natgillin/translations-raw huggingface dataset:
A hazard ratio less than 1 indicates an advantage for the ixazomib regimen.
Omjer hazarda manji od 1 ukazuje na prednost terapijskog režima iksazomibom.
It is unknown whether ixazomib or its metabolites are excreted in human milk.
Nije poznato izlučuju li se iksazomib ili njegovi metaboliti u majčino mlijeko u ljudi.
Patients received one to three prior therapies (median of 1) including prior treatment with bortezomib (69%), carfilzomib (<1%), thalidomide (45%), lenalidomide (12%), melphalan (81%).
Bolesnici su primili jednu do 3 prethodne terapije (medijan 1) uključujući prethodnu terapiju bortezomibom (69%), karfilzomibom (< 1%), talidomidom (45%), lenalidomidom (12%), melfalanom (81%).
Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhoea (2%).
Ozbiljne nuspojave prijavljene u ≥ 2% bolesnika uključivale su trombocitopeniju (2%) i dijareju (2%).
Ixazomib was positive in an in vitro clastogenicity test in human peripheral blood lymphocytes.
Iksazomib je bio pozitivan u in vitro testu klastogenosti na limfocitima periferne ljudske krvi.
Days 23 to 28
23. do 28. dan
Non-clinical safety pharmacology studies both in vitro (on hERG channels) and in vivo (in telemetered dogs following single oral administration) demonstrated no effects of ixazomib on cardiovascular or respiratory functions at AUC more than 8-fold higher than the clinical value.
Neklinička ispitivanja sigurnosne farmakologije in vitro (na hERG kanalima) te in vivo (u telemetrijski praćenih pasa nakon peroralne primjene pojedinačne doze) nisu dokazala učinke iksazomiba na kardiovaskularne ili respiratorne funkcije pri AUC-u 8 puta većem od kliničke vrijednosti.
Treatment with ixazomib in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited (see section 5.1).
Liječenje iksazomibom u kombinaciji s lenalidomidom i deksametazonom dulje od 24 ciklusa treba se temeljiti na procjeni odnosa koristi i rizika za svakog pojedinog bolesnika, jer su podaci o podnošljivosti i toksičnosti za više od 24 ciklusa ograničeni (vidjeti dio 5.1).
Ixazomib is 99% bound to plasma proteins and distributes into red blood cells with a blood-to-plasma AUC ratio of 10.
Iksazomib je 99% vezan za proteine plazme i distribuira se u eritrocite s omjerom AUC krv/plazma od 10.
Ixazomib did not induce CYP1A2, CYP2B6, and CYP3A4/5 activity or corresponding immunoreactive protein levels.
Iksazomib nije inducirao aktivnost CYP1A2, CYP2B6 i CYP3A4/5 ili razine odgovarajućih imunoreaktivnih proteina.
• severe skin rashes such as red to purple bumps (Sweet's syndrome) or rash with skin peeling and mouth sores (Stevens-Johnson syndrome)
• teški kožni osipi poput crvenih do ljubičastih plakova (Sweetov sindrom) ili osip s guljenjem kože i ranama u ustima (Stevens-Johnsonov sindrom)
• cold-like symptoms (upper respiratory tract infection)
• simptomi nalik prehladi (infekcija gornjeg dišnog sustava)
Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%).
Mnogi bolesnici uključeni u ispitivanje imali su uznapredovalu bolest Durie-Salmon stadija III (69%) pri početnoj dijagnozi i povijest liječenja u kojem su primili najmanje 2 prethodne terapije (60%), uz refraktornost na talidomid (63%).
Patients included in studies with ixazomib who received antiviral prophylaxis had a lower incidence of herpes zoster infection compared to patients who did not receive prophylaxis.
Bolesnici uključeni u ispitivanja iksazomiba koji su primali antivirusnu profilaksu imali su nižu incidenciju infekcije herpes zosterom u usporedbi s bolesnicima koji nisu primili profilaksu.
If you have liver or kidney problems, your doctor may prescribe NINLARO capsules containing 3 mg.
