natgillin/translations-raw huggingface dataset:
In subjects with advanced cancer, who received multiple doses of 120 mg every 4 weeks an approximate 2-fold accumulation in serum denosumab concentrations was observed and steady-state was achieved by 6 months, consistent with time-independent pharmacokinetics. 
U ispitanika s uznapredovalim rakom koji su primali višestruke doze od 120 mg svaka 4 tjedna primijećena je približno dvostruka akumulacija serumskih koncentracija denosumaba, a stanje dinamičke ravnoteže je postignuto u roku od 6 mjeseci, u skladu s vremenski neovisnom farmakokinetikom.
Available clinical data does not suggest an increased risk of malignancy in giant cell tumour of bone patients treated with XGEVA. 
Dostupni klinički podaci ne ukazuju na povećan rizik od maligne bolesti u bolesnika s gigantocelularnim tumorom kosti koji se liječe lijekom XGEVA.
In clinical trials, musculoskeletal pain was very common in both the denosumab and zoledronic acid treatment groups. 
U kliničkim ispitivanjima mišićno-koštana bol je bila vrlo česta i u skupini liječenoj denosumabom i u skupini liječenoj zoledronatnom kiselinom.
Patients being treated with XGEVA should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications). 
Tijekom liječenja lijekom XGEVA bolesnike ne bi trebalo istodobno liječiti drugim lijekovima koji sadrže denosumab (za liječenje osteoporoze).
• new or unusual pain in your hip, groin or thigh (this may be an early indication of a possible fracture of the thigh bone), 
• nova ili neobična bol u Vašem kuku, preponama ili bedru (to mogu biti rani simptomi mogućeg prijeloma bedrene kosti),
In patients with giant cell tumour of bone, denosumab binds to RANK ligand, significantly reducing or eliminating osteoclast-like giant cells. 
U bolesnika s gigantocelularnim tumorom kosti, denosumab se veže na RANK ligand i značajno smanjuje broj ili eliminira gigantske stanice nalik osteoklastima.
If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with XGEVA. 
U slučaju niske razine kalcija u krvi, liječnik se može odlučiti za nadomjestak kalcija prije početka liječenja lijekom XGEVA.
These could be signs that you have low calcium levels in the blood. 
To bi mogli biti znakovi snižene razine kalcija u krvi.
XGEVA is not recommended in patients with growing skeletons (see section 4.2). 
XGEVA se ne preporučuje kod bolesnika sa skeletom u razdoblju rasta (vidjeti dio 4.2).
In a post-hoc analysis of the combined dataset, the median time to worsening pain (> 4-point worst pain score) in patients with mild or no pain at baseline was delayed for XGEVA compared to zoledronic acid (198 versus 143 days) (p = 0.0002). 
U post-hoc analizi zbirnih podataka medijan vremena do pogoršanja osjeta boli (> 4 boda u rezultatu za najveću bol) u bolesnika s umjerenom boli ili bez boli na početku, bio je dulji za lijek XGEVA nego za zoledronatnu kiselinu (198 naspram 143 dana) (p = 0,0002).
Kaplan-Meier plot for time to first on-study SRE in patients with newly diagnosed multiple myeloma 
Slika 2. Kaplan-Meierova krivulja vremena do prvog SRE tijekom ispitivanja u bolesnika s novom dijagnozom multiplog mijeloma
Across both study arms, 54.5% of patients intended to undergo autologous PBSC transplantation, 95.8% patients utilised/planned to utilise a novel anti-myeloma agent (novel therapies include bortezomib, lenalidomide, or thalidomide) in first-line therapy, and 60.7% of patients had a previous SRE. 
U objema skupinama ispitanika, 54,5% bolesnika namjeravalo je podvrgnuti se autolognoj transplantaciji perifernih krvotvornih matičnih stanica (engl. peripheral blood stem cell, PBSC), 95,8% bolesnika koristilo je/planiralo je koristiti novi lijek protiv mijeloma (nove terapije uključuju bortezomib, lenalidomid i talidomid) u terapiji prve linije, a 60,7% bolesnika imalo je prethodni SRE.
Study 6 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease. 
Ispitivanje 6 uključilo je 507 odraslih bolesnika ili koštano sazrelih adolescenata s gigantocelularnim tumorom kosti i dokazanom mjerljivom aktivnom bolesti.
In clinical trials, XGEVA has been administered in combination with standard anti-cancer treatment and in subjects previously receiving bisphosphonates. 
U kliničkim ispitivanjima XGEVA je primjenjivana u kombinaciji sa standardnim lijekovima za liječenje raka te u ispitanika koji su prethodno primali bisfosfonate.
