natgillin/translations-raw huggingface dataset:
Efficacy was evaluated by progression free survival (PFS) based on International Myeloma Working Group (IMWG) criteria.
Progression Free Survival, PFS) temeljenog na IMWG (engl.
VGPR or better (sCR + CR + VGPR) p-value
VGPR ili bolje (sCR + CR + VGPR) p-vrijednost
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
• u kombinaciji s lenalidomidom i deksametazonom, ili bortezomibom i deksametazonom, za liječenje odraslih bolesnika s multiplim mijelomom koji su primili barem jednu prethodnu terapiju.
In Study MMY2002, 106 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
U ispitivanju MMY2002, 106 bolesnika s relapsnim i refrakternim multiplim mijelomom primalo je DARZALEX u dozi od 16 mg/kg do progresije bolesti.
Based on four individual population PK analyses (1-4) in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), age (range: 31-93 years) had no clinically important effect on the PK of daratumumab, and the exposure of daratumumab was similar between younger (aged <65 years, n=518) and older (aged ≥65 to <75 years n=761; aged ≥75 years, n=334) patients.
Na temelju četiri zasebne populacijske farmakokinetičke analize (1.-4.) u bolesnika liječenih monoterapijom daratumumabom ili različitim kombiniranim liječenjima (1.-4. analiza), dob (raspon: 31 - 93 godine) nije imala klinički značajnog učinka na farmakokinetiku daratumumaba, a izloženost daratumumabu bila je slična u mlađih (dob <65 godina, n = 518) i starijih (dob ≥65 i <75 godina n=761; dob ≥75 godina, n=334)
Bortezomib was administered by SC injection or IV injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28 day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles 5 and 6) following ASCT after Cycle 4.
Bortezomib se primjenjivao s.c. injekcijom ili i.v. injekcijom u dozi od 1,3 mg/m2 tjelesne površine dvaput tjedno tijekom 2 tjedna (1., 4., 8. i 11. dana) u sklopu ponovljenih 28-dnevnih (4-tjednih) ciklusa uvodnog liječenja (1. - 4. ciklus) te dvaju ciklusa konsolidacijskog liječenja (5. i 6. ciklus) nakon ASCT-a koji je proveden poslije 4. ciklusa liječenja.
Week 25 onwards until disease progression b every four weeks
25. tjedan i nadalje do progresije bolesti
What DARZALEX is used for
Za što se DARZALEX koristi
The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Medijan dobi bolesnika bio je 64 godine (raspon 30 do 88 godina) i 12% imalo je ≥75 godina.
Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Ozbiljne nuspojave bile su pneumonija, bronhitis, infekcija gornjih dišnih putova, plućni edem, gripa, pireksija, dehidracija, proljev i atrijska fibrilacija.
DARZALEX infusion should be interrupted for IRRs of any severity and medical management/supportive treatment for IRRs should be instituted as needed.
Infuziju lijeka DARZALEX potrebno je privremeno prekinuti u slučaju nastupa reakcije na infuziju bilo koje težine i po potrebi treba uvesti medicinsko zbrinjavanje/potporno liječenje reakcija na infuziju.
How to store DARZALEX
Kako primjenjivati DARZALEX
Dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed patients eligible for autologous stem cell transplant (ASCT):
Raspored doziranja u kombinaciji s bortezomibom, talidomidom i deksametazonom (režimi 4-tjednog ciklusa) za liječenje novodijagnosticiranih bolesnika prikladnih za transplantaciju autolognih matičnih stanica (engl. autologous stem cell transplant, ASCT):
Symptoms predominantly included nasal congestion, cough, throat irritation, chills, vomiting and nausea.
Simptomi su pretežno uključivali kongestiju nosa, kašalj, nadraženost grla, zimicu, povraćanje i mučninu.
9/L, and platelets > 50 x 10 9/L without transfusion).
9/l bez transfuzije).
Infusion-related reaction
Reakcije na infuziju
Very Common 45
Vrlo često 45
No clinically important differences in the exposure to daratumumab were observed between patients with hepatic impairment and those with normal hepatic function.
Nisu primijećene klinički značajne razlike u izloženosti daratumumabu između bolesnika s oštećenjem funkcije bubrega i onih s normalnom funkcijom bubrega.
To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following DARZALEX infusions.
Radi smanjenja rizika odgođenih reakcija na infuziju, svim se bolesnicima nakon infuzije lijeka DARZALEX moraju dati oralni kortikosteroidi.
