natgillin/translations-raw huggingface dataset:
Patienter, der oplever diarré af grad 3 eller derover, og som kræver intravenøs væskebehandling, eller som har tegn eller symptomer på levertoksicitet som f.eks. forværring af udmattelse, kvalme, opkastning, gulsot, smerter eller ømhed i den øvre højre kvadrant, feber, udslæt eller eosinofili, bør undersøges for ændringer i leverfunktionstest.
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.
• Grad 2-diarré, der varer i 5 dage eller længere‡
• Grade 2 diarrhoea lasting 5 days or longer‡
Retningslinjer for justering af Nerlynx-dosen i tilfælde af diarré er vist i tabel 3.
Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3.
Der er ikke udført farmakokinetiske studier hos patienter med nedsat nyrefunktion eller i dialyse.
Pharmacokinetic studies in patients with renal impairment or undergoing dialysis have not been carried out.
Dette medfører vedvarende hæmning af disse vækstfaktor afhængige signalveje ved HER2-positiv eller HER2-muteret brystkræft.
This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
Meget almindelig Udmattelse
Very common Fatigue
• rifampicin (antimykobakterielt middel).
• rifampicin (antimycobacterial)
Det skal besluttes, om amning skal ophøre eller behandling med Nerlynx seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de treapeutiske forele for for moderen.
A decision must be made whether to discontinue breast-feeding or to discontinue Nerlynx, taking into account the importance of Nerlynx to the mother and the benefit of breast-feeding to the child.
Patienter med nedsat nyrefunktion har en højere risiko for komplikationer som følge af dehydrering, hvis de får diarré, og disse patienter bør overvåges nøje (se pkt.
Patients with renal impairment are at a higher risk of complications of dehydration if they develop diarrhoea, and these patients should be carefully monitored (see Section 4.2).
Patienter, der samtidigt behandles med terapeutiske stoffer, hvis metabolisering involverer P-gp-substrater i mave-tarm-kanalen, bør overvåges nøje.
Patients who are treated concomitantly with therapeutic agents whose metabolism involves P-gp substrates in the gastrointestinal tract should be monitored carefully.
Sekundære endepunkter i studiet omfattede sygdomsfri overlevelse (DFS), herunder duktalt carcinom in situ (DFS-DCIS), tid til metastaserecidiv (TTDR), metastasefri overlevelse (DDFS), kumulativ forekomst af centralnervesystem-recidiv og samlet overlevelse (OS).
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).
Den mediane alder i intention-to-treat (ITT)-populationen var 52,3 år (59,9 % var 50 år eller derover, 12,3 % var 65 år eller derover); 81,0 % var kaukasere, 2,6% var sorte eller afro-amerikanere, 13,6 % var asiater, og 2,9 % havde anden etnisk baggrund.
52.3 years (59.9% was ≥50 years old, 12.3% was ≥65 years old); 81.0% were Caucasian, 2.6% black or African American, 13.6% Asian and 2.9% other.
Neratinib bandt fortrinsvis til HSA og humant alfa-1-syreglykoprotein (AAG).
Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
I de kliniske studier var de bivirkninger, der blev forbundet med overdosering, i de fleste tilfælde diarré, med eller uden kvalme, opkastning og dehydrering.
In the clinical trial setting, adverse reactions associated with overdose were most commonly diarrhoea, with or without nausea, vomiting and dehydration.
Efter samtidig administration af gentagne 600 mg-doser rifampicin, der er en stærk CYP3A4/P-gpinducer, faldt eksponeringen for neratinib signifikant med gennemsnitlige værdier, der var 24 % og 13 % af referenceværdierne (neratinib administreret alene) for hhv. Cmax og AUC.
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.
Samtidig administration af følgende lægemidler, der er stærke inducere af CYP3A4/P-gp-isoformen af cytokrom P450:
Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450:
Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
Carton 2D barcode carrying the unique identifier included.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Lægen vil fortælle dig, om du fortsat skal tage et lægemiddel mod diarré efter de første to måneder.
Your doctor will tell you if you need to keep taking anti-diarrhoea medicine after the first two months to control your diarrhoea.
