natgillin/translations-raw huggingface dataset:
Hepatic-associated adverse reactions in the pivotal phase III study, ExteNET (3004), were reported more frequently in the Nerlynx arm compared to the placebo arm (12.4% vs. 6.6%), due primarily to alanine aminotransferase (ALT) increased (8.5% vs. 3.2%), aspartate aminotransferase (AST) increased (7.4 vs 3.3%) and blood alkaline phosphatase increased (2.1% vs. 1.1%). 
V ključni študiji III. faze, ExteNET (3004), so o neželenih učinkih, povezanih z jetri, v kraku z zdravilom Nerlynx poročali pogosteje kot v kraku s placebom (12,4 v primerjavi s 6,6 %), pretežno zaradi povečanja vrednosti alanin aminotransferaze (ALT) (8,5 v primerjavi s 3,2 %), povečanja vrednosti aspartat-aminotransferaze (AST) (7,4 v primerjavi s 3,3 %) in povečanja vrednosti alkalne fosfataze v krvi (2,1 v primerjavi z 1,1 %).
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
Severity of diarrhoea* 
Resnost driske*
The diarrhoea may be severe, and you may get dehydrated. 
Driska je lahko huda in lahko dehidrirate.
Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3. 
Smernice za prilagoditev odmerkov zdravila Nerlynx pri stanju z drisko so prikazane v preglednici 3.
- Keep taking anti-diarrhoea medicine during the first one to two months of Nerlynx treatment. 
- Zdravilo za zdravljenje driske jemljite v obdobju prvega oziroma prvih dveh mesecev zdravljenja z zdravilom Nerlynx.
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. 
zaradi driske je zdravljenje prekinilo 14,4 % bolnikov, zdravljenih z zdravilom Nerlynx brez profilakse z loperamidom.
The patient information pack should contain: o Patient information leaflet o A patient/carer treatment guide o “My Treatment Journal” The Patient/carer guide shall contain the following key messages (in lay language) 
Vodnik po zdravljenju za bolnika/negovalca mora vsebovati naslednja ključna sporočila (v laičnem jeziku):
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). 
Pri bolnicah, ki so bile ne glede na čas, ki je pretekel od zdravljenja s trastuzumabom, negativne za hormonski receptor, je razmerje tveganj za iDFS po dveh letih znašalo 0,93 z intervalom zaupanja
Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent. 
V splošnem se driska med zdravljenjem z zdravilom Nerlynx pojavi zgodaj, v prvem ali drugem tednu zdravljenja, in se lahko ponavlja.
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. 
Neratinib se pretežno izloča z blatom Po dajanju enkratnega radioaktivno označenega odmerka 200 mg neratiniba v obliki peroralne raztopine so v blatu in urinu dokazali 97,1 % oziroma 1,1 % danega odmerka.
Adverse reactions reported as serious included diarrhoea (1.9%), vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine aminotransferase increased (0.4%), aspartate aminotransferase increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and decreased appetite (0.2%). 
dehidracija (1,1 %), navzea (0,5 %), povečana vrednost alanin-aminotransferaze (0,4 %), povečana vrednost aspartat-aminotransferaze (0,4 %), bolečine v trebuhu (0,3 %), utrujenost (0,3 %) in zmanjšan tek (0,2 %).
Description of selected adverse reactions 
Opis izbranih neželenih učinkov Driska
Kaplan-Meier plot of disease-free survival - hormone receptor positive population who are less than one year from completion of trastuzumab therapy 
Kaplan-Meierjev prikaz preživetja brez ponovitve bolezni - populacija, pozitivna za hormonski receptor, ki je zdravljenje s trastuzumabom zaključila pred manj kot enim letom
* Per CTCAE v4.0 † Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia ‡ Despite being treated with optimal medical therapy 
† Med komplicirane značilnosti spadajo dehidracija, zvišana telesna temperatura, hipotenzija, odpoved ledvic ali nevtropenija stopnje 3 ali 4.
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. 
Izkazalo se je, da je zaviranje neratiniba zaradi predsistemskega zaviranja učinkovalo v glavnem na dejavnost P-gp v prebavilih.