Very Common 19
Vrlo često 19
Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab.
Prije i nakon infuzije potrebno je primijeniti lijekove za smanjivanje rizika od reakcija na infuziju daratumumaba.
The majority were white (85%), female (54%), 25% had an ECOG performance score of 0, 50% had an ECOG performance score of 1 and 25% had an ECOG performance score of 2.
Većina su bili bijelci (85%), žene (54%), 25% je imalo ECOG funkcionalni status 0, 50% je imalo ECOG funkcionalni status 1 i 25% je imalo ECOG funkcionalni status 2. Bolesnici su imali IgG/IgA/mijelom lakih lanaca u 64%/22%/10% slučajeva, 19% je imalo stadij
The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Medijan dobi bio je 71 (raspon: 40-93) godina, s 30% bolesnika u dobi od ≥75 godina.
Weeks 1 to 6
1. - 6. tjedan
This corresponds to 0.46% and 1.86% of the WHO recommended maximum daily intake of 2 g sodium for an adult, respectively.
To odgovara 0,46% odnosno 1,86% maksimalnog dnevnog unosa od 2 grama natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.
In this subgroup, median PFS was not reached in the DVMP group and was 17.9 months in the VMP group (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
U ovoj podskupini, medijan PFS-a nije postignut u D-VMP skupini, a bio je 17,9 mjeseci u VMP skupini (HR=0,56; 95% CI: 0,42; 0,75); p<0,0001).
Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose dexamethasone at 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or BMI <18.5).
Lenalidomid (25 mg jedanput na dan uzimano peroralno 1.-21. dan ponavljanih 28-dnevnih [4-tjednih] ciklusa) primijenjen je s niskom dozom deksametazona od 40 mg/tjedan (ili sniženom dozom od 20 mg/tjedno za bolesnike >75 godina ili s ITM-om < 18,5).
• medicines to lower swelling and irritation in your lungs (corticosteroids)
• lijekove koji ublažavaju oticanje i nadraženost pluća (kortikosteroide)
D-VTd=daratumumab-bortezomib-thalidomide-dexamethasone; VTd=bortezomib-thalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
DVd=daratumumab-bortezomib-deksametazon; Vd=bortezomib-deksametazon; MRD=minimalna rezidualna bolest; CI=interval pouzdanosti; NE=nije procjenjivo. p-vrijednost uz Cochran Mantel-Haenszel Hi-kvadrat test.
Table 8: Additional efficacy results from Study MMY3007
Tablica 8: Dodatni rezultati djelotvornosti iz ispitivanja MMY3007
On DARZALEX infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
U dane infuzije lijeka DARZALEX, primijenjena je doza od 20 mg deksametazona prije infuzije, a ostatak je primijenjen dan nakon infuzije.
Post-marketing adverse reactions are also included.
Uključene su također i nuspojave koje su se javile nakon stavljanja lijeka u promet.
The median patient age was 63.5 years (range, 31 to 84 years), 11% of patients were ≥75 years of age, 49% were male and 79% were Caucasian.
Medijan dobi bolesnika iznosio je 63,5 godina (raspon: 31 - 84 godine), 11% bolesnika imalo je ≥75 godina, 49% bolesnika bili su muškarci, a 79% bijelci.
Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Lenalidomid (25 mg jedanput na dan peroralno 1.-21. dan ponavljanih 28-dnevnih [4-tjednih] ciklusa) primijenjen je s niskom dozom oralnog ili intravenskog deksametazona od 40 mg tjedno (ili sniženom dozom od 20 mg tjedno za bolesnike u dobi od > 75 godina ili s indeksom tjelesne mase [ITM] < 18,5).
every three weeks (total of 5 doses)
Svaka tri tjedna (ukupno 5 doza)
Table 7: Additional efficacy results from Study MMY3008
Tablica 7: Dodatni rezultati djelotvornosti iz ispitivanja MMY3008
Phenotyping may be considered prior to starting daratumumab treatment as per local practice.
Prema lokalnoj praksi prije početka liječenja daratumumabom može se uzeti u obzir fenotipizacija.
Four individual population PK analyses were performed in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), and included a total of 1404 patients with normal hepatic function (total bilirubin [TB] and aspartate aminotransferase [AST] ≤ upper limit of normal [ULN]), 189 with mild hepatic impairment (TB 1.0 x to 1.5 x ULN or AST >ULN) and 8 patients with moderate (TB > 1.5 x to 3.0 x ULN; n=7), or severe (TB > 3.0 x ULN; n=1) hepatic impairment.
