FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the data from the CURRENTS study, no evidence was seen for any benefit of a higher erlotinib dose of 300 mg when compared with the recommended dose of 150 mg in active smokers.
Slovenian: Na podlagi podatkov iz študije CURRENTS ni videti dokazov za kakršno koli korist večjega odmerka erlotiniba 300 mg v primerjavi s priporočenim odmerkom 150 mg pri aktivnih kadilcih.
English: In patients who do not develop rash within the first 4 - 8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
Slovenian: Pri bolnikih, pri katerih se kožni izpuščaj v prvih 4 do 8 tednih zdravljenja ne pojavi, je treba ponovno pretehtati nadaljnje zdravljenje z zdravilom Tarceva (glejte poglavje 5.1).
English: The objective of the study was to compare the overall survival of first line maintenance therapy with erlotinib versus erlotinib administered at the time of disease progression.
Slovenian: Namen študije je bil primerjati celokupno preživetje pri vzdrževalnem zdravljenju z erlotinibom v prvi liniji z dajanjem erlotiniba v času napredovanja bolezni.
English: Due to the working mechanism, proteasome inhibitors including bortezomib may be expected to influence the effect of EGFR inhibitors including erlotinib.
Slovenian: Zaradi mehanizma delovanja lahko od zaviralcev proteasomov, vključno z bortezomibom, pričakujemo, da vplivajo na učinek zaviralcev EGFR, vključno z erlotinibom.
English: When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).
Slovenian: Pri predpisovanju zdravila Tarceva je treba upoštevati dejavnike, povezane s podaljšanim preživetjem (glejte poglavji 4.2 in 5.1).
English: Itching, dry skin and loss of hair
Slovenian: • srbenje, suha koža, izguba las,
English: Patients with low expression levels of UGT1A1 or genetic glucuronidation disorders (e.g. Gilbert's disease) may exhibit increased serum concentrations of bilirubin and must be treated with caution.
Slovenian: Bolniki z majhnim izražanjem UGT1A1 ali genetskimi motnjami glukuronidacije (npr. Gilbertova bolezen) imajo lahko povečane koncentracije bilirubina v serumu in jih je treba zdraviti pazljivo.
English: In non-clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death.
Slovenian: V nekliničnih modelih zaviranje fosfotirozina EGFR povzroči zastoj in/ali smrt celice.
English: Including in-growing eyelashes, excessive growth and thickening of the eyelashes.
Slovenian: Vključno z vraščenimi trepalnicami, povečano rastjo in odebelitvijo trepalnic.
English: Most were Grade 1/2 in severity and manageable without intervention.
Slovenian: Večina jih je bila glede na jakost stopnje 1/2 in je minila brez zdravljenja.
English: Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure (up to 2-fold and 10-fold higher, respectively, based on Cmax and/or AUC).
Slovenian: Dvoletne študije kancerogenosti z erlotinibom, ki so jih izvedli na podganah in miših, so bile negativne do izpostavljenosti, ki je presegla humano terapevtsko izpostavljenost (do 2-krat in 10-krat višje, glede na Cmax in/ali AUC).
English: See also below “Other medicines and Tarceva”
Slovenian: Glejte tudi “Druga zdravila in zdravilo Tarceva”.
English: There are no adequate data for the use of erlotinib in pregnant women.
Slovenian: O uporabi erlotiniba pri nosečnicah ni zadostnih podatkov.
English: • if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for example loperamide);
Slovenian: • imate drisko, ker vas bo morda zdravnik moral zdraviti z zdravili proti driski (na primer loperamidom);
English: If you become pregnant while you are being treated with Tarceva, immediately inform your doctor who will decide if the treatment should be continued.
Slovenian: Če med jemanjem zdravila Tarceva zanosite, takoj obvestite zdravnika, ki bo odločil o tem, ali boste z zdravljenjem nadaljevali.
English: 67% of placebo patients in the EGFR mutation positive subgroup received second or further line treatment with EGFR-TKIs.
Slovenian: 67 % bolnikov, ki so prejemali placebo v podskupini z EGFR-pozitivnimi tumorji, je prejelo drugo ali nadaljnjo linijo zdravljenja z zaviralcem tirozinske kinaze EGRF (EGFR-TKI).
