natgillin/translations-raw huggingface dataset:
I et klinisk studie medførte samtidig anvendelse af erlotinib og rifampicin (600 mg oralt én gang daglig i 7 dage), en potent CYP3A4-induktor, en reduktion på 69 % af den mediane erlotinib AUC.
In a clinical study, the concomitant use of erlotinib and rifampicin (600 mg orally once daily for 7 days), a potent CYP3A4 inducer, resulted in a 69% decrease in the median erlotinib AUC.
Patienter, der aldrig har røget, havde en større virkning af erlotinib (overlevelse HR = 0,42; 95 % konfidensinterval 0,28-0,64) sammenlignet med rygere eller eks-rygere (HR = 0,87; 95 % konfidensinterval 0,71-1,05).
Patients who never smoked had a much greater benefit from erlotinib (survival HR = 0.42, 95% CI 0.28-0.64) compared with current or ex-smokers (HR = 0.87, 95% CI 0.71-1.05).
Efter oral administration af erlotinib opnås peak-plasmakoncentrationer efter ca. 4 timer.
After oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing.
Tarceva er indiceret hos patienter med tumorer uden EGFR-aktiverende mutationer, når andre behandlingsmuligheder vurderes uegnede.
In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.
Erlotinib og coumarin-antikoagulantia
Erlotinib and coumarin-derived anticoagulants
Hvis det overvejes at give ranitidin, bør det administreres forskudt; dvs. Tarceva skal administreres mindst 2 timer før eller 10 timer efter ranitidindosering.
If the use of ranitidine is considered, it should be used in a staggered manner; i.e. Tarceva must be taken at least 2 hours before or 10 hours after ranitidine dosing.
Til de forskellige doseringer findes Tarceva i styrker på 25 mg, 100 mg eller 150 mg.
For the different dose regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.
I et randomiseret dobbeltblindet studie (BR.21: Administration af Tarceva som anden-linje behandling), var udslæt (75 %) og diarré (54 %) de hyppigst rapporterede bivirkninger.
In a randomised double-blind study (BR.21; Tarceva administered as second line therapy), rash (75%) and diarrhoea (54%) were the most commonly reported adverse drug reactions (ADRs).
• Irritation eller betændelse omkring fingerneglene
• Inflammatory reactions around the fingernail
• Diarré og opkastning (meget almindelig: kan påvirke flere end 1 ud af 10 behandlede).
Diarrhoea and vomiting (very common: may affect more than 1 out of 10 people).
I populationsfarmakokinetiske analyser ledsagedes øgede serumkoncentrationer af total bilirubin af en langsommere hastighed af erlotinib-clearance.
In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Udslæt herunder dermatitis acneiformis.
*** Rash included dermatitis acneiform.
Når erlotinib blev administreret samtidig med ciprofloxacin, som er en moderat CYP1A2-hæmmer, blev erlotinibeksponeringen [AUC] øget signifikant med 39 %, mens der ikke blev observeret signifikant ændring i Cmax.
When erlotinib was co-administered with ciprofloxacin, a moderate CYP1A2 inhibitor, the erlotinib exposure [AUC] increased significantly by 39%, while no statistically significant change in Cmax was found.
I gruppen, som fik Tarceva plus gemcitabin, blev der rapporteret om udslæt og diarré af grad 3/4 hos 5 % af patienterne.
In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients.
Samtidig administration af Tarceva med 300 mg ranitidin, en H2-receptor-antagonist, nedsatte erlotinibeksponeringen [AUC] og maksimumkoncentrationerne [Cmax] med henholdsvis 33 % og 54 %.
Concomitant administration of Tarceva with 300 mg ranitidine, an H2-receptor antagonist, decreased erlotinib exposure [AUC] and maximum concentrations [Cmax] by 33% and 54%, respectively.
I et studie hos 4 patienter (3 med ikke-småcellet lungecancer [NSCLC] og 1 med larynxcancer), som fik 150 mg Tarceva dagligt oralt, viste tumorprøver fra kirurgiske ekscisioner på behandlingsdag 9 en samlet gennemsnitlig koncentration af erlotinib i tumorvæv på 1,185 ng/g væv.
