natgillin/translations-raw huggingface dataset:
Ved at blokere androgener standser enzalutamid prostatakræftcellers vækst og deling. 
By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.
Mediantiden til forringelse af FACT-P var 11,3 måneder i enzalutamidgruppen og 5,6 måneder i placebogruppen. 
The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group.
Xtandi er ikke beregnet til anvendelse hos kvinder. 
- Xtandi is not for use in women.
Enzalutamids farmakokinetik blev undersøgt hos personer, der ved baseline havde let (N = 6), moderat (N = 8) eller svært (N=8) nedsat leverfunktion (henholdsvis Child-Pugh-klasse A, B eller C), og hos 22 matchede kontrolpersoner med normal leverfunktion. 
The pharmacokinetics of enzalutamide were examined in subjects with baseline mild (N = 6), moderate (N = 8) or severe (N = 8) hepatic impairment (Child-Pugh Class A, B or C, respectively) and in 22 matched control subjects with normal hepatic function.
Der er rapporteret krampeanfald hos 4 ud af hver 1.000 personer, der har fået Xtandi, og hos færre end én ud af hver 1.000 personer, der har fået placebo. 
Seizures were reported in 4 in every 1,000 people taking Xtandi, and in fewer than one in every 1,000 people taking placebo.
Brug ikke lægemidlet efter den udløbsdato, der står på paptegnebog og den ydre karton af pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP.
Hazard ratio er afledt fra en ikke-stratificeret, proportional hazards-model. 
Hazard Ratio is derived from an unstratified proportional hazards model.
ECOG-funktionsscoren var 0-1 for 91,5 % af patienterne og 2 for 8,5 % af patienterne; 28 % havde en gennemsnitlig Brief Pain Inventory-score på ≥4 (gennemsnit af patientens rapporterede værste smerter inden for de forudgående 24 timer beregnet for syv dage forud for randomisering). 
The ECOG performance score was 0 - 1 in 91.5% of patients and 2 in 8.5% of patients; 28% had a mean Brief Pain Inventory score of ≥ 4 (mean of patient's reported worst pain over the previous 24 hours calculated for seven days prior to randomisation).
In vitro-data indikerer, at enzalutamid og dets væsentlige metabolitter ikke hæmmer følgende transportører ved klinisk relevante koncentrationer: OATP1B1, OATP1B3, OCT2 eller OAT1. 
In vitro data indicate that enzalutamide and its major metabolites do not inhibit the following transporters at clinically relevant concentrations: OATP1B1, OATP1B3, OCT2, or OAT1.
Enzalutamid metaboliseres i stor udstrækning. 
Enzalutamide is extensively metabolised.
Enzalutamid er ikke substrat for effluxtransportørerne P-gp eller BCRP. 
Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP.
PREVAIL-studiet inkluderede kemoterapi-naive patienter med metastatisk CRPC, mens AFFIRM-studiet inkluderede patienter med metastatisk CRPC, der tidligere havde fået docetaxel, og PROSPER-studiet inkluderede patienter med ikke-metastatisk CRPC. 
The PREVAIL study enrolled metastatic CRPC chemotherapy-naïve patients; whereas the AFFIRM study enrolled metastatic CRPC patients who had received prior docetaxel; and the PROSPER study enrolled patients with non-metastatic CRPC.
Den i protokollen forudspecificerede interimanalyse efter 520 dødsfald påviste en statistisk signifikant superioritet i samlet overlevelse for patienter behandlet med enzalutamid sammenlignet med placebo (tabel 4 og figur 7 og 8). 
The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 4 and Figures 7 and 8).
Der er ikke udført reproduktionstoksikologiske studier for enzalutamid, men i studier med rotter (4 og 26 uger) og hunde (4, 13 og 39 uger) blev der observeret atrofi, aspermi/hypospermi og hypertrofi/hyperplasi i det reproduktive system, hvilket er i overensstemmelse med den farmakologiske aktivitet af enzalutamid. 
Reproductive toxicology studies were not conducted with enzalutamide, but in studies in rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), atrophy, aspermia/hypospermia, and hypertrophy/hyperplasia in the reproductive system were noted, consistent with the pharmacological activity of enzalutamide.
Hazard ratio (95 % KI)2 Opdateret overlevelsesanalyse Antal dødsfald (%) Median overlevelse, måneder (95 % KI) 
Hazard ratio (95% CI)2 Updated survival analysis Number of deaths (%) Median survival, months (95% CI)
Titandioxid (E 171) Renset vand 
Titanium dioxide (E171) Purified water
Ved steady-state er de gennemsnitlige Cmax-værdier for enzalutamid og dens aktive metabolit henholdsvis 16,6 μg/ml (23 % variationskoefficient [CV]) og 12,7 μg/ml (30 % CV). 
