natgillin/translations-raw huggingface dataset:
• The patient alert card shall contain the following key messages: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is using Alunbrig o That Alunbrig treatment may increase the risk of early onset pulmonary events (including interstitial lung disease and pneumonitis) o Signs or symptoms of the safety concern and when to seek attention from a HCP o Contact details of the Alunbrig prescriber
• Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne poruke: o upozorenje za zdravstvene radnike koji u bilo kojem trenutku skrbe za bolesnika, uključujući i u hitnim stanjima, da bolesnik uzima Alunbrig o da liječenje lijekom Alunbrig može povećati rizik od plućnih događaja rano tijekom liječenja (uključujući intestricijsku bolest pluća i pneumonitis) o znakove ili simptome sigurnosnih rizika i kad potražiti liječničku pomoć o kontakt podatke liječnika koji je propisao Alunbrig
Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).
Brigatinib je inhibitor tirozin kinaze koji cilja ALK, c-ros onkogen 1(ROS1) i receptor inzulinu sličnog faktora rasta 1 (IGF-1R).
The primary route of excretion of brigatinib is in faeces.
Primarni put izlučivanja brigatiniba je putem fecesa.
The most common serious adverse reactions (≥ 2%) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.
Najčešće ozbiljne nuspojave (≥ 2 %) prijavljene u bolesnika liječenih lijekom Alunbrig u preporučenom režimu doziranja, osim događaja vezanih za progresiju neoplazme, bile su pneumonitis, upala pluća i dispneja.
Findings included embryo-lethality, reduced foetal growth, and skeletal variations.
Nalazi su uključivali smrtnost embrija, smanjen rast fetusa i promjene kostura.
If you stop taking Alunbrig
Ako prestanete uzimati Alunbrig
Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib.
Budući da brigatinib pokazuje visok stupanj topljivosti i visok stupanj permeabilnosti, ne očekuje se da će inhibicija Pgp-a i BCRP-a rezultirati klinički značajnom promjenom u sistemskoj izloženosti brigatinibu.
If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
Ako se uzimanje lijeka Alunbrig prekine na 14 dana ili dulje zbog razloga koji nisu vezani uz nuspojave, liječenje treba nastaviti sa 90 mg jedanput dnevno tijekom 7 dana prije povećanja na prethodno podnošljivu dozu.
Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood pressure; at 0.5 times the human Cmax), and renal effects (reduced renal function; at 1-2.5 times the human Cmax), but did not indicate any potential for QT prolongation or neurofunctional effects.
Ispitivanja sigurnosne farmakologije brigatiniba identificirala su potencijal za učinke na pluća (promijenjena brzina disanja, kod 1 - 2 puta Cmax u ljudi), učinke na kardiovaskularni sustav (promijenjena srčana frekvencija i krvni tlak; kod 0,5 puta Cmax u ljudi) i učinke na bubrege (smanjena funkcija bubrega; kod 1 - 2,5 puta Cmax u ljudi), ali nisu ukazala na nikakav potencijal za produljenje QT intervala niti učinke na neurološku funkciju.
If Alunbrig is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to a foetus.
Ako se Alunbrig koristi tijekom trudnoće ili bolesnica zatrudni dok uzima ovaj lijek, bolesnicu treba obavijestiti o potencijalnim opasnostima po fetus.
Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index (e.g., digoxin, dabigatran, methotrexate).
Bolesnike se treba pažljivo nadzirati kad se Alunbrig daje istodobno sa supstratima tih transportera s uskim terapijskim indeksom (npr. digoksin, dabigatran, metotreksat).
Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency.
Nuspojave prijavljene u ispitivanju ALTA i Ispitivanju 101 pri preporučenom režimu doziranja prikazane su u Tablici 3 i navedene prema klasifikaciji organskih sustava, preporučenim izrazima i učestalosti.
Figure 1: Investigator-Assessed Systemic Progression-Free Survival: ITT Population by Treatment Arm (ALTA)
Slika 1: Preživljenje bez progresije prema procjeni ispitivača: ITT populacija po liječenoj skupni (ALTA)
Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1).
Među njima, 19 bolesnika imalo je potvrđenu stopu objektivnog odgovora prema procjeni ispitivača (76 %; 95 % CI: 55, 91) a medijan trajanja odgovora među tih 19 ispitanika s odgovorom prema KM procjeni bio je 26,1 mjesec (95 % CI: 7,9, 26,1).
Each pack consists of an outer carton with two inner cartons containing:
Svako pakiranje se sastoji od vanjske kutije s dvije unutarnje kutije koje sadrže:
Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
Vaš liječnik može prekinuti liječenje lijekom Alunbrig i uputiti vas oftlamologu.
