zabeležimo ime in številko serije zdravila zaradi sledljivosti bolnika in serije zdravila.
Oncaspar can also cause changes in liver function which can affect the way other medicines work.
Zdravilo Oncaspar lahko povzroči tudi spremembe v delovanju jeter, ki vplivajo na delovanje drugih zdravil.
Serum asparagine concentrations of approximately 1 µM persisted for approximately 3 weeks.
Raven asparagina v serumu približno 1 μM je vztrajala približno 3 tedne.
Instructions on how to prepare, store and dispose of Oncaspar Instructions for handling
Navodila za pripravo, shranjevanje in odstranjevanje zdravila Oncaspar Navodila za ravnanje
In addition, it is especially important to tell your doctor if you are also using any of the following medicines: - immunisation with live vaccines within three months of completing your leukaemia treatment.
Še zlasti je pomembno, da zdravniku poveste, če uporabljate katero izmed naslednjih zdravil: - živa cepiva v 3 mesecih po zaključku zdravljenja levkemije, saj lahko povečajo tveganje za hudo okužbo;
Patients who receive Oncaspar are at increased risk of bleeding and thrombotic disorders.
Bolniki, ki prejemajo zdravilo Oncaspar, imajo povečano tveganje za krvavitve in trombotične motnje.
White blood cell (WBC) criteria were: a) Age 1-10 years: WBC ≥50,000/μL; b) Age 10-30 years: Any WBC; c) Prior steroid therapy: Any WBC.
Kriteriji za levkocite so bili: a) starost 1-10 let: levkociti ≥ 50.000/μl; b) starost 10-30 let: vse ravni levkocitov; c) predhodno zdravljenje s steroidi:
Oncaspar lowers asparagine level in blood cancer cells and stops the cancer cells growing.
Zdravilo Oncaspar znižuje raven asparagina v rakavih krvnih celicah in ustavi rast raka.
Oral contraception is not an effective method of contraception while on treatment with Oncaspar.
Peroralna kontracepcija ni učinkovita metoda kontracepcije v času zdravljenja z zdravilom Oncaspar.
During the maintenance phase, 19 patients were evaluated, with 17 patients (89%) achieving complete remission, and 1 patient (5%) with therapeutic efficacy.
V vzdrževalni fazi so ovrednotili 19 bolnikov, pri čemer je 17 bolnikov (89 %) doseglo popolno remisijo, 1 bolnik (5 %) pa je dosegel terapevtsko učinkovitost.
Oncaspar should be discontinued in patients with serious thrombotic events.
Zdravljenje z zdravilom Oncaspar moramo prekiniti pri bolnikih z resnimi trombotičnimi dogodki.
Therefore and due to its pharmacological properties, Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.
Zdravila Oncaspar zaradi navedenega in farmakoloških lastnosti ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje s pegaspargazo.
Oncaspar should be discontinued in patients with serious hypersensitivity reactions (see sections 4.3 and 4.8).
Zdravljenje z zdravilom Oncaspar moramo prekiniti pri bolnikih z resnimi preobčutljivostnimi reakcijami (glejte poglavji 4.3 in 4.8).
A total of 239 patients were randomised, 237 of whom were treated with study drug (146 male and 91 female), of these, 119 patients (115 with a diagnosis of ALL) were treated with Oncaspar 2500 U/m2.
Randomiziranih je bilo skupno 239 bolnikov, od katerih je bilo 237 bolnikov zdravljenih s preiskovanim zdravilom (146 moških in 91 žensk), od teh je bilo 119 bolnikov (115 z diagnozo ALL) zdravljenih z zdravilom Oncaspar 2.500 e./m2.
In addition, by inhibiting protein synthesis and cell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate.
Poleg tega lahko pegaspargaza, z inhibicijo sinteze beljakovin in celične delitve, moti mehanizem delovanja drugih učinkovin, ki za svoj učinek potrebujejo celično delitev, kot je npr. metotreksat.
Patients should be advised not to drive or operate machines while receiving Oncaspar if they experience these or other adverse reactions which can impair their ability to drive or operate machines (see section 4.4).
Bolnikom moramo svetovati, naj med prejemanjem zdravila Oncaspar ne vozijo ali upravljajo strojev, če se pri njih pojavijo zgoraj navedeni ali drugi neželeni učinki, ki lahko ovirajo sposobnost vožnje ali upravljanja strojev (glejte poglavje 4.4).
Patients should be informed of the signs and symptoms of pancreatitis which, if left untreated, could become fatal.
Bolnike moramo poučiti o znakih in simptomih pankreatitisa, ki je lahko smrten, če ga ne zdravimo.
Embryotoxicity studies with L-asparaginase have given evidence of teratogenic potential in rats treated from day 6 to 15 of gestation with a No Observed Effect Level (NOEL) for teratogenic effects at 300 U/kg intravenous.