Hvis en toksicitet af grad 3 ikke bedres inden for 3 uger, skal Nerlynx seponeres permanent.
If grade 3 toxicity does not recover within 3 weeks, discontinue Nerlynx permanently.
Både udslæt og neglelidelser medførte seponering af behandlingen hos 0,6 % af de Nerlynxbehandlede patienter.
Both rash and nail disorders led to treatment discontinuation in 0.6% of Nerlynx-treated patients.
Samtidig brug af stærke CYP3A4/P-gp-hæmmere (f.eks. atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, ketoconazol, itraconazol, clarithromycin, telithromycin og voriconazol) bør undgås.
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.
Neratinib kan hæmme brystkræftresistent protein (BCRP) i moderat grad i henhold til in vitro-studier.
Neratinib may inhibit breast cancer resistance protein (BCRP) moderately as suggested by in vitro studies.
- syreneutraliserende lægemidler - indtagelse af disse lægemidler og Nerlynx bør foregå med mindst 3 timers mellemrum.
- antacid medicines - the dose of these medicines and Nerlynx should be separated by at least 3 hours.
Pakningsstørrelser og yderligere oplysninger Nerlynx indeholder:
Contents of the pack and other information What Nerlynx contains
Figur 2:
Figure 2:
Det er påvist, at neratinib-metabolitterne M3, M6, M7 og M11 i både in vitro-enzymanalyser (bindingsanalyser) og cellebaserede analyser har samme potens som neratinib mod celler, der udtrykker ERBB1, ERBB2 (HER2) og ERBB4.
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.
En enkeltdosis på 240 mg neratinib i kombination med lansoprazol reducerede AUC med op til 70 %.
A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000)
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)
Protonpumpehæmmere, H2-receptor antagonister og antacider Opløseligheden af neratinib er pH-afhængig.
Proton pump inhibitors, H2-receptor antagonists and antacids The solubility of neratinib is pH-dependent.
Nerlynx 40 mg filmovertrukne tabletter
Nerlynx 40 mg film-coated tablets
Hæmmere af brystkræftresistent protein
Breast cancer resistance protein inhibitors
Neratinib binder til HER2-receptoren, reducerer EGFR- og HER2-autophosphorylering samt MAPK- og AKT (downstream) signalering, og hæmmer i kraftig grad tumorcellevækst in vitro.
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.
Så meget Nerlynx skal du tage
How much Nerlynx to take
In vitro-studier har påvist, at neratinib er et substrat for Pglykoprotein (P-gp).
In vitro studies demonstrated that neratinib is a substrate for P-glycoprotein (P-gp).
Den anbefalede dosis Nerlynx er 240 mg (seks 40 mg tabletter), der tages én gang dagligt i et år.
The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year.
Diarré, opkastning, kvalme, mavesmerter, smerter i den øvre del af maven og stomatitis1
Diarrhoea, vomiting, nausea, abdominal pain, abdominal pain upper, and stomatitis1
Der er rapporteret om levertoksicitet hos patienter, der behandles med Nerlynx.
Hepatotoxicity has been reported in patients treated with Nerlynx.
Ikke almindelige bivirkninger: kan forekomme hos op til 1 ud af 100 patienter - Nyresvigt - ændringer i leverværdierne (f.eks. forhøjet bilirubin i blodet)
Uncommon: may affect up to 1 in 100 people - kidney failure - changes in liver blood test results (i.e., blood bilirubin increased)
Samtidig administration af en enkeltdosis oralt neratinib (240 mg) og ketoconazol (400 mg én gang dagligt i fem dage), en stærk CYP3A4/P-gp-hæmmer, øgede den systemiske neratinibeksponering.
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.
0,2 % af de Nerlynx-behandlede patienter oplevede neglelidelser af grad 3.
There were 0.2% of Nerlynx treated patients who experienced Grade 3 nail disorder.
Hos patienter med svært nedsat leverfunktion (ChildPugh C) uden kræft faldt neratinib-clearance med 36 %, og eksponeringen for neratinib steg ca. 3 gange sammenholdt med hos raske forsøgspersoner.
In subjects with severe pre-existing hepatic impairment (Child-Pugh Class C) without cancer, the clearance of neratinib was decreased by 36% and exposure to neratinib increased by about 3-fold as compared to healthy volunteers.