Alunbrig is available in plastic foil strips (blisters) packed in a carton with:
Alunbrig je dostupan u plastičnim blisterima s pokrovnom folijom, pakiranima u kutiji:
Each bottle contains one canister of a desiccant and is packed in a carton with:
Svaka bočica sadrži jedan spremnik sa sredstvom za sušenje, i pakirana je u kutiju:
In monkeys, findings included reduced size of testes along with microscopic evidence of hypospermatogenesis; these effects were reversible during the recovery period.
nalazi su uključivali smanjenu veličinu testisa zajedno s mikroskopskim dokazom postojanja hipospermatogeneze; ti su učinci bili reverzibilni tijekom razdoblja oporavka.
In repeated dose toxicity studies, lung changes (foamy alveolar macrophages) were noted in monkeys at ≥ 0.2 times the human AUC; however, these were minimal and similar to those reported as background findings in naive monkeys, and there was no clinical evidence of respiratory distress in these monkeys.
U ispitivanjima toksičnosti ponovljene doze, opažene su promjene na plućima (pjenasti alveolarni makrofagi) u majmuna pri izloženosti ≥ 0,2 puta AUC u ljudi; međutim, one su bile minimalne i slične onima prijavljenima kao osnovni nalaz u neliječenih majmuna pa nema kliničkih dokaza o respiratornom distresu u ovih majmuna.
A patient alert card
Kartica sa upozorenjima za bolesnika
Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Klinička ispitivanja interakcija s osjetljivim supstratima CYP3A nisu provedena.
bpm = beats per minute; CPK = Creatine Phosphokinase; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events.
CPK = kreatin fosfokinaza; DKT = dijastolički krvni tlak; SKT = sistolički krvni tlak; GGN = gornja granica normale *Stupnjevanje na temelju Zajedničkih terminoloških kriterija za nuspojave Nacionalnog instituta za rak.
Additionally, 2.3% of patients in ALTA experienced pneumonitis later in treatment, with 2 patients having Grade 3 pneumonitis (see sections 4.2 and 4.4).
Pored toga, 2,3 % bolesnika u ispitivanju ALTA imalo je pneumonitis kasnije tijekom liječenja, dok su 2 bolesnika imala pneumonitis 3. stupnja (vidjeti dijelove 4.2 i 4.4).
Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti-hypertensive medicinal product, or more intensive therapy than previously used indicated)
DKT ≥ 100 mmHg, indicirana medicinska intervencija, više od jednog antihipertenziva ili indicirana intenzivnija terapija nego što je ranije korištena)
No apparent adverse effects on female reproductive organs were observed in general toxicology studies in rats and monkeys.
U općim toksikološkim ispitivanjima nisu opaženi vidljivi štetni učinci na reproduktivne organe ženki štakora i majmuna.
In Study 101, the QT interval prolongation potential of Alunbrig was assessed in 123 patients with advanced malignancies following once daily brigatinib doses of 30 mg to 240 mg.
Ispitivanju 101, potencijal lijeka Alunbrig za produljenje QT intervala procijenjen je u 123 bolesnika s uznapredovalim zloćudnim bolestima nakon primjene doza brigatiniba od 30 mg do 240 mg jedanput dnevno.
Alunbrig contains lactose
Alunbrig sadrži laktozu
In Study 101, following administration of a single oral dose of brigatinib (30-240 mg) in patients, the median time to peak concentration (Tmax) was 1-4 hours postdose.
Ispitivanju 101, nakon peroralne primjene jedne doze brigatiniba (30 - 240 mg) u bolesnika, medijan vremena do postizanja vršne koncentracije (Tmax) bio je 1 - 4 sati od primjene.
If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time.
Ako bolesnik propusti dozu ili nakon uzimanja doze povrati, ne smije primijeniti dodatnu dozu, već sljedeću dozu treba uzeti u planirano vrijeme.
Testicular toxicity was observed in repeat-dose animal studies.
U ispitivanju ponovljenih doza na životinjama, opažena je testikularna toksičnost.
IRC assessments of intracranial ORR and duration of intracranial response in patients from ALTA with measurable brain metastases (≥ 10 mm in longest diameter) at baseline are summarised in Table 5.
Procjene IRC-a za intrakranijski ORR i trajanje intrakranijskog odgovora u bolesnika u ispitivanju ALTA, s mjerljivim metastazama na mozgu (≥ 10 mm na najduljem promjeru) na početku liječenja sažeto su prikazane u Tablici 5.