Ako imate problema s jetrom ili bubrezima, liječnik može propisati NINLARO kapsule u dozi od 3 mg.
If you are uncertain whether the condition above applies to you, talk to your doctor, pharmacist or nurse before taking NINLARO.
Ako niste sigurni odnosi li se nešto od gore navedenog na vas, razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom prije nego uzmete lijek NINLARO.
What NINLARO is and what it is used for
Što je NINLARO i za što se koristi
The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines.
Kombinacija iksazomiba i lenalidomida dokazala je sinergističke citotoksične učinke u staničnim linijama multiplog mijeloma.
If ixazomib is used during pregnancy or if the patient becomes pregnant while taking ixazomib, the patient should be apprised of the potential hazard to the foetus.
Ako se iksazomib koristi tijekom trudnoće ili ako bolesnica zatrudni za vrijeme terapije iksazomibom, bolesnicu treba obavijestiti o potencijalnoj opasnosti za fetus.
After oral administration of a radiolabeled dose, 70% of total drug-related material in plasma was accounted for by ixazomib.
Nakon peroralne primjene radiooznačene doze, 70% ukupnog materijala povezanog s lijekom u plazmi sastojalo se od iksazomiba.
Figure 1: Kaplan-Meier plot of progression-free survival in the intent-to-treat population
Slika 1: Kaplan-Meierova krivulja preživljenja bez napredovanja bolesti u populaciji bolesnika s namjerom liječenja
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA OVITAK
Closely monitor patients for disease control if coadministration with a strong CYP3A inducer cannot be avoided.
Potrebno je pažljivo nadzirati kontrolu bolesti ako se ne može izbjeći istodobna primjena jakih induktora CYP3A.
NINLARO is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine).
NINLARO se primjenjuje s lenalidomidom (lijekom koji utječe na način rada imunološkog sustava) i deksametazonom (protuupalnim lijekom).
The most common adverse reactions were blurred vision (5% in the ixazomib regimen and 4% in the placebo regimen), dry eye (4% in the ixazomib regimen and 1% in the placebo regimen), conjunctivitis (5% in the ixazomib regimen and 1% in the placebo regimen) and cataract (4% in the ixazomib regimen and 5% in the placebo regimen).
Najčešće nuspojave bile su zamućenje vida (5% u režimu s iksazomibom i 4% u režimu s placebom), suhoća oka (4% u režimu iksazomibom i 1% u režimu s placebom), konjunktivitis (5% u režimu s iksazomibom i 1% u režimu s placebom) i katarakta (4% u režimu s iksazomibom i 5% u režimu s placebom).
Thrombocytopenia can be managed with dose modifications (see section 4.2) and platelet transfusions as per standard medical guidelines.
Trombocitopenija se može zbrinuti prilagodbama doze (vidjeti dio 4.2) i transfuzijama trombocita prema standardnim medicinskim smjernicama.
Posterior reversible encephalopathy syndrome (PRES) has occurred in patients receiving ixazomib.
Prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (engl. posterior reversibile encephalopathy syndrome, PRES) u bolesnika koji su uzimali iksazomib.
Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma.
Liječenje mora započeti i nadzirati liječnik iskusan u liječenju multiplog mijeloma.
• Absolute neutrophil count should be ≥ 1,000/mm3
• Apsolutni broj neutrofila treba biti ≥ 1000/mm3
Do not crush, chew or open the capsule.
Nemojte lomiti, žvakati niti otvarati kapsulu.
Multiple myeloma is a cancer of the blood which affects a type of cell, called the plasma cell.
Multipli mijelom je rak krvi koji zahvaća vrstu stanica, takozvane plazma stanice.
‡ORR = CR+VGPR+PR §Based on responders in the response-evaluable population
‡ORR = CR+VGPR+PR §Na temelju bolesnika koji su reagirali na terapiju u populaciji kod koje je moguće procijeniti odgovor
Patients that changed therapies prior to disease progression were eligible for enrolment, as well as those with controlled cardiovascular conditions.
Za uključivanje su bili primjereni bolesnici koji su prije napredovanja bolesti mijenjali terapiju, kao i oni s kontroliranim kardiovaskularnim stanjima.