Nerlynx kan medføre diarré tidligt i behandlingen, medmindre du samtidigt tager et lægemiddel mod diarré for at forebygge eller mindske dette.
Nerlynx can cause diarrhoea early during treatment unless anti-diarrhoeal medicines are taken to prevent or reduce diarrhoea.
ALAT = alaninaminotransferase * I henhold til CTCAE v4.0
ULN=Upper Limit Normal; ALT= Alanine Aminotransferase * Per CTCAE v4.0
• Hvis diarréen bedres til grad 0-1 i løbet af en uge eller derunder, bør Nerlynx genoptages i samme dosis.
• If diarrhoea resolves to Grade 0-1 in one week or less, then resume Nerlynx treatment at the same dose.
Diarréen opstår typisk tidligt i behandlingen med Nerlynx og kan være så kraftig, at du dehydrerer.
Diarrhoea usually happens early in treatment with Nerlynx and may be severe, causing you to get dehydrated.
• ikke kan tåle 120 mg dagligt.
• For patients that are unable to tolerate 120 mg daily
Hvis du bliver gravid under behandlingen, vil lægen vurdere den mulige fordel for dig og risikoen for fostret ved at fortsætte behandlingen.
If you become pregnant while taking this medicine, the doctor will assess the potential benefit to you and the risk to the foetus, of continuing this medicine.
Nerlynx indeholder det aktive stof neratinib.
Nerlynx contains the active substance ‘neratinib'.
Hver filmovertrukket tablet indeholder neratinibmaleat svarende til 40 mg neratinib.
Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib.
Kvinder, der kan blive gravide, skal bruge en sikker præventionsmetode, herunder en barrieremetode: - mens de tager Nerlynx og - i en måned efter behandlingens afslutning.
Women who can become pregnant must use an effective method of contraception, including a barrier method: - while taking Nerlynx and - for one month after treatment has finished.
Fortæl det til lægen eller apotekspersonalet, hvis du oplever en eller flere af nedenstående bivirkninger:
Tell your doctor or pharmacist if you notice any of the following side effects:
De hyppigst indberettede alvorlige bivirkninger i gruppen af patienter på 65 år eller derover var opkastning (2,3 %), diarré (1,7 %), dehydrering (1,2 %) og nyresvigt (1,2 %).
The serious adverse reactions most frequently reported in the ≥65 years-old group were vomiting (2.3%), diarrhoea (1.7%), dehydration (1.2%), and renal failure (1.2%).
- Aktivt stof: neratinib.
- The active substance is neratinib.
Sværhedsgrad af diarré*
Severity of diarrhoea*
Neratinib medførte hæmmende aktivitet over for OCT1-uptake-transportøren med en IC50 på 2,9 mikroM.
Neratinib produced inhibitory activity in OCT1 uptake transporter, with an IC50 of 2.9 µM.
Samtidig behandling med CYP3A4- og P-gp-hæmmere Samtidig behandling med stærke CYP3A4- og P-gp-hæmmere bør undgås på grund af risikoen for øget eksponering for neratinib (se pkt.
Concomitant treatment with inhibitors of CYP3A4 and P-gp Concomitant treatment with strong CYP3A4 and P-gp inhibitors should be avoided due to risk of increased exposure to neratinib (see Section 4.2 and Section 4.5).
• Stop Nerlynx-behandlingen indtil bedring til ≤
• Stop Nerlynx until recovery to ≤ Grade 1
3 Omfatter neglelidelser som paronychion, onykoklase og misfarvning af neglene.
3 Includes nail disorder, paronychia, onychoclasis, and nail discolouration.
• Hvis grad 3-diarréen varer ved i mere end 3 uger, bør Nerlynx seponeres permanent.
• If grade 3 diarrhoea persists longer than 3weeks, discontinue Nerlynx permanently.