For elevations to Grade 3 and 4, the incidences for ALT and AST were 5.5% and 3.6%, respectively.
Incidencije porasta razina 3. i 4. stupnja, bile su 5,5% za ALT, odnosno 3,6 % za AST.
The European Medicines Agency has waived the obligation to submit the results of studies with Alunbrig in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Alunbrig u svim podskupinama pedijatrijske populacije za liječenje karcinoma pluća (karcinoma malih stanica i nemalih stanica) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Additional outcome measures included confirmed ORR as evaluated by an Independent Review Committee (IRC); time to response; progression free survival (PFS); duration of response (DOR); overall survival; and intracranial ORR and intracranial DOR as evaluated by an IRC.
Independent Review Committee, IRC); vrijeme do odgovora; preživljenje bez progresije bolesti (engl. progresion free survival, PFS); trajanje odgovora (engl. duration of response, DOR); ukupno preživljenje; i intrakranijski ORR i intrakranijski DOR, prema procjeni IRC-a.
Brigatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro.
Brigatinib je supstrat P-glikoproteina (P-gp) i proteina rezistencije raka dojke (BCRP) in vitro.
It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK).
Daje se bolesnicima čiji je rak pluća povezan s izmijenjenim oblikom gena zvanog kinaza anaplastičnog limfoma (ALK).
In ALTA, 6.4% of patients experienced pulmonary adverse reactions of any grade, including ILD/pneumonitis, pneumonia and dyspnoea, early in treatment (within 9 days, median onset: 2 days); 2.7% of patients had Grade 3-4 pulmonary adverse reactions and 1 patient (0.5%) had fatal pneumonia.
U ispitivanju ALTA, 6,4 % bolesnika imalo je na početku liječenja nuspojave na plućima nekog stupnja, uključujući IDL/pneumonitis, upalu pluća i dispneju (u roku od 9 dana, medijan vremena do pojave: 2 dana); 2,7 % bolesnika imalo je nuspojave na plućima 3 - 4. stupnja, a 1 bolesnik (0,5 %) imao je upalu pluća sa smrtnim ishodom.
Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg).
Alunbrig filmom obložene tablete su bijele do gotovo bijele, ovalne (90 mg i 180 mg) ili okrugle (30 mg).
Elevation of lipase or amylase
Porast vrijednosti lipaze ili amilaze
If pneumonitis is suspected, the dose of Alunbrig should be withheld, and the patient evaluated for other causes of symptoms (e.g., pulmonary embolism, tumour progression, and infectious pneumonia).
Ako se sumnja na pneumonitis, uzimanje sljedeće doze lijeka Alunbrig treba odgoditi, a bolesnika obraditi radi ocjene drugih uzroka simptoma (npr. plućna embolija, progresija tumora i infektivna upala pluća).
In ALTA, 13.5% of patients ≥ 65 years of age experienced an early pulmonary adverse reaction compared with 4.2% of patients < 65 years of age.
U ispitivanju ALTA, 13,5 % bolesnika ≥ 65 godina imalo je nuspojavu na plućima na početku liječenja, u usporedbi s 4,2 % bolesnika < 65 godina.
• weight loss
Gubitak težine
Coadministration of brigatinib with substrates of P-gp, (e.g., digoxin, dabigatran, colchicine, pravastatin), BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine), organic cation transporter 1 (OCT1), multidrug and toxin extrusion protein 1 (MATE1), and 2K (MATE2K) may increase their plasma concentrations.
Istodobna primjena brigatiniba sa supstratima P-gp-a, (poput digoksina, dabigatrana, kolhicina, pravastatina) ili BCRP-a (poput metotreksata, rosuvastatina, sulfasalazina), transportera organskih kationa 1 (OCT1), proteina za ekstruziju više lijekova i toksina 1 (MATE1), i 2K (MATE2K) može povisiti njihove plazmatske koncentracije.
Heart rate should be monitored more frequently in patients if concomitant use of a medicinal product known to cause bradycardia cannot be avoided.
Potrebno je češće pratiti srčanu frekvenciju ako se u bolesnika ne može izbjeći istodobna uporaba lijeka za kojeg je poznato da uzrokuje bradikardiju.
Note: Progression-Free survival was defined as time from initiation of treatment until the date at which disease progression was first evident or death, whichever comes first.
Skraćenice: ITT = populacija predviđena za liječenje (engl. intent to treat) Napomena: Preživljenje bez progresije bolesti definirano je kao vrijeme od početka liječenja do datuma u kojem je prvi put dokazana progresija bolesti ili je došlo do fatalnog ishoda, što god nastupi ranije.