At steady state, the mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% coefficient of variation [CV]) and 12.7 μg/mL (30% CV), respectively.
De daglige udsving i plasmakoncentrationerne er små (variationerne mellem laveste og højeste koncentration (peak/trough-ratio) er 1,25). 
Daily fluctuations in plasma concentrations are low (peak-to-trough ratio of 1.25).
Almindelig: Iskæmisk hjertesygdom† Ikke kendt*: QT-forlængelse (se pkt. 
Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5)
CRPC2 (AFFIRM)-studiet (patienter med metastatisk CRPC, der tidligere havde fået kemoterapi) 
CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy)
¥ Som vurderet ved afgrænsede SMQs (Standardised MedDRA Queries) af ”Konvulsioner” herunder krampe, grand mal krampe, komplekse partielle anfald, partielle anfald og status epilepticus. 
¥ As evaluated by narrow SMQs of ‘Convulsions' including convulsion, grand mal convulsion, complex partial seizures, partial seizures, and status epilepticus.
Hvis du har glemt at tage Xtandi 
If you forget to take Xtandi
Enzalutamids farmakokinetik er evalueret hos prostatacancerpatienter og hos raske mandlige forsøgspersoner. 
The pharmacokinetics of enzalutamide have been evaluated in prostate cancer patients and in healthy male subjects.
Ifølge tidligere kemoterapianamnese var andelen af patienter med ≥ 50 % reduktion i PSA-niveauerne 22,1 % og 23,2 % for henholdsvis de ikke tidligere kemoterapi- og tidligere kemoterapipatientgrupper. 
According to prior chemotherapy history, the results proportion of patients with a ≥ 50% decrease in PSA levels were 22.1% and 23.2%, for the no prior chemotherapy and prior chemotherapy patient groups, respectively.
Andre tumorer, som også potentielt er relateret til den primære farmakologi, omfatter fibroadenom i brystkirtlerne og benignt tymom i thymus hos hankøn, benigne granulosacelletumorer i ovarierne hos hunkøn, og adenom i pars distalis i hypofysen hos begge køn. 
Other tumours, which are also potentially related to the primary pharmacology include fibroadenoma of mammary glands and benign thymoma of thymus in males, benign granulosa cell tumours of ovaries in females, and adenoma of pituitary pars distalis in both sexes.
De filmovertrukne tabletter må ikke deles, knuses eller tygges, men bør synkes hele med vand og kan tages med eller uden mad. 
The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food.
Konsistente MFS resultater blev også observeret i alle forhåndsspecificerede patientundergrupper, inklusive PSADT (< 6 måneder eller ≥ 6 måneder), demografisk område (Nordamerika, Europa, resten af verden), alder (< 75 måneder eller ≥ 75), 
Consistent MFS results were also observed in all pre-specified patient subgroups including PSADT (< 6 months or ≥ 6 months), demographic region (North America, Europe, rest of world), age (< 75 or ≥ 75), use of a prior bone-targeting agent (yes or no).
• behandling af voksne mænd med metastatisk CRPC, som er asymptomatiske eller har lette symptomer efter svigt af androgen deprivationsbehandling, og hvor kemoterapi endnu ikke er klinisk indiceret (se pkt. 
• the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
Der er observeret en længere halveringstid for enzalutamid hos patienter med svært nedsat leverfunktion, som muligvis har sammenhæng med øget vævsdistribution. 
An increased half-life of enzalutamide has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.
visse former for medicin, som anvendes til behandling af astma og andre luftvejssygdomme (f.eks. aminophyllin, theophyllin). 
- Certain medicines used to treat asthma and other respiratory diseases (e.g. aminophylline, theophylline).
Fase 3-studierne udelukkede patienter med nylig myokardieinfarkt (inden for de seneste 6 måneder) eller ustabil angina (inden for de seneste 3 måneder), hjertesvigt af NYHA (New York Heart Association) klasse III eller IV, medmindre venstre ventrikels uddrivningsfraktion (LVEF) ≥ 45 %, bradykardi eller ukontrolleret hypertension. 
The phase 3 studies excluded patients with recent myocardial infarction (in the past 6 months) or unstable angina (in the past 3 months), New York Heart Association Class (NYHA) III or IV heart failure except if Left Ventricular Ejection Fraction (LVEF) ≥ 45%, bradycardia or uncontrolled hypertension.