Very common side effects may affect more than 1 in 10 people:
Vrlo česte nuspojave koje se mogu javiti u više od 1 na 10 osoba:
The most common type of rash reported in both regimens was maculo-papular and macular rash.
Najčešći tip osipa zabilježen u oba režima bili su makulopapularni i makularni osip.
*P-value is based on the stratified log-rank test. †Hazard ratio is based on a stratified Cox's proportional hazard regression model.
†Procjena omjera hazarda temelji se na Coxovom regresijskom modelu proporcionalnog hazarda.
3 packs of 1 hard capsule.
3 pakiranja s po 1 tvrdom kapsulom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
Datum prvog odobrenja: 21. studenoga 2016.
Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Germany
Takeda GmbH Production SiteSingen Robert Bosch Strasse 8 78224 Singen Njemačka
Fifty seven percent of patients had undergone prior stem cell transplantation.
Pedeset i sedam posto bolesnika podvrgnulo se prethodnoj transplantaciji matičnih stanica.
Co-administration of ixazomib with rifampicin decreased ixazomib Cmax by 54% and AUC by 74%.
Istodobna primjena iksazomiba s rifampicinom smanjila je Cmax iksazomiba za 54% i AUC za 74%.
Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Germany
Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Njemačka
• nausea, vomiting and diarrhoea
• mučnina, povraćanje i proljev
Thrombocytopenia did not result in an increase in haemorrhagic events or platelet transfusions.
Trombocitopenija nije uzrokovala porast u hemoragijskim događajima ili transfuzijama trombocita.
• reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
• reaktivacija virusa vodenih kozica, što može uzrokovati kožni osip i bol (herpes zoster)
Ixazomib is not recommended during pregnancy as it can cause foetal harm when administered to a pregnant woman.
Iksazomib se ne preporučuje tijekom trudnoće jer može uzrokovati oštećenje fetusa kada se primjenjuje kod trudnica.
At concentrations exceeding those observed clinically, ixazomib was metabolized by multiple CYP isoforms with estimated relative contributions of 3A4 (42.3%), 1A2 (26.1%), 2B6 (16.0%), 2C8 (6.0%), 2D6 (4.8%), 2C19 (4.8%) and 2C9 (< 1%).
Pri koncentracijama koje premašuju one uočene klinički, iksazomib se metabolizira putem više CYP izooblika s procijenjenim relativnim doprinosima za 3A4 (42,3%), 1A2 (26,1%), 2B6 (16,0%), 2C8 (6,0%), 2D6 (4,8%), 2C19 (4,8%) i 2C9 (< 1%).
• skin rash that may be itchy and in a few areas or all over the body
• kožni osip koji može svrbjeti i zahvatiti nekoliko mjesta ili cijelo tijelo
• Platelet count should be ≥ 75,000/mm3
• Broj trombocita treba biti ≥ 75 000/mm3
Other Grade 3 or 4 non-haematological toxicities
Druge nehematološke toksičnosti Druge nehematološke toksičnosti 3. ili 4. stupnja
Its active substance ixazomib works by blocking the action of proteasomes.
Njegova djelatna tvar, iksazomib, blokira djelovanje proteasoma.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Talidomid je poznata djelatna tvar s teratogenim učinkom na ljude koja uzrokuje teške životno ugrožavajuće urođene anomalije.
The ixazomib dose reduction steps are presented in Table 1 and the dose modification guidelines are provided in Table 2.
Koraci smanjenja doze iksazomiba prikazani su u Tablica 1, a smjernice za prilagodbu doze prikazane su u Error!
However, ixazomib was negative in an in vivo comet assay in mice, in which percent tail DNA was assessed in the stomach and liver.
Međutim, iksazomib je bio negativan u in vivo kometnom testu na miševima u kojima je postotak oštećene DNK procijenjen u trbuhu i jetri.
A missed dose should not be taken within 72 hours of the next scheduled dose.
Propuštenu dozu ne smije se uzeti unutar 72 sata prije sljedeće predviđene doze.
