natgillin/translations-raw huggingface dataset:
Der er blevet observeret palmoplantar erytrodysæstesi-syndrom (PPES) med cabozantinib.
Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Juvenile rotter (sammenlignelige med en >2 årig pædiatrisk population), der fik cabozantinib, udviste forhøjede leukocyt-parametre, nedsat hæmatopoiese, pubertært/umodent hunligt reproduktionssystem (uden forsinket vaginalåbning), abnormiteter i tænderne, reduceret mineralindhold i og densitet af knoglerne, leverpigmentering og lymfoid lymfeknudehyperplasi.
Juvenile rats (comparable to a >2 year- old paediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and lymph node lymphoid hyperplasia.
Ydermere blev der observeret hypospermatogenese hos hanhunde ved eksponeringsniveauer under det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
Further, hypospermatogenesis was observed in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
• Smerter i arme, ben og led, muskelkramper
• Pain in arms, legs and joints, muscle spasms
I toksicitetsstudier med gentagne doser hos rotter og hunde af op til 6 måneders varighed var målorganer for toksicitet mave-tarmkanal, knoglemarv, lymfevæv, nyrer, binyrer og reproduktionsorganer.
In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
CABOMETYX indeholder lactose
CABOMETYX contains lactose
CABOMETYX må ikke tages sammen med mad.
CABOMETYX should not be taken with food.
Brug af CABOMETYX sammen med mad
Taking CABOMETYX with food
Overvej at genstarte behandlingen ved en reduceret dosis.
Consider re-initiating at a reduced dose.
Hepatocellulært karcinom (HCC)
Hepatocellular Carcinoma (HCC)
Tættere monitorering af den samlede sikkerhed anbefales til patienter med let eller moderat nedsat leverfunktion (se også pkt.
Closer monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
ikke-planlagt interimanalyse af OS blev der påvist en statistisk signifikant forbedring hos patienter, der var randomiseret til CABOMETYX, sammenlignet med everolimus (320 hændelser, median på 21,4 måneder vs. 16,5 måneder; HR=0,66 [0,53- 0,83]; p=0,0003; Figur 2).
In a subsequent unplanned interim analysis of OS, a statistically significant improvement was demonstrated for patients randomized to CABOMETYX as compared with everolimus (320 events, median of 21.4 months vs. 16.5 months; HR=0.66 [0.53, 0.83], p=0.0003; Figure 2).
Tag ikke CABOMETYX - hvis du er allergisk over for cabozantinib eller et af de øvrige indholdsstoffer i CABOMETYX (angivet i punkt 6).
- - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
- har forhøjet blodtryk - har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg - har diarré - for nyligt har haft en større blødning - har gennemgået en operation inden for den sidste måned (eller hvis et kirurgisk indgreb er planlagt),
- have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall - have diarrhoea - have a recent history of significant bleeding - have had surgery within the last month (or if surgical procedures are planned), including dental surgery - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis,
Cabozantinib bør ikke gives til patienter, der har eller har risikofaktorer for alvorlig blødning.
Cabozantinib should not be administered to patients that have or are at risk for severe haemorrhage.
Nyrecellekarcinom (RCC)
Renal Cell Carcinoma (RCC)
Hvis du tager CABOMETYX samtidig med, at du tager svangerskabsforebyggende piller (p-piller), er p-pillerne måske ikke tilstrækkeligt effektive.
If you take CABOMETYX whilst using oral contraceptives, the oral contraceptives may be ineffective.
Cabozantinib skal seponeres ved vedvarende svær hypertension på trods af antihypertensiv behandling og reduktion af cabozantinibdosis.
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Objektiv responsrate n (%) pr. Investigator Fuldstændig respons
Objective Response Rate n (%) by Investigator Complete responses
Sådan skal du tage CABOMETYX 4.
How to take CABOMETYX 4.
Der blev påvist en statistisk signifikant forbedring i PFS for CABOMETYX sammenlignet med everolimus (Figur 1 og Tabel 3).
A statistically significant improvement in PFS was demonstrated for CABOMETYX compared to everolimus (Figure 1 and Table 3).
Gastrointestinale (GI) lidelser
Gastrointestinal (GI) disorders
Du må ikke tage CABOMETYX sammen med mad.
You should not take CABOMETYX with food.
En forlængelse i forhold til baseline i korrigeret QT-interval efter Fridericia (QTcF) på 10-15 ms på dag 29 (men ikke på dag 1) efter indledning af behandling med cabozantinib (ved en dosis på 140 mg dagligt) blev observeret i et kontrolleret klinisk studie med patienter med medullær thyroideacancer.
Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
• Tør hud, kraftig kløe i huden, akne
• Dry skin, severe itching of skin, acne
Ved mistanke om overdosering bør behandlingen med cabozantinib afbrydes og understøttende behandling initieres.
In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
Cabozantinib udviste dosis-relateret hæmning af tumorvækst og tumorregression og/eller hæmmede metastase i en lang række præ-kliniske tumormodeller.
Cabozantinib exhibited dose-related tumour growth inhibition, tumour regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Cabozantinib skal seponeres hos patienter, der får gastrointestinal perforation eller en fistel, der ikke kan behandles tilfredsstillende.
Cabozantinib should be discontinued in patients who experience a GI perforation or a fistula that cannot be adequately managed.
• Nedsat aktivitet af skjoldbruskkirtlen; symptomerne kan omfatte: træthed, vægtstigning, forstoppelse,
• Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
Mediantiden til opståen var 14 uger.
Median time to onset was 14 weeks.
Dosisafbrydelse eller -reduktion eller permanent seponering af cabozantinib bør overvejes ved vedvarende eller tilbagevendende signifikante afvigelser (se tabel 1).
Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant abnormalities (see Table 1).
• Gastro-øsofageal refluks (tilbageløb af mavesyre fra mavesækken til spiserøret)
• Gastro-oesophageal reflux disease (bringing up stomach acid)
• Blodpropper i blodårerne (vener og arterier) og i lungerne
• Blood clots in the veins, arteries and lungs
ORR (kun delvise responser) (95 % CI) p-værdi1
ORR (partial responses only) (95% CI) p-value1
Bivirkninger grad 4 (undtagen klinisk irrelevante laboratorieanormaliteter).
Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
NOAEL for embryo-føtal toksicitet og teratogene fund var lavere end det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
Niveauet uden observerede bivirkninger (NOAEL) for disse fund var lavere end det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
I HCC-studiet (CELESTIAL) blev fistler rapporteret hos 1,5 % (7/467) af HCC-patienterne.
In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients.
Bivirkninger grad 3 (undtagen klinisk irrelevante laboratorieanormaliteter).
Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Cabozantinibs farmakokinetik blev ikke undersøgt hos patienter med svært nedsat leverfunktion.
The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Administration af protonpumpe-hæmmeren (PPI) esomeprazol (40 mg dagligt i 6 dage) sammen med en enkelt dosis 100 mg cabozantinib til raske frivillige resulterede ikke i nogen klinisk signifikant virkning på cabozantinibs plasmaeksponering (AUC).
Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
36 % af patienterne havde knoglemetastaser.
Thirty-six percent (36%) of patients had bone metastases.
Forhøjet alkalisk fosfatase (ALP), forhøjet GGT, forhøjet kreatinin i blodet, forhøjet amylase, forhøjet lipase, forhøjet niveau af kolesterol i blodet, fald i antal hvide blodlegemer
Investigations weight decreased, serum ALT increased, AST increased blood ALP increased, GGT increased, blood creatinine increased, amylase increased, lipase increased, blood cholesterol increased, white blood cell count decreased blood triglycerides increased
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma
MARKETING AUTHORISATION HOLDER Ipsen Pharma
Der er blevet observeret tilfælde af venøs tromboemboli, herunder lungeemboli og arteriel tromboemboli, nogle gange letale, med cabozantinib.
Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Infektioner og parasitære sygdomme
Infections and infestations abscess
Kliniske data ved hepatocellulært karcinom
Clinical data in Hepatocellular Carcinoma
Hjerte myokardieinfarkt
Cardiac disorders myocardial infarction
28 filmovertrukne tabletter 30 filmovertrukne tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 28 film-coated tablets 30 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Dosisjustering er ikke nødvendig, når lægemidler til modificering af gastrisk pH (dvs. PPI'er, H2-receptorantagonister og antacida) administreres sammen med cabozantinib.
No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
I HCC-studiet (CELESTIAL) blev letale hæmoragiske hændelser rapporteret med en højere forekomst med cabozantinib end med placebo.
In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
De grundlæggende demografiske og sygdomskarakteristika var ens mellem CABOMETYX og sunitinibarmene ved baseline.
The baseline demographic and disease characteristics were similar between the CABOMETYX and sunitinib arms.
Forsigtighed er nødvendig ved administration af cabozantinib sammen med lægemidler, der er potente CYP3A4-hæmmere.
Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Samtidigt administrerede lægemidler
Concomitant medicinal products
Der er ingen data fra anvendelse af cabozantinib til gravide kvinder.
There are no studies in pregnant women using cabozantinib.
Dosisafbrydelse eller -reduktion eller permanent seponering af cabozantinib bør overvejes ved vedvarende eller tilbagevendende signifikante GI-bivirkninger (se tabel 1).
Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant GI adverse reactions (see Table 1).
Cabozantinib (XL184) blev metaboliseret in vivo.
Cabozantinib was metabolized in vivo.
Samtidig administration af lægemidler, der er potente CYP3A4-hæmmere, bør ske med forsigtighed, og langvarig administration af lægemidler, der er potente CYP3A4-induktorer, bør undgås (se pkt.
Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Brug af anden medicin sammen med CABOMETYX
Other medicines and CABOMETYX
I HCC-studiet (CELESTIAL) blev hepatisk encefalopati (hepatisk encefalopati, encefalopati, hyperammonæmisk encefalopati) rapporteret hos 5,6 % af de cabozantinib-behandlede patienter (26/467); Grad 3-4-hændelser hos 2,8 % og én (0,2 %) grad 5-hændelse.
In the HCC study (CELESTIAL), hepatic encephalopathy (hepatic encephalopathy, encephalopathy, hyperammonaemic encephalopathy) was reported in 5.6% of cabozantinib-treated patients (26/467); Grade 3-4 events in 2.8%, and one (0.2%) Grade 5 event.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med CABOMETYX i en eller flere undergrupper af den pædiatriske population ved behandlingen af hepatocellulært karcinom og nyre- og nyrebækkenkarcinom (undtagen nefroblastom, nefroblastomatose, clearcelle-sarkom, mesoblastisk nefrom, medullært karcinom i nyrerne og rabdoid tumor i nyrerne) (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with CABOMETYX in all subsets of the paediatric population in treatment of hepatocellular carcinoma, and kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
I HCC-studiet (CELESTIAL) blev der observeret portal venetrombose med cabozantinib, herunder et letalt tilfælde.
In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 mennesker)
Very common side effects (may affect more than 1 in 10 people)
Antal i risikogruppe: CABOMETYX Everolimus
Number at risk: CABOMETYX Everolimus
• Rødme, hævelse eller smerter i munden eller svælget, taleproblemer, hæshed, hoste
• Redness, swelling or pain in the mouth or throat, Difficulty in speaking, hoarseness, cough
Mediantiden til opståen var 20,9 uger.
Median time to onset was 20.9 weeks.
Cabozantinib var en hæmmer (IC50 = 7,0 μM) af, men ikke et substrat for P-glykoprotein (P-gp) transportaktivitet i et to-rettet assay-system, der anvendte MDCK-MDR1-celler.
Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Cabozantinib var en hæmmer (IC50 = 7,0 μM) af, men ikke et substrat for P-gp-transportaktivitet i et to-rettet assay-system, der anvendte MDCK-MDR1-celler.
Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Mediantiden til opståen var 30,3 uger.
Median time to onset was 30.3 weeks.
De mest almindelige alvorlige bivirkninger i HCC-populationen (≥1 % incidens) er hepatisk encefalopati, palmoplantar erytrodysætesisyndrom, asteni og diarré.
The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Alle patienter bør monitoreres for hypertension under behandling med cabozantinib og om nødvendigt have standard antihypertensiv behandling.
During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
• Hævelse, smerter i dine hænder og fødder eller kortåndethed.
• Swelling, pain in your hands and feet, or shortness of breath.
Administration af MRP2-hæmmere kan resultere i øgede cabozantinib-plasmakoncentrationer.
Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Cabozantinib skal seponeres hos patienter med sårhelingskomplikationer, der kræver intervention.
Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) CABOMETYX 20 mg filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) Cabometyx 20 mg film-coated tablets
Hos rotter medførte cabozantinib postimplantationstab, føtalt ødem, hareskår/ganespalte, dermal aplasi og krøllet eller rudimentær hale.
In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Administration af MRP2-hæmmere kan derfor resultere i øgede cabozantinib-plasmakoncentrationer.
Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Dehydrering, hypoalbuminæmi, hypofosfatæmi, hyponatriæmi, hypocalcæmi, hyperkaliæmi, hyperbilirubinæmi, hyperglykæmi, hypoglykæmi
Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia dehydration, hypoalbuminaemia, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia hyperglycaemia, hypoglycaemia
I HCC-studiet (CELESTIAL) blev trombocytopeni og nedsat antal blodplader rapporteret.
