natgillin/translations-raw huggingface dataset:
Cabometyx is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as cabozantinib has not been studied in this population and exposure might be increased in these patients.
Upotreba Cabometyxa ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) budući da kabozantinib nije ispitan u toj populaciji te izloženost može biti povećana u tih bolesnika.
For intermediate risk disease, one or two of the following risk factors were met, while for poor risk, three or more factors were met: time from diagnosis of RCC to systemic treatment < 1 year, Hgb < LLN, Corrected calcium > ULN, KPS < 80%, Neutrophil count > ULN and Platelet count > ULN.
Kod bolesti srednjeg rizika bila su prisutna jedan ili dva sljedeća čimbenika rizika, dok je kod bolesti lošeg rizika bilo prisutno tri ili više čimbenika: vrijeme od dijagnoze RCC-a do sistemskog liječenja <1 godine, Hgb <DGN, korigirani kalcij >GGN, KPS (Karnofskyjeva ljestvica) <80 %, broj neutrofila >GGN i broj trombocita >GGN.
A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
U relativno većeg udjela bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh B) došlo je do razvoja hepatičke encefalopatije uz liječenje kabozantinibom.
Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Učinak kabozantiniba na farmakokinetiku kontracepcijskih steroida nije ispitan.
Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution (see section 4.5).
Stoga istodobnoj primjeni inhibitora MRP2 (npr. ciklosporina, efavirenza, emtricitabina) treba pristupiti s oprezom (vidjeti dio 4.5).
A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed.
Uočen je porast Cmax za 19 % pri primjeni tableta (CABOMETYX) u usporedbi s primjenom kapsula (COMETRIQ).
Objective response rate (ORR) findings are summarized in Table 5.
Rezultati za stopu objektivnog odgovora (ORR) sažeto su prikazani u tablici 5.
What CABOMETYX is and what it is used for
Što je CABOMETYX i za što se koristi
Cabozantinib should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Kabozantinib treba oprezno primijeniti u bolesnika s anamnezom produljenja QT intervala, u bolesnika koji uzimaju antiaritmike ili bolesnika s relevantnom prethodno postojećom srčanom bolesti, bradikardijom ili poremećajima ravnoteže elektrolita.
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).
Istodobna primjena lijekova koji su jaki inhibitori CYP3A4 mora se provoditi uz oprez, a kronična istodobna primjena lijekova koji su jaki induktori CYP3A4 mora se izbjegavati (vidjeti dijelove 4.4 i 4.5).
In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
U ispitivanju HCC-a (CELESTIAL) tromboza portalne vene opažena je s kabozantinibom, uključujući jedan smrtonosni događaj.
Cases of hepatic encephalopathy in HCC patients can be attributed to the development of electrolyte disturbances.
Slučajevi hepatičke encefalopatije u bolesnika s hepatocelularnim karcinomom mogu se pripisati razvoju poremećaja elektrolita.
• Low level of albumin in blood
• Niska razina albumina u krvi
Consider re-initiating at a reduced dose.
Razmotrite ponovno uvođenje liječenja sa smanjenom dozom.
Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, naljepnici boce i kutiji iza oznake „Rok valjanosti“.
ORR (partial responses only) (95% CI) p-value1
ORR (samo parcijalni odgovori) (95 % CI) p-vrijednost1
In the 2-year rat carcinogenicity study, cabozantinibrelated neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
U dvogodišnjem ispitivanju kancerogenosti u štakora, neoplastični nalazi povezani s kabozantinibom sastojali su se od povećane incidencije benignog feokromocitoma, samog ili u kombinaciji s malignim feokromocitomom / kompleksnim malignim feokromocitomom srži nadbubrežne žlijezde u oba spola kod izloženosti koje su znatno niže od predviđene izloženosti u ljudi.
The safety and efficacy of CABOMETYX were evaluated in a randomized, double-blind, placebocontrolled Phase 3 study (CELESTIAL).
Sigurnost i djelotvornost CABOMETYXA ispitane su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze 3 (CELESTIAL).
The results from the Investigator determined analysis and IRC-determined analysis of PFS were consistent.
Rezultati analize za PFS koju je proveo ispitivač bili su sukladni rezultatima analize IRC-a.
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer.
Kabozantinib je mala molekula koja inhibira različite receptorske tirozin kinaze (RTK) povezane s rastom tumora i angiogenezom, patološkom pregradnjom kostiju, rezistencijom na lijek te metastatskom progresijom raka.
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.
U ispitivanjima toksičnosti ponovljenih doza u štakora i pasa u trajanju do 6 mjeseci, ciljni organi za toksičnost bili su GI trakt, koštana srž, limfno tkivo, bubreg te nadbubrežno tkivo i tkivo reproduktivnog trakta.
Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Promjene na maternici/jajnicima te smanjena hematopoeza pokazale su se prolaznima, dok su učinci na parametre kostiju i pigmentaciju jetre bili dugoročni.
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Profili ovisnosti koncentracije u plazmi o vremenu pokazuju drugu vršnu vrijednost apsorpcije otprilike 24 sata nakon primjene, što ukazuje na mogućnost da kabozantinib podliježe enterohepatičkoj cirkulaciji.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Sindrom reverzibilne posteriorne leukoencefalopatije (RPLS)
CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
CABOMETYX je indiciran za liječenje uznapredovalog karcinoma bubrežnih stanica: - u prethodno neliječenih odraslih bolesnika sa srednjim ili lošim rizikom (vidjeti dio 5.1) - u odraslih, nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (engl. vascular endothelial growth factor, VEGF).
Adverse reactions are listed in Table 2 according to MedDRA System Organ Class and frequency categories.
U tablici 2 navedene su nuspojave prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
When using cabozantinib, periodic monitoring with ontreatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Kada se primjenjuje kabozantinib, treba razmotriti povremeno praćenje EKG-a i elektrolita tijekom liječenja (serumski kalcij, kalij i magnezij).
Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Kabozantinib je povezan s povećanom incidencijom abnormalnosti elektrolita (uključujući hipokalijemiju, hiperkalijemiju, hipomagnezemiju, hipokalcijemiju, hiponatrijemiju).
Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Lokoregionalna transarterijska embolizacija ili postupci kemoinfuzije: 44 % Radioterapija prije liječenja kabozantinibom: 37 %
• Redness, swelling or pain in the mouth or throat, Difficulty in speaking, hoarseness, cough
• Crvenilo, oticanje ili bol u ustima ili grlu, otežan govor, promuklost, kašalj
Nervous system disorders dysgeusia, headache, dizziness peripheral sensory neuropathy convulsion cerebrovascul ar accident
Poremećaji živčanog sustava disgeuzija, glavobolja, omaglica periferna senzorna neuropatija konvulzije cerebrovaskularni inzult
Olbrachtova 2006/9, 140 00 Praha 4
Ipsen Pharma, s.r.o., Olbrachtova 2006/9, 140 00 Praha 4
Patients with both positive and negative MET status showed a favourable effect with CABOMETYX compared to sunitinib, with greater activity in patients with a positive MET status compared to patients with a negative MET status (HR=0.32 (0.16, 0.63) vs 0.67 (0.37, 1.23)) respectively.
Povoljan učinak CABOMETYXA u usporedbi sa sunitinibom pokazao se i u bolesnika s pozitivnim i u onih s negativnim MET-statusom, s time da je veća aktivnost opažena u bolesnika s pozitivnim MET-statusom nego u onih s negativnim MET-statusom (HR=0,32 (0,16; 0,63) naspram 0,67 (0,37; 1,23)).
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Napomena: Stupnjevi toksičnosti određeni su u skladu s verzijom 4.0 Zajedničkih kriterija terminologije za nuspojave Nacionalnog instituta za rak (engl.
• A burning or stinging sensation of the tongue
• Osjećaj žarenja ili bockanja u jeziku
• A painful tear or abnormal connection of the tissues in your body
• Bolan rascjep ili nenormalni spoj tkiva u organizmu
CABOMETYX contains lactose
CABOMETYX sadrži laktozu
Figure 5: Kaplan Meier curve for progression-free survival (CELESTIAL)
Slika 5: Kaplan Meierova krivulja preživljenja bez progresije bolesti (CELESTIAL)
Patient distribution by IMDC risk groups was 81% intermediate (1-2 risk factors) and 19% poor (≥3 risk factors).
Prema IMDC skupinama rizika, 81 % bolesnika pripadalo je skupini sa srednjim (1-2 čimbenika rizika), a 19 % skupini s lošim rizikom (≥3 čimbenika rizika).
The incidence of systemic non-radiation and local liver-directed systemic non-protocol anticancer therapy (NPACT) was 26% in the cabozantinib arm and 33% in the placebo arm.
Incidencija sistemske terapije protiv karcinoma isključujući zračenja i lokalne sistemske, neprotokolarne terapije protiv karcinoma usmjerene na jetru (NPACT) bila je 26 % u skupini koja je primala kabozantinib i 33 % u skupini koja je primala placebo.
Data for the following reactions are based on patients who received Cabometyx 60 mg qd po in the pivotal studies in RCC following prior VEGF-targeted therapy and in treatment-naïve RCC and in HCC following prior systemic therapy (section 5.1).
Podaci o sljedećim nuspojavama temelje se na podacima bolesnika koji su primali Cabometyx od 60 mg peroralno jednom dnevno u pivotalnim ispitivanjima RCC-a nakon prethodne terapije usmjerene na VEGF i prethodno neliječenih bolesnika s RCC-om i kod HCC-a nakon prethodne sistemske terapije (dio 5.1).
