natgillin/translations-raw huggingface dataset:
CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia. 
Študija CONFIRMS: študija CONFIRMS je randomizirana, kontrolirana, 26-tedenska študija 3. faze, v kateri se je ocenjevalo varnost in učinkovitost 40 mg in 80 mg odmerkov febuksostata v primerjavi s 300 mg ali 200 mg odmerki alopurinola pri bolnikih s protinom in hiperurikemijo.
There was no evidence of impaired fertility, teratogenic effects, or harm to the foetus due to febuxostat. 
Znakov vpliva na plodnost, teratogenih učinkov ali škodljivih učinkov na plod zaradi febuksostata niso ugotovili.
What you need to know before you take Febuxostat Mylan 
Kaj morate vedeti, preden boste vzeli zdravilo Febuksostat Mylan
In the FLORENCE study febuxostat demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug. 
V študiji FLORENCE se je pri febuksostatu pokazalo boljše uravnavanje vrednosti sečne kisline v primerjavi z alopurinolom pri bolnikih, ki so bili predvideni za prejem slednjega zdravila.
Febuxostat should not be used during pregnancy. 
Febuksostata med nosečnostjo ne smete uporabljati.
Desipramine/CYP2D6 substrates 
Dezipramin/substrati CYP2D6
Mylan Denmark ApS Tel: +45 28 11 69 32 
Danmark Mylan Denmark ApSTel: +45 28 11 69 32
If you stop taking Febuxostat Mylan your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys. 
Če prenehate jemati zdravilo Febuksostat Mylan, se lahko ravni sečne kisline znova povišajo in pride do poslabšanja simptomov zaradi nastajanja novih kristalov urata v sklepih in ledvicah.
Mylan Healthcare Sp. z o.o. 
Polska Mylan Healthcare Sp. z o.o.
However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested (80 mg multiple dose). 
Vendar pa klinično pomembnih sprememb znižanja sečne kisline v serumu niso opazili (ponavljajoči se odmerek 80 mg).
Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat. 
Močni induktorji encimov UGT lahko pospešijo presnovo febuksostata in zmanjšajo učinkovitost zdravljenja.
CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease. 
Študija CARES je bila multicentrična, randomizirana, dvojno slepo preskušanje neinferiornosti, kjer so primerjali srčno-žilne izide pri febuksostatu v primerjavi z alopurinolom pri bolnikih s protinom in hudimi srčno-žilnimi boleznimi vključno z miokardnim infarktom (MI), hospitalizacijo zaradi nestabilne angine pektoris, koronarnega ali cerebralnega revaskularizacijskega postopka, možgansko kapjo, hospitalizacijo zaradi prehodnega ishemičnega napada, periferno vaskularno boleznijo ali sladkorno boleznijo z dokazi mikrovaskularne ali makrovaskularne bolezni.
• localised swelling due to retention of fluids in tissues (oedema) 
• lokalizirana oteklina zaradi zastajanja tekočine v tkivu (edem).
Excipient with known effect Each tablet contains 236.0 mg of lactose. 
Pomožna snov z znanim učinkom: Ena tableta vsebuje 236,0 mg laktoze.
Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid. 
Sečna kislina je končni produkt presnove purina pri ljudeh in nastaja v kaskadi hipoksantin → ksantin → sečna kislina.
This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome. 
Tega v pilotski klinični študiji s febuksostatom pri sindromu tumorske lize ni bilo opaženo.
Mylan Ireland Limited Tel: +353 (0) 87 1694982 
Mylan Ireland Tel: +353 (0) 87 1694982
Febuxostat Mylan 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. 
Zdravilo Febuksostat Mylan 120 mg tablete uporabljamo tudi za zdravljenje in preprečevanje visokih ravni sečne kisline v krvi, ki se lahko pojavijo ob začetku zdravljenja krvnega raka s kemoterapijo.
