natgillin/translations-raw huggingface dataset:
Elderly patients (≥65 years of age) are at a higher risk of renal insufficiency and dehydration which may be a complication of diarrhoea and these patients should be carefully monitored.
Stariji bolesnici (≥65 godina) izloženi su većem riziku od bubrežne insuficijencije i dehidracije, koje mogu biti komplikacija proljeva; te je bolesnike potrebno pažljivo pratiti.
The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
Preporučena doza lijeka Nerlynx je 6 tableta jednom dnevno (ukupno 240 mg).
Studies in animals have shown embryo-foetal lethality and foetal morphological anomalies (see Section 5.3).
Ispitivanja provedena na životinjama pokazala su mortalitet embrija i fetusa te morfološke anomalije fetusa (vidjeti dio 5.3).
Also some other medicines can affect the way Nerlynx works.
Neki drugi lijekovi također mogu utjecati na djelovanje lijeka Nerlynx.
1236 patients were <65 years, 172 were ≥65 years, of whom 25 were 75 years or older.
65 ili više godina, od čega je njih 25 imalo 75 ili više godina.
It appeared that the inhibitory effect of neratinib was primarily on P-gp activity in the gastrointestinal tract as a result of pre-systemic inhibition.
Čini se da neratinib ima inhibitorski učinak prvenstveno na djelovanje P-gp-a u gastrointestinalnom traktu uslijed presistemske inhibicije.
Oval, red film-coated tablet with ‘W104' debossed on one side.
Ovalne, crvene filmom obložene tablete s oznakom ‘W104' utisnutom na jednoj strani.
The diarrhoea may be severe and associated with dehydration.
Proljev može biti težak i povezan s dehidracijom.
Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Neratinib nije djelovao kao inhibitor prema transporterima unosa, OATP1B1*1a, OATP1B3, OAT1, OAT3 i OCT2; prijavljene vrijednosti IC50 iznosile su > 10 µM.
If neratinib is used during pregnancy, or if the patient becomes pregnant while taking Nerlynx, the patient should be informed of the potential hazard to the foetus.
Ako se neratinib primjenjuje tijekom trudnoće ili ako bolesnica zatrudni dok uzima Nerlynx, bolesnicu treba obavijestiti o mogućem riziku za fetus.
• Grade 2 diarrhoea lasting 5 days or longer‡
• Proljev 2. stupnja koji traje 5 ili više dana‡
Diarrhoea was also the most common adverse reaction leading to discontinuation, 14.4 % of patients treated with Nerlynx without loperamide prophylaxis discontinued treatment due to diarrhoea.
Proljev je također bio najčešća nuspojava koja je dovela do prekida terapije; 14,4 % bolesnika liječenih lijekom Nerlynx bez profilakse loperamidom prekinulo je liječenje zbog proljeva.
It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Trenutačno nije poznato smanjuje li Nerlynx učinkovitost hormonalnih kontraceptiva koji djeluju sistemski.
It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method.
Trenutačno nije poznato može li neratinib smanjiti djelotvornost sistemski djelujućih hormonalnih kontraceptiva, zbog čega žene koje koriste sistemski djelujuće hormonalne kontraceptive trebaju uvesti i mehaničku metodu.
The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Učestalost događaja 3. stupnja bila je slična u Azijata i bijelaca (1,6 %, odnosno 1,0 %).
This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
Ova presistemska interakcija neratiniba s digoksinom može biti klinički relevantna za supstrate P-gp-a s uskim terapijskim indeksom (npr. dabigatran, digoksin i feksofenadin).
Nerlynx can cause changes in liver function - these are shown in blood tests.
Nerlynx može uzrokovati promjene u funkciji jetre, koje će biti vidljive u krvnim pretragama.
For hormone receptor positive patients, the relative treatment benefit of Nerlynx within pre-specified patient subgroups is presented in Figure 2.
Za bolesnice pozitivne na hormonske receptore relativna korist od liječenja lijekom Nerlynx unutar prethodno utvrđenih podskupina bolesnica prikazana je na slici 2.