In the analysis of pooled safety data, the majority of TEAEs in the Skin and Subcutaneous Disorders SOC in Asians were Grade 1 (43.3%) and Grade 2 (12.3%); in Caucasians, the incidence of Grade 1 and Grade 2 events was 25.6% and 7.8%, respectively. 
Po analizi zbranih varnostnih podatkov je bila večina neželenih dogodkov v organskem sistemu bolezni kože in podkožja, ki so se pojavili zaradi zdravljenja, pri azijskih bolnikih stopnje 1 (43,3 %) in stopnje 2 (12,3 %), pri belcih pa je pojavnost dogodkov stopnje 1 in stopnje 2 znašala 25,6 oziroma 7,8 %.
There is no specific antidote, and the benefit of haemodialysis in the treatment of Nerlynx overdose is unknown. 
Specifičnega antidota ni in koristi hemodialize pri zdravljenju prevelikega odmerjanja zdravila
The most common TEAEs in the Skin SOC that occurred more frequently in Asian patients than in Caucasian patients were rash (29.4% vs. 13.5%), Palmar-plantar erythrodysaesthesia syndrome (9.9% vs. 1.0%), and dermatitis acneiform (6.0 vs. 1.0%). 
Najpogostejši neželeni dogodki v organskem sistemu bolezni kože in podkožja, ki so se pojavili zaradi zdravljenja in ki so se pri Azijcih pojavljali pogosteje kot pri belcih, so bili izpuščaj (29,4 v primerjavi s 13,5 %), sindrom palmarno-plantarne eritrodisestezije (9,9 v primerjavi z 1,0 %) in akniformni dermatitis (6,0 v primerjavi z 1,0 %).
The safety of Nerlynx and how effective it is has not been studied in this age group. 
Nerlynx v tej starostni skupini niso preučevali.
White, 60 mL high density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal. 
Bela, 60-mililitrska zaobljena plastenka iz polietilena visoke gostote (HDPE) s polipropilensko zaporko, varno za otroke, ter zaprto z notranjo folijo, zavarjeno z indukcijo.
The clinical status of the patient should be considered when assessing the patient's ability to perform tasks that require judgment, motor, or cognitive skills. 
Pri ocenjevanju bolnikove sposobnosti za izvajanje opravil, pri katerih so potrebne sposobnost presoje,
What Nerlynx is used for 
Za kaj se zdravilo Nerlynx uporablja
INFORMATION IN BRAILLE 
PODATKI V BRAILLOVI PISAVI Škatla :
Carton 2D barcode carrying the unique identifier included. 
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
In the pivotal phase III study, ExteNET (3004), the frequency of Treatment Emergent Adverse Events (TEAEs) in the Skin and Subcutaneous Disorders System Organ Class (SOC) in Asian patients treated with Nerlynx was higher than in Caucasian patients (56.4% vs. 34.5%) but comparable in placebo patients (24.9% vs. 22.8%). 
V ključni študiji III. faze, ExteNET (3004), je bila pogostnost neželenih dogodkov v organskem sistemu bolezni kože in podkožja, ki so se pojavili zaradi zdravljenja, pri azijskih bolnikih, zdravljenih z zdravilom Nerlynx, večja od pogostnosti pri belcih, zdravljenih z zdravilom Nerlynx (56,4 v primerjavi s 34,5 %), medtem ko je bila pri Azijcih in belcih, zdravljenih s placebom, primerljiva (24,9 v primerjavi z 22,8 %).
• St John's wort (Hypericum perforatum) (herbal product) 
• šentjanževka (Hypericum perforatum) (zdravilo rastlinskega izvora);
Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone 
Jedro tablete manitol (E421) mikrokristalna celuloza krospovidon povidon brezvodni koloidni silicijev dioksid magnezijev stearat
Nerlynx is for oral use. 
Zdravilo Nerlynx je namenjeno peroralni uporabi.
Pregnancy Neratinib may cause foetal harm when administered to pregnant women (see Section 4.6). 
Nosečnost Če neratinib jemljejo nosečnice, lahko poškoduje plod (glejte poglavje 4.6).
