natgillin/translations-raw huggingface dataset:
d) Neuropati (brændende fornemmelse, dysæstesi, ”myrekryb”, gangforstyrrelser, hyperæstesi, hypæstesi, hypotoni, motorisk dysfunktion, muskelatrofi, muskelsvaghed, neuralgi, neuritis, perifer neuropati, neurotoksicitet, paræstesi, perifer motorisk neuropati, perifer sensorisk-motorisk neuropati, perifer sensorisk neuropati, parese fra perifere nerver, polyneuropati, føleforstyrrelser, brændende fornemmelse i huden).
d. Neuropathy (Burning sensation, Dysaesthesia, Formication, Gait disturbance, Hyperaesthesia, Hypoaesthesia, Hypotonia, Motor dysfunction, Muscle atrophy, Muscular weakness, Neuralgia, Neuritis, Neuropathy peripheral, Neurotoxicity, Paraesthesia, Peripheral motor neuropathy, Peripheral sensorimotor neuropathy, Peripheral sensory neuropathy, Peroneal nerve palsy, Polyneuropathy, Sensory disturbance, Skin burning sensation).
Hvis QTc forlænges til ≥500 ms, skal en kardiolog straks konsulteres.
If QTc increases to greater than or equal to 500 msec, cardiologist advice must be immediately sought.
Der er ingen dyreforsøg med crizotinib til evaluering af fertilitet, men baseret på fund fra repeat-dose toksicitetsstudier i rotter vurderes crizotinib at have potentiale for at påvirke reproduktion og fertilitet hos mennesker.
No specific studies with crizotinib have been conducted in animals to evaluate the effect on fertility; however, crizotinib is considered to have the potential to impair reproductive function and fertility in humans based on findings in repeat-dose toxicity studies in the rat.
Mediantid til forekomst af diarré og obstipation var hhv. 13 og 17 dage.
Median times to onset for diarrhoea and constipation were 13 and 17 days, respectively.
Hold pause indtil forbedring til grad ≤ 1 eller baseline, herefter genoptages dosering med 250 mg en gang dagligt med stigning til 200 mg 2 gange dagligt, hvis det tolereres klinisk b,c
Withhold until recovery to Grade 1 or baseline, then resume at 250 mg once daily and escalate to 200 mg twice daily if clinically toleratedb,c
In vitro studier med humane hepatocytter antyder at crizotinib kan inducere preganan-X-receptor (PXR)- og konstitutiv androstanreceptor (CAR)-regulerede enzymer (fx CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
In vitro studies in human hepatocytes indicated that crizotinib may induce pregnane X receptor (PXR)and constitutive androstane receptor (CAR)-regulated enzymes (e.g., CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
Understøttende behandling af diarré og obstipation bør omfatte brug af standardbehandling med henholdsvis obstipantia og laksantia.
Supportive care for diarrhoea and constipation should include the use of standard antidiarroheal and laxative medicinal products, respectively.
Crizotinib metaboliseres i stort omfang i leveren.
Crizotinib is extensively metabolized in the liver.
• Atazanavir, ritonavir, cobicistat bruges til behandling af hiv-infektioner/AIDS.
• Atazanavir, ritonavir, cobicistat, used to treat HIV infections/AIDS.
I alt 53 patienter med ROS1-positiv fremskreden NSCLC var inkluderet i studiet på datacutoff, herunder 46 patienter, der tidligere var blevet behandlet for ROS1-positiv fremskreden NSCLC, og et begrænset antal patienter (N=7), der ikke tidligere havde fået systemisk behandling.
A total of 53 ROS1-positive advanced NSCLC patients were enrolled in the study at the time of data cutoff, including 46 patients with previously treated ROS1-positive advanced NSCLC and a limited number of patients (N=7) who had no prior systemic treatment.
Du bør dog ikke drikke grapefrugtjuice eller spise grapefrugt, mens du er i behandling med XALKORI, fordi grapefrugt kan ændre på mængden af XALKORI i kroppen.
You can take XALKORI with or without food; however, you should avoid drinking grapefruit juice or eating grapefruit while on treatment with XALKORI as they may change the amount of XALKORI in your body.
Den anbefalede dosis af XALKORI er 250 mg 2 gange dagligt (500 mg dagligt) indtaget kontinuerligt.
The recommended dose schedule of XALKORI is 250 mg twice daily (500 mg daily) taken continuously.
Der er tilgængelig information fra 45 responsevaluerbare patienter med tidligere behandlet nonadenokarcinom NSCLC (herunder 22 patienter med SCC) i studie 1005.