Other medicines and Nerlynx
Drugi lijekovi i Nerlynx
Nerlynx is associated with skin and subcutaneous tissue disorders.
Nerlynx je povezan s poremećajima kože i potkožnog tkiva.
• Grade 3 diarrhoea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days
≥ 7 stolica dnevno u odnosu na polazno stanje; inkontinencija, indicirana hospitalizacija; ograničena sposobnost obavljanja aktivnosti njege za samog sebe u svakodnevnom životu] u trajanju od ≤ 2 dana
There are no data from the use of Nerlynx in pregnant women.
Nema podataka o primjeni lijeka Nerlynx u trudnica.
Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent.
Proljev se najčešće pojavljuje rano tijekom prvog ili drugog tjedna liječenja lijekom Nerlynx i može se ponavljati.
Blood creatinine increased
Povišena razina kreatinina u krvi
If you stop taking Nerlynx
Ako prestanete uzimati Nerlynx
The physician educational material should contain:
Edukacijski materijal za liječnika treba sadržavati sljedeće:
Approximately 10% of patients had Stage I tumours, approximately 40% had Stage II tumours and approximately 30% had Stage III tumours.
I. faze, približno 40 % imalo je tumore II. faze, a približno 30 % imalo je tumore III. faze.
The frequency and severity of gastrointestinal disorders (diarrhoea, abdominal pain, nausea and vomiting) appeared to be dose-related.
Čini se da su učestalost i težina gastrointestinalnih poremećaja (proljev, bol u abdomenu, mučnina i povraćanje) bili povezani s dozom.
The table below lists adverse reactions observed with neratinib based on the assessment of pooled data from 1,710 patients.
U tablici u nastavku prikazane su nuspojave uočene kod uzimanja neratiniba na temelju ocjenjivanja podataka prikupljenih od 1710 bolesnika.
1-3 Positive Nodes
1-3 pozitivna čvora
Then resume Nerlynx at the next lower dose level.
Nakon toga nastaviti liječenje lijekom Nerlynx na razini sljedeće niže doze.
The side effects of Nerlynx (for example, dehydration and dizziness resulting from diarrhoea, fatigue, and fainting) may affect how tasks that require judgment, motor or cognitive skills are carried out.
Nuspojave lijeka Nerlynx (primjerice, dehidracija i omaglica zbog proljeva, umor i nesvjestica) mogu utjecati na provedbu zadataka koji zahtijevaju prosudbu, motoričke ili kognitivne vještine.
What you need to know before you take Nerlynx 3.
Što morate znati prije nego počnete uzimati Nerlynx
Diarrhoea has been reported during treatment with Nerlynx (see Section 4.2 and Section 4.8).
Proljev je prijavljen tijekom liječenja lijekom Nerlynx (vidjeti dio 4.2 i dio 4.8).
Patients with a significant chronic gastrointestinal disorder Patients with a significant chronic gastrointestinal disorder with diarrhoea as a major symptom were not included in the pivotal study, and should be carefully monitored.
Bolesnici sa značajnim kroničnim poremećajem gastrointestinalnog sustava Bolesnici sa značajnim kroničnim gastrointestinalnim poremećajem kod kojeg je proljev značajan simptom nisu obuhvaćeni ključnim ispitivanjem i potrebno ih je pažljivo pratiti.
- Your doctor will tell you how to take the anti-diarrhoea medicine.
- Vaš će Vam liječnik reći kako uzimati lijek protiv proljeva.
• Fail to recover to Grade 0 to 1 from treatment-related toxicity,
• koji se ne oporave do 0. ili 1. stupnja toksičnosti povezane s liječenjem,
The neratinib metabolites M3, M6, M7 and M11 were shown to have similar potencies to neratinib in either in vitro enzyme (binding assays) or cell based assays against cells expressing ERBB1, ERBB2 (HER2) and ERBB4.