Četiri zasebne populacijske farmakokinetičke analize bile su provedene u bolesnika koji su primali daratumumab u monoterapiji ili u različitim kombiniranim terapijama (1.-4. analiza) i uključile su ukupno 1404 bolesnika s normalnom funkcijom jetre (ukupni bilirubin [UB] i aspartat aminotransferaza [AST] ≤ gornje granice normale [GGN]), 189 s blagim oštećenjem funkcije jetre (UB 1,0 x do 1,5 x GGN ili AST >GGN) i 8 bolesnika s umjerenim (UB > 1,5 x do 3,0 x GGN; n=7) ili teškim (UB > 3,0 x GGN; n=1) oštećenjem funkcije jetre.
Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow.
Kod liječenja daratumumabom primijećena su značajna povećanja apsolutnog broja CD4+ i CD8+ T-stanica i postotka limfocita u perifernoj punoj krvi i koštanoj srži.
Figure 2:
PRILOG II.
Very good partial response (VGPR)
Vrlo dobar djelomičan odgovor (VGPR) [n(%)]
every three weeks (total of 16 doses)
Svaka tri tjedna (ukupno 16 doza)
The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Medijan dobi bolesnika bio je 65 godina (raspon 34 do 89 godina) i 11% je imalo ≥75 godina.
Four individual population PK analyses were performed based on pre-existing renal function data in patients receiving daratumumab monotherapy, or various combination therapies (Analyses 1-4), and included a total of 441 patients with normal renal function (creatinine clearance [CRCL] ≥90 mL/min), 621 with mild renal impairment (CRCL <90 and ≥60 mL/min), 523 with moderate renal impairment (CRCL <60 and ≥30 mL/min), and 27 with severe renal impairment or end stage renal disease
Četiri zasebne populacijske farmakokinetičke analize provedene su na temelju otprije postojećih podataka o bubrežnoj funkciji u bolesnika liječenih daratumumabom u monoterapiji, ili u različitim kombiniranim terapijama (1.-4. analiza) te su uključile ukupno 441 bolesnika s normalnom bubrežnom funkcijom (klirens kreatinina [CrCl] ≥90 ml/min), 621 bolesnika s blagim oštećenjem bubrežne funkcije (CrCl <90 i ≥60 ml/min), 523 bolesnika s umjerenim oštećenjem bubrežne funkcije (CrCl <60 i ≥30 ml/min) i 27 bolesnika s teškim oštećenjem bubrežne funkcije ili u terminalnoj fazi bubrežne bolesti (CrCl <30 ml/min).
Table 6 summarises the adverse drug reactions that occurred in patients receiving DARZALEX.
U Tablici 6 sažeto se navode nuspojave koje su se javile u bolesnika liječenih lijekom DARZALEX.
Eighty percent of patients had received prior autologous stem cell transplantation (ASCT).
Medijan prethodnih terapijskih linija koje su bolesnici primili bio je 5. Osamdeset posto (80%) bolesnika prethodno je podvrgnuto presađivanju autolognih matičnih stanica (ASCT).
Dilution volume
Volumen razrijeđene otopine
Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
Interferencija s indirektnim antiglobulinskim testom (indirektan Coombsov test) Daratumumab se veže za CD38, koji se u malim količinama nalazi na crvenim krvnim stanicama (eritrocitima) te može dovesti do pozitivnog nalaza indirektnog Coombsova testa.
Upper respiratory tract infection
bronhitis infekcija gornjih dišnih putova infekcija mokraćnih putova
Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Tablica 1: Raspored primjene lijeka DARZALEX u kombinaciji s lenalidomidom (režim doziranja 4-tjednog ciklusa) i u monoterapiji
Patients had IgG/IgA/Light chain myeloma in 64%/22%/10% of instances, 19% had ISS Stage I, 42% had ISS Stage II, 38% had ISS Stage III disease and 84% had standard risk cytogenetics.
I bolesti prema ISS klasifikaciji, 42% je imalo ISS stadij II, 38% je imalo ISS stadij III i 84% je imalo citogenetiku standardnog rizika.
The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Medijan dobi bolesnika iznosio je 64 godine (raspon: 44 - 76 godina), 64% bolesnika bili su muškarci, a 76% bijelci.
DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
Kako DARZALEX izgleda i sadržaj pakiranja DARZALEX je koncentrat za otopinu za infuziju te bezbojna do žuta tekućina.