In the HCC study (CELESTIAL), thrombocytopenia and decreased platelets were reported.
Afvigelser i biokemiske laboratorieværdier
Biochemical laboratory test abnormalities
I studiet af behandlingsnaivt RCC (CABOSUN), blev der rapporteret GI-perforationer hos 2,6 % (2/78) af de cabozantinib-behandlede patienter.
In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
Tablettens indhold Mikrokrystallinsk cellulose Vandfri lactose Hypromellose Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
Tablet content Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
CABOMETYX' sikkerhed og virkning, ved behandling af nyrecellekarcinom efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling, blev evalueret i et randomiseret, åbent fase IIImulticenterstudie (METEOR).
The safety and efficacy of CABOMETYX for the treatment of renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy were evaluated in a randomized, openlabel, multicenter Phase 3 study (METEOR).
Samtidig administration af cabozantinib og den potente CYP3A4-induktor rifampicin resulterede i en nedsættelse af cabozantinibs plasmaeksponering.
Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Mediantiden til opståen var 10,0 uger.
Median time to onset was 10.0 weeks.
Der er blevet observeret hypertension med cabozantinib.
Hypertension has been observed with cabozantinib.
Samtidig administration af cabozantinib og den potente CYP3A4-hæmmer ketoconazol resulterede i en stigning i cabozantinibs plasmaeksponering.
Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Der er ingen klinisk erfaring hos patienter med svært nedsat leverfunktion (Child Pugh C), hvorfor cabozantinib ikke anbefales til disse patienter (se pkt.
and 5.2).There is no clinical experience in patients with severe hepatic impairment (Child Pugh C), so cabozantinib is not recommended for use in these patients (see section 5.2).
Der er blevet observeret alvorlig blødning, nogle gange letal, med cabozantinib.
Severe haemorrhage, sometimes fatal, has been observed with cabozantinib.
Ved hepatocellulært karcinom efter forudgående systemisk behandling forekom dosisreduktioner og dosisafbrydelser hos henholdsvis 62 % og 84 % af de cabozantinib-behandlede patienter i det kliniske forsøg (CELESTIAL).
In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Ved nyrecellekarcinom efter tidligere vaskulær endothelial vækstfaktor (VEGF) målrettet behandling, forekom dosisreduktion og behandlingsafbrydelse på grund af en bivirkning hos henholdsvis 59,8 % og 70 % af de cabozantinibbehandlede patienter i det pivotale kliniske studie (METEOR).
In renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy, dose reductions and dose interruptions due to an AE occurred in 59.8% and 70%, respectively, of cabozantinib-treated patients in the pivotal clinical trial (METEOR).
De demografiske data ved baseline og sygdomskarakteristika var sammenlignelige mellem CABOMETYXog everolimus-gruppen.
The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
I HCC-studiet (CELESTIAL) blev GI-perforeringer rapporteret hos 0,9 % af de cabozantinib-behandlede patienter (4/467).
In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467).
Derfor skal der udvises forsigtighed ved samtidig anvendelse af MRP2-hæmmere (f.eks. ciclosporin, efavirenz, emtricitabin) (se pkt.
Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution (see section 4.5).
De hyppigste bivirkninger af en hvilken som helst grad (oplevet af mindst 25 % af patienterne) i RCCpopulationen inkluderede diarré, hypertension, træthed, forhøjet ASAT, forhøjet ALAT, kvalme, nedsat appetit, PPES, dysgeusi, nedsat trombocyttal, stomatitis, anæmi, opkastninger, vægttab, dyspepsi og forstoppelse.
The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Administration af den potente CYP3A4-hæmmer ketoconazol (400 mg dagligt i 27 dage) til raske frivillige nedsatte cabozantinib-clearance (med 29 %) og øgede cabozantinibs plasmaeksponering (AUC) (efter en enkelt dosis) med 38 %.
Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
De mest almindelige alvorlige bivirkninger i RCC-populationen (≥1 % incidens) er diarré, hypertension, dehydrering, hyponatriæmi, kvalme, nedsat appetit, emboli, træthed, hypomagnesiæmi, palmoplantar erytrodysæstesisyndrom (PPES).
The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Kliniske data ved nyrecellekarcinom efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling:
Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Progressionsfri overlevelse (PFS)3 Median PFS i måneder (95 % CI) HR (95 % CI)1 p-værdi1
Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Der er ikke udført studier med forsøgspersoner med svært nedsat nyrefunktion.
Subjects with severe renal impairment have not been studied.