natgillin/translations-raw huggingface dataset:
However, the effects on lymph nodes and tooth malalignment persisted, and minimal to moderate mineralisation in multiple tissues was seen in one animal (relation to treatment uncertain).
Međutim, ostao je učinak na limfne čvorove i poremećen raspored zuba te je zamijećena minimalna do umjerena mineralizacija u više tkiva kod jedne životinje (povezanost s liječenjem nije utvrđena).
1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
1,7 ml otopine u bočici za jednokratnu uporabu (staklo tip I) s čepom (elastomer obložen fluoropolimerom) i aluminijskim prstenom s „flip-off“ kapicom.
All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with denosumab.
Sve bolesnike treba poticati na održavanje dobre higijene usne šupljine, odlazak na redovite stomatološke preglede i da odmah prijave bilo kakve simptome vezane uz usnu šupljinu kao što su klimanje zubi, bol ili oticanje, ili nezarastanje rana ili iscjedak tijekom liječenja denosumabom.
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
• Odmah se obratite svom liječniku i stomatologu ako primijetite bilo kakve probleme s usnom šupljinom ili zubima kao što su klimanje zubi, bol ili oticanje, nezarastanje rana ili iscjedak, jer to mogu biti znakovi osteonekroze čeljusti.
Your doctor may recommend a dental examination before you start treatment with XGEVA.
Vaš liječnik može preporučiti stomatološki pregled prije početka liječenja lijekom XGEVA.
Osteonecrosis of the external auditory canal3,4
Osteonekroza vanjskog slušnog kanala3,4
XGEVA was evaluated in an international, randomised (1:1), double-blind, active-controlled study comparing XGEVA with zoledronic acid in patients with newly diagnosed multiple myeloma, study 4.
XGEVA je procijenjena u međunarodnom, randomiziranom (1:1), dvostruko slijepom, aktivno kontroliranom ispitivanju lijeka XGEVA u usporedbi sa zoledronatnom kiselinom u bolesnika s novom dijagnozom multiplog mijeloma, ispitivanju 4.
Clinical efficacy in patients with multiple myeloma
Klinička djelotvornost u bolesnika s multiplim mijelomom
In clinical studies, neutralising antibodies have not been observed for denosumab.
U kliničkim ispitivanjima nije zabilježeno stvaranje neutralizirajućih protutijela na denosumab.
Women of child-bearing potential should use effective methods of contraception while being treated with XGEVA and for at least 5 months after stopping treatment with XGEVA.
Žene reproduktivne dobi trebaju koristiti učinkovite metode kontracepcije tijekom liječenja lijekom XGEVA i najmanje 5 mjeseci nakon prestanka liječenja lijekom XGEVA.
In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but can occur later.
Nakon puštanja lijeka u promet zabilježena je teška simptomatska hipokalcijemija (uključujući i smrtne slučajeve) (vidjeti dio 4.8), gdje se većina slučajeva pojavila u prvim tjednima nakon početka liječenja, iako se mogu pojaviti i kasnije.
When OPG-Fc was combined with hormonal therapy (tamoxifen) or chemotherapy (docetaxel) in these models, there was additive inhibition of skeletal tumour growth in breast, and prostate or lung cancer respectively.
Kada je kod ovih modela OPG-Fc kombiniran s hormonskom terapijom (tamoksifen) ili kemoterapijom (docetaksel), postojala je dodatna inhibicija rasta koštanog tumora kod raka dojke, prostate i pluća.
1 single use vial 3 single use vials 4 single use vials
1 bočica za jednokratnu upotrebu 3 bočice za jednokratnu upotrebu 4 bočice za jednokratnu upotrebu
The decreases in serum calcium were generally appropriately managed by calcium and vitamin D supplementation.
Smanjenja razine kalcija u serumu općenito su se uspješno liječila nadomjestkom kalcija i vitamina D.
Study 1*
Ispitivanje 1*
XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
XGEVA se primjenjuje u odraslih osoba koje boluju od uznapredovalog raka za sprečavanje ozbiljnih komplikacija uzrokovanih koštanim metastazama (primjerice, prijelom kosti, pritisak na leđnu moždinu ili potreba za terapijom zračenjem ili operacijom).
No data are available on the effect of denosumab on human fertility.
Nema podataka o učincima denosumaba na plodnost u ljudi.
Most subjects were receiving or had received chemotherapy.
Većina je bolesnika paralelno primala ili je ranije primala kemoterapiju.
XGEVA has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks.
XGEVA je u kliničkim ispitivanjima primjenjivana u dozama do 180 mg svaka 4 tjedna i 120 mg tjedno tijekom 3 tjedna.
Anaphylactic reaction1
Anafilaktička reakcija1
Disease progression and overall survival with bone metastases from solid tumours
Progresija bolesti i ukupno preživljenje s koštanim metastazama solidnih tumora
XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
XGEVA sadrži denosumab, protein (monoklonsko protutijelo) koji usporava razaranje kosti uzrokovano širenjem raka na kosti (koštane metastaze) ili gigantocelularnim tumorom kosti.
Please tell your doctor and dentist immediately if you experience any of these symptoms while being treated with XGEVA or after stopping treatment (may affect up to 1 in 10 people):
Molimo odmah obavijestite svog liječnika ili stomatologa ako primijetite bilo koji od sljedećih simptoma tijekom liječenja lijekom XGEVA ili nakon prestanka liječenja (mogu se pojaviti u do 1 na 10 osoba):
In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was reported in 5.7% of patients.