English: Tarceva has not been studied for its possible effects on the ability to drive and use machines but it is very unlikely that your treatment will affect this ability.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravila Tarceva niso proučevali glede možnih vplivov na sposobnost upravljanja vozil in strojev, vendar pa je malo verjetno, da bi vaše zdravljenje vplivalo na te sposobnosti.
English: This analysis demonstrated that covariants affecting erlotinib clearance in patients from the pancreatic study were very similar to those seen in the prior single agent pharmacokinetic analysis.
Slovenian: Ta analiza je pokazala, da so sospremenljivke, ki vplivajo na očistek erlotiniba pri bolnikih iz študije pri raku trebušne slinavke, zelo podobne opaženim v prejšnji farmakokinetični analizi z enim zdravilom.
English: Loss of appetite, decreased weight
Slovenian: • izguba apetita, zmanjšanje telesne mase,
English: A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).
Slovenian: Koristen vpliv zdravila Tarceva na podaljšanje preživetja so opazili tudi pri bolnikih, ki niso dosegli objektivnega odgovora na zdravljenje (po kriterijih RECIST).
English: No studies have been conducted to assess the impact of Tarceva on milk production or its presence in breast milk.
Slovenian: Študije za oceno vpliva zdravila Tarceva na nastajanje mleka ali prisotnosti zdravila v mleku doječih mater niso bile izvedene.
English: The primary endpoint of the study included progression free survival (PFS) in all patients.
Slovenian: Primarni cilj preskušanja je vključeval preživetje brez napredovanja bolezni (PFS) pri vseh bolnikih.
English: • The active substance of Tarceva is erlotinib.
Slovenian: • Učinkovina zdravila Tarceva je erlotinib.
English: Therefore, in such patients, periodic liver function testing should be considered.
Slovenian: Pri teh bolnikih je treba zato premisliti o rednem spremljanju jetrnega delovanja.
English: Erlotinib increases platinum concentrations.
Slovenian: Erlotinib poveča koncentracijo platine.
English: No new covariate effects were identified.
Slovenian: Novih učinkov sospremenljivk niso opazili.
English: A population pharmacokinetic analysis in 591 patients receiving single agent Tarceva shows a mean apparent clearance of 4.47 l/hour with a median half-life of 36.2 hours.
Slovenian: Populacijska farmakokinetična analiza je pri 591 bolnikih, ki so prejemali le zdravilo Tarceva, pokazala srednji navidezni očistek 4,47 l/uro z mediano razpolovnega časa 36,2 ure.
English: The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
Slovenian: Priporočeni dnevni odmerek zdravila Tarceva je 100 mg, ki ga vzamemo najmanj eno uro pred zaužitjem hrane ali dve uri po tem, v kombinaciji z gemcitabinom (glejte Povzetek glavnih značilnosti zdravila za gemcitabin, indikacija rak trebušne slinavke).
English: Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na erlotinib ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.
Slovenian: Če ste pozabili vzeti enega ali več odmerkov zdravila Tarceva, obvestite zdravnika ali farmacevta takoj, ko je mogoče.
English: Any Grade
Slovenian: katera koli stopnja 3
English: -Palmar plantar erythrodysaesthesia syndrome
Slovenian: - sindrom palmarnoplantarne eritrodisestezije
English: The tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Slovenian: Tablete vsebujejo laktozo in se jih ne sme dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze.
English: Therefore, concomitant administration of these combinations should be avoided (see section 4.5).
Slovenian: Zato se je treba sočasnemu dajanju teh kombinacij izogibati (glejte poglavje 4.5).
English: Reduced exposure may also occur with other inducers e.g. phenytoin, carbamazepine, barbiturates or St. John's Wort (hypericum perforatum).
Slovenian: Zmanjšana izpostavljenost se lahko pojavi tudi z drugimi induktorji, kot so fenitoin, karbamazepin, barbiturati ali šentjanževka (Hypericum perforatum).
English: Studies in animals have shown no evidence of impaired fertility.
Slovenian: Študije na živalih niso pokazale znakov vpliva na plodnost.
English: Although the Cmax was statistically significant lower in moderately hepatic impaired patients, this difference is not considered clinically relevant.
Slovenian: Čeprav je bila Cmax pri bolnikih z zmerno jetrno okvaro statistično značilno manjša, te razlike ne smatramo za klinično pomembno.
English: Patients taking coumarin-derived anticoagulants should be monitored regularly for any changes in prothrombin time or INR.
