natgillin/translations-raw huggingface dataset:
Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution (see section 4.5).
Zato je potrebna pri sočasni uporabi zaviralcev MRP2 (npr. ciklosporin, efavirenz, emtricitabin) previdnost (glejte poglavje 4.5).
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).
V nadaljnji nenačrtovani vmesni analizi OS je bilo statistično značilno izboljšanje dokazano za bolnike, randomizirane za zdravilo CABOMETYX, v primerjavi z everolimusom (320 dogodkov, mediana 21,4 mesecev v primerjavi s 16,5 mesecev; HR = 0,66 [0,53; 0,83], p = 0,0003; slika 2).
A negative effect of Cabometyx versus placebo on the EQ-5D utility index score was observed during the first weeks of treatment.
Med prvimi tedni zdravljenja so v primerjavi s placebom opazili negativen vpliv zdravila CABOMETYX na EQ-5D oceno kazalnika koristnosti.
Objective Response Rate n (%) by IRC Complete responses
Delež objektivnega odziva n (%) po oceni IRC Popolni odzivi
The baseline demographic and disease characteristics were similar between the CABOMETYX and sunitinib arms.
Izhodiščne demografske značilnosti in značilnosti bolezni so bile med skupino z zdravilom CABOMETYX in skupino s sunitinibom podobne.
There are limited data in patients with cardiac impairment.
Podatkov pri bolnikih s srčno okvaro je malo.
Nervous system disorders dysgeusia, headache, dizziness peripheral sensory neuropathy convulsion cerebrovascul ar accident
Bolezni živčevja paragevzija, glavobol, omotica periferna senzorična nevropatija konvulzije možganska kap
Each carton contains 4 blisters with 28 film-coated tablets.
Ena škatla vsebuje 4 pretisne omote z 28 filmsko obloženimi tabletami.
Taking CABOMETYX with food
Zdravilo CABOMETYX skupaj s hrano
Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Neželeni učinki 4. stopnje (razen klinično nepomembne laboratorijske nepravilnosti)
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).
Bolnike (N=707) s HCK, ki niso bili primerni za kurativno zdravljenje in so se predhodno že zdravili s sorafenibom zaradi napredovale bolezni, so randomizirali (v razmerju 2:1) na prejemanje zdravila CABOMETYX (N=470) ali placeba (N=237).
Objective response rate (ORR) findings are summarized in Table 5.
Povzetek rezultatov deleža objektivnega odziva (ORR) je prikazan v preglednici 5.
ambrisentan, dabigatran etexilate, digoxin, talinolol, and tolvaptan - Medicines for diabetes, such as saxagliptin and sitagliptin - Medicines used to treat gout, such as colchicine - Medicines used to treat HIV or AIDS, such as efavirenz, ritonavir, maraviroc and emtricitabine - Medicines used to prevent transplant rejection (ciclosporin) and ciclosporin-based regimens in rheumatoid arthritis and psoriasis
ambrisentan, dabigatran eteksilat, digoksin, talinolol in tolvaptan - zdravila za zdravljenje sladkorne bolezni, kot sta saksagliptin in sitagliptin - zdravila za zdravljenje protina, kot je kolhicin - zdravila za zdravljenje okužbe z virusom HIV ali AIDS-a, kot so efavirenz, ritonavir, maravirok ali emtricitabin - zdravila za preprečevanje zavrnitve presadka (ciklosporin) in režimi na osnovi ciklosporina pri revmatoidnem artritisu in luskavici
ORR (partial responses only) (95% CI) p-value1
ORR (le delni odzivi) (95-% IZ) p-vrednost1
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).
Raziskovalna analiza celokupnega preživetja (OS) s krnjenimi podatki za uporabo NPACT, je podprla primarno analizo: razmerje ogroženosti (HR), prilagojeno za faktorje stratifikacije (po IxRS), je znašalo 0,66 (95-% interval zaupanja: 0,52; 0,84; stratificirana logrank p-vrednost = 0,0005).
The safety and efficacy of CABOMETYX were evaluated in a randomized, double-blind, placebocontrolled Phase 3 study (CELESTIAL).