Neonatal RANK/RANKL knockout mice exhibited decreased body weight, reduced bone growth, altered growth plates and lack of tooth eruption. 
Kod novorođenih RANK/RANKL knockout miševa utvrđeno je smanjenje tjelesne težine, smanjen rast kostiju, promjene u pločama rasta i izostanak izbijanja zuba.
In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 2.7 to 15 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity. 
U ispitivanju toksičnosti s jednostrukom i ponovljenom dozom kod cynomolgus majmuna, doze denosumaba koje rezultiraju od 2,7 do 15 puta većom sistemskom izloženošću od preporučene doze za ljude nisu imale utjecaja na kardiovaskularnu fiziologiju, plodnost u mužjaka ili ženki te nisu izazivale specifičnu toksičnost za ciljne organe.
Knockout mouse studies suggest absence of RANKL during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3). 
Ispitivanja s knockout miševima upućuju na to da izostanak RANKL-a tijekom trudnoće može omesti sazrijevanje mliječnih žlijezda što dovodi do postporođajnih problema s laktacijom (vidjeti dio 5.3).
XGEVA has not been tested in pregnant women. 
Primjena lijeka XGEVA nije ispitana u trudnica.
In mouse bone metastasis models of oestrogen receptor positive and negative human breast cancer, prostate cancer and non-small cell lung cancer, OPG-Fc reduced osteolytic, osteoblastic, and osteolytic/osteoblastic lesions, delayed formation of de novo bone metastases, and reduced skeletal tumour growth. 
U mišjim modelima koštanih metastaza estrogen receptor pozitivnog i negativnog humanog raka dojke, raka prostate i raka pluća nemalih stanica, OPG-Fc smanjio je osteolitičke, osteoblastičke i osteolitičke/osteoblastičke lezije, odgodio stvaranje de novo koštanih metastaza te reducirao rast koštanog tumora.
The median time to ONJ was 19.4 months (range: 11 - 40). 
Medijan vremena do ONČ-a iznosio je 19,4 mjeseci (raspon: 11 - 40).
In a mouse model of mammary tumour induction, RANK-Fc reduced hormone-induced proliferation in mammary epithelium and delayed tumour formation. 
U mišjem modelu za indukciju tumora mliječnih žlijezda RANK-Fc smanjio je hormonski induciranu proliferaciju epitela mliječnih žlijezda i odgodio nastanak tumora.
LIST OF EXCIPIENTS Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, water for injections. 
POPIS POMOĆNIH TVARI Acetatna kiselina, ledena, natrijev hidroksid, sorbitol (E420), polisorbat 20, voda za injekcije.
It is unknown whether denosumab is excreted in human milk. 
Nije poznato izlučuje li se denosumab u majčino mlijeko u ljudi.
The risk of developing hypocalcaemia during XGEVA treatment is greater with increasing degree of renal impairment. 
Rizik od razvoja hipokalcijemije tijekom liječenja lijekom XGEVA povećava se s povećanjem stupnja oštećenja bubrega.
Proportion of subjects without SRE 
Udio ispitanika bez SRE
The median time to ONJ was 20.6 months (range: 4 - 53). 
Medijan vremena do ONČ-a iznosio je 20,6 mjeseci (raspon: 4 - 53).
In the post-marketing setting, musculoskeletal pain, including severe cases, has been reported in patients receiving XGEVA. 
Nakon stavljanja lijeka u promet, mišićno-koštana bol, uključujući i teške slučajeve, prijavljena je u bolesnika koji su primali lijek XGEVA.
The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy. 
Preporučena doza lijeka XGEVA je 120 mg primijenjeno jednom svaka 4 tjedna u obliku jednokratne supkutane injekcije u bedro, abdomen ili nadlakticu s dodatnim dozama od 120 mg 8. i 15. dana liječenja prvog mjeseca terapije.
The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year. 
Incidencija prilagođena prema bolesnik-godini za ONČ iznosila je 0,2% tijekom prve godine liječenja i 1,7% u drugoj godini.
In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester of pregnancy, denosumab doses resulting in 9 times greater systemic exposure than the recommended human dose did not induce maternal toxicity or foetal harm during a period equivalent to the first trimester, although foetal lymph nodes were not examined. 
U ispitivanju kod cynomolgus majmuna kod kojih je primijenjen denosumab tijekom razdoblja koje odgovara prvom tromjesečju trudnoće, doze denosumaba koje rezultiraju 9 puta većom sistemskom izloženošću od preporučene doze za ljude nisu inducirale toksičnost kod majke ili oštećenje fetusa tijekom razdoblja koje odgovara prvom tromjesečju, iako limfni čvorovi kod fetusa nisu ispitivani.