Slovenian: Bolnikom, ki jemljejo kumarinske antikoagulante, je treba redno kontrolirati protrombinski čas ali INR.
English: If you forget to take Tarceva
Slovenian: Če ste pozabili vzeti zdravilo Tarceva
English: The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
Slovenian: Primarna presnovka erlotiniba OSI-420 in OSI-413, ki nastaneta z O-demetiliranjem katere koli stranske verige, imata primerljivo učinkovitost z erlotinibom v nekliničnih in vitro metodah in in vivo tumorskih modelih.
English: In a clinical study, the concomitant use of erlotinib with carboplatin and paclitaxel led to an increase of total platinum AUC0-48 of 10.6%.
Slovenian: V klinični študiji je sočasna uporaba erlotiniba s karboplatinom in paklitakselom povečala celokupno AUC0-48 platine za 10,6 %.
English: In population pharmacokinetic analysis, no clinically significant relationship was observed between erlotinib clearance and creatinine clearance, but there are no data available for patients with creatinine clearance <15 ml/min.
Slovenian: V populacijski farmakokinetični analizi niso opazili klinično pomembne povezave med očistkom erlotiniba in očistkom kreatinina, vendar za bolnike s kreatininskim očistkom < 15 ml/min podatkov ni.
English: What Tarceva is and what it is used for What you need to know before you take Tarceva How to take Tarceva
Slovenian: Kaj je zdravilo Tarceva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tarceva Kako jemati zdravilo Tarceva Možni neželeni učinki
English: Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Tarceva mora nadzorovati zdravnik z izkušnjami pri zdravljenju raka.
English: In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.
Slovenian: Pri bolnikih, katerih tumorji nimajo EGFR-aktivirajočih mutacij, je zdravilo Tarceva indicirano le, kadar druga možna zdravljenja niso primerna.
English: Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing.
Slovenian: Zdrave osebe so ponavljajoče dajanje odmerka 200 mg dvakrat na dan slabo prenašale že po nekaj dneh jemanja.
English: If you develop symptoms such as sudden difficulty in breathing associated with cough or fever contact your doctor immediately as you could suffer from this disease.
Slovenian: Če se pri vas pojavijo simptomi, kot so nenadne težave z dihanjem, ki so povezane s kašljem ali vročino, nemudoma obvestite zdravnika, ker imate lahko to bolezen.
English: You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.
Slovenian: Če se zdravite z zdravilom Tarceva, vam svetujemo, da kajenje opustite, saj lahko kajenje zmanjša količino vašega zdravila v krvi.
English: Based on the data from the BO25460 (IUNO) study, Tarceva use is not recommended for first-line maintenance treatment in patients without an EGFR activating mutation.
Slovenian: Na podlagi podatkov iz študije BO25460 (IUNO) uporaba zdravila Tarceva ni priporočljiva za prvo linijo vzdrževalnega zdravljenja bolnikov brez EGFR-aktivirajočih mutacij.
English: The physiological relevance of the strong inhibition of CYP1A1 is unknown due to the very limited expression of CYP1A1 in human tissues.
Slovenian: Fiziološki pomen močne inhibicije CYP1A1 ni znan, saj se v človeških tkivih CYP1A1 izraža v zelo majhni meri.
English: • if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or influence its effect (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort or proteasome inhibitors), talk to your doctor.
Slovenian: • če jemljete druga zdravila, ki lahko povečajo ali zmanjšajo količino erlotiniba v vaši krvi ali vplivajo na njegov učinek (na primer antimikotiki, kot je ketokonazol, zaviralci proteaz, eritromicin, klaritromicin, fenitoin, karbamazepin, barbiturati, rifampicin, ciprofloksacin, omeprazol, ranitidin, šentjanževka ali zaviralci proteasomov), se posvetujte z zdravnikom.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: 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).
Slovenian: Neželeni učinki iz kliničnih preskušanj (preglednica 1) so navedeni po organskih sistemih razvrstitve MedDRA. Za vsak neželeni učinek zdravila je določena ustrezna kategorija pogostnosti, ki temelji na naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Tarceva contains a sugar called lactose monohydrate.
Slovenian: Zdravilo Tarceva vsebuje sladkor, ki se imenuje laktoza monohidrat.
English: In the event of severe or persistent diarrhoea, nausea, anorexia, or vomiting associated with dehydration, Tarceva therapy should be interrupted and appropriate measures should be taken to treat the dehydration (see section 4.8).