No dose adjustment is required in patients with Child-Pugh A or B (mild to moderate) hepatic impairment. 
Pri bolnikih z okvaro jeter stopnje A ali B po Child-Pughovi klasifikaciji (manjšo do zmerno okvaro jeter) odmerka ni treba prilagoditi.
Tablet coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 
Obloga tablete polivinilalkohol titanov dioksid (E171) makrogol smukec rdeči železov oksid (E172)
Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450: 
Sočasno dajanje z naslednjimi zdravili, ki so močni induktorji izoforme CYP3A4/P-gp citokroma
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. 
Po enkratnem odmerku 240 mg neratiniba, vzetem skupaj s hrano, sta se vrednosti Cmax in AUC v primerjavi z dajanjem na tešče povečali za približno 17 oziroma 23 %.
Nerlynx can cause diarrhoea early during treatment unless anti-diarrhoeal medicines are taken to prevent or reduce diarrhoea. 
Zdravilo Nerlynx lahko v zgodnjem obdobju zdravljenja povzroči drisko, razen če za njeno preprečevanje in zmanjševanje jemljete zdravila za zdravljenje driske.
Dose modifications for diarrhoea 
Prilagoditve odmerka za drisko
1 Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, and mucosal inflammation. 
1 Vključuje stomatitis, aftozni stomatitis, razjede v ustih, mehurjenje sluznice v ustih in vnetje sluznice.
Diarrhoea, vomiting, nausea, abdominal pain, abdominal pain upper, and stomatitis1 
Bolezni prebavil zelo pogosti driska, bruhanje, navzea, bolečine v trebuhu, bolečine v zgornjem delu trebuha in stomatitis1
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. 
Tveganje za ledvično okvaro in dehidracijo, ki sta lahko zapleta pri driski, je pri starejših (starih ≥ 65 let) večje in te bolnike je treba skrbno spremljati.
Hormone receptor positive population who are less than one year from completion of trastuzumab 
Populacija, pozitivna za hormonski receptor, ki je zdravljenje s trastuzumabom zaključila pred manj kot enim letom
Both rash and nail disorders led to treatment discontinuation in 0.6% of Nerlynx-treated patients. 
Zaradi izpuščajev in bolezni nohtov je moralo zdravljenje prekiniti 0,6 % bolnikov, zdravljenih z zdravilom Nerlynx.
How to take Nerlynx 
Kako jemati zdravilo Nerlynx
Each bottle contains 180 film-coated tablets. 
180 filmsko obloženih tablet.
• Diet modifications 
• Spremembe prehrane.
An HDPE desiccant canister with 1 g silica gel is enclosed with the tablets in each bottle. 
V vsaki plastenki je tabletam priložen vsebnik iz HDPE s sušilnim sredstvom v obliki 1 g silikagela.
A single oral dose of 240 mg neratinib taken with a meal high in fat increased both Cmax and AUC by approximately 100%. 
Po enkratnem peroralnem odmerku 240 mg neratiniba, vzetem skupaj s hrano, bogato z maščobami, sta se vrednosti Cmax in AUC povečali za približno 100 %.
16 vs. 23 
s 23
Nerlynx has not been studied in patients with less than lower limit of normal left ventricular ejection fraction (LVEF) or with significant cardiac history. 
pri katerih je bila iztisna frakcija levega prekata (LVEF) nižja od najnižje normalne meje, ali pri bolnikih z anamnezo hudih težav s srcem.
Nerlynx film-coated tablets are packaged in a white, high-density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal for a tamper-evident seal. 
Filmsko obložene tablete zdravila Nerlynx so pakirane v belo, zaobljeno plastenko iz polietilena visoke gostote (HDPE) s polipropilensko za otroke varno zaporko in induktivno zavarjeno notranjo zaščitno folijo, zaradi česar je takoj vidno, ali je bila plastenka že odprta.
Adverse drug reactions due to Nerlynx in monotherapy breast cancer studies 
Preglednica 5: Neželeni učinki zaradi zdravila Nerlynx v študijah monoterapije za zdravljenje raka dojke Organski sistem
• Grade 3 ALT (>5-20 x ULN) 
• ALT stopnje 3 (> 5-20 x ULN)
Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists is not recommended. 