• Periodic Safety Update Reports 
• Redna posodobljena poročila o varnosti zdravila (PSUR)
Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase 
Občasni diabetes mellitus, hiperlipidemija, zmanjšanje apetita, povečanje telesne mase
• Theophylline (used to treat asthma) 
• teofilin (uporablja se za zdravljenje astme)
Rare Blurred vision 
Redki zamegljen vid
Patients with an overdose should be managed by symptomatic and supportive care. 
Pri bolnikih, ki vzamejo prevelik odmerek, je treba uvesti simptomatsko in podporno zdravljenje.
• abnormal liver test results 
• nenormalni izvidi testov delovanja jeter,
What Febuxostat Mylan is and what it is used for 
Kaj je zdravilo Febuksostat Mylan in za kaj ga uporabljamo
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended. 
Ker ni izkušenj s febuksostatom pri bolnikih z Lesch-Nyhan sindromom, se njegova uporaba ne priporoča.
Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172). 
Filmska obloga: hipromeloza, titanov dioksid (E171), etil celuloza, rumeni železov oksid (E172), triacetin in črni železov oksid (E172).
Three years data showed a decrease in the incidence of gout flares with less than 4% of patients requiring treatment for a flare (i.e. more than 96% of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36. 
Triletni podatki so pokazali zmanjšanje napadov protina in manj kot 4 % bolnikov je potrebovalo nadaljnjo zdravljenje izbruhov protina (tj. več kot 96 % bolnikov ni bilo potrebno zdraviti zaradi izbruhov protina) v mesecih od 16 do 24 in v mesecih od 30 do 36.
Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation. 
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza sta opisani kot progresiven kožni izpuščaj z mehurčki ali razjedami na sluznici in draženjem oči.
Eligible patients had to be candidates for allopurinol treatment or have no access to rasburicase. 
Bolniki, ki so lahko prisostvovali študiji, so bili kandidati za zdravljenje z alopurinolom ali pa niso imeli na voljo razburikaze.
• Azathioprine (used to reduce immune response) 
• azatioprin (uporablja se za zaviranje imunskega odziva),
• rash (including various types of rash, please see below under “uncommon” and “rare” 
• izpuščaj (vključno z različnimi tipi izpuščajev, ki so našteti spodaj med »občasnimi« in
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. 
Bolnike, ki so imeli 3 zaporedne vrednosti sUA na ravni > 6,0 mg/dl, so izključili iz raziskave.
Febuxostat Mylan is for adults. 
Zdravilo Febuksostat Mylan je za odrasle.
Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28. 
Pri od 46 % do 55 % zdravljenih oseb pride do izbruhov protina med 8. in 28 tednom.
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). 
Terapevtski cilj je zmanjšati in vzdrževati koncentracijo sečne kisline v serumu pod 6 mg/dl (357 /l).
Rates of adjudicated hospitalization for heart failure, hospital admissions for arrhythmias not associated with ischemia, venous thromboembolic events and hospitalization for transient ischemic attacks were comparable for febuxostat and allopurinol. 
Stopnja odobrenih hospitalizacij zaradi srčnega popuščanja, bolnišničnih sprejemov zaradi aritmij, ki niso povezani z ishemijo, venoznih tromboemboličnih dogodkov in hospitalizacij zaradi prehodnih ishemičnih napadov, so bili primerljivi v skupini, ki je prejemala febuksostat in alopurinol.
Hepatitis, jaundice*, liver injury* 
Redki hepatitis, zlatenica*, poškodba jeter*
• nervousness 
• živčnost,
In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with febuxostat for Tumor Lysis Syndrome. 
Pri bolnikih, ki imajo zelo visoke vrednosti sečne kisline (npr. tisti, ki prejemajo kemoterapijo zaradi rakavega obolenja), lahko zdravila za zniževanje sečne kisline vodijo v odlaganje ksantina v sečilih, z možnimi kamni, čeprav tega ni bilo opaženo pri bolnikih, ki so se zdravili z zdravilom Febuksostat Mylan zaradi sindroma tumorske lize.
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). 
Učinkovitosti in varnosti febuksostata pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) niso raziskovali.
Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets. 
Filmsko obložene tablete Febuksostat Mylan so rumene bikonveksne tablete v obliki kapsul.
Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity. 
Zaviranje ksantinske oksidaze s febuksostatom lahko povzroči povečane plazemske koncentracije teh zdravil, kar vodi do toksičnosti.
Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours. 
Povprečen navidezni končni razpolovni čas izločanja (t1/2) febuksostata je približno 5 do 8 ur.
• itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions 
• srbenje, izpuščaj, vnetje ali sprememba barve kože, rdečkasto ali škrlatno obarvane pike na koži, drobne, sploščene rdeče pike na koži, rdečkaste lise na koži, pokrite z majhnimi izboklinami, izpuščaj, rdečkasta in pikasta področja na koži, druge vrste kožnih težav,
Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted. 
Študij medsebojnega delovanja febuksostata z drugimi citotoksičnimi kemoterapevtiki niso izvedli.
The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L). 
Primarni opazovani dogodek učinkovitosti v študijah APEX in FACT je bil delež bolnikov, pri katerih je bil nivo sečne kisline v serumu v zadnjih 3 mesecih < 6,0 mg/dl (357 µmol/l).
• abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation) 
• nenormalnosti izvidov EKG, neenakomeren ali hiter srčni utrip, občutek bitja srca (palpitacija),
0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000). 
4,0970 [95 % interval zaupanja: -0,6467 ; 8,8406]; p=0,0903).
At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2). 
Ob začetku zdravljenja s febuksostatom se za preprečitev ponovnega izbruha priporoča preventivno zdravljenje z NSAID ali kolhicinom vsaj 6 mesecev (glejte poglavje 4.2).
No dose adjustment was required for enrolled patients on the basis of hepatic function. 
Prilagajanje odmerka za bolnike, ki so sodelovali v študiji, na podlagi jetrnega delovanja ni bila potrebna.
The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 µg⋅h/mL in the normal renal function group to 13.2 µg.h/mL in the severe renal dysfunction group. 
Povprečni skupni AUC febuksostata se je povišal za približno 1,8-krat od 7,5 gh/ml v skupini oseb z normalnim delovanjem ledvic na 13,2 gh/ml v skupini s hudo motnjo delovanja ledvic.
Excipient with known effect Each tablet contains 354.0 mg of lactose 
Pomožna snov z znanim učinkom: Ena tableta vsebuje 354,0 mg laktoze.
Weight decrease, increase appetite, anorexia 
Redki zmanjšanje telesne mase, povečanje apetita, anoreksija
• If you have or have had liver disease or liver function test abnormalities 
• če imate ali ste imeli bolezen jeter ali nenormalne rezultate jetrnih testov,
14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 84 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets (calendar) 84 film-coated tablets (calendar) 
14 filmsko obloženih tablet 28 filmsko obloženih tablet 42 filmsko obloženih tablet 84 filmsko obloženih tablet 28 × 1 filmsko obložena tableta 28 filmsko obloženih tablet (koledarsko) 84 filmsko obloženih tablet (koledarsko)
There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours. 
Za odmerke med 10 mg do 240 mg, ki se dajejo vsakih 24 ur, ni omembe vrednega kopičenja.
Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system. 
Večji del presnove febuksostata poteka s konjugacijo prek encimskega sistema uridil difosfat glukuroniltransferaze (UDPGT) in z oksidacijo s citokromi P450 (CYP).
Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects. 
Dajanje febuksostata (80 mg ali 120 mg enkrat na dan) z varfarinom ni imelo učinka na farmakokinetiko varfarina pri zdravih osebah.
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. 
Presnova febuksostata je odvisna od encimov uridil-difosfat-glukuroniltransferaze (UGT).
Rare Anaphylactic reaction*, drug hypersensitivity* 
Redki anafilaktične reakcije*, preobčutljivost na zdravilo*
Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits 
Delež bolnikov s koncentracijo sečne kisline v serumu < 6,0 mg/dl (357 µmol/l) Zadnji trije mesečni obiski
Plasma protein binding of the active metabolites ranges from about 82% to 
Delež vezave aktivnih presnovkov na plazemske beljakovine je približno 82 % do 91 %.