In preclinical bone quality studies in monkeys on long-term denosumab treatment, decreases in bone turnover were associated with improvement in bone strength and normal bone histology. 
U pretkliničkim ispitivanjima kvalitete kosti kod majmuna dugotrajno izloženih denosumabu smanjenja u koštanoj pregradnji bila su povezana s poboljšanjem snage kostiju i normalnom histologijom kosti.
In studies demonstrating superiority of XGEVA to zoledronic acid, patients were offered open-label XGEVA in a pre-specified 2-year extension treatment phase. 
U kliničkim ispitivanjima koja su pokazala superiornost lijeka XGEVA u usporedbi sa zoledronatnom kiselinom, bolesnicima je otvoreno ponuđena XGEVA u unaprijed specificiranom dvogodišnjem nastavku faze liječenja.
Patients being treated with XGEVA should not be treated concomitantly with bisphosphonates. 
Tijekom liječenja lijekom XGEVA bolesnici ne bi trebali istodobno uzimati bisfosfonate.
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ. 
Potrebno je izraditi plan zbrinjavanja za bolesnike koji razviju ONČ, u bliskoj suradnji između liječnika i stomatologa, odnosno oralnog kirurga koji ima iskustva s ONČ.
Denosumab 120 mg Q4W (N = 859) Zoledronic Acid 4 mg Q4W (N = 859) 
Denosumab 120 mg svaka 4 tjedna (N = 859) Zoledronatna kiselina 4 mg svaka 4 tjedna (N = 859)
In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level. 
U kliničkim ispitivanjima faze II u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, supkutana (s.c.) primjena doze lijeka XGEVA svaka 4 tjedna ili svakih 12 tjedana rezultirala je brzim smanjenjem biljega resorpcije kosti (uNTx/Cr, serumski CTx), s medijanom smanjenja od približno 80% za uNTx/Cr unutar 1 tjedna bez obzira na prethodnu terapiju bisfosfonatima i početne vrijednosti uNTx/Cr.
Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone 
Klinička djelotvornost i sigurnost u odraslih i koštano sazrelih adolescenata s gigantocelularnim tumorom kosti
The median time to ONJ was 18.7 months (range: 1 - 44). 
Medijan vremena do ONČ iznosio je 18,7 mjeseci (raspon: 1 - 44).
Upon enrolment of 282 patients, in Study 6 cohorts 1 and 2 combined, a clinically meaningful reduction in worst pain (i.e. ≥ 2-point decrease from baseline) was reported for 31.4% of patients at risk (i.e. those who had a worst pain score of ≥ 2 at baseline) within 1 week of treatment, and ≥ 50% at week 5. 
Prilikom uključivanja 282 bolesnika u Ispitivanje 6, u kohorte 1 i 2 zajedno, zabilježeno je klinički značajno smanjenje najjače boli (tj. smanjenje od ≥ 2 boda u odnosu na početnu vrijednost) u 31,4% bolesnika s rizikom (tj. kod kojih je početni rezultat najjače boli bio ≥ 2) unutar 1 tjedna liječenja, te ≥ 50% u 5. tjednu.
The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone. 
Sigurnost i djelotvornost lijeka XGEVA nisu ustanovljene kod pedijatrijskih bolesnika (u dobi < 18) osim kod koštano sazrelih adolescenata s gigantocelularnim tumorom kosti.
• high calcium levels in the blood (hypercalcaemia) after stopping treatment in patients with giant cell tumour of the bone, 
• visoke razine kalcija u krvi (hiperkalcijemija) nakon prestanka liječenja u bolesnika s gigantocelularnim tumorom kosti,
Musculoskeletal pain leading to discontinuation of study treatment was uncommon. 
Slučajevi kada je mišićno-koštana bol dovela do prekida liječenja u ispitivanju bili su manje česti.
Calcium and vitamin D supplementation 
Nadomjestak kalcija i vitamina D
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/703/001
In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg XGEVA subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function). 
U ovom ispitivanju, 1718 bolesnika s dijagnozom multiplog mijeloma s najmanje jednom koštanom lezijom randomizirano je za primanje 120 mg lijeka XGEVA supkutano svaka 4 tjedna ili 4 mg zoledronatne kiseline intravenski svaka 4 tjedna (doza prilagođena za funkciju bubrega).