Information is available from 45 response-evaluable patients with previously treated non-adenocarcinoma NSCLC (including 22 patients with SCC) in Study 1005.
Leverfunktionsundersøgelse, herunder test for ALAT, ASAT- og bilirubinstigninger, skal udføres hver uge de første 2 behandlingsmåneder, og derefter 1 gang om måneden samt hvis det er klinisk nødvendigt, med hyppigere undersøgelser ved grad 2, 3 eller 4 stigninger.
Liver function tests including ALT, AST, and total bilirubin should be monitored once a week during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3 or 4 elevations.
In vitro er crizotinib ikke en hæmmer af galdesalt-eksportpumpen (BSEP) ved klinisk relevante koncentrationer.
In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations.
En præcis og valideret test for enten ALK eller ROS1 er vigtig for selektion af patienter til XALKORI-behandling (se pkt.
An accurate and validated assay for either ALK or ROS1 is necessary for the selection of patients for treatment with XALKORI (see section 5.1 for information on assays used in the trials).
De patientrapporterede symptomer og den generelle livskvalitet (QoL) blev indsamlet ved hjælp af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13).
Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Alle øvre grænser for 90% CI for LS middelændring af QTcF fra baseline på alle tidspunkter på dag 1 i cyklus 2 var <20 ms.
All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec.
Hold pause ved mistanke om ILD/pneumonitis, og seponer permanent, hvis behandlingsrelateret ILD/pneumonitis diagnosticeres
Withhold if ILD/pneumonitis is suspected, and permanently discontinue if treatment-related ILD/pneumonitis is diagnosedd
Hos patienter med nyligt opstået grad 4 synstab bør behandlingen med crizotinib seponeres, og der skal udføres en oftalmologisk undersøgelse.
In patients with new onset of Grade 4 visual loss, crizotinib treatment should be discontinued and ophthalmological evaluation should be performed.
Lægemiddelinduceret ILD/pneumonitis bør overvejes som differentialdiagnose hos patienter med ILD-lignende tilstande såsom pneumonitis, strålepneumonitis, allergisk alveolitis, interstitiel pneumonitis, lungefibrose, akut respiratorisk distress-syndrom (ARDS), alveolitis, lungeinfiltration, pneumoni, lungeødemer, kronisk obstruktiv lungesygdom, pleuraeffusion, aspirationspneumoni, bronkitis, bronchiolitis obliterans og bronkiektase.
Drug-induced ILD/pneumonitis should be considered in the differential diagnosis of patients with ILD-like conditions such as: pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome (ARDS), alveolitis, lung infiltration, pneumonia, pulmonary oedema, chronic obstructive pulmonary disease, pleural effusion, aspiration pneumonia, bronchitis, obliterative bronchiolitis, and bronchiectasis.
Crizotinib bør anvendes med forsigtighed hos patienter, der har risiko for gastrointestinal perforation (fx divertikulitis i anamnesen, metastaser i mave-tarm-kanalen, samtidig brug af lægemidler med en kendt risiko for gastrointestinal perforation).
Crizotinib should be used with caution in patients at risk for gastrointestinal perforation (e.g., history of diverticulitis, metastases to the gastrointestinal tract, concomitant use of medicinal products with a recognized risk of gastrointestinal perforation).
Anti-tumorvirkningen af crizotinib er dosisafhængig og korrelerer til farmakodynamisk hæmning af fosforyleringen af ALK-fusionsproteiner (herunder EML4-ALK og NPM-ALK) i tumorer in vivo.
The antitumour efficacy of crizotinib was dose-dependent and correlated to pharmacodynamic inhibition of phosphorylation of ALK fusion proteins (including EML4-ALK and NPM-ALK) in tumours in vivo.
QT-forlængelse kan manifestere sig klinisk som bradykardi, svimmelhed og synkope.
QT prolongation may clinically manifest as bradycardia, dizziness, and syncope.
Tre patienter kunne ikke evalueres med hensyn til respons i studie 1001, og 42 patienter kunne ikke evalueres med hensyn til respons i studie 1005.
b. Three patients were not evaluable for response in Study 1001, and 42 patients were not evaluable for response in Study 1005. c. Estimated using the Kaplan-Meier method.