118 (14 %) af de enzalutamidbehandlede patienter og 321 (40 %) af patienterne i placebogruppen oplevede en hændelse. 
One hundred and eighteen (14%) enzalutamide-treated patients and 321 (40%) of placebo-treated patients had an event.
Medianalderen ved randomisering var 74 år i enzalutamidarmen og 73 år i placeboarmen. 
The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm.
Tabel 1: Bivirkninger identificeret i kontrollerede kliniske studier og efter markedsføring MedDRAsystemorganklasse 
Table 1: Adverse reactions identified in controlled clinical trials and post-marketing MedDRA System organ class Adverse reaction and frequency
I et enkeltarmet studie (9785-CL-0410) med patienter, tidligere behandlet i mindst 24 uger med abirateron (plus prednison), havde 22,4 % en reduktion på ≥ 50 % i PSA-niveauerne fra baseline. 
In a single arm trial (9785-CL-0410) of patients previously treated with at least 24 weeks of abiraterone (plus prednisone), 22.4% had a ≥ 50% decrease from baseline in PSA levels.
I de tre kliniske studier fik patienter i kontrolarmen placebo, og det var tilladt, men ikke påkrævet, at patienterne fik prednison (maksimal daglig tilladte dosis var 10 mg prednison eller ækvivalent). 
In the three clinical trials, patients received placebo in the control arm and patients were allowed, but not required, to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
I studiet blev der observeret sten og krystaller i rotte urinblærer. 
In the study, calculi and crystals were observed in rat urinary bladders.
† Som vurderet ved afgrænsede SMQs af ”Myokardieinfarkt” og ”Andre Iskæmiske Hjertesygdomme” inklusive følgende foretrukne termer observeret i mindst 2 patienter i randomiserede placebokontrollerede fase 3 studier: Angina pectoris, koronararteriesygdom, myokardieinfarkt, akut myokardieinfarkt, akut koronarsyndrom, ustabil angina, myokardie iskæmi og åreforkalkning af koronararterie. 
† As evaluated by narrow SMQs of ‘Myocardial Infarction' and ‘Other Ischemic Heart Disease' including the following preferred terms observed in at least two patients in randomized placebo-controlled phase 3 studies: angina pectoris, coronary artery disease, myocardial infarctions, acute myocardial infarction, acute coronary syndrome, angina unstable, myocardial ischaemia, and arteriosclerosis coronary artery.
De hyppigste bivirkninger er asteni/træthed, hedestigninger, frakturer og hypertension. 
The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension.
De mest fremtrædende af disse var benigne Leydigs celletumorer, urotelialt papillom og karcinom i urinblæren. 
The most prominent of these were benign Leydig cell tumours, urothelium papilloma, and carcinoma of urinary bladder.
• Antibiotika (f.eks. clarithromycin, doxycyclin) 
• Antibiotics (e.g. clarithromycin, doxycycline)
I prækliniske studier har enzalutamid ikke androgenreceptor-agonistaktivitet. 
In preclinical studies enzalutamide lacks androgen receptor agonist activity.
N-desmethyl-enzalutamid blev ikke metaboliseret af CYP-isoenzymer in vitro. 
N-desmethyl enzalutamide was not metabolised by CYPs in vitro.
In vitro-data indikerer, at enzalutamid ikke er substrat for OATP1B1, OATP1B3 eller OCT1, og Ndesmethyl-enzalutamid er ikke substrat for P-gp eller BCRP. 
In vitro data indicate that enzalutamide is not a substrate for OATP1B1, OATP1B3, or OCT1; and N-desmethyl enzalutamide is not a substrate for P-gp or BCRP.
Hvis du har glemt at tage Xtandi en hel dag, skal du tage din sædvanlige dosis den følgende dag. 
- If you forget to take Xtandi for the whole day, take your usual dose the following day.
PROSPER-studiet inkluderede 1401 patienter med asymptomatisk, højrisiko, ikke-metastatisk CRPC, som fortsatte med androgen deprivationsbehandling (ADT, defineret som LHRH-analog eller tidligere bilateral orkiektomi). 
The PROSPER study enrolled 1401 patients with asymptomatic, high-risk non-metastatic CRPC who continued on androgen deprivation therapy (ADT; defined as LHRH analogue or prior bilateral orchiectomy).
Hvis du har taget flere tabletter end foreskrevet, skal du holde op med at tage Xtandi og kontakte lægen. 
If you take more tablets than prescribed, stop taking Xtandi and contact your doctor.