If you have side effects, your doctor may prescribe NINLARO capsules containing 3 mg or 2.3 mg.
Ako imate nuspojave, liječnik može propisati NINLARO kapsule u dozi od 3 mg ili 2,3 mg.
If you forget to take NINLARO
Ako ste zaboravili uzeti lijek NINLARO
At clinically relevant ixazomib concentrations, in vitro studies using human cDNA-expressed cytochrome P450 isozymes indicate that no specific CYP isozyme predominantly contributes to ixazomib metabolism and non-CYP proteins contribute to overall metabolism.
Pri klinički značajnim koncentracijama iksazomiba, in vitro ispitivanja koristeći izoenzime citokroma P450 eksprimirane iz ljudske cDNK ukazuju da nijedan specifični CYP izoenzim ne pridonosi pretežno metabolizmu iksazomiba i da ne-CYP proteini pridonose ukupnom metabolizmu.
In the event that a ixazomib dose is delayed or missed, the dose should be taken only if the next scheduled dose is ≥ 72 hours away.
U slučaju odgode ili propuštanja doze iksazomiba, dozu treba uzeti samo ako je vrijeme do sljedeće predviđene doze ≥ 72 sata.
If contact occurs, wash thoroughly with soap and water.
U slučaju doticaja s lijekom, kožu temeljito operite vodom i sapunom.
How and when to take NINLARO
Kako i kada uzimati NINLARO
A total of 722 patients (intent-to-treat [ITT] population) were randomised in a 1:1 ratio to receive either the combination of ixazomib, lenalidomide, and dexamethasone (N=360; ixazomib regimen) or placebo, lenalidomide and dexamethasone (N=362; placebo regimen) until disease progression or unacceptable toxicity.
Ukupno 722 bolesnika (populacija bolesnika s namjerom liječenja [ITT]) randomizirano je u omjeru 1:1 kako bi primali ili kombinaciju iksazomiba, lenalidomida i deksametazona (N = 360; režim s iksazomibom) ili placebo, lenalidomid i deksametazon (N = 362; režim s placebom) sve do napredovanja bolesti ili neprihvatljive toksičnosti.
The most commonly reported reaction was peripheral sensory neuropathy (16% and 12% in the ixazomib and placebo regimen, respectively).
Najčešće prijavljena nuspojava bila je periferna senzorna neuropatija (16% i 12% u skupinama koje su primale iksazomib, odnosno placebo).
• Withhold ixazomib until peripheral neuropathy recovers to ≤ Grade 1 without pain or patient's baseline.
• Odgodite primjenu iksazomiba dok se periferna neuropatija ne vrati na ≤ 1. stupanj bez boli ili na početno bolesnikovo stanje.
• rapid death of cancer cells that may cause dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (tumour lysis syndrome)
• ubrzana smrt stanica raka koja može uzrokovati omaglicu, smanjeno mokrenje, smetenost, povraćanje, mučninu, oticanje, nedostatak zraka ili poremećaje srčanog ritma (sindrom lize tumora)
• irregular heart rate (arrhythmia)
• nepravilni srčani otkucaji (aritmija)
NINLARO, lenalidomide and dexamethasone are taken in 4-week treatment cycles.
NINLARO, lenalidomid i deksametazon uzimaju se u 4-tjednim terapijskim ciklusima.
If the capsule breaks, clean up the powder, taking care that it does not cause dust in the air.
U slučaju loma kapsule, počistite prašak, pazeći da se ne podiže u zrak.
The recommended dose of dexamethasone is 40 mg taken once a week on the same day for all 4 weeks of the cycle.
Preporučena doza deksametazona je 40 mg jedanput tjedno na isti dan tijekom sva četiri tjedna ciklusa.
Protein produced by myeloma cells can damage the kidneys.
Protein koji stvaraju mijelomske stanice može oštetiti bubrege.
Women should avoid becoming pregnant while being treated with ixazomib.
Žene trebaju izbjegavati trudnoću dok se liječe iksazomibom.
• In the capsule: microcrystalline cellulose, magnesium stearate and talc.
