natgillin/translations-raw huggingface dataset:
Patients were maintained on study treatments until there was PSA progression (confirmed 25% increase over the patient's baseline/nadir) together with protocol-defined radiographic progression and symptomatic or clinical progression.
Bolesnike se održavalo na lijekovima u ispitivanju do progresije PSA (potvrđen 25%-tni porast u odnosu na bolesnikove početne vrijednosti/nadir) uz protokol definirane radiografske progresije i simptomatske ili kliničke progresije.
In the event of an overdose, administration should be withheld and general supportive measures undertaken, including monitoring for arrhythmias, hypokalaemia and for signs and symptoms of fluid retention.
U slučaju predoziranja, treba zaustaviti primjenu lijeka i primijeniti opće potporne mjere, uključujući nadzor zbog moguće pojave aritmije, hipokalemije te znakova i simptoma retencije tekućine.
Administration of abiraterone acetate with food, compared with administration in a fasted state, results in up to a 10-fold (AUC) and up to a 17-fold (Cmax) increase in mean systemic exposure of abiraterone, depending on the fat content of the meal.
Primjena abirateronacetata s hranom, u usporedbi s primjenom natašte, rezultira do 10 puta (AUC), odnosno do 17 puta (Cmax) većom srednjom sustavnom izloženošću abirateronu, ovisno o sadržaju masnoće u obroku.
As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive organs, and the adrenal, pituitary and mammary glands were observed.
Kao rezultat toga opaženo je smanjenje mase organa te morfološke i/ili histopatološke promjene spolnih organa, hipofize, nadbubrežnih i mliječnih žlijezda.
For patients who develop hepatotoxicity during treatment, suspension of treatment and dose adjustment may be required (see sections 4.2 and 4.4).
U bolesnika u kojih se tijekom liječenja razvije hepatotoksičnost možda će biti potrebno prekinuti liječenje i prilagoditi dozu (vidjeti dijelove 4.2 i 4.4).
The AUC to abiraterone increased by approximately 600% and the fraction of free drug increased by 80% in subjects with severe hepatic impairment compared to subjects with normal hepatic function.
AUC abirateronu povećana je za približno 600%, te je slobodna frakcija lijeka povećana približno 80% u ispitanika s teškim oštećenjem jetre u odnosu na ispitanike s normalnom funkcijom jetre.
Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Medicinska kastracija analogom hormona koji oslobađa luteinizirajući hormon (engl. luteinising hormone releasing hormone, LHRH) mora se nastaviti tijekom liječenja u bolesnika koji nisu kastrirani operativnim zahvatom.
There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C).
Nema podataka o kliničkoj sigurnosti i djelotvornosti višestrukih doza abirateronacetata kada ga uzimaju bolesnici s umjerenim ili teškim oštećenjem jetre (Child-Pugh stadij B ili C).
C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
C-abirateronacetata u obliku kapsula, abirateronacetat se hidrolizira u abirateron, koji se zatim primarno metabolizira u jetri sulfacijom, hidroksilacijom i oksidacijom.
PARTICULARS TO APPEAR ON BLISTERS or STRIPS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
Radiographic progression included progression by bone scan (according to modified PCWG2) or progression of soft tissue lesions by CT or MRI (according to RECIST 1.1).
Radiografska progresija uključila je progresiju prema snimci kosti (prema modicifiranim PCWG2 kriterijima) ili progresiju lezija mekog tkiva prema CT-u ili MR-u (prema RECIST 1,1 kriterijima).
Abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see section 5.1).
Abirateronacetat in vivo brzo prelazi u abirateron, inhibitor biosinteze androgena (vidjeti dio 5.1).
In a planned analysis conducted after 552 deaths were observed, 42% (333 of 797) of patients treated with ZYTIGA compared with 55% (219 of 398) of patients treated with placebo, had died.
U planiranoj analizi provedenoj nakon 552 zabilježena smrtna ishoda, ustanovljeno je da je umrlo 42% (333 od 797) bolesnika liječenih lijekom ZYTIGA u odnosu na 55% (219 od 398) bolesnika koji su primali placebo.
A skeletal-related event was defined as a pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Koštani događaj definiran je kao patološka fraktura, kompresija leđne moždine, palijativno zračenje kosti ili kirurški zahvat na kosti.
This is important because ZYTIGA may increase the effects of a number of medicines including heart medicines, tranquilisers, herbal medicines (e.g., St John's wort) and others.