Continue to take Febuxostat Mylan every day even when you are not experiencing gout flare or attack. 
Z jemanjem zdravila Febuksostat Mylan nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome) 
Občasni hipertenzija, zardevanje, navali vročine, hemoragija (glejte poglavje Sindrom tumorske lize)
HDPE bottle with polypropylene (PP) screw cap closure with desiccant containing 28 or 84 tablets. 
Plastenka iz HDPE s polipropilenskim (PP) navojnim pokrovčkom in sušilnim sredstvom, ki vsebuje 28 ali 84 tablet.
There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. 
Redko so se pri jemanju febuksostata pojavili potencialno življenjsko nevarni kožni izpuščaji (Stevens-Johnsonov sindrom), ki so vidni na začetku kot rdečkaste, tarči podobne pike ali krožne lise, pogosto z mehurjem v sredini trupa.
Libido decreased, insomnia Rare 
Občasni zmanjšanje libida, nespečnost Redki živčnost
• inflammation of the liver (hepatitis) 
• vnetje jeter (hepatitis),
In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure. 
Pri podganjih samcih so opazili statistično pomembno večjo pojavnost tumorjev sečnega mehurja (prehodnocelični papilom in karcinom) samo v povezavi s ksantinskimi kamni pri skupini, ki je bila izpostavljena visokim odmerkom, približno 11-kratni izpostavljenosti človeka.
The back of the calendar blister pack is marked with the days of the week to help you check that you have taken a dose each day. 
• Običajni odmerek je ena tableta na dan. Na hrbtni strani koledarskega pretisnega omota so oznake z dnevi v tednu, s pomočjo katerih lahko nadzirate vsakodnevno jemanje odmerka.
INR and Factor VII activity were also not affected by the co-administration of febuxostat. 
Tudi INR in aktivnost faktorja VII se nista spremenili pri sočasnem dajanju febuksostata.
EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT). 
EXCEL študija (C02-021): Excel študija, študija podaljšanje varnosti 3. faze, je potekala tri leta in je bila odprta, multicentrična, randomizirana, s kontrolno skupino zdravljeno s alopurinolom, za bolnike, ki so zaključili študije ključne 3. faze (APEX in FACT).
Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience in gout patients. 
Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročne podaljšane študije in poročila v obdobju trženja pri bolnikih s protinom.
OUTER CARTON (BLISTERS AND BOTTLES) 
ŠKATLA (PRETISNI OMOTI IN PLASTENKE)
Inducers of glucuronidation 
Induktorji glukuronidacije
• dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia) 
• omotičnost, občutek odrevenelosti ali ščemenja, zmanjšano ali spremenjeno zaznavanje (hipoestezija, hemipareza ali parestezija) sprememba čuta za okušanje, zmanjšanje občutka za vonj (hiposmija),
The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs. 
Poročila raziskovalcev o srčno-žilnih dogodkih APTC v kombiniranih študijah 3. faze (APEX, FACT in CONFIRMS študijah) so bila 0,7 v primerjavi z 0,6 dogodka na 100 bolniških let.
An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied). 
Analiza pri bolnikih s protinom in okvaro ledvic je bila nato določena v študiji CONFIRMS in pokazala, da je bil febuksostat statistično pomembno učinkovitejši pri zmanjševanju serumskih ravni sečne kisline na < 6 mg/dl v primerjavi s 300 mg/200 mg alopurinola pri bolnikih s protinom in blago do zmerno okvaro ledvic (65 % bolnikov).
Following multiple doses of 80 mg of febuxostat in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function. 
Po večkratnih odmerkih 80 mg febuksostata pri bolnikih z blago, zmerno ali hudo ledvično okvaro, se vrednost Cmax febuksostata ni spremenila v primerjavi z osebami z normalnim delovanjem ledvic.
In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo. 
V študiji na zdravih prostovoljcih sočasno jemanje 120 mg febuksostata štirikrat na dan in enkratnega 4 mg peroralnega odmerka rosiglitazona ni imelo nobenega farmakokinetičnega učinka na rosiglitazon in njegove Ndemetilrosiglitazon presnovke, kar nakazuje, da febuksostat ni zaviralec encima CYP2C8 in vivo.