Pokazalo se da metaboliti neratiniba M3, M6, M7 i M11 imaju potenciju sličnu neratinibu u in vitro enzimskim testovima (testovi vezanja) ili u ispitivanjima na stanicama koje izražavaju ERBB1, ERBB2 (HER2) i ERBB4.
Neratinib was not a potent inhibitor of human BSEP efflux transporter activity in vitro, with a reported IC50 value of > 10µM.
Neratinib nije bio snažan inhibitor aktivnosti ljudskog efluksnog transportera BSEP in vitro, uz prijavljenu vrijednost IC50 od > 10 µM.
If you are pregnant, the doctor will assess the potential benefit to you and risk to the foetus before giving this medicine to you.
Ako ste trudni, liječnik će ocijeniti moguću korist za Vas i rizik za fetus prije nego što vam propiše lijek.
Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Preliminarno profiliranje metabolita u ljudskoj plazmi pokazuje da neratinib nakon peroralne primjene prolazi kroz oksidativni metabolizam putem CYP3A4.
Neratinib metabolites M3, M6, M7 and M11 are negative in the standard battery of in vitro genotoxicity studies.
Metaboliti neratiniba M3, M6, M7 i M11 negativni su u standardnoj seriji in vitro ispitivanja genotoksičnosti.
Elderly No dose adjustment is required.
Nije potrebna prilagodba doze.
Paediatric population There is no relevant use of Nerlynx in the paediatric population in the indication breast cancer.
Ne postoji relevantna primjena lijeka Nerlynx u pedijatrijskoj populaciji za indikaciju raka dojke.
Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive.
Prije primjene lijeka Nerlynx moraju se provesti ispitivanja kako bi se vidjelo je li Vaš rak HER2
- antacid medicines - the dose of these medicines and Nerlynx should be separated by at least 3 hours.
- antacidi - doza tih lijekova i lijeka Nerlynx trebaju se uzimati u razmaku od barem 3 sata.
Left ventricular dysfunction has been associated with HER2 inhibition.
Disfunkcija lijeve klijetke povezana je s inhibicijom proteina HER2.
Tell your doctor or pharmacist if you notice any of the following side effects:
Obavijestite svog liječnika ili ljekarnika ako primijetite bilo koju od sljedećih nuspojava:
In the clinical trial setting, adverse reactions associated with overdose were most commonly diarrhoea, with or without nausea, vomiting and dehydration.
U kliničkim ispitivanjima nuspojave povezane s predoziranjem najčešće su bile proljev, sa ili bez mučnine, povraćanje i dehidracija.
• rifampicin (antimycobacterial)
• rifampicin (antimikobakterijski lijek)
Diarrhoea, vomiting, nausea, abdominal pain, abdominal pain upper, and stomatitis1
Proljev, povraćanje, mučnina, bol u abdomenu, bol u gornjem dijelu abdomena i stomatitis1
- The other ingredients are: - Tablet core: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate - Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172)
- Jezgra tablete: manitol (E421), mikrokristalična celuloza, krospovidon, povidon, koloidni bezvodni silicijev dioksid, magnezijev stearat - Ovojnica tablete: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E172)
In HER2-positive breast cancer, the cancer cells have a large amount of HER2 receptors on their surface.
Kod raka dojke pozitivnog na HER2, na površini stanica raka nalaze se velike količine receptora HER2.
If grade 3 toxicity does not recover within 3 weeks, discontinue Nerlynx permanently.
Ako ne dođe do oporavka od toksičnosti 3. stupnja u roku od 3 tjedna, trajno obustaviti primjenu lijeka Nerlynx.
Nerlynx has not been studied in patients with less than lower limit of normal left ventricular ejection fraction (LVEF) or with significant cardiac history.
Lijek Nerlynx nije ispitivan u bolesnika s ejekcijskom frakcijom lijeve klijetke (engl. left ventricular ejection fraction, LVEF) ispod donje granice normale ili sa značajnom kardiološkom anamnezom.
The mass balance after administration of a single oral dose of 200 mg of neratinib was studied in six healthy subjects.