Sočasno dajanje z zaviralci protonske črpalke (PPI) in antagonisti receptorja H2 ni priporočljivo.
Hepatotoxicity has been reported in patients treated with Nerlynx. 
Pri bolnikih, zdravljenih z zdravilom Nerlynx, so poročali o hepatotoksičnosti.
- 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) 
- Druge sestavine zdravila so: jedro tablete: manitol (E421), mikrokristalna celuloza, krospovidon, povidon, brezvodni koloidni silicijev dioksid, magnezijev stearat;
Women of childbearing potential/Contraception in females and males Based on findings in animals, neratinib may cause foetal harm when administered to pregnant women. 
Na podlagi ugotovitev pri živalih lahko neratinib poškoduje plod, če ga jemljejo nosečnice.
Distant disease-free survival Time to distant recurrence CNS recurrence 
Preživetje brez oddaljene ponovitve bolezni
There was no difference in frequency of SAEs in the Skin SOC between Asian and Caucasian subgroups. 
Med azijsko in belsko podskupino ni bilo razlik v pogostnosti resnih neželenih dogodkov v organskem sistemu bolezni kože in podkožja.
Neratinib produced inhibitory activity in OCT1 uptake transporter, with an IC50 of 2.9 µM. 
Neratinib je zaviral transporter privzema OCT1, pri čemer so vrednosti IC50 znašale 2,9 µM.
Nerlynx dose 
Odmerek zdravila Nerlynx
No. of Patients 
Št. bolnic
Proton pump inhibitors, H2-receptor antagonists and antacids Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists are not recommended. 
Zaviralci protonske črpalke, antagonisti receptorja H2 in antacidi Sočasno dajanje z zaviralci protonske črpalke (PPI) in antagonisti receptorja H2 ni priporočljivo.
There was a higher frequency of treatment discontinuations due to adverse reactions in the ≥65 years age group than <65 years age group; in the Nerlynx arm, the respective percentages were 44.8% compared with 25.2%, respectively. 
V starostni skupini bolnikov, starih ≥ 65 let, so bile prekinitve zdravljenja zaradi neželenih učinkov pogostejše kot v starostni skupini bolnikov, starih < 65 let; zadevni deleži v kraku z zdravilom Nerlynx so znašali 44,8 oziroma 25,2 %.
Neratinib Better 
Boljše - neratinib
Reproductive toxicity 
Vpliv na razmnoževanje
In in-vitro studies, neratinib is an inhibitor of P-glycoprotein (P-gp) substrates. 
V študijah in vitro je neratinib zaviralec substratov za glikoprotein P (P-gp).
• Adjust anti-diarrhoeal treatment 
• Prilagodite zdravljenje driske.
Section 6), - if you have a severe liver problem, - if you are taking fluconazole (a medicine for fungal infections), - if you are taking rifampicin (a medicine for tuberculosis (TB)), - if you are taking erythromycin (antibiotic for infections), - if you are taking carbamazepine, phenobarbital, or phenytoin (medicines for seizures), - if you are taking diltiazem or verapamil (medicines for high blood pressure and chest pain), - if you are taking St. John's wort (herbal product for depression). 
- če ste alergični na neratinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate hude težave z jetri; - če jemljete flukonazol (zdravilo za glivične okužbe); - če jemljete rifampicin (zdravilo za tuberkulozo); - če jemljete eritromicin (antibiotik proti okužbam); - če jemljete karbamazepin, fenobarbital ali fenitoin (zdravila za preprečevanje epileptičnih napadov);
If an antacid is taken, separate the dosing of Nerlynx and the antacid by at least 3 hours. 
Če bolnik jemlje antacid, naj med jemanjem odmerkov zdravila Nerlynx in antacida pretečejo vsaj tri ure.
No dose adjustment is necessary in patients with mild to moderate renal impairment. 
Pri bolnikih z manjšo do zmerno okvaro ledvic odmerka ni treba prilagoditi.