• U kapsuli: mikrokristalična celuloza, magnezijev stearat i talk.
If a dose is missed or delayed, you should take the dose as long as the next scheduled dose is more than 3 days or 72 hours away.
Ako propustite ili zakasnite s primjenom doze, uzmite je ako je vrijeme do sljedeće predviđene doze dulje od 3 dana ili 72 sata.
Patients received ixazomib 4 mg or placebo on Days 1, 8, and 15 plus lenalidomide (25 mg) on Days 1 through 21 and dexamethasone (40 mg) on Days 1, 8, 15, and 22 of a 28-day cycle.
Bolesnici su primali iksazomib 4 mg ili placebo na 1., 8. i 15. dan, plus lenalidomid (25 mg) od 1. do 21. dana i deksametazon (40 mg) na 1., 8., 15. te 22. dan 28-dnevnog ciklusa.
The dose should be adjusted for severe (Grade 3-4) symptoms (see section 4.2).
Dozu treba prilagoditi za teške (3.−4. stupnja) simptome (vidjeti dio 4.2).
Therefore, co-administration of strong CYP3A inducers with ixazomib is not recommended (see section 4.4).
Stoga se ne preporučuje istodobna primjena jakih induktora CYP3A s iksazomibom (vidjeti dio 4.4).
Unbound dose-normalized AUC was 27% higher in patients with moderate or severe hepatic impairment as compared to patients with normal hepatic function (see section 4.2).
AUC nevezane frakcije lijeka normaliziran za dozu bio je 27% viši u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre u usporedbi s bolesnicima s normalnom funkcijom jetre (vidjeti dio 4.2).
Ixazomib is not dialyzable and, therefore, can be administered without regard to the timing of dialysis (see section 5.2).
Iksazomib se ne uklanja dijalizom te se stoga može primijeniti bez obzira na vrijeme dijalize (vidjeti dio 5.2).
Refer to the lenalidomide SmPC, section 4.2 for the dose reduction steps for these toxicities.
Proučite dio 4.2 sažetka opisa svojstava lijeka za lenalidomid za korake smanjenja doze za te toksičnosti.
The most frequently reported adverse reactions (≥ 20%) across 417 patients treated within the ixazomib regimen and 418 patients within the placebo regimen were diarrhoea (39% vs. 32%), thrombocytopenia (33% vs. 21%), neutropenia (33% vs. 30%), constipation (30% vs. 22%), peripheral neuropathy (25% vs. 20%), nausea (23% vs. 18%), peripheral oedema (23% vs. 17%), vomiting (20% vs. 10%) and upper respiratory tract infection (21% vs. 16%).
Najčešće zabilježene nuspojave (≥ 20%) među 417 bolesnika koji su primali iksazomib i 418 bolesnika koji su primali placebo bile su dijareja (39% naspram 32%), trombocitopenija (33% naspram 21%), neutropenija (33% naspram 30%), konstipacija (30% naspram 22%), periferna neuropatija (25% naspram 20%), mučnina (23% naspram 18%), periferni edem (23% naspram 17%), povraćanje (20% naspram 10%) i infekcija gornjeg dišnog trakta (21% naspram 16%).
Ixazomib was not mutagenic in a bacterial reverse mutation assay (Ames assay) or clastogenic in a bone marrow micronucleus assay in mice.
Iksazomib nije bio mutagen u testu reverzne mutacije na bakterijama (Amesov test) ili klastogen u mikronukleusnom testu koštane srži u miševa.
NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
NINLARO je u kombinaciji s lenalidomidom i deksametazonom indiciran za liječenje odraslih bolesnika s multiplim mijelomom koji su primili barem jednu prethodnu terapiju.
• Withhold lenalidomide until rash recovers to ≤ Grade 1.
• Odgodite primjenu lenalidomida dok se osip ne vrati na ≤ 1. stupanj.
Breast-feeding should be stopped when taking NINLARO.
Dojenje treba prekinuti tijekom uzimanja lijeka NINLARO.
Ixazomib is given in combination with lenalidomide.