Masena bilanca nakon primjene pojedinačne peroralne doze od 200 mg neratiniba ispitana je na šest zdravih osoba.
- Your doctor will also tell you if you need to change the dose of Nerlynx because of diarrhoea.
Također će Vam reći trebate li promijeniti dozu lijeka Nerlynx zbog proljeva.
This results in the cancer cells dividing and growing faster.
To dovodi do brže podjele i rasta stanica raka.
The MedDRA frequency convention and system organ class database has been utilised for the classification of frequency: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data)
često (≥ 1/100 i < 1/10) manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i < 1/1000) vrlo rijetko (< 1/10 000)
A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Jedna doza neratiniba od 240 mg u kombinaciji s lansoprazolom smanjila je AUC za do 70 %.
Patients who are treated with BCRP inhibitors (e.g., rosuvastatin and sulfasalazine) should be monitored carefully.
Potrebno je pažljivo nadzirati bolesnike koji se liječe inhibitorima BCRP-a (npr. rosuvastatinom i sulfasalazinom).
Neratinib binds to the HER2 receptor, reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and potently inhibits tumour cell proliferation in vitro.
Neratinib se vezuje za receptor HER2, smanjuje autofosforilaciju EGFR i HER2 i aktivaciju nizvodnih signalnih puteva MAPK i AKT te snažno inhibira proliferaciju stanica tumora in vitro.
Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Metabolizam neratiniba provodi se prvenstveno u jetrenim mikrosomima putem CYP3A4 te u manjoj mjeri putem flavin-monooksigenaze (FMO).
The safety of Nerlynx and how effective it is has not been studied in this age group.
Sigurnost i djelotvornost lijeka Nerlynx nije ispitana u ovoj dobnoj skupini.
Patients with symptomatic skin and subcutaneous tissue disorders should be carefully monitored (see Section 4.8).
Potrebno je pažljivo pratiti bolesnike sa simptomatičnim poremećajima kože i potkožnog tkiva (vidjeti dio 4.8).
Patients who are treated concomitantly with therapeutic agents whose metabolism involves P-gp substrates in the gastrointestinal tract should be monitored carefully.
Potrebno je pažljivo pratiti bolesnike koji se istodobno liječe terapijskim tvarima čiji metabolizam uključuje P-gp supstrate u gastrointestinalnom traktu.
Secondary endpoints of the study included disease-free survival (DFS) including ductal carcinoma in situ (DFS-DCIS), time to distant recurrence (TTDR), distant disease-free survival (DDFS), cumulative incidence of central nervous system recurrence and overall survival (OS).
Sekundarne mjere ishoda ispitivanja obuhvaćale su preživljenje bez simptoma bolesti (DFS), uključujući duktalni karcinom in situ (DFS-DCIS), razdoblje do recidiva bolesti na udaljenom mjestu (TTDR), preživljenje bez bolesti na udaljenom mjestu (DDFS), ukupnu pojavnost recidiva u središnjem živčanom sustavu i ukupno preživljenje (OS).
The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Učestalost poremećaja 1. stupnja bila je 6,2 %, a 2. stupnja 1,4 %.
In patients that were hormone receptor negative, regardless of time from trastuzumab therapy, the hazard ratio for iDFS at 2 years was 0.93, with 95% CI (0.60, 1.43).
Kod bolesnica koje su bile negativne na hormonske receptore, neovisno o razdoblju proteklom od liječenja trastuzumabom, omjer hazarda za iDFS pri 2 godine iznosio je 0,93 uz 95 % CI (0,60;
- lansoprazole, omeprazole or similar medicines called ‘proton pump inhibitors' or PPIs and ranitidine, cimetidine or similar medicines called ‘H2 receptor antagonists' are not recommended.
- lijekove za želučane probleme, kao što su: - lansoprazol, omeprazol ili slični lijekovi koji se nazivaju „inhibitori protonske pumpe” ili PPI te rantidin, cimetidin ili slični lijekovi koji se nazivaju „antagonisti H2 receptora” se ne preporučuju.