• mibefradil: a medicine to treat irregular heart rhythm and high blood pressure
• mibefradil: lijek za liječenje nepravilnog srčanog ritma i visokog krvnog tlaka
Symptomatic bradycardia
Simptomatska bradikardija
Intracranial disease control rate
Stopa kontrole intrakranijske bolesti
Alunbrig may cause foetal harm when administered to a pregnant woman.
Alunbrig može naštetiti fetusu ako se primjenjuje u trudnica.
Table 1: Recommended Alunbrig dose reduction levels Dose
Tablica 1: Preporučene razine smanjenja doze lijeka Alunbrig Doza
Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.
Brigatinib može sniziti razine istodobno primijenjenih lijekova u plazmi koji se uglavnom metaboliziraju putem CYP3A.
Creatine phosphokinase (CPK) elevation
Porast razine kreatin fosfokinaze (CPK)
Moderate CYP3A inducers may decrease the AUC of brigatinib by approximately 50% based on simulations from a physiologically-based pharmacokinetic model.
Umjereni induktori CYP3A mogu smanjiti AUC brigatiniba za približno 50 %, temeljeno na simulacijama iz fiziološki temeljenog farmakokinetičkog modela.
• increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests -may indicate liver cell damage.
• povišene razine jetrenih enzima u nalazima krvi (aspartat aminotransferaze, alanin aminotransferaze) mogu ukazivati na oštećenje stanica jetre.
• reduced number of white blood cells, called neutrophils and lymphocytes, in blood tests
• smanjen broj bijelih krvnih stanica, zvanih neutrofili i limfociti u nalazima krvi
Moderate CYP3A inhibitors (e.g., diltiazem and verapamil) may increase the AUC of brigatinib by approximately 40% based on simulations from a physiologically-based pharmacokinetic model.
Umjereni inhibitori CYP3A (npr. diltiazem i verapamil) mogu povećati AUC brigatiniba za približno 40 %, temeljeno na simulacijama iz fiziološki temeljenog farmakokinetičkog modela.
• tissue swelling caused by excess fluid
• oticanje tkiva uzrokovano prekomjernim nakupljanjem tekućine
Overall, these effects on the male reproductive organs in rats and monkeys occurred at exposures ≥ 0.2-times the AUC observed in patients at the 180 mg once daily dose.
Ukupno, ti učinci na reproduktivne organe mužjaka štakora i majmuna javljali su se pri izloženostima ≥ 0,2 - puta od AUCa opaženog u bolesnika na dozi od 180 mg jedanput dnevno.
Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor.
Alunbrig sadrži djelatnu tvar brigatinib, vrstu lijeka protiv raka koji pripada u skupinu inhibitora kinaze.
Brigatinib inhibited the in vitro and in vivo viability of cells expressing mutant forms of EML4-ALK associated with resistance to ALK inhibitors, including G1202R and L1196M.
Brigatinib je inhibirao, in vitro i in vivo, vijabilnost stanica koje eksprimiraju mutirane oblike EML4-ALK povezane s rezistencijom na inhibitore ALK, uključujući G1202R i L1196M.
Very common Anaemia Lymphocyte count decreased APTT increased White blood cell count decreased
Vrlo često Anemija Smanjen broj limfocita Povišen APTT Smanjen broj bijelih krvnih stanica
Post-authorisation efficacy study (PAES): In order to further characterise the efficacy and safety of brigatinib in the treatment of patients with ALK positive NSCLC, the MAH should submit the clinical study report of the phase III study AP26113-13-301 comparing brigatinib versus crizotinib in patients with advanced ALK+ NSCLC who have not previously received ALK-directed therapy.
Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Radi daljnje karakterizacije djelotvornosti i sigurnosti brigatiniba u liječenju bolesnika s ALK pozitivnim NSCLC-om, nositelj odobrenja treba predati izvješće kliničkog ispitivanja faze III AP26133-13-301 koje uspoređuje primjenu brigatiniba u odnosu na krizotinib u bolesnika s uznapredovalim ALK+ NSCLCom koji nisu prethodno primili terapiju usmjerenu na ALK.
Alunbrig is available in plastic bottles with child resistant screw top closures.
Alunbrig je dostupan u plastičnim bočicama s navojnim sigurnosnim zatvaračima za djecu.
• If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved.
• Ako se adekvatna kontrola hiperglikemije ne može postići optimalnim medicinskim zbrinjavanjem, potrebno je prekinuti primjenu lijeka Alunbrig do postizanja odgovarajuće kontrole hiperglikemije.
The population pharmacokinetic analyses showed that body weight, age, and albumin concentration had no clinically relevant impact on the pharmacokinetics of brigatinib.