Doses up to 24 mg/kg have been administered intravenously in a clinical study.
U jednom su se kliničkom ispitivanju intravenski primjenjivale doze do 24 mg/kg.
• Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing 0.9% Sodium Chloride.
• Izvucite potreban volumen otopine lijeka DARZALEX iz bočica i razrijedite ga dodavanjem u istu infuzijsku vrećicu/spremnik koji sadrži 0,9%-tnu otopinu natrijeva klorida za injekciju.
Table 12: Additional efficacy results from Study MMY3004 Response evaluable patient number
Tablica 12: Dodatni rezultati djelotvornosti iz ispitivanja MMY3004 Broj bolesnika s mogućnošću procjene odgovora
However, baseline levels of NK cells did not show an association with clinical response.
Međutim, nije primijećena povezanost između početnog broja NK stanica i kliničkog odgovora.
The majority were male (59%), 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1 and 10% had an ECOG performance score of 2.
Većina bolesnika bili su muškarci (59%), 48% bolesnika imalo je ECOG funkcionalni status 0, njih 42% ECOG funkcionalni status 1, a njih 10% ECOG funkcionalni status 2. Četrdeset posto (40%) bolesnika imalo je stadij
• The active substance is daratumumab.
• Djelatna tvar je daratumumab.
Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
Striktan potpuni odgovor (sCR) [n (%)] Potpuni odgovor (CR) [n] Vrlo dobar djelomičan odgovor (VGPR) [n (%)]
One mL of concentrate contains 20 mg daratumumab.
Jedan ml koncentrata sadrži 20 mg daratumumaba.
Partial response (PR)
Djelomičan odgovor (PR) [n(%)]
Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Nemojte upotrijebiti otopinu ako sadrži vidljive neprozirne čestice, ako je promijenila boju ili ako primijetite bilo kakve druge strane čestice.
Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
Teške reakcije na infuziju uključile su bronhospazam, dispneju, edem larinksa, plućni edem, hipoksiju i hipertenziju.
Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Pojavile su se teške reakcije, uključujući bronhospazam, hipoksiju, dispneju, hipertenziju, edem larinksa i plućni edem.
Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
I prema ISS klasifikaciji, njih 45% imalo je stadij II, a njih 15% stadij III.
Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6.
U 5. i 6. ciklusu liječenja deksametazon se primjenjivao u dozi od 20 mg 1., 2., 8., 9., 15. i 16. dana.
Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of DARZALEX as follows:
1-3 sata prije svake infuzije lijeka DARZALEX, svim se bolesnicima moraju primijeniti lijekovi za smanjenje rizika od reakcija na infuziju, kako slijedi:
Dyspnoea Pulmonary oedema
dispneja plućni edem
Median PFS was not reached in the D-VMP arm and was 19.3 months in the VMP arm (HR=0.46; 95% CI: 0.36, 0.60; p<0.0001).
Medijan PFS-a nije bio dostignut u D-VMP skupini i bio je 19,3 mjeseca u VMP skupini (HR=0,46; 95% CI: 0,36; 0,60; p<0,0001).
Overall response (sCR+CR+VGPR+PR) n(%) p-value
Ukupni odgovor (sCR+CR+VGPR+PR), n (%) p-vrijednost
A decision should be made whether to discontinue breast-feeding or to discontinue DARZALEX therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Uzimajući u obzir korist dojenja za dijete i korist liječenja za majku, potrebno je donijeti odluku o tome hoće li se prekinuti dojenje ili prekinuti liječenje lijekom DARZALEX.
• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• u kombinaciji s lenalidomidom i deksametazonom ili bortezomibom, melfalanom i prednizonom za liječenje odraslih bolesnika s novodijagnosticiranim multiplim mijelomom koji nisu prikladni za autolognu transplantaciju matičnih stanica.
The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Medijan dobi bio je 73 godine (raspon: 45-90 godina), 44% bolesnika imalo je ≥ 75 godina.
Table 11: Additional efficacy results from Study MMY3003 Response evaluable patient number
Tablica 11: Dodatni rezultati djelotvornosti iz ispitivanja MMY3003 Broj bolesnika s mogućnošću ocjene odgovora
These studies suggest that daratumumab can induce tumour cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis in malignancies expressing CD38.