Symptomatisk, kan være alvorlig og klinisk signifikant, medicinsk intervention er indiceret
Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
Den centrale tendensanalyse indikerede, at alle øvre grænser for 90% CI for middelændringen (beregnet efter mindste kvadraters metode LS) i QTcF fra baseline ved alle målepunkter på dag 1 i cyklus 2 var <20 ms. En farmakokinetisk/farmakodynamisk analyse antyder en sammenhæng mellem crizotinibs plasmakoncentration og QTc.
The central tendency analysis indicated that all upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec. A pharmacokinetic/pharmacodynamic analysis suggested a relationship between crizotinib plasma concentration and QTc.
g. Baseret på den stratificerede Cochran-Mantel-Haenszel-test (2-sidet).
g. Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
• Phenytoin, carbamazepin eller phenobarbital, medicin mod epileptiske kramper eller anfald.
• Phenytoin, carbamazepine or phenobarbital, anti-epileptics used to treat seizures or fits.
• Efavirenz, raltegravir til behandling af hiv-infektion.
• Efavirenz, raltegravir, used to treat HIV infection.
Dosis blev reduceret, eller behandlingen seponeret permanent på grund af neutropeni hos henholdsvis 3% og <1% af patienterne.
Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and <1% of patients, respectively.
e) Synsforstyrrelser (diplopi, halo-syn, fotofobi, fotopsi, sløret syn, nedsat synsskarphed, visuel lysintensitet, nedsat syn, visuel perseveration, ”flyvende fluer”).
e. Vision disorder (Diplopia, Halo vision, Photophobia, Photopsia, Vision blurred, Visual acuity reduced, Visual brightness, Visual impairment, Visual perseveration, Vitreous floaters).
Crizotinibs antitumoreffektivitet var dosisafhængig og udviste korrelation med in vivo hæmning af ROS1-fosforylering.
The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo.
• Alfentanil og anden korttidsvirkende stærk smertestillende medicin som fx fentanyl (anvendes under operation).
• Alfentanil and other short acting opiates such as fentanyl (painkillers used for surgical procedures).
Andre mulige årsager til ILD/pneumonitis skal udelukkes, og crizotinib skal seponeres permanent hos patienter, som diagnosticeres med behandlingsrelateret ILD/pneumonitis (se pkt.
Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Hver æske indeholder 60 hårde kapsler.
Each carton contains 60 hard capsules.
Ifølge en uafhængig undersøgelseskomités (IRC) vurdering af patienter med ALK-positiv NSCLC (N=1.669) havde 20 (1,2%) af patienterne ILD/pneumonitis, herunder 10 (<1%) med dødelig udgang.
According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 (<1%) patients with fatal cases.
Crizotinib hæmmer P-glykoprotein (P-gp) in vitro.
Crizotinib is an inhibitor of P-glycoprotein (P-gp) in vitro.
Crizotinib viser antitumoreffekt, inklusive udpræget cytoreduktiv antitumor-aktivitet, i mus som er bærere af tumor-xenografter, som udtrykker ALK-fusionsproteiner.
Crizotinib demonstrated antitumour efficacy, including marked cytoreductive antitumour activity, in mice bearing tumour xenografts that expressed ALK fusion proteins.
• Methadon, til behandling af smerter og til behandling af misbrug.
• Methadone, used to treat pain and for the treatment of opioid dependence.
Der var én ALK-positiv patient >85 år ud af 154 patienter i enkeltarmsstudiet 1001 (se også pkt.
There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Startdosis bør justeres til 250 mg oralt 1 gang dagligt hos patienter med svært nedsat nyrefunktion, som ikke kræver peritonealdialyse eller hæmodialyse.
The crizotinib starting dose should be adjusted to 250 mg taken orally once daily in patients with severe renal impairment not requiring peritoneal dialysis or haemodialysis.
Efter administration af en radioaktivt mærket enkeltdosis på 250 mg crizotinib til raske forsøgspersoner, blev der genfundet henholdsvis 63% og 22% af den administrerede dosis i fæces og i urin.
Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in faeces and urine, respectively.
• Forhøjede indhold af enzymet alkalisk fosfatase i blodet (det kan tyde på et dårligt fungerende eller beskadiget organ, såsom lever, bugspytkirtel, knogle, skjoldbruskkirtel eller galdeblære).
• Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
I repeat-dose toksicitetsstudier i rotter og hunde af op til 3 måneders varighed var de primært påvirkede organer relateret til følgende organsystemer mave-tarmkanal (kvalme, fæcesændringer, obstipation), hæmatopoietisk (knoglemarvshypocellularitet), kardiovaskulær (blandede ionkanalblokkere, nedsat hjerterytme og blodtryk, forøgede LVEDP, QRS og PR-intervaller og nedsat myokardiekontraktion), eller reproduktive (degenerering af spermatocytter i testis, enkeltcellenekrose i ovariefollikler).