U dva klinička ispitivanja faze II na jednoj skupini bolesnika s gigantocelularnim tumorom kosti, hipokalcijemija je prijavljena u 5,7% bolesnika.
Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
Bolesnici u ispitivanju faze II koji su bili podvrgnuti kompletnoj resekciji gigantocelularnog tumora kosti, primali su terapiju dodatnih 6 mjeseci nakon operacije sukladno protokolu ispitivanja.
The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Bočicu možete ostaviti izvan hladnjaka kako bi prije injiciranja postigla sobnu temperaturu (do 25°C).
Atypical femoral fracture1
Atipična femoralna fraktura1
If you are nursing during treatment with XGEVA, please inform your doctor.
Ako dojite tijekom liječenja s lijekom XGEVA molimo Vas obavijestite svog liječnika o tome.
Study 3*
Ispitivanje 3*
It is not known whether XGEVA is excreted in breast milk.
Nije poznato izlučuje li se XGEVA u majčino mlijeko.
Discontinuation of XGEVA therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment.
Prekid liječenja lijekom XGEVA kod bolesnika za koje se sumnja da imaju atipičnu femoralnu frakturu treba razmotriti na temelju individualne procjene koristi i rizika za svakog bolesnika.
The most common adverse reactions with XGEVA are musculoskeletal pain.
Najčešća nuspojava na lijek XGEVA je mišićno-koštana bol.
XGEVA is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumour of the bone whose bones have stopped growing.
XGEVA se ne preporučuje u djece i adolescenata mlađih od 18 godina, osim kod adolescenata s gigantocelularnim tumorom kosti čije su kosti završile s rastom.
Giant cell tumours of bone are characterised by neoplastic stromal cells expressing RANK ligand and osteoclast-like giant cells expressing RANK.
Gigantocelularne tumore kosti karakteriziraju neoplastične stromalne stanice koje eksprimiraju RANK ligand i gigantske stanice nalik osteoklastima koje eksprimiraju RANK.
Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation.
Klinički značajna hiperkalcijemija koja je zahtijevala hospitalizaciju i koju je dodatno komplicirala akutna ozljeda bubrega prijavljena je u bolesnika s gigantocelularnim tumorom kosti liječenih lijekom XGEVA tjednima do mjesecima nakon prekida liječenja.
Overall of 225 patients for whom giant cell tumours of bone surgery (excluding lung metastases only) was planned, 109 had no surgery performed and 84 underwent a less morbid procedure than planned at baseline.
Od ukupno 225 bolesnika s gigantocelularnim tumorom kosti (kod kojih su jedino isključene metastaze na plućima) za koje je planirana operacija, kod njih 109 operacija nije obavljena, a 84 bolesnika je podvrgnuto manje rizičnom postupku nego je prvobitno planirano.
Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles.
Bistra, bezbojna do blago žuta otopina koja može sadržavati u tragovima prozirne do bijele proteinske čestice.
There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N-telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure.
Nisu potvrđene nikakve klinički relevantne promjene u najnižoj serumskoj koncentraciji i farmakodinamici denosumaba (urinarni N-telopeptid prilagođen za kreatinin, uNTx/Cr) kod istodobne primjene kemoterapije i/ili hormonske terapije ili kod prethodne intravenske izloženosti bisfosfonatima.
In clinical trials, the incidence of ONJ was higher with longer duration of exposure; ONJ has also been diagnosed after stopping treatment with XGEVA with the majority of cases occurring within 5 months after the last dose.
U kliničkim ispitivanjima, incidencija ONČ je bila viša kod duljeg izlaganja; ONČ je također dijagnosticirana nakon prestanka liječenja lijekom XGEVA pri čemu se većina slučajeva javila unutar 5 mjeseci nakon zadnje doze.
Your healthcare professional will not administer XGEVA to you if you have unhealed wounds from dental or oral surgery.
Vaš zdravstveni radnik neće Vam dati lijek XGEVA ukoliko imate nezacijeljene rane nakon stomatološkog ili oralnog kirurškog zahvata.
The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively.
Kumulativna incidencija u jednoj godini iznosila je 1,1% za denosumab i 0,6% za zoledronatnu kiselinu.
First radiation to bone Median time (months)
Prva radijacija kosti Medijan vremena (mjeseci)
Efficacy results for XGEVA compared to zoledronic acid in patients with newly diagnosed multiple myeloma
Rezultati djelotvornosti za lijek XGEVA u usporedbi sa zoledronatnom kiselinom u bolesnika s novom dijagnozom multiplog mijeloma
In subjects with multiple myeloma who received 120 mg every 4 weeks, median trough levels varied by less than 8% between months 6 and 12.
U ispitanika s multiplim mijelomom koji su primali 120 mg svaka 4 tjedna medijan najnižih postignutih razina varirao je manje od 8% između 6. i 12. mjeseca.
Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Slične frakture zabilježene u kombinaciji s bisfosfonatima često su bile obostrane, stoga se u bolesnika liječenih denosumabom koji su zadobili frakturu tijela femoralne kosti treba pregledati i nasuprotni femur.
The trials in patients with breast or prostate cancer included an XGEVA extension treatment phase (median overall exposure of 14.9 months; range: 0.1 - 67.2).
Ispitivanja u bolesnika s rakom dojke ili prostate uključivala su fazu produžetka liječenja lijekom XGEVA (medijan ukupne izloženosti 14,9 mjeseci; raspon: 0,1 - 67,2).
• A 27 gauge needle is recommended for the administration of denosumab.
• Za primjenu denosumaba preporučuje se igla veličine 27 G.
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.