In a study of 4 patients (3 with non-small cell lung cancer [NSCLC], and 1 with laryngeal cancer) receiving 150 mg daily oral doses of Tarceva, tumour samples from surgical excisions on Day 9 of treatment revealed tumour concentrations of erlotinib that averaged 1185 ng/g of tissue.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Tarceva 25 mg filmovertrukne tabletter
QUALITATIVE AND QUANTITATIVE COMPOSITION Tarceva 25 mg film coated tablets
Hvis Tarceva derimod blev administreret forskudt enten 2 timer før eller 10 timer efter 150 mg ranitidin 2 gange daglig, blev erlotinibeksponeringen [AUC] og maksimumkoncentrationerne [Cmax] kun reduceret med henholdsvis 15 % og 17 %.
However, when Tarceva was dosed in a staggered manner 2 hours before or 10 hours after ranitidine 150 mg b.i.d., erlotinib exposure [AUC] and maximum concentrations [Cmax] decreased only by 15% and 17%, respectively.
Erlotinib er substrat for P-glykoprotein lægemiddeltransportøren.
Erlotinib is a substrate for the P-glycoprotein active substance transporter.
Patienterne blev randomiseret 1:1 til at få Tarceva 150 mg daglig eller op til 4 cyklusser med platinbaseret dublet-kemoterapi.
Patients were randomised 1:1 to receive Tarceva 150 mg daily or up to 4 cycles of platinum based doublet chemotherapy.
Proteasomhæmmere, inklusiv bortezomib, kan forventes at påvirke effekten af EGFR hæmmere, inklusiv erlotinib, på grund af virkningsmekanismen.
Due to the working mechanism, proteasome inhibitors including bortezomib may be expected to influence the effect of EGFR inhibitors including erlotinib.
Tarceva skal administreres under opsyn af en læge med erfaring i anvendelsen af antineoplastiske lægemidler.
Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Sikkerheden og virkningen af erlotinib er ikke undersøgt hos patienter med svær leverdysfunktion (ASAT og ALAT > 5 x ULN).
The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
Både udslæt og diarré medførte seponering af Tarceva hos 1 % af patienterne.
Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients.
I et fase I-dosiseskaleringsstudie hos NSCLC-patienter, som var rygere, indikerede en farmakokinetisk analyse ved steady-state en dosis-proportional stigning i erlotinibeksponeringen, når Tarceva-dosis blev øget fra 150 mg til den maksimale toleransdosis på 300 mg. I dette studie var steady-stateplasmakoncentrationen ved en dosis på 300 mg hos rygere 1,22 µg/ml (n=17).
In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg. Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
Udslæt og diarré medførte seponering af Tarceva hos henholdsvis 1 % og < 1 % af patienterne i studie BO18192, mens ingen patienter seponerede Tarceva pga. udslæt og diarré i studie BO25460.
Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460.
Erlotinib og capecitabin
Erlotinib and Capecitabine
Virkning og sikkerhed af Tarceva som anden- og tredje-linje behandling blev dokumenteret i et randomiseret, dobbeltblindet, placebokontrolleret studie (BR.21) hos 731 patienter med lokalt fremskreden eller metastatisk NSCLC efter behandlingssvigt af mindst et kemoterapiregime.
The efficacy and safety of Tarceva as second/third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Virkning og sikkerhed af Tarceva i kombination med gemcitabin som 1. linje behandling blev vurderet i et randomiseret, dobbeltblindt, placebokontrolleret studie hos patienter med lokalt fremskreden inoperabel eller metastaserende pancreascancer.
The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
• I sjældne tilfælde blev der observeret leversvigt (sjælden: kan påvirke op til 1 ud af 1.000 behandlede).
In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people).
Hvis du udsættes for sollys, er beskyttende påklædning og/eller solcreme (f.eks. mineralholdig)
If you are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable Infection
Erlotinib og gemcitabin
Erlotinib and Gemcitabine
Erlotinib nedbrydes primært i leveren.
Erlotinib is primarily cleared by the liver.
• En betændelseslignende reaktion (inflammation) i den farvede del af øjet.