In rat and dog repeat-dose toxicity studies up to 3-month duration, the primary target organ effects were related to the gastrointestinal (emesis, faecal changes, congestion), haematopoietic (bone marrow hypocellularity), cardiovascular (mixed ion channel blocker, decreased heart rate and blood pressure, increased LVEDP, QRS and PR intervals, and decreased myocardial contractility), or reproductive (testicular pachytene spermatocyte degeneration, single-cell necrosis of ovarian follicles) systems.
Det er ikke nødvendigt at justere startdosis hos patienter med let nedsat leverfunktion.
No starting dose adjustment is recommended for patients with mild hepatic impairment.
Objektiv responsrate (baseret på IRR) Objektiv response rate % (95% CI)
Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
I studie 1014 var den mediane varighed af studiebehandlingen 47 uger for patienter i crizotinib-armen (N=171); den mediane behandlingsvarighed var 23 uger for patienter, der overgik fra kemoterapi-armen til at få crizotinibbehandling (N=109).
In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
Hvis du holder op med at tage XALKORI
If you stop taking XALKORI
Den mediane behandlingsvarighed var 22,4 måneder (95% CI: 15,0; 35,9).
The median duration of treatment was 22.4 months (95% CI: 15.0, 35.9).
Der blev observeret stigning af blod-kreatinin og nedsat kreatininclearance hos patienter i kliniske studier med crizotinib.
Blood creatinine increase and creatinine clearance decreased were observed in patients in clinical studies with crizotinib.
Yderligere oplysninger om XALKORI findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
For ROS1-positive NSCLC-patienter i studie 1001 (N=53) var den mediane behandlingstid 101 uger.
For ROS1-positive NSCLC patients in Study 1001 (N=53), the median duration of treatment was 101 weeks.
Pædiatrisk population Crizotinibs sikkerhed og virkning er ikke klarlagt.
The safety and efficacy of crizotinib in paediatric patients has not been established.
Effektdata fra studie 1001 og 1005 ses i skema 6.
Efficacy data from Studies 1001 and 1005 are provided in Table 6.
Effektdata fra det randomiserede fase 3-studie 1007 er sammenfattet i skema 5, og Kaplan-Meierkurverne for PFS og samlet (OS) er vist i henholdsvis figur 4 og 5.
Efficacy data from Study 1007 are summarised in Table 5, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
De patientrapporterede symptomer og den generelle livskvalitet blev indsamlet ved hjælp af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13) ved baseline (dag 1, cyklus 1) og dag 1 i hver af de efterfølgende behandlingscyklusser.
Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13) at baseline (Day 1 Cycle 1) and Day 1 of each subsequent treatment cycle.
Patienterne fik crizotinib 250 mg oralt to gange dagligt.
Patients received crizotinib 250 mg orally twice daily.
Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
If you experience any side effects, talk to your doctor, pharmacist, or nurse.
Den geometriske gennemsnitsværdi af distributionsvolumen ved steady state (Vdss) er 1772 liter ved infusion af en dosis på 50 mg, hvilket tyder på udtalt fordeling fra plasma in i vævene.
The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma.
Kapselindhold: kolloid vandfri silica, mikrokrystallinsk cellulose, vandfrit calciumhydrogenphosphat, natriumstivelsesglycolat (type A), magnesiumstearat.
Capsule content: colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
Der blev indberettet nyresvigt og akut nyresvigt hos patienter, som blev behandlet med crizotinib i kliniske studier og efter markedsføring.
Renal failure and acute renal failure were reported in patients treated with crizotinib in clinical trials and during post marketing.
Grad 4 Øjne (synstab)
Grade 4 Ocular Disorder (Visual Loss)
Median OS på tidspunktet for data cutoff var 51,4 måneder (95% CI: 29,3; NR).
The median OS at the time of data cutoff was 51.4 months (95% CI: 29.3, NR).
In vitro studier tyder på at crizotinib er substrat for P-glykoprotein (P-gp).
In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
Patienterne kunne fortsætte crizotinibbehandlingen efter sygdomsprogression som defineret i Response Evaluation Criteria in Solid Tumours (RECIST), hvis patienten fortsat havde klinisk gavn af behandlingen, og det var i overensstemmelse med investigators skøn.