Populacijska farmakokinetička analiza pokazala je da tjelesna težina, dob i koncentracija albumina nisu imali klinički značajan utjecaj na farmakokinetiku brigatiniba.
In in vitro kinase and cellular assays, the metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than brigatinib.
U in vitro testovima kinaze i kulture stanica, metabolit AP26123 inhibirao je ALK uz približno trostruko nižu potentnost nego brigatinib.
Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see section 5.3).
U ispitivanjima toksičnosti ponovljenih doza na mužjacima životinja, pokazalo se da Alunbrig može uzrokovati smanjenu plodnost mužjaka (vidjeti dio 5.3).
Alunbrig may be taken with or without food.
Alunbrig se može uzimati s hranom ili bez nje.
It is unknown whether Alunbrig is excreted in human milk.
Nije poznato izlučuje li se Alunbrig u majčino mlijeko u ljudi.
If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced by approximately 50% (i.e. from 180 mg to 90 mg, or from 90 mg to 60 mg).
Ako se ne može izbjeći istodobna primjena snažnih inhibitora CYP3A, dozu lijeka Alunbrig treba smanjiti za približno 50 % (tj. sa 180 mg na 90 mg ili sa 90 mg na 60 mg).
• muscle problems
• probleme s mišićima
In case of life-threatening bradycardia, if no contributing concomitant medication is identified or in case of recurrence, treatment with Alunbrig should be discontinued (see section 4.2).
U slučaju bradikardije opasne po život, ako se ne identificira istodobno primjenjivani lijek koji pridonosi stanju, ili u slučaju ponovne pojave, potrebno je prekinuti liječenje lijekom Alunbrig (vidjeti dio 4.2).
The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided (see section 4.5).
Istodobnu primjenu lijeka Alunbrig s jakim i umjerenim induktorima CYP3A treba izbjegavati (vidjeti dio 4.5).
180 mg once daily reduce to 120 mg once daily reduce to 90 mg once daily reduce to 60 mg once daily
180 mg jedanput dnevno smanjiti na 120 mg jedanput dnevno smanjiti na 90 mg jedanput dnevno smanjiti na 60 mg jedanput dnevno
• pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels
• pravastatin, rosuvastatin: lijekovi za snižavanje povišenih razina kolesterola
If you forget to take Alunbrig
Ako ste zaboravili uzeti Alunbrig
Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification.
Nuspojave na plućima 1-2. stupnja povukle su se s prekidom liječenja ili prilagodbom doze.
Patients with a history of pulmonary interstitial disease or drug-related pneumonitis were excluded.
Bolesnici s anamnezom intersticijske plućne bolesti ili pneumonitisa povezanog s lijekom su bili isključeni.
In healthy subjects, compared to overnight fasting, a high fat meal reduced brigatinib Cmax by 13% with no effect on AUC.
U zdravih ispitanika, obrok s visokim udjelom masti, u usporedbi s primjenom natašte, umanjiio je Cmax brigatiniba za 13 % bez utjecaja na AUC.
Brigatinib is a substrate of the transporter proteins P-gp and BCRP.
Brigatinib je supstrat transportnih proteina P-gp i BCRP.
Brigatinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) or the mammalian cell chromosomal aberration assays, but slightly increased the number of micronuclei in a rat bone marrow micronucleus test.
Brigatinib nije bio mutagen in vitro u bakterijskom testu reverzne mutacije (Ames) ili testovima kromosomskih aberacija u stanicama sisavaca, ali je blago povisio broj mikronukleusa u mikronukleusnom testu koštane srži štakora.
These factors should be considered when initiating treatment with Alunbrig.
Te čimbenike treba uzeti u obzir pri početku liječenja lijekom Alunbrig.
In urine and faeces combined, 48%, 27%, and 9.1% of the radioactive dose was excreted as unchanged brigatinib, N-desmethyl brigatinib (AP26123), and brigatinib cysteine conjugate, respectively.
Putem urina i fecesa zajedno, izlučeno je 48 %, 27 % i 9,1 % radioaktivne doze u obliku nepromijenjenog brigatiniba, N-desmetilbrigatiniba (AP26123), odnosno konjugata brigatiniba s cisteinom.
Table 3: Adverse reactions reported in patients treated with Alunbrig in ALTA and Study 101 (per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) System organ class
Tablica 3: Nuspojave prijavljene u bolesnika liječenih lijekom Alunbrig u ispitivanju ALTA i Ispitivanju 101 (prema Zajedničkim terminološkim kriterijima za nuspojave (CTCAE), verzija 4.0)