HR (95% CI) / RRR (%) Superiority p-value 
HR (95% CI) / RRR p-vrijednost za superiornost
In a phase III trial in patients with non-metastatic prostate cancer (a patient population for which XGEVA is not indicated), with longer treatment exposure of up to 7 years, the patient-year adjusted incidence of confirmed ONJ was 1.1% during the first year of treatment, 3.0% in the second year, and 7.1% per year thereafter. 
U ispitivanju faze III na skupini bolesnika s ne-metastatskim rakom prostate (populacija bolesnika za koju XGEVA nije indicirana), s dužim izlaganjem liječenju u trajanju do 7 godina, incidencija prilagođena prema bolesnik-godini za potvrđenu ONČ iznosila je 1,1% tijekom prve godine liječenja, 3,0% u drugoj godini i 7,1% po godini nakon toga.
• spasms, twitches, cramps in your muscles, numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness. 
• spazme, trzanje mišića, grčeve u mišićima, obamrlost ili trnce u prstima ruku ili nogu ili oko usta i/ili napadaje, smetenost ili gubitak svijesti.
Overall survival was longer for XGEVA in non-small cell lung cancer (hazard ratio [95% CI] of 0.79 [0.65, 0.95]; n = 702) and longer for zoledronic acid in multiple myeloma (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180) and similar between XGEVA and zoledronic acid in other tumour types (hazard ratio [95% CI] of 1.08 (0.90, 1.30); n = 894). 
Ukupno preživljenje bilo je dulje za lijek XGEVA kod raka pluća nemalih stanica (omjer hazarda [95% CI] od 0,79 [0,65; 0,95]; n = 702), dulje za zoledronatnu kiselinu kod multiplog mijeloma (omjer hazarda [95% CI] od 2,26 [1,13; 4,50]; n = 180) i slično za lijek XGEVA i zoledronatnu kiselinu kod drugih tipova tumora (omjer hazarda [95% CI] of 1,08 (0,90; 1,30); n = 894).
Some people have developed unusual fractures in their thigh bone while being treated with XGEVA. 
Kod nekih ljudi dolazi do neuobičajenih prijeloma bedrene kosti tijekom liječenja lijekom XGEVA.
Musculoskeletal pain1 
Mišićnokoštana bol1
In preclinical studies knockout mice lacking RANK or RANKL had an absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) and exhibited impairment of lymph node formation. 
U nekliničkim ispitivanjima kod knockout miševa bez RANK ili RANKL izostala je laktacija zbog inhibicije sazrijevanja mliječnih žlijezda (razvoj lobulo-alveolarne žlijezde u trudnoći) i utvrđeno je oštećenje formiranja limfnih čvorova.
The highest incidence of hypocalcaemia was observed in a phase III trial in patients with multiple myeloma. 
Najveća incidencija hipokalcijemije opažena je u kliničkom ispitivanju faze III u bolesnika s multiplim mijelomom.
Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults. 
Liječenje koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom: doziranje je isto kao u odraslih.
How to store XGEVA 
Kako čuvati lijek XGEVA
In phase III clinical trials of patients with advanced malignancies involving bone, median uNTx/Cr reductions of approximately 80% were maintained through 49 weeks of XGEVA treatment (120 mg every Q4W). 
U kliničkim ispitivanjima faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, medijan smanjenja uNTx/Cr od otprilike 80% zadržan je tijekom 49 tjedana liječenja lijekom XGEVA (120 mg svaka 4 tjedna).
XGEVA 120 mg solution for injection denosumab 
XGEVA 120 mg otopina za injekciju denosumab
Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. 
Bolesnici s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili bolesnici koji su na dijalizi imaju povećan rizik za razvoj hipokalcijemije.
Tooth extraction 
Vađenje zuba
2 RECIST 1.1: Modified Response Evaluation Criteria in Solid Tumours to evaluate tumour burden based on computed tomography (CT)/magnetic resonance imaging (MRI) 3 EORTC: Modified European Organisation for Research and Treatment of Cancer criteria to evaluate metabolic response using fluorodeoxyglucose positron emission tomography (FDG-PET) 4 Density/Size: Modified Inverse Choi criteria to evaluate tumour size and density using Hounsfield units based on CT/MRI 
3 EORTC: Modified European Organization for Research and Treatment of Cancer criteria - Izmijenjeni kriteriji Europske organizacije za istraživanje i liječenje raka za procjenu metaboličkog odgovora uz korištenje pozitronske emisijske tomografije s fluorodeoksiglukozom (FDG-PET) 4 Gustoća/veličina: Izmijenjeni inverzni kriterij po Choi-u za procjenu veličine i gustoće tumora uz korištenje Hounsfield-ovih jedinica, temeljeno na CT/MRI
In a clinical study in patients without advanced cancer, 19% of patients with severe renal impairment (creatinine clearance < 30 mL/min) and 63% of patients receiving dialysis developed hypocalcaemia despite calcium supplementation. 