Varnost in učinkovitost zdravila CABOMETYX so vrednotili v randomizirani, dvojno slepi, s placebom nadzorovani študiji 3. faze (CELESTIAL).
Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Neželeni učinki 3. stopnje (razen klinično nepomembne laboratorijske nepravilnosti)
Median time to onset was 14 weeks.
Mediani čas do pojava je bil 14 tednov.
Cabozantinib should be discontinued in patients who experience a GI perforation or a fistula that cannot be adequately managed.
Uporabo kabozantiniba je treba pri bolnikih, pri katerih se pojavi gastrointestinalna perforacija ali fistula, ki je ni možno ustrezno obravnavati, prekiniti.
The primary efficacy endpoint was overall survival (OS).
Primarni opazovani dogodek učinkovitosti je bilo celokupno preživetje (OS; overall survival).
Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Ocenili so zaviralno aktivnost kabozantiniba pri različnih kinazah in ugotovili, da zavira receptorje MET (receptorski protein za hepatocitni rastni faktor) in VEGF (vaskularni endotelijski rastni faktor).
Bioequivalence could not be demonstrated between the cabozantinib capsule and tablet formulations following a single 140 mg dose in healthy subjects.
Bioekvivalentnosti med kapsulami kabozantiniba in obliko v tabletah za en 140 mg odmerek pri zdravih prostovoljcih ni uspelo dokazati.
Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dosing recommendation can be provided.
Pri bolnikih z zmerno okvaro jeter (Child Pugh B) je na voljo le malo podatkov, zato priporočil za odmerjanje ni možno podati.
• Redness, swelling or pain in the mouth or throat, Difficulty in speaking, hoarseness, cough
• rdečina, oteklina ali bolečina v ustih ali žrelu, težave z govorjenjem, hripavost, kašelj
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).
Podatki za naslednje učinke temeljijo na bolnikih, ki so peroralno jemali zdravilo Cabometyx 60 mg enkrat na dan v ključnih študijah, izvedenih pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF, pri predhodno nezdravljenih bolnikih s KLC in pri bolnikih s HCK po predhodnem sistemskem zdravljenju (poglavje 5.1).
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.
Pri mladih podganah (primerljivo z > 2-letno pediatrično populacijo), ki so dobivale kabozantinib, so se pokazali zvišani parametri belih krvnih celic, znižana hematopoeza, pubertetni/nezrel ženski reprodukcijski sistem (brez zakasnitve odpiranja nožnice), nenormalnosti zobovja, zmanjšana mineralna vsebnost in gostota kosti, pigmentacija jeter in hiperplazija žolčevoda.
Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia dehydration, hypoalbuminaemia, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia hyperglycaemia, hypoglycaemia
Presnovne in prehranske motnje zmanjšan apetit, hipomagneziemija, hipokaliemija dehidracija, hipoalbuminemija, hipofosfatemija, hiponatriemija, hipokalciemija, hiperkaliemija, hiperbilirubinemija, hiperglikemija, hipoglikemija
Reversible posterior leukoencephalopathy syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES), has been observed with cabozantinib.
Sindrom posteriorne reverzibilne levkoencefalopatije Pri uporabi kabozantiniba so opazili sindrom reverzibilne posteriorne levkoencefalopatije (RPLS, Reversible Posterior Leukoencephalopathy Syndrome), znan tudi kot sindrom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome).
Stable disease Progressive Disease
Stabilna bolezen
Overall Survival Median OS in months (95% CI)
Celokupno preživetje Mediana OS v mesecih (95-% IZ)
Hypertension was observed more frequently in the treatment naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy
O hipertenziji so pogosteje poročali pri predhodno nezdravljeni populaciji bolnikov s KLC (67 %), v primerjavi z bolniki s KLC po predhodnem zdravljenju, usmerjenem v VEGF (37 %).
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).
Pri bolnikih s hudo okvaro jeter (Child Pugh C) klinične izkušnje niso na voljo, zato pri teh bolnikih uporaba kabozantiniba ni priporočljiva (glejte poglavje 5.2).
Based on an integrated population pharmacokinetic analysis of cabozantinib in healthy subjects and cancer patients (including HCC), no clinically significant difference in the mean cabozantinib plasma exposure was observed amongst subjects with normal liver function (n=1425) and mild hepatic impairment (n=558).