1 Event-free rates for all endpoints, except for CNS recurrence for which cumulative incidence is reported.
1 Stope bez događaja za sve mjere ishoda, osim za recidiv u CNS-u za koji je prijavljena ukupna pojavnost.
Patients who experience ≥ Grade 3 diarrhoea requiring IV fluid treatment or any signs or symptoms of hepatotoxicity, such as worsening of fatigue, nausea, vomiting, jaundice, right upper quadrant pain or tenderness, fever, rash, or eosinophilia, should be evaluated for changes in liver function tests.
Kod bolesnika kod kojih se pojave proljev ≥ 3. stupnja koji zahtijeva liječenje intravenskom nadoknadom tekućine ili bilo koji znakovi ili simptomi hepatotoksičnosti, kao što su pogoršanje umora, mučnina, povraćanje, žutica, bol ili osjetljivost u gornjem desnom kvadrantu, vrućica, osip ili eozinofilija treba provjeriti moguće promjene u rezultatima ispitivanja funkcije jetre.
Following oral administration of 240 mg neratinib, absorption was slow and peak plasma concentrations of neratinib occurred around 7 hours after administration.
Nakon peroralne primjene 240 mg neratiniba, apsorpcija je bila spora, a do vršnih koncentracija neratiniba u plazmi došlo je oko 7 sati nakon primjene.
Pooled safety data of 1710 patients treated with Nerlynx monotherapy showed a higher incidence of dermatologic toxicities in Asian patients (57.1%) versus Caucasian patients (34.6%).
Skupni podaci o sigurnosti za 1710 bolesnika liječenih samo lijekom Nerlynx ukazuju na veću učestalost dermatoloških toksičnosti u Azijata (57,1 %) u odnosu na bijelce (34,6 %).
Grade 3 ALT or bilirubin occurs again despite one dose reduction, permanently discontinue Nerlynx.
ALT-a ili bilirubina 3. stupnja unatoč jednom smanjenju doze, potrebno je trajno obustaviti liječenje lijekom Nerlynx.
What Nerlynx is and what it is used for What Nerlynx is
Što je Nerlynx i za što se koristi Što je Nerlynx
Left ventricular function
Funkcija lijeve klijetke
Nerlynx contains the active substance ‘neratinib'.
Nerlynx sadržava djelatnu tvar „neratinib”.
In a dose escalation study in healthy volunteers, single oral doses of Nerlynx up to 800 mg were administered.
U ispitivanju povećanja doze u zdravih dobrovoljaca primijenjena je po jedna peroralna doza lijeka Nerlynx od najviše 800 mg.
If you take more Nerlynx than you should, contact a doctor or a hospital straight away.
Ako uzmete veću dozu lijeka Nerlynx nego biste trebali, odmah se obratite liječniku ili idite u bolnicu.
• If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
• Ako se težina proljeva smanji na 0.-1. stupanj u roku duljem od tjedan dana, nastaviti liječenje lijekom Nerlynx u smanjenoj dozi (vidjeti tablicu 1).
How to take Nerlynx
Kako uzimati Nerlynx
• Patient information pack
• Paket s informacijama za bolesnika
Abdominal distension, dry mouth and dyspepsia
Distenzija abdomena, suha usta i dispepsija
You should take an anti-diarrhoea medicine so that your diarrhoea does not become severe, and to prevent you from getting dehydrated during treatment with Nerlynx.
Trebate uzeti lijek protiv proljeva kako proljev ne bi postao težak te kako biste spriječili dehidraciju tijekom liječenja lijekom Nerlynx.
Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
Neratinib se većinom vezao za HSA i ljudski alfa-1 kiseli glikoprotein (AAG).
Dose reductions occurred in 24.7% of Nerlynx-treated patients.
Do smanjenja doze došlo je u 24,7 % bolesnika liječenih lijekom Nerlynx.
Median time from the last adjuvant trastuzumab treatment to randomization was 4.5 months.