To je važno jer ZYTIGA može pojačati djelovanje brojnih lijekova uključujući djelovanje lijekova za srce, za smirenje biljnih lijekove (npr. Gospina trava) te drugih lijekova.
Study 3011 enrolled patients who were newly diagnosed (within 3 months of randomization) mHSPC who had high-risk prognostic factors.
U ispitivanje 3011 bili su uključeni bolesnici s novodijagnosticiranim mHSPC-om (unutar 3 mjeseca od randomizacije) koji su imali prognostičke faktore visokog rizika.
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When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).
Kada se ZYTIGA propisuje u ranom stadiju bolesti pri kojem još odgovara na hormonsko liječenje, koristi se uz liječenje koje snižava testosteron (liječenje deprivacijom androgena).
ZYTIGA contains a medicine called abiraterone acetate.
ZYTIGA sadrži lijek koji se zove abirateronacetat.
The median time to degradation in FACT-P (Total Score) was 12.7 months in the ZYTIGA group and 8.3 months in the placebo group.
Medijan vremena do degradacije u FACT-P (ukupni rezultat) bio je 12,7 mjeseci u skupini s lijekom ZYTIGA i 8,3 mjeseci u placebo skupini.
Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Može se javiti pad broja crvenih krvnih stanica, smanjen sploni nagon (libido), mišićna slabost i/ili bol u mišićima.
Moderate hepatic impairment (Child-Pugh Class B) has been shown to increase the systemic exposure to abiraterone by approximately four-fold following single oral doses of abiraterone acetate 1,000 mg (see section 5.2).
Pokazalo se da umjereno oštećenje jetre (Child-Pugh stadij B) povećava sustavnu izloženost abirateronu približno četiri puta nakon primjene pojedinačnih oralnih doza abirateronacetata od 1000 mg (vidjeti dio 5.2).
- if you have shortness of breath - if you have gained weight rapidly - if you have swelling in the feet, ankles, or legs - if you have taken a medicine known as ketoconazole in the past for prostate cancer - about the need to take this medicine with prednisone or prednisolone - about possible effects on your bones - if you have high blood sugar.
- ako Vam nedostaje zraka - ako Vam se povećala težina u kratkom vremenskom periodu - ako Vam otiču stopala, gležnjevi ili noge - ako ste ikada u prošlosti, za liječenje karcinoma prostate, uzeli lijek poznat pod imenom ketokonazol - o potrebi uzimanja ovog lijeka s prednizonom ili prednizolonom - o mogućim nuspojavama kostiju - ako imate povišen šećer u krvi.
The median rPFS was 16.5 months in the abiraterone acetate group and 8.3 months in the placebo group.
Medijan rPFS bio je 16,5 mjeseci u skupini koja je primala abirateronacetat i 8,3 mjeseci u skupini koja je primala placebo.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete ovaj lijek.
Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two.
Opće stanje 11% uključenih bolesnika ocijenjeno je ocjenom 2 na ECOG ljestvici; 70% bolesnika imalo je radiografski dokaz progresije bolesti s ili bez progresije PSA; 70% bolesnika prethodno je primilo jednu, a 30% dvije citotoksične kemoterapije.
ZYTIGA is for use in male patients only.
ZYTIGA je namijenjena za primjenu isključivo kod muških bolesnika.
Following oral administration of abiraterone acetate in the fasting state, the time to reach maximum plasma abiraterone concentration is approximately 2 hours.
Nakon peroralne primjene abirateronacetata natašte vrijeme do postizanja vršne koncentracije abiraterona u plazmi iznosi približno 2 sata.
The ECOG performance status was 0 or 1 for 97% of patients.
Za 97% bolesnika ECOG funkcionalno stanje bilo je 0 ili 1.
In study 302, (n = 1,088) the median age of enrolled patients was 71 years for patients treated with ZYTIGA plus prednisone or prednisolone and 70 years for patients treated with placebo plus prednisone or prednisolone.
U ispitivanju 302, (n=1088) medijan dobi uključenih bolesnika bio je 71 godina za bolesnike koji su bili liječeni lijekom ZYTIGA uz prednizon ili prednizolon i 70 godina za bolesnike koji su bili liječeni placebom uz prednizon ili prednizolon.
Pain: Treatment with ZYTIGA significantly reduced the risk of average pain intensity progression by 18% compared with placebo (p = 0.0490).
Bol: Liječenje lijekom ZYTIGA značajno je smanjilo rizik za pojavu progresije intenziteta prosječne boli za18% u usporedbi s placebom (p=0,0490).