(angivet i punkt 6), - hvis du har en alvorlig leversygdom, - hvis du tager fluconazol (et lægemiddel mod svampeinfektioner), - hvis du tager rifamcipin (et lægemiddel mod tuberkulose), - hvis du tager erythromycin (antibiotikum mod infektioner), - hvis du tager carbamazepin, phenobarbital eller phenytoin (lægemidler mod krampeanfald), - hvis du tager diltiazem eller verapamil (lægemidler mod forhøjet blodtryk og brystsmerter), - hvis du tager prikbladet perikon (naturlægemiddel mod nedtrykthed, modløshed og tristhed).
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).
Det er især vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager et af nedenstående lægemidler: - ketoconazol eller fluconazol - lægemidler mod svampeinfektioner - erythromycin eller clarithromycin - lægemidler mod bakterielle infektioner - rifampicin - et lægemiddel mod tuberkulose - proteasehæmmere - lægemidler mod virus - carbamazepin, phenobarbital eller phenytoin - lægemidler mod krampeanfald - prikbladet perikon - et naturlægemiddel mod nedtrykthed, modløshed og tristhed - diltiazem eller verapamil - lægemidler mod forhøjet blodtryk og brystsmerter - digoxin - et lægemiddel mod hjerteproblemer - lægemidler mod maveproblemer som f.eks.:
In particular tell your doctor or pharmacist if you are taking any of the following medicines: - ketoconazole or fluconazole - medicines for fungal infections - erythromycin or clarithromycin - medicines for bacterial infections - rifampicin - a medicine for tuberculosis (TB) - protease inhibitors - antiviral medicines - carbamazepine, phenobarbital, or phenytoin - medicines for seizures - St John's wort - an herbal product for depression - diltiazem or verapamil - medicines for high blood pressure and chest pain - digoxin - a medicine for heart problems - medicines for stomach problems such as:
Cirkulerende metabolitter omfatter neratinibpyridin-N-oxid (M3), N-desmethyl-neratinib (M6), neratinib-dimethylamin-N-oxid (M7) og spor af hydroxyl-neratinib-N-oxid og neratinib-bis-N-oxid (M11).
Circulating metabolites include neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine N-oxide (M7) and traces of
Cmax for neratinib steg 3,2 gange, og AUC steg 4,8 gange ved samtidig administration af ketoconazol sammenholdt med administration af neratinib alene.
The Cmax of neratinib increased by 3.2 fold and AUC increased by 4.8 fold when coadministered with ketoconazole, compared with neratinib administered alone.
1-3 positive knuder ≥ 4 positive knuder
1-3 Positive Nodes
Neratinib hæmmede EGFR- og/eller HER2-positive carcinom cellelinjer med en cellulær IC50 < 100 nM.
Neratinib inhibited EGFR and/or HER2-expressing carcinoma cell lines with a cellular IC50 <100 nM.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Neglelidelser3, revner i huden og tør hud
Nail disorder3, skin fissures and dry skin
En enkeltdosis på 240 mg neratinib taget sammen med mad øgede Cmax og AUC med hhv. ca. 17 % og 23 % sammenholdt med administration i fastende tilstand.
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.
Mænd skal bruge en sikker barrieremetode såsom kondom: - mens de tager Nerlynx og - i tre måneder efter behandlingens afslutning.
Men must use an effective barrier method of contraception such as a condom: - while taking Nerlynx and - for three months after treatment has finished.
Patienter med symptomatisk sygdom i huden og det subkutane væv bør overvåges nøje (se pkt.
Patients with symptomatic skin and subcutaneous tissue disorders should be carefully monitored (see Section 4.8).
Udskillelse af neratinib sker primært via fæces
Excretion of neratinib is primary via the faeces
I analysen af de puljede sikkerhedsdata var størstedelen af de behandlingsrelaterede bivirkninger i systemorganklassen "Hud og subkutane væv" blandt asiater af grad 1 (43,3 %) og grad 2 (12,3 %); blandt kaukasere var forekomsten af grad 1- og grad 2-tilfælde hhv. 25,6 % og 7,8 %.
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.
Dosisjustering ved diarré Sværhedsgrad af diarré*
Dose modifications for diarrhoea Severity of diarrhoea*
I et dosiseskaleringsstudie med raske forsøgspersoner blev der givet enkeltdoser af oralt Nerlynx på op til 800 mg.
In a dose escalation study in healthy volunteers, single oral doses of Nerlynx up to 800 mg were administered.