Ta ispitivanja ukazuju na to da kod zloćudnih tumora koji eksprimiraju CD38 daratumumab može inducirati lizu tumorske stanice putem citotoksičnosti ovisne o komplementu, stanično posredovane citotoksičnosti ovisne o protutijelima i stanične fagocitoze ovisne o protutijelima.
every two weeks (total of 8 doses)
Svaka dva tjedna (ukupno 8 doza)
Ringaskiddy, Co. Cork Ireland
Cork Irska
How much is given
Koliko ćete lijeka primiti
Median PFS was not reached in the DRd arm and was 33.8 months in the Rd arm (HR=0.56; 95% CI: 0.44, 0.71; p<0.0001).
Medijan PFS-a nije bio dosegnut u DRd skupini, dok je u Rd skupini iznosio 33,8 mjeseci (HR=0,56; 95% CI: 0,44; 0,71; p<0,0001).
All patients should be monitored throughout the infusion for IRRs.
Tijekom trajanja infuzije sve je bolesnike potrebno nadzirati na pojavu reakcija na infuziju.
Kaplan-Meier Curve of Primary Analysis of PFS in Study MMY3007
Slika 2: Kaplan-Meierova krivulja primarne analize PFS-a u ispitivanju MMY3007
Mantel-Haenszel estimate of the common odds ratio for stratified tables is used.
Korištena je Mantel-Haenszelova procjena običnog omjera izgleda (engl.common odds ratio) za stratificirane tablice.
If not used immediately, in-use storage times and conditions are the responsibility of the user and should be no more than 24 hours at refrigerated conditions (2°C-8°C) protected from light, followed by 15 hours (including infusion time) at room temperature (15°C-25°C) and room light.
(2°C - 8°C) zaštićeno od svjetlosti, a zatim 15 sati (uključujući vrijeme primjene infuzije) na sobnoj temperaturi (15°C-25°C) i sobnoj svjetlosti.
every two weeks (total of 4 doses)
Svaka dva tjedna (ukupno 4 doze)
Part 1 compared induction and consolidation treatment with DARZALEX 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (D-VTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
U prvom dijelu ispitivanja uspoređivalo se uvodno i konsolidacijsko liječenje lijekom DARZALEX 16 mg/kg u kombinaciji s bortezomibom, talidomidom i deksametazonom (DVTd) s liječenjem bortezomibom, talidomidom i deksametazonom (VTd) u bolesnika s novodijagnosticiranim multiplim mijelomom pogodnih za ASCT.
• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• u kombinaciji s bortezomibom, talidomidom i deksametazonom za liječenje odraslih bolesnika s novodijagnosticiranim multiplim mijelomom koji su prikladni za autolognu transplantaciju matičnih stanica.
500 mL 50 mL/hour 50 mL/hour every hour
50 ml/sat svakih sat vremena
Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
Kombinirano liječenje s bortezomibom, melfalanom i prednizonom (VMP) u bolesnika kod kojih nije prikladna autologna transplantacija matičnih stanica:
If an anaphylactic reaction or life-threatening (Grade 4) infusion reaction occurs, appropriate emergency resuscitation should be initiated immediately.
Ukoliko se pojavi anafilaktička ili po život opasna reakcija na infuziju (4. stupnja), odmah je potrebno započeti s prikladnom reanimacijom za hitne slučajeve te se liječenje lijekom DARZALEX mora odmah trajno obustaviti (vidjeti dijelove 4.2 i 4.3).
Manufacturer Janssen Biologics B.V. Einsteinweg 101
Proizvođač Janssen Biologics B.V.
Overall response rate 1 (ORR: sCR+CR+VGPR+PR) [n (%)]
1 (ORR: sCR+CR+VGPR+PR) [n
Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Kombinirano liječenje bortezomibom, talidomidom i deksametazonom (VTd) u bolesnika kod kojih je prikladna transplantacija autolognih matičnih stanica (ASCT):
• Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration.
• Prije uporabe, vizualno pregledajte lijekove za parenteralnu primjenu kako biste provjerili sadrže li čestice i jesu li promijenili boju.
NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
Poznato je da NK (engl. natural killer) stanice eksprimiraju velike količine proteina CD38 i da su osjetljive na staničnu lizu pod djelovanjem daratumumaba.
No formal studies of daratumumab in patients with hepatic impairment have been conducted.
Nisu provedena formalna ispitivanja daratumumaba u bolesnika s oštećenjem funkcije bubrega.
DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval
DRd=daratumumab-lenalidomid-deksametazon; Rd=lenalidomid-deksametazon; MRD=minimalna rezidualna bolest; CI=interval pouzdanosti