• Inflammation of the coloured part of the eye
I det pivotale fase III-NSCLC-studie opnåede rygere en erlotinibplasmakoncentration ved steady-state på 0,65 µg/ml (n=16), hvilket var ca. 2 gange mindre end koncentrationen, som blev opnået hos tidligere rygere eller hos patienter, der aldrig havde røget (1,28 µg/ml, n=108).
In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
• Kløe, tør hud og hårtab
Itching, dry skin and loss of hair
Plasmakoncentrationerne af metabolitterne er <10 % af erlotinibs plasmakoncentrationer, og har samme farmakokinetik som erlotinib.
They are present in plasma at levels that are <10% of erlotinib and display similar pharmacokinetics as erlotinib.
I et åbent, randomiseret fase III-studie, ML20650, som inkluderede 154 patienter, blev sikkerheden af Tarceva til første-linje-behandling af NSCLC-patienter med EGFR-aktiverende mutationer undersøgt hos 75 patienter.
In an open-label, randomised phase III study, ML20650 conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients.
Rygere havde dog en øget clearance-hastighed.
However, smokers had an increased rate of erlotinib clearance.
Opdateret analyse (62% af data tilgængelige for den samlede overlevelse) (n=173)
Updated Analysis (62% OS maturity) (n=173)
Hvis der kommer svær eller persisterende diarré, kvalme, anoreksi eller opkastning, ledsaget af dehydrering, skal behandlingen med Tarceva stoppes, og dehydreringen skal behandles på passende måde (se pkt.
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).
I dette studie havde den samlede population fordel af behandlingen vist ved det primære endepunkt, progressionsfri overlevelse (hazard ratio= 0,71; p< 0,0001) og det sekundære endepunkt, samlet overlevelse (hazard ratio= 0,81; p=0,0088).
In this study, the overall population showed a benefit for the primary PFS end-point (HR= 0.71 p< 0.0001) and the secondary OS end-point (HR= 0.81 p=0.0088).
Virkninger af kronisk behandling, som observeredes hos mindst en dyreart eller i et studie, omfattede virkninger på cornea (atrofi, ulceration), hud (follikulær degeneration og inflammation, rødme og alopeci), ovarier (atrofi), lever (levernekrose), nyre (renal papillær nekrose og tubulær dilatation), mave-tarmkanalen (forsinket gastrisk tømning og diarré).
Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary (atrophy), liver (liver necrosis), kidney (renal papillary necrosis and tubular dilatation), and gastrointestinal tract (delayed gastric emptying and diarrhoea).
Samtidig behandling med disse stoffer skal undgås (se pkt.
Concomitant treatment with these types of agents should be avoided (see section 4.5).
• Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglycolat type A, natriumlaurilsulfat, magnesiumstearat (se også punkt 2 vedrørende lactosemonohydrat).
Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate).
Sekundære endepunkt var alle i overensstemmelse med det primære endepunkt og ingen forskel var observeret for samlet overlevelse mellem patienter behandlet med erlotinib 300 mg og 150 mg daglig (hazard ratio 1,03; 95 % konfidensinterval 0,80 til 1,32).
Secondary efficacy endpoints were all consistent with the primary endpoint and no difference was detected for OS between patients treated with erlotinib 300 mg and 150 mg daily (HR 1.03, 95% CI 0.80 to 1.32).
Den mediane overlevelse var 6,7 måneder i Tarceva-gruppen (95 % konfidensinterval: 5,5 til 7,8 måneder) sammenlignet med 4,7 måneder i placebogruppen (95 % konfidensinterval: 4,1 til 6,3 måneder).
The median overall survival was 6.7 months in the Tarceva group (95% CI, 5.5 to 7.8 months) compared with 4.7 months in the placebo group (95% CI, 4.1 to 6.3 months).
Psyk iske forstyrrelser Depression
Psychiatric disorders Depression very common
I et fase 1b-studie var der ingen signifikant virkning af gemcitabin på erlotinibs farmakokinetik og heller ingen signifikant virkning af erlotinib på gemcitabins farmakokinetik.
In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine.
Sådan skal du tage Tarceva
How to take Tarceva
Der skal udføres en valideret, robust, pålidelig og sensitiv test med præspecificeret grænseværdi for positivitet og påvist anvendelighed til bestemmelse af EGFR-mutationsstatus ifølge lokal klinisk praksis.