Patients could continue crizotinib treatment beyond the time of Response Evaluation Criteria in Solid Tumours (RECIST)-defined disease progression at the discretion of the investigator if the patient was still experiencing clinical benefit.
b) Anæmi (anæmi, nedsat hæmoglobin, hypokrom anæmi).
b. Anaemia (Anaemia, Haemoglobin decreased, Hypochromic anaemia).
Det anbefales, at patienterne får taget ekg og målt elektrolytter (fx calcium, magnesium og kalium) så sent som muligt inden den første dosis og periodisk monitoreres for elektrolytter og får taget ekg især i starten af behandlingen i tilfælde af opkastning, diarré, dehydrering eller nedsat nyrefunktion.
When using crizotinib, ECG and electrolytes (e.g., calcium, magnesium, potassium) should be obtained as close as possible prior to the first dose and periodic monitoring with ECGs and electrolytes is recommended, especially at the beginning of treatment in case of vomiting, diarrhoea, dehydration or impaired renal function.
Hos 14 (36,8%) af de 30 patienter blev der rapporteret en okulær abnormitet af en eller anden type, og hos 16 (42,1%) patienter var der ingen okulære fund.
Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Crizotinib forlængede PFS signifikant, som var det primære studieendepunkt, sammenlignet med kemoterapi efter vurdering ved IRR.
Crizotinib significantly prolonged PFS, the primary objective of the study, compared to chemotherapy as assessed by IRR.
Progressionsfri overlevelse (baseret på IRR) Antal med hændelse, n (%) Hændelsestype, n (%) Progredierende sygdom Dødsfald uden objektiv progression Median PFS i måneder (95% CI)
Progression-Free Survival (Based on IRR) Number with event, n (%) Type of event, n (%) Progressive Disease Death without objective progression Median PFS in months (95% CI)
Titadioxid (E171) Rød jernoxid (E172)
Titanium dioxide (E171) Red iron oxide (E172)
Det er derfor ikke sandsynligt, at der vil være kliniske interaktioner som følge af crizotinib-medieret hæmning af leverens eller nyrernes elimination af lægemidler, som er substrat for disse transportproteiner.
Therefore, clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the hepatic or renal uptake of medicinal products that are substrates for these transporters.
Hvis du har taget for mange kapsler, skal du omgående kontakte lægen eller skadestuen.
If you accidentally take too many capsules, tell your doctor or pharmacist right away.
Afhængigt af individuel sikkerhed og tolerabilitet kan dosis eventuelt øges til 200 mg 2 gange dagligt efter mindst 4 ugers behandling (se pkt.
The dose may be increased to 200 mg twice daily based on individual safety and tolerability after at least 4 weeks of treatment (see sections 4.4 and 5.2).
Derfor kan samtidig administration af crizotinib og lægemidler, som er substrat for P-pg (fx digoxin, dabigatran, colchicin, pravastatin), medføre øget virkning og øgede bivirkninger af disse lægemidler.
Therefore, administration of crizotinib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.
Der er set et forøget postimplantationstab ved doser ≥50 mg/kg/dag (ca. 0,4 gange AUC ved anbefalede humane doser) i rotter og nedsat føtalvægt som bivirkning i rotter og kaniner ved henholdsvis 200 og 60 mg/kg/dag (ca. 1,2 gange human klinisk eksponering baseret på AUC).
Post-implantation loss was increased at doses ≥50 mg/kg/day (approximately 0.4 times the AUC at the recommended human dose) in rats, and reduced fetal body weights were considered adverse effects in the rat and rabbit at 200 and 60 mg/kg/day, respectively (approximately 1.2-fold human clinical exposure based on AUC).
• Blodmangel (nedsat antal røde blodlegemer).
• Reduction in the number of red blood cells (anaemia).
Administration af crizotinib sammen med CYP3A4-substrater med lille terapeutisk indeks bør undgås (se pkt.
The concomitant use of crizotinib with CYP3A4 substrates with narrow therapeutic indices should be avoided (see section 4.5).
Permanent seponering på grund af bivirkninger uanset kausalitet forekom hos 302 (18%) patienter, hvoraf de hyppigste (≥1%) var interstitiel lungesygdom (1%) og aminotransferasestigning (1%).
All-causality adverse events associated with permanent treatment discontinuation occurred in 302 (18%) patients of which the most frequent (≥1%) were interstitial lung disease (1%) and elevated transaminases (1%).
• Første dosisreduktion: XALKORI 200 mg oralt 2 gange dagligt
• First dose reduction: XALKORI 200 mg taken orally twice daily