En enkeltdosis på 240 mg oralt neratinib taget sammen med et måltid med højt fedtindhold øgede både Cmax og AUC med ca. 100 %.
A single oral dose of 240 mg neratinib taken with a meal high in fat increased both Cmax and AUC by approximately 100%.
De hyppigste grad 3-4-bivirkninger var diarré (grad 3: 36,9 %; grad 4: 0,2 %) og opkastning (grad 3: 3,4 %; grad 4: 0,1%).
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%).
Diarréen kan være kraftig, og du kan blive dehydreret.
The diarrhoea may be severe, and you may get dehydrated.
Alvorlige bivirkninger omfattede diarré (1,9 %), opkastning (1,3 %), dehydrering (1,1 %), kvalme (0,5 %), forhøjet alaninaminotransferase (0,4 %), forhøjet aspartataminotransferase (0,4 %), mavesmerter (0,3 %), udmattelse (0,3 %) og nedsat appetit (0,2 %).
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%).
Der er i de kliniske studier ikke givet enkeltdoser af Nerlynx på over 800 mg.
Single doses of Nerlynx greater than 800 mg have not been administered in the clinical studies.
Kaplan-Meier-diagram over sygdomsfri overlevelse - hormonreceptor-positiv population, som har afsluttet trastuzumab-behandling for mindre end ét år siden
Kaplan-Meier plot of disease-free survival - hormone receptor positive population who are less than one year from completion of trastuzumab therapy
Seponér Nerlynx permanent.
Discontinue Nerlynx permanently.
Dosisjustering hos patienter med let til moderat nedsat leverfunktion (Child-Pugh A eller B) er ikke nødvendig.
No dose adjustment is required in patients with Child-Pugh A or B (mild to moderate) hepatic impairment.
Behandling af patienter med svært nedsat nyrefunktion eller af patienter i dialyse anbefales ikke (se pkt.
Treatment of patients with severe renal impairment or on dialysis is not recommended (see Section 5.2).
Hvis patienten tager et antacid, bør administration af Nerlynx og antacidet ske med mindst 3 timers mellemrum.
If an antacid is taken, separate the dosing of Nerlynx and the antacid by at least 3 hours.
• Hvis diarréen bedres til grad 0-1, efter at der er gået mere end en uge, bør Nerlynx genoptages ved en lavere dosis (se tabel 1).
• If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
Meget almindelig Udslæt2 Almindelig
Very Common Rash2 Common
Hvis du har taget for mange Nerlynx tabletter, skal du straks kontakte en læge eller tage på skadestuen.
If you take more Nerlynx than you should, contact a doctor or a hospital straight away.
Der var en højere forekomst af behandlingsophør på grund af bivirkninger i gruppen af patienter på 65 år eller derover end i gruppen af patienter under 65 år; i Nerlynx-gruppen var andelen hhv. 44,8 % og 25,2 %.
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.
Hvid, rund 60 ml-beholder af højdensitetspolyetylen (HDPE) med børnesikret lukning af polypropylen og indvendig varmeinduceret folieforsegling.
White, 60 mL high density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal.
ÆSKE OG BEHOLDER
CARTON AND BOTTLE
I det pivotale fase 3-studie (ExteNET (3004)) var hyppigheden af behandlingsrelaterede bivirkninger (TEAE'er) i systemorganklassen "Hud og subkutane væv" højere blandt de asiatiske patienter, der fik Nerlynx, end blandt de kaukasiske patienter (56,4 % vs. 34,5 %), men på omtrent samme niveau hos placebo-behandlede patienter (24,9 % vs. 22,8 %).
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%).
Nerlynx 40 mg filmovertrukne tabletter neratinib
Nerlynx 40 mg film-coated tablets neratinib
Invasiv sygdoms-fri overlevelse Sygdomsfri overlevelse, herunder duktalt karcinom in situ Metastasefri overlevelse Tid til metastaserecidiv Centralnervesystem-recidiv CNS = centralnervesystem.
Invasive disease-free survival Disease-free survival including ductal carcinoma in situ Distant disease-free survival Time to distant recurrence CNS recurrence CNS = central nervous system.