Medijan vremena od posljednjeg adjuvantnog liječenja trastuzumabom do randomizacije iznosio je
Figure 2:
Slika 2:
A single dose of 240 mg neratinib taken with food increased Cmax and AUC by approximately 17% and 23%, respectively, compared with administration in the fasting state.
Pojedinačna doza od 240 mg neratiniba uzeta s hranom povećala je Cmax i AUC za oko 17 %, odnosno 23 %, u usporedbi s primjenom natašte.
No significant changes in fertility parameters in male and female rats were detected in dosing up to 12 mg/kg/day (see Section 5.3).
Kod doza do 12/mg/kg dnevno nisu uočene značajne promjene u parametrima plodnosti u mužjaka i ženki štakora (vidjeti dio 5.3).
The following side effects may happen with this medicine:
Kod uzimanja ovog lijeka može doći do sljedećih nuspojava:
The most common Grade 3-4 adverse reactions were diarrhoea (Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade 4, 0.1%).
Najčešće nuspojave 3.-4. stupnja bile su proljev (3. stupanj, 36,9 % i 4. stupanj, 0,2 %) i povraćanje (3. stupanj, 3,4 % i 4. stupanj, 0,1 %).
In healthy subjects, digoxin increased Cmax by 54% and AUC increased by 32% when co-administered with multiple oral doses of neratinib 240 mg compared with exposures of digoxin alone.
U zdravih ispitanika digoksinu se povećao Cmax za 54 % te AUC za 32 % kada se primjenjivao zajedno s višestrukim peroralnim dozama neratiniba od 240 mg u usporedbi s izloženosti samom digoksinu.
Nerlynx 40 mg film-coated tablets
Nerlynx 40 mg filmom obložene tablete
Concomitant use of strong CYP3A4/P-gp inhibitors (e.g. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, and voriconazole) should be avoided.
Potrebno je izbjegavati istodobnu primjenu snažnih inhibitora CYP3A4/Pgp (npr. atazanavira, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, ketokonazola, itrakonazola, klaritromicina, telitromicina i vorikonazola).
After discontinuation of a strong CYP3A4/P-gp inhibitor, resume previous dose of Nerlynx 240 mg (see Section 4.4 and Section 4.5).
Nakon prestanka primjene snažnog inhibitora CYP3A4/Pgp, nastaviti s prethodnom dozom lijeka Nerlynx od 240 mg (vidjeti dio 4.4 i dio 4.5).
Very Common Decreased appetite Common
Smanjen apetit
Neratinib is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).
(ERBB) tirozin kinaze (TKI) koji blokira transdukciju signala za mitogeni faktor rasta putem kovalentne veze visokog afiniteta za mjesto vezanja ATP-a 3 receptora epidermalnog faktora rasta (EGFR-ovi): EGFR (kojeg kodira ERBB1), HER2 (kojeg kodira ERBB2) i HER4 (kojeg kodira ERBB4) ili njihovih aktivnih heterodimera s HER3 (kojeg kodira ERBB3).
Nerlynx has not been studied in patients with severe renal impairment including patients on dialysis.
Liječenje lijekom Nerlynx nije ispitano u bolesnika s teškim oštećenjem funkcije bubrega, uključujući bolesnike koji se liječe dijalizom.
Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
Muškarci bi trebali koristiti mehaničku kontracepcijsku metodu tijekom liječenja te 3 mjeseca nakon prestanka liječenja.
Nail disorder3, skin fissures and dry skin
Poremećaj noktiju3, raspukline na koži i suha koža
This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
To dovodi do trajne inhibicije tih putova za promicanje rasta kod prekomjerno izraženih hormonskih receptora HER2 ili kod karcinoma dojke s mutacijom HER2.
Following the administration of a single radiolabelled dose of 200 mg neratinib oral solution, 97.1% and 1.1% of the administered dose was recovered in the faeces and urine, respectively.
Nakon primjene pojedinačne radioaktivno obilježene doze oralne otopine od 200 mg neratiniba, 97,1 % odnosno 1,1 % primijenjene doze izlučeno je kroz stolicu i mokraću.