Respiratory, thoracic and mediastinal disorders rare: allergic alveolitis
Poremećaji dišnog sustava, prsišta i sredoprsja rijetko: alergijski alveolitis
High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash.
Visoke razine masnoća u krvi, bol u prsnom košu, nepravilni otkucaji srca (treperenje srčanih pretklijetki), zatajenje srca, ubrzano kucanje srca, teške infekcije koje se nazivaju sepsa, prijelomi kostiju, probavne tegobe, krv u mokraći, osip.
Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol (the latter three medicinal products requiring CYP2D6 to form their active analgesic metabolites).
Neki od lijekova koji se metaboliziraju putem CYP2D6 su metoprolol, propranolol, dezipramin, venlafaksin, haloperidol, risperidon, propafenon, flekainid, kodein, oksikodon i tramadol (posljednja tri lijeka trebaju CYP2D6 za stvaranje svojih aktivnih metabolita koji imaju analgetičko djelovanje).
Study 3011 (patients with newly diagnosed high risk mHSPC) In Study 3011, (n=1199) the median age of enrolled patients was 67 years.
Ispitivanje 3011 (bolesnici s novodijagnosticiranim mHSPC-om visokog rizika) U ispitivanju 3011, (n=1199) medijan dobi uključenih bolesnika bio je 67 godina.
Subgroup survival analyses showed a consistent survival benefit for treatment with ZYTIGA (see Figure 7).
Analiza preživljenja po podskupinama pokazala je dosljednu korist liječenja lijekom ZYTIGA za preživljenje (vidjeti Sliku 7).
In addition to the co-primary endpoint measures, benefit was also assessed using time to skeletal-related event (SRE), time to subsequent therapy for prostate cancer, time to initiation of chemotherapy, time to pain progression, and time to PSA progression.
Dodatno uz koprimarne mjere ishoda, korist je procijenjena i pomoću vremena do pojave koštanih događaja, vremena do sljedeće terapije za rak prostate, vremena do započinjanja kemoterapije, vremena do progresije boli i vremena do progresije PSA.
Abiraterone acetate (ZYTIGA) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor.
Abirateronacetat (ZYTIGA) se in vivo pretvara u abirateron, inhibitor biosinteze androgena.
Radiographic progression free survival (rPFS) was assessed with the use of sequential imaging studies as defined by PCWG2 criteria (for bone lesions) and modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for soft tissue lesions).
Radiographic progression free survival, rPFS) bilo je procijenjeno uz primjenu istraživanja sekvencijskih slika (od engl. sequential imaging studies), definirano prema kriterijima PCWG2 (za lezije na kostima) i modificiranom Kriteriju za procjenu odgovora u solidnim tumorima (RECIST, od engl.
Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalaemia (e.g., those on cardiac glycosides), or fluid retention (e.g., those with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment).
Potreban je oprez u liječenju bolesnika čije se postojeće bolesti mogu pogoršati zbog povišenja krvnog tlaka, hipokalemije (npr. bolesnici koji uzimaju srčane glikozide) ili retencije tekućine (npr. bolesnici sa zatajenjem srca, bolesnici s teškom ili nestabilnom anginom pektoris, nedavnim infarktom miokarda ili ventrikularnom aritmijom, te bolesnici s teškim oštećenjem bubrega).
Sixty-five percent (354 of 546) of patients treated with ZYTIGA, compared with 71% (387 of 542) of patients treated with placebo, had died.
Umrlo je šezdeset i pet posto (354 od 546) bolesnika liječenih lijekom ZYTIGA, u usporedbi sa 71% (387 od 542) bolesnika koji su primali placebo.
Patients in the control arm received ADT and placebos for both ZYTIGA and prednisone.
Bolesnici u kontrolnoj skupini primili su ADT i placebo umjesto lijeka ZYTIGA i prednizona.
The study was unblinded based on the magnitude of clinical benefit observed and patients in the placebo group were offered treatment with ZYTIGA.
Ispitivanje je bilo otkriveno (engl. unblinded) radi značaja uočene kliničke koristi, te je bolesnicima u placebo skupini bilo ponuđeno liječenje lijekom ZYTIGA.
A score of 0-1 on Brief Pain Inventory-Short Form (BPI-SF) worst pain in last 24 hours was considered asymptomatic, and a score of 2-3 was considered mildly symptomatic.
Brief Pain Inventory-Short Form) za najjaču bol u posljednja 24 sata smatrao se asimptomatskim, a rezultat 2-3 blago simptomatskim.
Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Tegobe s nadbubrežnim žlijezdama (povezane s problemima s razinom soli i vode), poremećaj srčanog ritma (aritmija), slabost u mišićima i/ili bolovi u mišićima.
In Phase 3 clinical studies, treatment discontinuations due to ALT and AST increases or abnormal hepatic function were reported in 1.1% of patients treated with abiraterone acetate and 0.6% of patients treated with placebo; no deaths were reported due to hepatotoxicity events.
U kliničkim ispitivanjima faze 3, prekidi liječenja zbog povišenja ALT i AST ili poremećaja funkcije jetre prijavljeni su u 1,1% bolesnika liječenih abirateronacetatom odnosno 0,6% bolesnika koji su primali placebo; nije prijavljena nijedna smrt zbog hepatotoksičnosti.
The proportion of subjects with measurable disease at baseline who had an objective response was 36% in the ZYTIGA group and 16% in the placebo group (p < 0.0001).
Udio ispitanika s mjerljivom bolesti na početku, koji su imali objektivni odgovor bio je 36% u skupini s lijekom ZYTIGA i 16% u placebo skupini (p < 0,0001).
Upon discontinuation of treatment, both patients had normalisation of their liver function tests and one patient was re-treated without recurrence of the elevations.
Nakon prekida liječenja, u oba su se bolesnika normalizirale vrijednosti testova jetrene funkcije, a u jednog je bolesnika ZYTIGA ponovno uvedena u liječenje, bez naknadnog porasta vrijednosti testova jetrene funkcije.
Use with chemotherapy
Primjena s kemoterapijom
Janssen-Cilag Polska Sp. z o.o.
Janssen-Cilag Polska Sp. z o.o. ul.
- ZYTIGA is taken with a medicine called prednisone or prednisolone.
- ZYTIGA se uzima s lijekom koji se zove prednizon ili prednizolon.
In the 3011 trial, patients with baseline ALT and AST > 2.5 X ULN, bilirubin > 1.5 X ULN or those with active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction were excluded.
Iz ispitivanja 3011, bili su isključeni bolesnici s početnom vrijednosti ALT-a i AST-a > 2,5 X GGN, bilirubin > 1,5 X GGN ili oni s aktivnim ili simptomatskim virusnim hepatitisom ili kroničnom bolesti jetre; ascitesom ili poremećajima krvarenja sekundarnima u odnosu na disfunkciju jetre.
Patients with known brain metastasis, uncontrolled hypertension, significant heart disease, or NYHA Class IIIV heart failure were excluded.
Bolesnici s utvrđenim metastazama na mozgu, nekontroliranom hipertenzijom, značajnom bolesti srca ili zatajenjem srca NYHA stupnja II-IV bili su isključeni.
All patients enrolled (both active and placebo-treated patients) were concomitantly treated with androgen deprivation therapy, predominantly with the use of LHRH analogues, which has been associated with diabetes, myocardial infarction, cerebrovascular accident and sudden cardiac death.
Svi uključeni bolesnici (i oni koji su primali lijek i oni koji su primali placebo) istodobno su liječeni androgenom deprivacijom, najčešće primjenom LHRH-analoga, a ta je terapija bila povezana s dijabetesom, infarktom miokarda, cerebrovaskularnim događajima i slučajevima iznenadne srčane smrti.
CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond.
CYP17 katalizira konverziju pregnenolona i progesterona u prekursore testosterona, i to 17α-hidroksilacijom u prekursor DHEA, odnosno cijepanjem veze C17,20 u prekursor androstenedion.
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No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A.
Nije potrebno prilagođavati dozu u bolesnika s postojećim blagim oštećenjem jetre, Child-Pugh stadij A.
Cardiac disorders common: cardiac failure*, angina pectoris, atrial fibrillation, tachycardia uncommon: other arrhythmias not known: myocardial infarction, QT prolongation (see sections 4.4 and 4.5)
Srčani poremećaji često: zatajenje srca*, angina pektoris, fibrilacija atrija, tahikardija manje često: ostale aritmije nepoznato: infarkt miokarda, produljenje QT intervala (vidjeti dijelove 4.4 i 4.5)
If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
Ako se i pri smanjenoj dozi od 500 mg na dan ponovno pojavi hepatotoksičnost, liječenje treba prekinuti.
Patients with prior ketoconazole treatment for prostate cancer were excluded from this study.
Bolesnici koji su karcinom prostate prethodno liječili ketokonazolom nisu uključivani u ovo ispitivanje.
Use with products known to prolong QT interval Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc.