Progressionsfri overlevelse blev defineret som objektiv evidens for radiografisk sygdomsprogression ved uafhængig central vurdering, skeletrelaterede hændelser, initiering af ny antineoplastisk behandling eller død uanset årsag, uafhængigt af hvad der indtraf først. 
Progression-free survival was defined as objective evidence of radiographic disease progression by independent central review, skeletal-related events, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Hvis du har taget flere bløde kapsler end foreskrevet, skal du holde op med at tage Xtandi og kontakte lægen. 
If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor.
Studiet var et enkeltarmet studie med 214 patienter med progressiv metastatisk CRPC, der fik enzalutamid (160 mg en gang daglig) efter mindst 24 ugers behandling med abirateronacetat plus prednison. 
The study was a single-arm study in 214 patients with progressing metastatic CRPC who received enzalutamide (160 mg once daily) after at least 24 weeks of treatment with abiraterone acetate plus prednisone.
PSA respons (defineret som ≥ 50 % reduktion fra baseline) var 22,4 % (95 % KI: 17,0, 28,6). 
PSA Response (defined as ≥ 50% decrease from baseline) was 22.4% (95% CI: 17.0, 28.6).
Der blev observeret en ensartet gavnlig effekt på rPFS i alle forudspecificerede patientundergrupper (f.eks. alder, ECOG-funktion ved baseline, PSA og LDH ved baseline, Gleasonscore ved diagnosticering og visceral sygdom ved screening). 
Consistent rPFS benefit was observed across all pre-specified patient subgroups (e.g. age, baseline ECOG performance, baseline PSA and LDH, Gleason score at diagnosis, and visceral disease at screening).
Den mediane rPFS var 19,7 måneder i enzalutamidgruppen og 5,4 måneder i placebogruppen. 
The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group.
Enzalutamid (160 mg én gang dagligt) bevirkede ikke en klinisk relevant ændring i AUC eller Cmax for koffein (CYP1A2-substrat) eller pioglitazon (CYP2C8-substrat). 
Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate).
In vivo-studier har vist, at enzalutamid er en kraftig induktor af CYP3A4 og en moderat induktor af CYP2C9 og CYP2C19. 
In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19.
Der blev observeret en konsistent fordel af enzalutamid over bicalutamid på PFS i alle forhåndsspecificerede patientundergrupper. 
Consistent benefit of enzalutamide over bicalutamide on PFS was observed in all pre-specified patient subgroups.
Studieresultater har også vist, at enzalutamid og/eller dets metabolitter overføres til væv hos nyfødte rotter via mælk og efterfølgende elimineres. 
Study results also have shown that enzalutamide and/or its metabolites are transferred to infant rat tissues via milk and subsequently eliminated.
Medianalderen var 69 år (interval 41-92), og racefordelingen var 93 % kaukasiere, 4 % sorte, 1 % asiater og 2 % andre. 
The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other.
Yderligere ændringer af reproduktivt væv omfattede hypertrofi/hyperplasi af hypofysen og atrofi i sædblærer hos rotter og testikelhypospermi og degeneration af sædkanaler hos hunde. 
Additional changes to reproductive tissues included hypertrophy/hyperplasia of the pituitary gland and atrophy in seminal vesicles in rats and testicular hypospermia and seminiferous tubule degeneration in dogs.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med enzalutamid i alle undergrupper af den pædiatriske population ved prostatakarcinom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with enzalutamide in all subsets of the paediatric population in prostate carcinoma (see section 4.2 for information on paediatric use).
Hvis patienten har samleje med en kvinde i den fødedygtige alder, skal der anvendes kondom og anden form for prævention under og i 3 måneder efter behandling. 
If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 3 months after treatment.
BATCHNUMMER Lot 
BATCH NUMBER
Ca. 45 % af patienterne havde målbar bløddelssygdom ved inklusion i studiet, og 12 % af patienterne havde viscerale metastaser (i lunge og/eller lever). 
Approximately 45% of patients had measurable soft tissue disease at study entry, and 12% of patients had visceral (lung and/or liver) metastases.
Patienter med en anamnese med krampeanfald eller en tilstand, der kan prædisponere for krampeanfald, og patienter med moderate eller kraftige smerter fra prostatacancer blev udelukket. 
Patients with a previous history of seizure or a condition that might predispose to seizure and patients with moderate or severe pain from prostate cancer were excluded.