Iksazomib se daje u kombinaciji s lenalidomidom.
NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma.
NINLARO ćete primati zajedno s lenalidomidom i deksametazonom, drugim lijekovima koji se koriste za liječenje multiplog mijeloma.
Day 1 Days 2 to 7
4. tje dan dan 2. do 7. dan dan
In vitro, ixazomib affected cell types found in the bone marrow microenvironment including vascular endothelial cells, osteoclasts and osteoblasts.
In vitro je iksazomib utjecao na vrste stanica nađene u mikrookolini koštane srži uključujući stanice vaskularnog endotela, osteoklaste i osteoblaste.
At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the ixazomib regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60).
U primarnoj analizi (medijan praćenja od 8 mjeseci i medijan od 6 ciklusa) medijan PFS-a iznosio je 6,7 mjeseci u režimu s iksazomibom, u usporedbi s 4 mjeseca u režimu s placebom (p-vrijednost = 0,035, HR = 0,60).
Ixazomib is not expected to produce drug-drug interactions via CYP inhibition or induction.
Ne očekuje se da će iksazomib uzrokovati interakcije lijekova putem inhibicije ili indukcije CYP enzima.
There was no discernible relationship between ixazomib concentration and the RR interval suggesting no clinically meaningful effect of ixazomib on heart rate.
Nije bilo primjetne povezanosti između koncentracije iksazomiba i RR intervala, što ukazuje da iksazomib nema klinički značajan utjecaj na srčani ritam.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S
A planned interim analysis for overall survival (OS) at a median follow up of 23 months was conducted with 35% of the required number of deaths for final OS analysis in the ITT population; there were 81 deaths in the ixazomib regimen and 90 deaths in the placebo regimen.
Planirana interim analiza ukupnog preživljenja pri medijanu praćenja od 23 mjeseca provedena je s 35% smrtnih slučajeva potrebnih za konačnu analizu ukupnog preživljenja u populaciji s namjerom liječenja; zabilježen je 81 smrtni slučaj u skupini koja je primala režim s iksazomibom i 90 smrtnih slučajeva u skupini koja je primala terapijski režim s placebom.
Avoid becoming pregnant or breast-feeding while being treated with NINLARO.
Izbjegavajte trudnoću ili dojenje dok se liječite lijekom NINLARO.
= intake of medicinal product
= Primjena lijeka
The efficacy and safety of ixazomib in combination with lenalidomide and dexamethasone was evaluated in an international randomised, double-blind, placebo-controlled, multicenter Phase 3 superiority study (C16010) in patients with relapsed and/or refractory multiple myeloma who had received at least one prior therapy.
Djelotvornost i sigurnost iksazomiba u kombinaciji s lenalidomidom i deksametazonom procijenjene su u međunarodnom randomiziranom dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju superiornosti faze 3 (C16010) u bolesnika s recidivirajućim i/ili refraktornim multiplim mijelomom koji su primili barem jednu prethodnu terapiju.
In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma.
In vivo je iksazomib pokazao antitumorsku aktivnost u različitim tumorskim modelima ksenografta uključujući modele multiplog mijeloma.
Thrombocytopenia has been reported with ixazomib (see section 4.8) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle (see section 4.8).
Trombocitopenija je zabilježena pri primjeni iksazomiba (vidjeti dio 4.8) s najnižim vrijednostima trombocita koje su se u pravilu javljale između 14. i 21. dana svakog 28-dnevnog ciklusa i oporavljale na početno stanje do početka sljedećeg ciklusa (vidjeti dio 4.8).
Ixazomib is not a reversible or a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.
Iksazomib nije reverzibilni ili o vremenu ovisan inhibitor enzima CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ili 3A4/5.
• low platelet counts (thrombocytopenia) which may increase the risk of nose bleeds and you may easily bruise
• nizak broj trombocita (trombocitopenija) koji može povećati rizik od krvarenja iz nosa i lakog stvaranja modrica
NINLARO is used to treat a cancer of the bone marrow called multiple myeloma.
NINLARO se koristi za liječenje raka koštane srži zvanog multipli mijelom.