V študijah embriotoksičnosti L-asparaginaze so dokazali teratogeni potencial pri podganah, ki so prejemale učinkovino od 6. do 15. dne gestacije, pri čemer je bila raven brez opaznega teratogenega učinka (NOEL - no observed effect level) 300 e./kg intravensko.
If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours (see section 6.3).
Če razredčene raztopine ni mogoče uporabiti takoj, jo lahko do 48 ur hranite pri temperaturi 2 °C-8 °C (glejte poglavje 6.3).
Oncaspar is for single use only.
Zdravilo Oncaspar je samo za enkratno uporabo.
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Fatty liver can be observed very frequently.
Zelo pogosto lahko opazimo zamaščena jetra.
Haemorrhagic or necrotising pancreatitis occurs rarely.
Hemoragični ali nekrotizirajoči pankreatitis se pojavi redko.
Oncaspar is used to treat acute lymphoblastic leukaemia (ALL) in children from birth to 18 years and adults.
Zdravilo Oncaspar se uporablja za zdravljenje akutne limfoblastne levkemije (ALL) pri otrocih od rojstva do 18 let in odraslih.
Oncaspar efficacy in ALL in patients with relapse/refractory disease and a history of prior clinical allergic reaction to native E. coli L-asparaginase was based on a pool of 94 patients from six open-label studies [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 and ASP-001C/003C].
Učinkovitost zdravila Oncaspar pri ALL pri bolnikih z recidivno/neodzivno boleznijo in anamnezo predhodne klinične alergijske reakcije na nativno L-asparaginazo iz E. coli je temeljila na združeni skupini 94 bolnikov iz šestih odprtih študij [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 in ASP-001C/003C].
In the other study, with 29 hypersensitive ALL patients exposed to Oncaspar, 11 patients were evaluated for response during induction.
V preostali študiji z 29 bolniki z ALL s preobčutljivostjo, ki so bili izpostavljeni zdravilu Oncaspar, so 11 bolnikov ovrednotili glede na odziv med indukcijo.
An indirect interaction cannot be ruled out between pegaspargase and oral contraceptives due to pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives.
Ni mogoče izključiti možnosti posredne interakcije med pegaspargazo in peroralnimi kontraceptivi zaradi hepatotoksičnosti pegaspargaze, ki lahko privede do zmanjšanja jetrnega očistka peroralnih kontraceptivov.
If used at the same time as Oncaspar there is an increased risk of side effects or allergic reactions.
Če se uporabi sočasno z zdravilom Oncaspar, se poveča tveganje za pojav neželenih učinkov ali alergijskih reakcij;
- cytarabine, a medicine which can be used in cancer treatment, and could interfere with the effects of Oncaspar.
- citarabin, zdravilo, ki se lahko uporablja pri zdravljenju raka in lahko moti učinek zdravila
The below mentioned studies were performed on the solution for injection/infusion formulation.
Spodaj navedene študije so izvedli z raztopino za injiciranje/infundiranje.
Serum asparagine concentrations during the induction phase are shown in Figure 1.
Serumske ravni asparagina v fazi indukcije so prikazane na Sliki 1.
Cases of encephalopathy (including reversible posterior leukoencephalopathy syndrome) have been reported (see section 4.8).
Poročali so o primerih encefalopatije (vključno s sindromom posteriorne reverzibilne levkoencefalopatije) (glejte poglavje 4.8).
For intravenous or intramuscular use.
za intravensko ali intramuskularno uporabo
Methotrexate and cytarabine can interact differently with Oncaspar: their prior administration can increase the action of pegaspargase synergistically.
Metotreksat in citarabin lahko povzročita različno medsebojno delovanje z zdravilom Oncaspar: predhodno dajanje lahko sinergistično poveča delovanje pegaspargaze.
Caution is required when Oncaspar is given in combination with hepatotoxic products, especially if there is pre-existing hepatic impairment.
Previdnost je potrebna, če zdravilo Oncaspar dajemo v kombinaciji s hepatotoksičnimi zdravili, zlasti v primeru obstoječe okvare jeter.
Your doctor will decide what dose of the medicine is needed and how often, based on your age and body surface area which is calculated from your height and weight.
Na osnovi vaše starosti in telesne površine, ki se izračuna na podlagi vaše telesne višine in mase, bo zdravnik presodil, kakšen odmerek potrebujete in kako pogosto ga morate prejemati.
The PEGylation does not change the enzymatic properties of L-asparaginase, but it influences the pharmacokinetics and immunogenicity of the enzyme.
PEGilacija ne spremeni encimskih lastnosti L-asparaginaze, temveč vpliva na farmakokinetiko in imunogenost encima.