Discontinue Nerlynx for patients who: 
Prekinite dajanje zdravila Nerlynx pri bolnikih:
In the Nerlynx monotherapy group, 7.8% patients experience nail disorders. 
V skupini bolnikov, ki so se zdravili z monoterapijo z zdravilom Nerlynx, so se pri 7,8 % bolnikov pojavile bolezni nohtov.
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. 
Pri zdravih osebah se je zaradi digoksina, ki je bil dan sočasno z več peroralnimi 240-miligramskimi odmerki neratiniba, v primerjavi z izpostavljenostjo izključno digoksinu vrednost Cmax povečala za 54 %, vrednost AUC pa za 32 %.
Very common: may affect more than 1 in 10 people - diarrhoea - stomach pain, feeling or being sick, low appetite - dry or inflamed mouth, including blisters or mouth ulcers - rash - muscle spasms or cramps - feeling very tired 
- bolečine v trebuhu, siljenje na bruhanje ali bruhanje, slab tek; - suha ali vneta usta, vključno z mehurčki ali razjedami v ustih; - izpuščaj; - mišični krči; - občutek hude utrujenosti.
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated (see Section 4.2). 
Med zdravljenjem ali kot je klinično indicirano, je treba v prvem tednu, nato pa prve tri mesece mesečno in nato vsakih šest tednov opraviti teste delovanja jeter, vključno s spremljanjem alanin-aminotransferaze (ALT),
Alanine aminotransferase increased, and aspartate aminotransferase increased 
Bolezni jeter, žolčnika in žolčevodov pogosti povečane vrednosti alanin aminotransferaze in aspartataminotransferaze občasni zvišana raven bilirubina v krvi
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišični krči
Left ventricular dysfunction has been associated with HER2 inhibition. 
Z zaviranjem HER2 je povezana okvara levega prekata.
Discontinue Nerlynx permanently. 
dajanje zdravila Nerlynx trajno ukinite.
CYP3A4/P-gp inducers 
Uporaba zaviralcev CYP3A4/P-gp
Dose modifications for adverse reactions 
Prilagoditve odmerka pri neželenih učinkih
You may or may not have signs or symptoms of liver problems (e.g., yellow skin and/or eyes, dark urine, or light-colour stools). 
Znake ali simptome težav z jetri (npr. rumeno kožo in/ali oči, temen urin ali svetlo blato) lahko imate ali pa tudi ne. Pred zdravljenjem z zdravilom Nerlynx in med njim bo vaš zdravnik opravil preiskave krvi.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa
Dose modifications for diarrhoea Severity of diarrhoea* 
Preglednica 3: Prilagoditve odmerka za drisko Resnost driske*
Placebo) HR (95% CI) 
HR (95odstotni IZ)
Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking Nerlynx and for 1 month after stopping treatment. 
Zato morajo ženske v rodni dobi med jemanjem zdravila Nerlynx in en mesec po koncu zdravljenja uporabljati visoko učinkovite kontracepcijske metode.
9 vs. 28 
z 28
Talk to your doctor or pharmacist before taking Nerlynx. 
Pred začetkom jemanja zdravila Nerlynx se posvetujte z zdravnikom ali farmacevtom.
- Start taking anti-diarrhoea medicine with the first dose of Nerlynx. 
- Skupaj s prvim odmerkom zdravila Nerlynx začnite jemati zdravilo za zdravljenje driske.
Co-administration of a single oral dose of 240 mg of neratinib in the presence of ketoconazole (400 mg once daily for 5 days), a strong CYP3A4/P-gp inhibitor, increased neratinib systemic exposure. 
(400 mg enkrat dnevno pet dni), močnega zaviralca CYP3A4/P-gp, se je povečala sistemska izpostavljenost neratinibu.
Primary efficacy analyses - ITT and hormone receptor positive populations who are less than one year from completion of trastuzumab therapy 
Preglednica 6: Analize primarne učinkovitosti - populacija z namenom zdravljenja in populacija, pozitivna za hormonski receptor, ki sta zdravljenje s trastuzumabom zaključili pred manj kot enim letom
In the Nerlynx monotherapy group, 16.7% of patients experienced rash. 