A validated, robust, reliable and sensitive test with a prespecified positivity threshold and demonstrated utility for the determination of EGFR mutation status, using either tumor DNA derived from a tissue sample or circulating free DNA (cfDNA) obtained from a blood (plasma) sample, should be performed according to local medical practice.
Hos NSCLCpatienter, som er rygere, var den maksimale tolererede dosis af Tarceva 300 mg.
The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg.
6 Inklusive letale tilfælde.
Including fatalities.
Konfunderende faktorer har indbefattet tidligere leversygdom eller samtidig administration af hepatotoksiske lægemidler.
Confounding factors have included pre-existing liver disease or concomitant hepatotoxic medications.
Potente CYP3A4-induktorer kan nedsætte virkningen af erlotinib, mens potente CYP3A4-hæmmere kan medføre øget toksicitet.
Potent inducers of CYP3A4 may reduce the efficacy of erlotinib whereas potent inhibitors of CYP3A4 may lead to increased toxicity.
Erlotinibs opløselighed reduceres ved pH over 5.
Erlotinib is characterised by a decrease in solubility at pH above 5.
Udslæt og diarré af grad 3 opstod hos henholdsvis 9 % og 4 % af patienterne.
Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively.
For patienter, som behøver samtidig behandling med Tarceva og en potent CYP3A4-induktor, som f.eks. rifampicin, bør det overvejes at hæve dosis til 300 mg, med tæt monitorering af patienterne (herunder nyre- og leverfunktionen samt serumelektrolytter).
For patients who require concomitant treatment with Tarceva and a potent CYP3A4 inducer such as rifampicin an increase in dose to 300 mg should be considered while their safety (including renal and liver functions and serum electrolytes) is closely monitored, and if well tolerated for more than 2 weeks, further increase to 450 mg could be considered with close safety monitoring.
Capecitabin kan øge koncentrationen af erlotinib.
Capecitabine may increase erlotinib concentrations.
Lægemidler, der ændrer pH i den øvre del af mavetarmkanalen, som eksempelvis protonpumpehæmmere, H2-antagonister og antacida, kan ændre erlotinibs opløselighed og derved dets biotilgængelighed.
Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract, like proton pump inhibitors, H2 antagonists and antacids, may alter the solubility of erlotinib and hence its bioavailability.
Inklusive letale tilfælde (se pkt.
Including fatalities (see section 4.4).
Den mediane PFS var 9,7 uger i Tarceva-gruppen (95 % konfidensinterval; 8,4 til 12,4 uger) sammenlignet med 8,0 uger i placebo-gruppen (95 % konfidensinterval; 7,9 til 8,1 uger).
The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
I et klinisk studie medførte samtidig anvendelse af erlotinib og ketoconazol (200 mg oralt to gange daglig i 5 dage), en potent CYP3A4-hæmmer, en øgning af erlotinib-eksponeringen (86 % af AUC og 69 % af Cmax).
In a clinical study, the concomitant use of erlotinib with ketoconazole (200 mg orally twice daily for 5 days), a potent CYP3A4 inhibitor, resulted in an increase of erlotinib exposure (86% of AUC and 69% of Cmax).
Erlotinib er en potent hæmmer af CYP1A1 og en moderat hæmmer af CYP3A4 og CYP2C8 samt en stærk hæmmer af glukoronidiseringen af UGT1A1 in vitro.
Erlotinib is a potent inhibitor of CYP1A1, and a moderate inhibitor of CYP3A4 and CYP2C8, as well as a strong inhibitor of glucuronidation by UGT1A1 in vitro.
Virkningen og sikkerheden af Tarceva som vedligeholdelsesbehandling efter første-linjekemoterapibehandling afNSCLC blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie (BO18192, SATURN).
The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomised, double-blind, placebo-controlled trial (BO18192, SATURN).
Alle grader 3
Any Grade
4 ”Bivirkninger”.
See also section 4 “Possible side effects”.
Når Tarceva administreres samtidig med disse stoffer, vil en øget dosis af Tarceva sandsynligvis ikke kompensere for eksponeringstabet.
Increasing the dose of Tarceva when co-administered with such agents is not likely to compensate for the loss of exposure.