Slovenian: V primeru hude ali dolgotrajne driske, navzee, anoreksije ali bruhanja, povezanih z dehidracijo, je treba zdravljenje z zdravilom Tarceva prekiniti in dehidracijo ustrezno zdraviti (glejte poglavje 4.8).
English: There were treatment-related increases in ALT, AST and bilirubin.
Slovenian: Opazili so z zdravljenjem povezana zvišanja ALT, AST in bilirubina.
English: Survival was evaluated in the intent-to-treat population based on follow-up survival data.
Slovenian: Preživetje so vrednotili v populaciji, ki so jo nameravali zdraviti (ITT, intent to treat), na osnovi podatkov o preživetju, ki so jih dobili iz sledenja.
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)
Slovenian: • hudi mehurji na koži ali močno luščenje kože (kar nakazuje na Stevens-Johnsonov sindrom),
English: Erlotinib and its metabolites are not significantly excreted by the kidney, as less than 9% of a single dose is excreted in the urine.
Slovenian: Erlotinib in njegovi presnovki se ne izločajo v velikem obsegu prek ledvic, saj se jih po enkratnem odmerku v urin izloči manj kot 9 %.
English: See sections 4.2, 4.4, 4.5 and 5.1.
Slovenian: Glejte poglavja 4.2, 4.4, 4.5 in 5.1.
English: Pre-treatment or co-administration of Tarceva did not alter the clearance of the prototypical CYP3A4 substrates, midazolam and erythromycin, but did appear to decrease the oral bioavailability of midazolam by up to 24%.
Slovenian: Predhodno ali sočasno zdravljenje z zdravilom Tarceva ni spremenilo očistka prototipov substratov CYP3A4, midazolama in eritromicina, vendar pa je do 24 % zmanjšalo peroralno biološko uporabnost midazolama.
English: (Voir/siehe Belgique/Belgien)
Slovenian: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
English: Cases were mainly mild to moderate in severity, transient in nature or associated with liver metastases.
Slovenian: Večinoma so bile nepravilnosti blage do zmerne, prehodne narave ali povezane z jetrnimi metastazami.
English: Erlotinib is characterised by a decrease in solubility at pH above 5.
Slovenian: Za erlotinib je značilno zmanjšanje topnosti pri pH nad 5.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila Tarceva posvetujte z zdravnikom.
English: PFS (median in months), Investigator assessed p<0.0001
Slovenian: Preživetje brez napredovanja bolezni (mediana v mesecih), raziskovalčeva ocena p < 0,0001
English: This was confirmed in a pharmacokinetic study in non-smoking and currently cigarette smoking healthy subjects receiving a single oral dose of 150 mg erlotinib.
Slovenian: To so dokazali v farmakokinetični študiji pri zdravih osebah, nekadilcih in kadilcih, ki so prejeli enkraten peroralni odmerek 150 mg erlotiniba.
English: • if you are taking anticoagulants (a medicine which helps to prevent thrombosis or blood clotting e.g. warfarin), Tarceva may increase your tendency to bleed.
Slovenian: • če jemljete antikoagulante (zdravila, ki pomagajo preprečevati trombozo oziroma nastajanje krvnih strdkov, npr. varfarin), saj lahko zdravilo Tarceva zveča vašo nagnjenost h krvavitvam.
English: Patients receiving Tarceva are at increased risk of developing gastrointestinal perforation, which was observed uncommonly (including some cases with a fatal outcome).
Slovenian: Bolniki, ki prejemajo zdravilo Tarceva, imajo večje tveganje za razvoj perforacij v prebavilih, ki so jih opazili občasno (vključno z nekaterimi primeri, ki so se končali s smrtnim izidom).
English: Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
Slovenian: V nekaterih primerih je bila vzrok huda dehidracija zaradi driske, bruhanja in/ali anoreksije, pri drugih pa je k nastanku pripomogla sočasno prejeta kemoterapija.
English: Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR).
Slovenian: Zdravilo Tarceva uporabljamo za zdravljenje raka, saj preprečuje delovanje beljakovine, imenovane receptor za epidermalni rastni dejavnik.
English: Erlotinib and other CYP substrates
Slovenian: Erlotinib in drugi substrati CYP
English: If the use of antacids is considered necessary during treatment with Tarceva, they should be taken at least 4 hours before or 2 hours after the daily dose of Tarceva.