U kliničkom ispitivanju kod bolesnika bez uznapredovalog raka, kod 19% bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) i kod 63% bolesnika na dijalizi zabilježena je hipokalcijemija, iako su primali nadomjestak kalcija.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. 
Liječenje odraslih i koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom.
Please tell your doctor immediately if you have spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness while being treated with XGEVA. 
Obavezno se obratite svom liječniku ako primijetite spazme, trzanje ili grčeve u mišićima i/ili obamrlost ili trnce u prstima ruku, nogu ili oko usta i/ili napadaje, smetenost ili gubitak svijesti tijekom liječenja lijekom XGEVA.
ONJ has been reported commonly in patients receiving XGEVA (see section 4.8). 
ONČ je prijavljena često u bolesnika koji su primali lijek XGEVA (vidjeti dio 4.8).
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 120 mg, odnosno zanemarive količine natrija.
In the clinical trial programme, atypical femoral fractures have been reported uncommonly in patients treated with XGEVA and the risk increased with longer duration of treatment. 
U programu kliničkih ispitivanja u bolesnika liječenih lijekom XGEVA manje često su zabilježene atipične femoralne frakture , a rizik se povećavao s duljinom trajanja liječenja.
In patients whose disease is controlled by XGEVA, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment. 
Nije se vršila procjena učinka prekida ili obustave liječenja kod bolesnika kod kojih je bolest kontrolirana lijekom XGEVA, međutim, ograničeni podaci u tih bolesnika ne ukazuju na povratni (engl. rebound) učinak nakon obustave liječenja.
At the completion of the double-blind treatment phase of this trial, the patient-year adjusted incidence (number of events per 100 patient years) of confirmed ONJ in the XGEVA group (median exposure of 19.4 months; range 1 - 52), was 2.0% during the first year of treatment, 5.0% in the second year, and 4.5% per year thereafter. 
Po završetku dvostruko slijepe faze liječenja u ovom ispitivanju, incidencija prilagođena prema bolesnik-godini (broj događaja na 100 bolesnik-godina) za potvrđenu ONČ u skupini bolesnika koji su primali lijek XGEVA (medijan izloženosti od 19,4 mjeseci; raspon: 1 - 52) iznosila je 2,0% tijekom prve godine liječenja, 5,0% u drugoj godini i 4,5% po godini nakon toga.
Elderly patients (age ≥ 65) No dose adjustment is required in elderly patients (see section 5.2). 
Prilagodba doze nije potrebna kod starijih bolesnika (vidjeti dio 5.2).
In a combined pre-specified analysis from studies 1, 2 and 3, overall survival was similar between XGEVA and zoledronic acid (hazard ratio and 95% CI 0.99 [0.91, 1.07]). 
ispitivanja 1, 2, 3 ukupno preživljenje bilo je slično kod lijeka XGEVA i zoledronatne kiseline (omjer hazarda i 95% CI 0,99 [0,91; 1,07]).
In three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, hypocalcaemia was reported in 9.6% of patients treated with XGEVA and 5.0% of patients treated with zoledronic acid. 
U tri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, hipokalcijemija je zabilježena u 9,6% bolesnika koji su primali lijek XGEVA i u 5,0% bolesnika koji su primali zoledronatnu kiselinu.
In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at systemic exposures 12-fold higher than the human dose, there were increased stillbirths and postnatal mortality; abnormal bone growth resulting in reduced bone strength, reduced haematopoiesis, and tooth malalignment; absence of peripheral lymph nodes; and decreased neonatal growth. 
U drugom ispitivanju na cynomolgus majmunima koji su tijekom gestacije bili izloženi dozama denosumaba koje rezultiraju 12 puta većom sistemskom izloženošću od preporučene doze za ljude, zabilježeno je povećanje broja mrtvorođenčadi i postnatalne smrtnosti; abnormalan rast kostiju koji je rezultirao smanjenom čvrstoćom kostiju, smanjenom hematopoezom i poremećajem rasporeda zuba; nedostatkom perifernih limfnih čvorova i smanjenim neonatalnim rastom.
The risk of developing hypocalcaemia and accompanying elevations in parathyroid hormone increases with increasing degree of renal impairment. 
Rizik od razvoja hipokalcijemije, te pratećeg porasta paratiroidnog hormona povećava se s povećanjem stupnja oštećenja bubrega.
- The active substance is denosumab. 
Što XGEVA sadrži - Djelatna tvar je denosumab.