Reduction in serum uric acid level to <6.0 mg/dL (357 µmol/L) was noted by the Week 2 visit and was maintained throughout treatment. 
Znižanje vrednosti sečne kisline v serumu na < 6,0 mg/dl (357 µmol/l) so opazili pri obisku v 2. tednu, ohranilo pa se je ves čas zdravljenja.
Atrial fibrillation, palpitations, ECG abnormal Rare 
Občasni atrijska fibrilacija, palpitacije, nenormalni EKG Redki nenadna kardialna smrt*
The Cmax and AUC of active metabolites increased up to 2- and 4-fold, respectively. 
Cmax aktivnih presnovkov se je povišala za 2-krat in AUC za 4-krat.
Febuxostat Mylan tablets contain lactose. 
Tablete zdravila Febuksostat Mylan vsebujejo laktozo.
• erectile difficulties 
• težave z erekcijo.
Marketing Authorisation Holder Mylan S.A.S. 
Imetnik dovoljenja za promet z zdravilom Mylan S.A.S.
These adverse reactions were mostly mild or moderate in severity. 
Ti neželeni učinki so bili glede na resnost v glavnem blagi do zmerni.
In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department. 
Če ste vzeli večji odmerek zdravila Febuksostat Mylan, kot bi smeli V primeru nenamerno vzetega prevelikega odmerka se o tem, kaj morate storiti, posvetujte s svojim zdravnikom ali pojdite v najbližji urgentni oddelek za nezgode in nujne primere.
Uncommon Dyspnoea, bronchitis, upper respiratory tract infection, cough 
Občasni dispneja, bronhitis, okužba zgornjih dihal, kašelj
28 film-coated tablets 84 film-coated tablets 
28 filmsko obloženih tablet 84 filmsko obloženih tablet
Co-administration of febuxostat 80 mg and theophylline 400 mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5). 
Ob sočasnem jemanju 80 mg febuksostata in 400 mg teofilina v enkratnem odmerku pri zdravih prostovoljcih ni bilo nikakršnih farmakokinetičnih interakcij (glejte poglavje 4.5).
No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups. 
Razlik v deležih bolnikov, ki so potrebovali zdravljenje zaradi izbruhov protina, v skupinah z 80 mg in 40 mg febuksostata niso opazili.
No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). 
Študij pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) niso izvedli.
Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). 
Zdravilo Febuksostat Mylan je indicirano za preventivo in zdravljenje hiperurikemije pri odraslih bolnikih, pri katerih poteka zdravljenje hematološkega malignega obolenja s srednje visokim do visokim tveganjem nastanka sindroma tumorske lize (TLS - Tumor Lysis Syndrome) s kemoterapijo.
When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented. 
Rakaste celice se med kemoterapijo razkrojijo, posledično pa se poveča raven sečne kisline v krvi razen, če se prekine tvorba sečne kisline.
To achieve sUA less than 6 mg/dL, the dose of febuxostat was titrated from 40 mg up to 80 mg (regardless of renal function) and the dose of allopurinol was titrated in 100 mg increments from 300 to 600 mg in patients with normal renal function and mild renal impairment and from 200 to 400 mg in patients with moderate renal impairment. 
S ciljem, da se doseže vrednost sečne kisline v serumu pod 6 mg/dl, je bil odmerek febuksostata titriran od 40 mg do največ 80 mg (ne glede na ledvično funkcijo), odmerek v velikosti 100 mg alopurinola pa je bil dan v korakih od 300 do 600 mg pri bolnikih z normalno ledvično funkcijo in blago ledvično okvaro ter po korakih od 200 do 400 mg pri bolnikih z zmerno ledvično okvaro.
APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study. 
Študija APEX: Z alopurinolom in s placebom kontrolirana študija učinkovitosti febuksostata (Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat - APEX) je bila randomizirana, dvojno slepa, multicentrična, 28-tedenska študija 3. faze.