Renal Cell Carcinoma (RCC)
Karcinom bubrežnih stanica (engl. renal cell carcinoma, RCC)
Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78).
Bolesnici (N=157) s prethodno neliječenim, lokalno uznapredovalim ili metastatskim RCC-om s komponentom svijetlih stanica bili su randomizirani (1:1) kako bi primali CABOMETYX (N=79) ili sunitinib (N=78).
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).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka CABOMETYX u svim podskupinama pedijatrijske populacije u liječenju hepatocelularnog karcinoma, karcinoma bubrega i karcinoma bubrežne nakapnice (osim nefroblastoma, nefroblastomatoze, sarkoma svijetlih stanica, mezoblastičnog nefroma, medularnog karcinoma bubrega i rabdoidnog tumora bubrega) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Patients (N=658) with advanced RCC with a clear cell component who had previously received at least 1 prior VEGF receptor tyrosine kinase inhibitor (VEGFR TKI) were randomized (1:1) to receive CABOMETYX (N=330) or everolimus (N=328).
Bolesnici (N=658) s uznapredovalim RCC-om svijetlih stanica koji su prethodno primili najmanje jedan inhibitor receptorske tirozin kinaze VEGF receptora (VEGFR TKI) bili su randomizirani (1:1) kako bi primali CABOMETYX (N=330) ili everolimus (N=328).
• Low level of a type of white blood cell (lymphocytes)
• Niske razine vrste bijelih krvnih stanica (limfocita)
• Feeling drowsy, confused or loss of consciousness due to liver problems
• Omamljenost, zbunjenost ili gubitak svijesti zbog problema s jetrom.
If you have taken more CABOMETYX than you have been instructed to, talk to a doctor or go to the hospital with the tablets and this leaflet straight away.
Vam je rečeno, odmah se obratite liječniku ili otiđite u bolnicu s tabletama i ovom uputom.
Objective Response Rate n (%)3
Stopa objektivnog odgovora (ORR) n (%)3
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
Pretrage smanjenje tjelesne težine, porast ALT-a u serumu, porast AST-a porast ALP-a u krvi, porast GGTa, porast kreatinina u krvi, porast amilaze, porast lipaze, porast kolesterola u krvi, smanjenje broja bijelih krvnih stanica porast triglicerida u krvi
Fistulas
Fistule
The CELESTIAL study excluded patients with concomitant anticoagulation treatment or antiplatelet agents.
Iz ispitivanja CELESTIAL bili su isključeni bolesnici koji su istodobno liječeni antikoagulansima ili antitrombocitnim lijekovima.
Further, hypospermatogenesis was observed in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Pored toga, zabilježena je hipospermatogeneza u mužjaka pasa pri razinama izloženosti manjima od razina kliničke izloženosti u ljudi pri primjeni predviđene terapijske doze.
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).
U sljedećoj neplaniranoj interim analizi OS-a, pokazalo se statistički značajno poboljšanje u bolesnika randomiziranih na CABOMETYX u usporedbi s everolimusom (320 događaja, medijan od 21,4 mjeseca naspram 16,5 mjeseci; HR=0,66 [0,53; 0,83]; p=0,0003; Slika 2).
In the treatment-naïve RCC study (CABOSUN), no cases of fistulas were reported.
U ispitivanju prethodno neliječenog RCC-a (CABOSUN) slučajevi fistula nisu zabilježeni.
Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
4. stupanj nuspojava (osim abnormalnih laboratorijskih nalaza koji nisu klinički značajni)
A less than 10% difference in the AUC was observed between cabozantinib tablet (CABOMETYX) and capsule (COMETRIQ) formulations.
Uočena je razlika u AUC između tableta kabozantiniba (CABOMETYX) i kapsula kabozantiniba (COMETRIQ) manja od 10 %.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
VJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Most patients (87%) had ECOG performance status of 0 or 1; 13% had an ECOG performance status of 2.
U većine bolesnika (87 %) ECOG status bio je 0 ili 1; 13 % bolesnika imalo je ECOG status 2. Trideset i šest posto (36 %) bolesnika imalo je koštane metastaze.
The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Razina bez primijećenih štetnih učinaka (NOAEL) za ove nalaze bila je manja od razina kliničke izloženosti u ljudi pri predviđenoj terapijskoj dozi.
MARKETING AUTHORISATION HOLDER Ipsen Pharma
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Ipsen Pharma
Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 3 to 4 hours post-dose.
Nakon peroralne primjene kabozantiniba, vršne koncentracije kabozantiniba u plazmi postignute su za 3 do 4 sata nakon uzimanja doze.
The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Farmakokinetika kabozantiniba nije procijenjena u bolesnika s teškim oštećenjem funkcije bubrega.
NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
NOAEL za embriofetalnu toksičnost i teratogene nalaze bile su manje od razina kliničke izloženosti u ljudi pri primjeni predviđene terapijske doze.
Add supportive care as indicated.
Uvedite potporne mjere prema indikacijama.
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).
Istodobna primjena inhibitora protonske pumpe (IPP) esomeprazola (40 mg dnevno tijekom 6 dana) s jednokratnom dozom od 100 mg kabozantiniba u zdravih dobrovoljaca nije imala klinički značajan učinak na plazmatsku izloženost kabozantinibu (AUC).
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.
Crohnovu bolest, ulcerozni kolitis, peritonitis, divertikulitis ili apendicitis), imaju infiltraciju GI sustava tumorom ili koji imaju komplikacije prethodne GI operacije (naročito komplikacije koje su povezane s usporenim ili nepotpunim cijeljenjem) mora se napraviti pažljiva procjena prije početka terapije kabozantinibom te ih se, slijedom navedenog, mora pažljivo pratiti zbog moguće pojave simptoma perforacija i fistula uključujući apscese i sepsu.
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).
Eksplorativna analiza ukupnog preživljenja cenzurirana za upotrebu NPACT-a podržala je primarnu analizu: HR, prilagođen za faktore stratifikacije (prema IxRS), bio je 0,66 (95 % CI: 0,52; 0,84; p-vrijednost = 0,0005 za stratificirani log rang).
Predisposing risk factors for severe haemorrhage in the advanced HCC population may include tumour invasion of major blood vessels and the presence of underlying liver cirrhosis resulting in oesophageal varices, portal hypertension, and thrombocytopenia.
Predisponirajući faktori nastanka teškog krvarenja u populaciji uznapredovalog hepatocelularnog karcinoma mogu uključivati invaziju tumora u velike krvne žile i prisutnost podležeće ciroze jetre što dovodi do varikoziteta jednjaka, portalne hipertenzije i trombocitopenije.
• Abscess (collection of pus, with swelling and inflammation)
• Apsces (nakupljanje gnoja s oticanjem i upalom)
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).
Kliničko iskustvo u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh C) ne postoji, pa se primjena kabozantiniba u tih bolesnika ne preporučuje (vidjeti dio 5.2).
A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Statistički značajno poboljšanje ukupnog preživljenja dokazano je za CABOMETYX u usporedbi s placebom (Tablica 6 i Slika 4).
Therefore, chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Prema tome, mora se izbjegavati kronična primjena lijekova koji su jaki induktori CYP3A4 s kabozantinibom (vidjeti dijelove 4.2 i 4.5).
Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Potreban je oprez prilikom primjene kabozantiniba s lijekovima koji su jaki inhibitori CYP3A4.
Use caution when driving or using machines.
Budite oprezni pri upravljanju vozilima i radu sa strojevima.
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.
Obrok s visokim udjelom masti umjereno je povećao Cmax i AUC vrijednosti (41 %, odnosno 57 %) u odnosu na stanje natašte u zdravih dobrovoljaca pri primjeni jedne peroralne doze kabozantiniba od 140 mg.
Taking CABOMETYX with food
Uzimanje CABOMETYXA s hranom
Median time to onset was 14 weeks.
Medijan vremena do pojave bio je 14 tjedana.
Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr .
Srednja vrijednost klirensa (CL/F) u stanju dinamičke ravnoteže procijenjena je na 2,48 l/h.
• Increased or decreased blood glucose level
• Povišena ili snižena razina glukoze u krvi
CABOMETYX is a cancer medicine that contains the active substance cabozantinib.
Što je CABOMETYX CABOMETYX je lijek protiv raka koji sadrži djelatnu tvar kabozantinib.
Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
3. stupanj nuspojava (osim abnormalnih laboratorijskih nalaza koji nisu klinički značajni)
Patients (N=707) with HCC not amenable to curative treatment and who had previously received sorafenib for advanced disease were randomized (2:1) to receive CABOMETYX (N=470) or placebo (N=237).
Bolesnici (N=707) s HCC-om, koji ne odgovara na kurativno liječenje, prethodno liječeni sorafenibom radi uznapredovale bolesti randomizirani su (2:1) za primanje lijeka CABOMETYX (N=470) ili placeba (N=237).
Reversible posterior leukoencephalopathy syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES), has been observed with cabozantinib.
Prilikom primjene kabozantiniba zabilježen je sindrom reverzibilne posteriorne leukoencefalopatije (RPLS), također poznat kao sindrom posteriorne reverzibilne encefalopatije (PRES).
In patients with mild hepatic impairment no dose adjustment is required.
U bolesnika s blagim oštećenjem funkcije jetre nije potrebna prilagodba doze.