De mest almindelige bivirkninger hos patienter med pancreascancer, som fik Tarceva 100 mg plus gemcitabin i det pivotale studie PA.3, var træthed, udslæt og diarré.
The most common adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash and diarrhoea.
Forudplanlagt interimanalyse (35% af data tilgængelige for den samlede overlevelse) (n=153)
Pre-planned Interim Analysis (35% OS maturity) (n=153)
Tarceva er også indiceret til behandling af patienter med lokalt fremskreden eller metastatisk NSCLC efter behandlingssvigt af mindst et tidligere kemoterapiregime.
Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
4.2, 4.4, 4.5 og 5.2.
See sections 4.2, 4.4, 4.5 and 5.1.
Erlotinib metaboliseres i leveren af de hepatiske, humane cytokromer, primært af CYP3A4 og i mindre udstrækning af CYP1A2.
Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2.
Behandling med Tarceva skal pauseres eller seponeres, hvis patienten får alvorlig bulløs, blærefyldt eller eksfoliativ hud.
Tarceva treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions.
- Palmoplantar erytrodysæstesi
-Palmar plantar erythrodysaesthesia syndrome
De hyppigste bivirkninger, der blev observeret hos patienter behandlet med Tarceva i studie ML20650, var udslæt og diarré (henholdsvis 80 % og 57 % for alle grader).
The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention.
Ikke-småcellet lungecancer (administration af Tarceva som monoterapi)
Non-small cell lung cancer (Tarceva administered as monotherapy)
Den samlede overlevelse med Tarceva i første-linjevedligeholdelsesbehandling var ikke bedre end Tarceva som anden-linje-behandling hos patienter, hvor tumoren ikke havde EGFR-aktiverende mutation (hazard ratio= 1,02; 95 % konfidensinterval, 0,85-1,22; p=0,82).
OS of Tarceva in first line maintenance was not superior to Tarceva as second line treatment in patients whose tumor did not harbor an EGFR-activating mutation (HR= 1.02, 95% CI, 0.85 to 1.22, p=0.82).
3 ”Sådan skal du tage Tarceva”.
See also section 3 ‘How to take Tarceva'
Anvendelse af Tarceva til patienter med svær leverdysfunktion anbefales ikke (se pkt.
Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
Lægemidler, der ændrer pH i den øvre del af mavetarmkanalen, kan ændre erlotinibs opløselighed og derved dets biotilgængelighed.
Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract may alter the solubility of erlotinib and hence its bioavailability.
Både udslæt og diarré medførte dosisreduktion hos 2 % af patienterne og udtrædelse af studiet hos op til 1 % af patienterne, som fik Tarceva plus gemcitabin.
Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Disse studier blev gennemført med i alt 1532 patienter med fremskreden, recidiverende eller metastatisk NSCLC som opfølgning på første-linje standard platinbaseret kemoterapi.
These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy, no new safety signals were identified.
Der blev ikke observeret udslæt og diarré af grad 4.
No Grade 4 rash or diarrhoea was observed.
Hver 100 mg filmovertrukken tablet indeholder 69,21 mg lactosemonohydrat.
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Der var ingen signifikant virkning af erlotinib på capecitabins farmakokinetik.
There were no significant effects of erlotinib on the pharmacokinetics of capecitabine.
Tarceva gives i kombination med gemcitabin.
Tarceva is given in combination with gemcitabine treatment.
Dette bør udvises, selvom eksponeringen af erlotinib hos patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) var lignende den, der blev set hos patienter med sufficient leverfunktion.
Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Tarceva er indiceret til første-linje-behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer (NSCLC) med EGFR-aktiverende mutationer.
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with EGFR activating mutations.
Når der ordineres Tarceva, skal der tages hensyn til faktorer forbundet med forlænget overlevelse (se pkt.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).
Hypokaliæmi og nyreinsufficiens (herunder fatale tilfælde) er sjældent rapporteret.
There have been rare reports of hypokalaemia and renal failure (including fatalities).
• Appetitmangel, vægttab
Loss of appetite, decreased weight
- Behandling af NSCLC efter svigt af mindst et tidligere kemoterapiregime (administration af Tarceva som monoterapi)
- NSCLC treatment after failure of at least one prior chemotherapy regimen (Tarceva administered as monotherapy)