V skupini bolnikov, ki so se zdravili z monoterapijo z zdravilom Nerlynx, se je pri 16,7 % bolnikov pojavil izpuščaj.
• Grade 4 ALT (>20 x ULN) 
• ALT stopnje 4 (> 20 x ULN)
• Interrupt Nerlynx treatment 
• Prekinite zdravljenje z zdravilom Nerlynx.
Following concomitant administration with repeated doses of 600 mg rifampicin, a strong CYP3A4/Pgp inducer, neratinib exposures were significantly decreased with mean values that were 24% and 13% of reference values (neratinib administered alone) for Cmax and AUC, respectively. 
CYP3A4/P-gp, so se vrednosti izpostavljenosti neratinibu pomembno zmanjšale, pri čemer so srednje vrednosti znašale 24 in 13 % referenčnih vrednosti (pri samostojno danem neratinibu) za vrednosti
* Refer to Table 3 and Table 4 below for management of diarrhoea and hepatotoxicity † Per CTCAE v4.0 
* Za obvladovanje driske in hepatotoksičnosti glejte preglednici 3 in 4.
Your doctor will do blood tests before and during your treatment with Nerlynx. 
Pred zdravljenjem z zdravilom Nerlynx in med njim bo vaš zdravnik opravil preiskavo krvi.
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. 
Z encimskimi testi in vitro (preskusi vezave) ali testi na celični osnovi s celicami, ki izražajo ERBB1, ERBB2
1 vs. 4 
s 4
The film-coated tablets are red oval shaped and debossed with ‘W104' on one side and plain on the other side. 
Filmsko obložene tablete so rdeče barve in ovalne oblike, na eni strani je vanje vtisnjena oznaka
• Grade 3 bilirubin (>3-10 x ULN) 
• bilirubin stopnje 3 (> 3-10 x ULN).
Separate dosing of Nerlynx and antacids by at least 3 hours. 
Med jemanjem odmerkov zdravila Nerlynx in antacida naj pretečejo vsaj 3 ure.
Tablet core 
Tableta meri
• Grade 4 bilirubin (>10 x ULN) 
• bilirubin stopnje 4 (> 10 x ULN).
No. of Events (Neratinib vs. 
Št. dogodkov (neratinib v prim.
3 Includes nail disorder, paronychia, onychoclasis, and nail discolouration. 
3 Vključuje bolezen nohtov, paronihijo, onihoklazo in obarvanje nohtov.
Effects of neratinib on other substances 
Učinki neratiniba na druge učinkovine
Co-administration with moderate CYP3A4/P-gp inhibitors: 
Sočasno dajanje z naslednjimi zmernimi zaviralci CYP3A4/P-gp:
STATEMENT OF ACTIVE SUBSTANCE(S) 
Razmerje tveganj (HR)
Neratinib is extensively metabolised in the liver. 
Neratinib se obsežno presnavlja v jetrih.
• If diarrhoea resolves to Grade 0-1 in one week or less, then resume Nerlynx treatment at the same dose. 
• Če se driska v enem tednu ali prej izboljša na stopnjo 0-1, znova začnite dajati zdravilo
The most common adverse reactions of any grade were diarrhoea (93.6%), nausea (42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%), rash (15.4%), decreased appetite (13.7%), abdominal pain upper (13.2%), stomatitis (11.2%), and muscle spasms (10.0%). 
(27,3 %), bruhanje (26,8 %), bolečine v trebuhu (22,7 %), izpuščaj (15,4 %), zmanjšan tek (13,7 %),
Nerlynx contains the active substance ‘neratinib'. 
Zdravilo Nerlynx vsebuje učinkovino neratinib.
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 veže na receptor HER2, zmanjša avtofosforilacijo EGFR in
7 vs. 20 
z 20
Neratinib inhibited EGFR and/or HER2-expressing carcinoma cell lines with a cellular IC50 <100 nM. 
Neratinib je zaviral celične linije rakavih celic, ki izražajo EGFR in/ali HER2, s celično vrednostjo