Slovenian: Če menimo, da je uporaba antacidov med zdravljenjem z zdravilom Tarceva potrebna, jih je treba jemati najmanj 4 ure pred ali 2 uri po dnevnem odmerku zdravila Tarceva.
English: Similarly, the exposure to the active metabolite increased by about 60% and 48% for AUC and Cmax, respectively.
Slovenian: Podobno se je izpostavljenost aktivnemu presnovku [AUC] povečala za približno 60 %, Cmax pa za 48 %.
English: Current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Slovenian: Bolnikom, ki kadijo, je treba svetovati, naj prenehajo kaditi, saj so plazemske koncentracije erlotiniba pri kadilcih zmanjšane v primerjavi s plazemskimi koncentracijami pri nekadilcih.
English: Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
Slovenian: Uporaba zdravila Tarceva pri bolnikih s hudo jetrno disfunkcijo ni priporočljiva (glejte poglavje 5.2).
English: Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Slovenian: Sočasna uporaba zaviralcev Pgp, kot sta ciklosporin in verapamil, lahko vodi v spremenjeno porazdelitev in/ali spremenjeno izločanje erlotiniba.
English: The effect of antacids on the absorption of erlotinib has not been investigated but absorption may be impaired, leading to lower plasma levels.
Slovenian: Učinka antacidov na absorpcijo erlotiniba niso proučevali, vendar je ta lahko zmanjšana, kar vodi v nižje plazemske koncentracije.
English: • if you use contact lenses and/or have a history of eye problems such as severe dry eyes, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye, tell your doctor.
Slovenian: • če uporabljate kontaktne leče in/ali če ste v preteklosti imeli težave z očmi, kot so zelo suhe oči, vnetje sprednjega dela očesa (roženice) ali razjede na sprednjem delu očesa, o tem obvestite zdravnika.
English: It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations.
Slovenian: Lahko vam ga predpiše kot začetno zdravljenje ali kot zdravljenje, ko je vaša bolezen po začetni kemoterapiji ostala v večji meri nespremenjena, če so v vaših rakavih celicah prisotne določene mutacije receptorja za epidermalni rastni dejavnik.
English: Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Slovenian: Pomemben vpliv na očistek drugih substratov CYP3A4 zato ni verjeten.
English: They are present in plasma at levels that are <10% of erlotinib and display similar pharmacokinetics as erlotinib.
Slovenian: V plazmi sta prisotna v koncentracijah, manjših od 10 % koncentracije erlotiniba, in kažeta podobno farmakokinetiko kakor erlotinib.
English: This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Slovenian: Temu učinku se je pridružilo tudi zmanjšanje navideznega plazemskega očistka erlotiniba za 24 %.
English: In two other double-blind, randomised, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Tarceva was administered as maintenance after first-line chemotherapy.
Slovenian: V dveh drugih dvojno slepih, randomiziranih, s placebom primerjanih študijah faze III, BO18192 (SATURN) in BO25460 (IUNO), so zdravilo Tarceva dajali kot vzdrževalno zdravljenje po kemoterapiji v prvi liniji.
English: However, an adverse effect on the pregnancy can not be excluded as rat and rabbit studies have shown increased embryo/foetal lethality (see section 5.3).
Slovenian: Vendar pa škodljivega učinka na nosečnost ni mogoče izključiti, ker so študije na podganah in kuncih pokazale povečano smrtnost zarodkov oziroma plodov (glejte poglavje 5.3).
English: The most frequent ADRs seen in patients treated with Tarceva in studies BO18192 and BO25460 were rash (BO18192: all grades 49.2%, grade 3: 6.0%; BO25460: all grades 39.4%, grade 3: 5.0%) and diarrhoea (BO18192: all grades 20.3%, grade 3: 1.8%; BO25460: all grades 24.2%, grade 3: 2.5%).
Slovenian: Najpogostejša neželena učinka, ki so ju opazili pri bolnikih, zdravljenih z zdravilom Tarceva v študijah BO18192 in BO25460, sta bila kožni izpuščaj (BO18192: vse stopnje: 49,2 %, stopnja 3: 6,0 %; BO25460: vse stopnje: 39,4 %, stopnja 3: 5,0 %) in driska (BO18192: vse stopnje: 20,3 %, stopnja 3: 1,8 %; BO25460: vse stopnje: 24,2 %, stopnja 3: 2,5 %).