natgillin/translations-raw huggingface dataset:
Tabel 2: Bivirkninger indberettet i kliniske forsøg hos patienter i behandling med cabozantinib 
Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib
Tabel 1: Anbefalede dosisændringer af CABOMETYX ved bivirkninger Bivirkning og sværhedsgrad 
Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
En planlagt interimanalyse af OS, udført på tidspunktet for PFS-analysen, nåede ikke interimgrænsen for statistisk signifikans (202 hændelser, HR=0,68 [0,51-0,90], p=0,006). 
A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006).
Et måltid med højt fedtindhold øgede Cmax og AUC moderat (henholdsvis 41 % og 57 %) i forhold til fastende tilstand hos raske frivillige, der fik en enkelt oral dosis på 140 mg cabozantinib. 
A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
I en populationsfarmakokinetisk analyse af cabozantinib med anvendelse af data fra oral administration af cabozantinibdoser fra 20 til 140 mg til 1883 patienter og 140 raske frivillige var cabozantinibs terminale halveringstid i plasma ca. 110 timer. 
In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
• Følelsesløshed, prikkende, brændende fornemmelse eller smerter i lemmerne 
• Numbness, tingling, burning sensation or pain in the limbs
Figur 3: Kaplan-Meier-kurve for progressionsfri overlevelse ved IRC hos behandlings-naive RCCpatienter 
Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Sikkerhed og effekt af CABOMETYX til behandling af behandlingsnaivt nyrecellekarcinom blev evalueret i et randomiseret, open-label, multicenter studie (CABOSUN). 
The safety and efficacy of CABOMETYX for the treatment of treatment-naïve renal cell carcinoma were evaluated in a randomized, open-label, multicenter study (CABOSUN).
En eksploratorisk OS-analyse censureret til anvendelsen af NPACT understøttede den primære analyse: HR, justeret for stratifikationsfaktorer (pr. IxRS), var 0,66 (95 % CI: 0,52; 0,84; stratificeret logrank p-værdi = 0,0005). 
An exploratory OS analysis censoring for the use of NPACT supported the primary analysis: the HR, adjusted for stratification factors (per IxRS), was 0.66 (95% CI: 0.52, 0.84; stratified logrank p-value = 0.0005).
Tabel 5: Resultat af effekt på behandlingsnaive RCC-patienter (ITT-population, CABOSUN) CABOMETYX (N=79) 
Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
CYP3A4-hæmmere og -induktorer 
CYP3A4 inhibitors and inducers
Hver beholder indeholder 30 filmovertrukne tabletter. 
Each bottle contains 30 film-coated tablets.
Patienter, som har inflammatorisk tarmsygdom (f.eks. Crohns sygdom, ulcerativ colitis, peritonitis eller diverticulitis eller appendicitis), tumorinfiltration i gastrointestinalkanalen eller komplikationer fra tidligere gastrointestinalkirurgi (især forbundet med forsinket eller ufuldstændig heling), skal evalueres omhyggeligt inden indledning af behandling med cabozantinib og monitoreres tæt for symptomer på perforation og fisteldannelse, herunder absces og sepsis. 
Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Delvis respons ORR (Kun delvis respons) Stabil sygdom Progressiv sygdom a i overensstemmelse med EU-censurering b Stratificeringsfaktorer pr. IxRS omfatter IMDC-risikokategorier (middel risiko, høj risiko og knoglemetastaser (ja,nej) c Estimeret ved hjælp af Cox proportionel risikomodel justeret for stratificeringsfaktorer pr. IxRS. 
Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS.
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.