Primjena s lijekovima poznatim po produljenju QT intervala Budući da liječenje androgenom deprivacijom može produljiti QT interval, savjetuje se oprez kad se lijek ZYTIGA primijenjuje s lijekovima za koje se zna da produljuju QT interval ili s lijekovima koji mogu inducirati torsades de pointes poput antiaritmika skupine IA (npr. kinidin, dizopiramid) ili skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid), metadona, moksifloksacina, antipsihotika, itd.
56 film-coated tablets 60 film-coated tablets
56 filmom obloženih tableta 60 filmom obloženih tableta
Oreškovićeva 6h 10010 Zagreb
Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h 10010 Zagreb
th percentile in the ZYTIGA group was twice that of the control group at 9.9 months versus 4.9 months.
Vrijeme do nastupa prvog koštanog događaja na 25. percentili u skupini liječenoj lijekom ZYTIGA bilo je dva puta dulje nego u kontrolnoj skupini - 9,9 mjeseci naspram 4,9 mjeseci.
How much to take The recommended dose is 1,000 mg (four tablets) once a day.
Koliko lijeka uzeti Preporučena doza je 1000 mg (četiri tablete) jednom na dan.
ZYTIGA decreases serum testosterone and other androgens to levels lower than those achieved by the use of LHRH analogues alone or by orchiectomy.
ZYTIGA snižava razinu testosterona i drugih androgena u serumu na vrijednosti niže od onih koje se postižu primjenom samo LHRH- analoga ili orhidektomijom.
Metabolism and nutrition disorders very common: hypokalaemia common: hypertriglyceridaemia
Poremećaji metabolizma i prehrane vrlo često: hipokalemija često: hipertrigliceridemija
- Swallow the tablets whole with water.
- Tablete progutajte cijele s vodom.
Discard unused contents appropriately in accordance with local requirements.
Neiskorišteni sadržaj potrebno je odgovarajuće zbrinuti sukladno nacionalnim propisima.
In studies of patients with metastatic advanced prostate cancer who were using an LHRH analogue, or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with low dose prednisone or prednisolone (either 5 or 10 mg daily depending on the indication).
U ispitivanjima bolesnika s metastatskim uznapredovalim karcinomom prostate koji su liječeni analogom LHRH-a, ili su ranije podvrgnuti orhidektomiji, ZYTIGA je primjenjena u dozi od 1000 mg na dan u kombinaciji s niskom dozom prednizona ili prednizolona (bilo 5 ili 10 mg na dan ovisno o indikaciji).
In another trial, the pharmacokinetics of abiraterone were examined in subjects with pre-existing severe (n = 8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function.
U drugom ispitivanju, farmakokinetika abiraterona ispitana je u ispitanika s postojećim teškim (n=8) oštećenjem jetre (Child Pugh stadij C), te u 8 zdravih ispitanika kontrolne skupine s normalnom funkcijom jetre.
These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40 x ULN and bilirubin elevations 2 to 6 x ULN.
U ta dva bolesnika, koja su na početku imala normalnu jetrenu funkciju, došlo je do porasta ALT-a ili AST-a 15 do 40 x GGN, a bilirubina 2 do 6 x GGN.
Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess ZYTIGA may cause hypertension, hypokalaemia and fluid retention (see section 4.8) as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition (see section 5.1).
ZYTIGA može uzrokovati hipertenziju, hipokalemiju i retenciju tekućine (vidjeti dio 4.8) kao posljedicu povećane razine mineralokortikoida uslijed inhibicije enzima CYP17 (vidjeti dio 5.1).
The median time to progression was 26.7 months in the ZYTIGA group and 18.4 months in the placebo group.
Medijan vremena do progresije bio je 26,7 mjeseci u skupini s lijekom ZYTIGA i 18,4 mjeseci u placebo skupini.
WALLET 500 mg (30 days)
OMOT za 500 mg (30 dana)
In an analysis of adverse reactions of composite Phase 3 studies with ZYTIGA, adverse reactions that were observed in ≥10% of patients were peripheral oedema, hypokalaemia, hypertension urinary tract infection, and alanine aminotransferase increased and/or aspartate aminotransferase increased.
U analizi nuspojava u ispitivanjima faze 3 s lijekom ZYTIGA, nuspojave koje su bile zabilježene u ≥10% bolesnika bile su periferni edem, hipokalemija, hipertenzija, infekcija mokraćnih puteva i povišena alanin aminotransferaza i/ili povišena aspartat aminotransferaza.