• Antipsykotika (f.eks. haloperidol) 
• Antipsychotics (e.g. haloperidol)
Dyrestudier har påvist, at enzalutamid påvirker det reproduktive system hos hanrotter og -hunde (se pkt. 
Animal studies showed that enzalutamide affected the reproductive system in male rats and dogs (see section 5.3).
I enkeltarmet studiet 9785-CL-0403 (UPWARD) til at vurdere forekomsten af krampeanfald hos patienter med prædisponerende faktorer for krampeanfald (hvoraf 1,6% havde en anamnese med krampeanfald), oplevede 8 ud af 366 (2,2%) patienter, behandlet med enzalutamid, et krampeanfald. 
In the 9785-CL-0403 (UPWARD) single-arm trial to assess incidence of seizure in patients with predisposing factors for seizure (whereof 1.6% had a history of seizures), 8 of 366 (2.2%) patients treated with enzalutamide experienced a seizure.
Astellas Pharmaceuticals AEBE Eλλάδα 
Astellas Pharmaceuticals AEBE
Enzalutamid (N = 800) 
Enzalutamide (N = 800)
Hvis du har glemt at tage Xtandi på det sædvanlige tidspunkt, skal du tage din sædvanlige dosis, så snart du kommer i tanke om det. 
- If you forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
Der blev observeret kønsforskelle i brystkirtler hos rotter (atrofi hos hanner og lobulær hyperplasi hos hunner). 
Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia).
Ud fra in vitro-data kan hæmning af BCRP og MRP2 (i tarmen), samt organisk aniontransportør 3 (OAT3) og organisk kationtransportør 1 (OCT1) (systemisk) ikke udelukkes. 
Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded.
Medianalderen var 71 år (interval 42-93), og racefordelingen var 77 % kaukasiere, 10 % asiater, 2 % sorte og 11 % andre eller ukendt. 
The median age was 71 years (range 42 - 93) and the racial distribution was 77% Caucasian, 10% Asian, 2% Black and 11% other or unknown races.
Indeholder sorbitol (E 420). 
Contains sorbitol (E420).
In vitro-data indikerer, at enzalutamid kan være hæmmer af effluxtransportøren P-gp. 
In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp.
Interimanalyse rapporten for Samlet Overlevelse skal indsendes: 
The Interim Analysis report of OS should be submitted by:
Hvis samtidig administration af den kraftige CYP2C8-hæmmer stoppes, bør dosis af enzalutamid ændres tilbage til den dosis, der blev anvendt inden initiering af den kraftige CYP2C8hæmmer (se pkt. 
If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5).
Virkningen af enzalutamid er fastlagt i tre randomiserede placebokontrollerede kliniske fase 3multicenterstudie [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] hos patienter med progressiv prostatacancer, som ikke responderede på androgen deprivationsbehandling [LHRH-analog eller efter bilateral orkiektomi]. 
Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy].
Den absolutte forskel i objektiv bløddelsrespons mellem enzalutamid- og placebogruppen var [53,9 % (95 % KI: 48,5, 59,1), p < 0,0001]. 
The absolute difference in objective soft tissue response between enzalutamide and placebo arms was [53.9% (95% CI: 48.5, 59.1), p < 0.0001].
• Kortikosteroider (f.eks. dexamethason, prednisolon) 
• Corticosteroids (e.g. dexamethasone, prednisolone)
Andre lægemidlers potentiale til at påvirke enzalutamideksponeringer 
Potential for other medicinal products to affect enzalutamide exposures
Behandling med enzalutamid reducerede risikoen for forringelse af FACT-P med 37,5 % sammenlignet med placebo (p < 0,0001). 
Treatment with enzalutamide decreased the risk of FACT-P degradation by 37.5% compared with placebo (p < 0.0001).
De fleste patienter (91 %) havde knoglemetastaser, og 23 % havde viscerale lunge- og/eller levermetastaser. 
Most (91%) patients had metastases in bone and 23% had visceral lung and/or liver involvement.
Efter oral administration af 14C-enzalutamid genfindes 84,6 % af radioaktiviteten 77 dage efter dosering: Der genfindes 71,0 % i urinen (primært som den inaktive metabolit, med spormængder af enzalutamid og den aktive metabolit), og 13,6 % genfindes i fæces (0,39 % af dosis som uændret enzalutamid). 
Following oral administration of 14C-enzalutamide, 84.6% of the radioactivity is recovered by 77 days post dose: 71.0% is recovered in urine (primarily as the inactive metabolite, with trace amounts of enzalutamide and the active metabolite), and 13.6% is recovered in faeces (0.39% of dose as unchanged enzalutamide).