Podatki integrirane analize populacijske farmakokinetike kabozantiniba pri zdravih osebah in bolnikih z rakom (vključno s HCK) ne kažejo na klinično pomembne razlike v srednji plazemski izpostavljenosti kabozantinibu pri osebah z normalnim delovanjem jeter (n=1.425) in osebah z blago okvaro jeter (n=558).
• Low level of platelets and white blood cells
• nizko število trombocitov in belih krvnih celic
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 28 film-coated tablets 30 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 28 filmsko obloženih tablet 30 filmsko obloženih tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba Pred uporabo preberite priloženo navodilo!
• Increased or decreased blood glucose level
• zvišanje ali znižanje ravni glukoze v krvi
Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1).
Pri sumu na neželene reakcije na zdravilo bo morda treba zdravljenje z zdravilom CABOMETYX začasno prekiniti in/ali zmanjšati odmerek (glejte preglednico 1).
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).
Varnost in učinkovitost zdravila CABOMETYX pri zdravljenju karcinoma ledvičnih celic po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF), so vrednotili v randomizirani, odprti, multicentrični študiji 3. faze (METEOR).
If there are still 12 hours or more before your next dose is due, then take the missed dose as soon as you remember.
Če ste pozabili vzeti zdravilo CABOMETYX - Če je do naslednjega odmerka še 12 ur ali več, vzemite izpuščeni odmerek takoj, ko se spomnite.
You should not eat anything for at least 2 hours before taking CABOMETYX and for 1 hour after taking the medicine.
Vsaj 2 uri, preden vzamete odmerek zdravila CABOMETYX, in 1 uro po uporabi tega zdravila ne smete ničesar jesti.
CABOMETYX is a cancer medicine that contains the active substance cabozantinib.
Zdravilo CABOMETYX je zdravilo proti raku in vsebuje učinkovino kabozantinib.
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.
V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), so o jetrni encefalopatiji (jetrna encefalopatija, encefalopatija, hiperamoniemična encefalopatija) poročali pri 5,6 % bolnikov, ki so se zdravili s kabozantinibom (26/467); dogodki 3.-4. stopnje pri 2,8 % bolnikov in pri enem bolniku (0,2 %) dogodek 5. stopnje.
A statistically significant improvement in PFS was demonstrated for CABOMETYX compared to everolimus (Figure 1 and Table 3).
Za zdravilo CABOMETYX je bilo dokazano statistično značilno izboljšanje PFS v primerjavi z everolimusom (slika 1 in preglednica 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
zvišanje vrednosti ALP v krvi, zvišanje vrednosti GGT, zvišanje vrednosti kreatinina v krvi, zvišanje vrednosti amilaze, zvišanje vrednosti lipaze, zvišanje vrednosti holesterola v krvi, zmanjšanje števila zvišanje vrednosti trigliceridov v krvi
Further, hypospermatogenesis was observed in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Nadalje so pri pasjih samcih pri ravneh izpostavljenosti, nižjih kot so ravni klinične izpostavljenosti pri človeku pri nameravanemu terapevtskemu odmerku, opazili hipospermatogenezo.
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).
Sočasno dajanje zaviralca protonske črpalke esomeprazola (40 mg na dan za 6 dni), z enkratnim odmerkom 100 mg kabozantiniba, zdravim prostovoljcem ni povzročilo klinično značilnih učinkov na izpostavljenost kabozantinibu v plazmi (AUC).
Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Dogodki, ki se običajno pojavijo zgodaj, vključujejo hipokalciemijo, hipokaliemijo, trombocitopenijo, hipertenzijo, sindrom palmarno-plantarne eritrodisestezije (PPES, palmar-plantar erythrodysaesthesia syndrome), proteinurijo in gastrointestinalne (GI) dogodke (bolečine v trebuhu, vnetje sluznice, zaprtje, driska, bruhanje).
In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
V primeru suma na preveliki odmerek je treba zdravljenje s kabozantinibom ustaviti in uvesti podporno zdravljenje.
Therefore, chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Zato se je treba kronični uporabi učinkovin, ki so močni induktorji CYP3A4, skupaj s kabozantinibom, izogibati (glejte poglavji 4.2 in 4.5).
Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
Bolezni kože in podkožja sindrom palmarno-plantarne eritrodisestezije, izpuščaj pruritus, alopecija, suha koža, akneiformni dermatitis, sprememba barve las oz. dlak
Platelet levels should be monitored during cabozantinib treatment and the dose modified according to the severity of the thrombocytopenia (see Table 1).
Med zdravljenjem s kabozantinibom je treba spremljati vrednosti trombocitov in odmerek prilagoditi glede na resnost trombocitopenije (glejte preglednico 1).
Median time to onset was 20.9 weeks.
Mediani čas do pojava je bil 20,9 tednov.
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).
Varnost in učinkovitost zdravila CABOMETYX pri zdravljenju predhodno nezdravljenega karcinoma ledvičnih celic so vrednotili v randomizirani, odprti, multicentrični študiji (CABOSUN).
In the treatment-naïve RCC study (CABOSUN), no cases of fistulas were reported.
V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), o primerih fistul niso poročali.
Median time to onset was 30.3 weeks.
Mediani čas do pojava je bil 30,3 tednov.
Closer monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Pri bolnikih z blago ali zmerno okvaro jeter je priporočljivo skrbno spremljanje celokupne varnosti (glejte poglavji 4.2 in 5.2).
• Symptoms including pain in the abdomen, nausea (feeling sick), vomiting, constipation, or fever.
• simptomi, ki vključujejo bolečine v trebuhu, slabost (siljenje na bruhanje), bruhanje, zaprtost ali zvišano telesno temperaturo.
40 Boulevard de Champaret 38300 Bourgoin Jallieu, France
Patheon France 40 Boulevard de Champaret 38300 Bourgoin Jallieu Francija ali
Cabozantinib should not be administered to patients that have or are at risk for severe haemorrhage.
Kabozantiniba se ne sme dajati bolnikom, ki hudo krvavijo, ali pri katerih obstaja tveganje za hudo krvavitev.
Tablet content Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Jedro tablete mikrokristalna celuloza brezvodna laktoza hidroksipropilceluloza premreženi natrijev karmelozat brezvodni koloidni silicijev dioksid magnezijev stearat
It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of cabozantinib treatment and to monitor closely during treatment.
Pred uvedbo zdravljenja s kabozantinibom je priporočljivo izvesti preiskave delovanja jeter (ALT, AST in bilirubin) in vrednosti skrbno spremljati med zdravljenjem.
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.
CABOMETYX ni priporočljiva, saj uporabe kabozantiniba pri tej populaciji bolnikov niso raziskovali, izpostavljenost pa je pri teh bolnikih lahko večja.
Figure 5: Kaplan Meier curve for progression-free survival (CELESTIAL)
Slika 5: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (CELESTIAL)
A statistically significant improvement in PFS as retrospectively assessed by a blinded Independent Radiology Committee (IRC) was demonstrated for CABOMETYX compared to sunitinib (Figure 3 and Table 5).
Za zdravilo CABOMETYX je bilo v primerjavi s sunitinibom dokazano statistično pomembno izboljšanje preživetja brez napredovanja bolezni (PFS), kar je retrospektivno slepo ocenila neodvisna radiološka komisija (IRC) (slika 3 in preglednica 5).
In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Pri podganah je kabozantinib povzročil izgubo po vsaditvi, edeme zarodka, razcepljeno nebo/zajčjo ustnico, dermalno aplazijo in upognjen ali nerazvit rep.
• Pain in arms, legs and joints, muscle spasms
• bolečina v rokah, nogah in sklepih, mišični krči
Median time to onset was 10.0 weeks.
Mediani čas do pojava je bil 10,0 tednov.
Respiratory, thoracic, and mediastinal disorders dysphonia, dyspnoea, cough pulmonary embolism
Bolezni dihal, prsnega koša in mediastinalnega prostora disfonija, dispneja, kašelj pljučna embolija
Seventy-two percent (72%) of patients had received one and 28% had received 2 prior systemic therapy regimens for advanced disease.
Zaradi napredovale bolezni se je predhodno z enim režimom sistemskega zdravljenja zdravilo 72 % bolnikov, z dvema režimoma sistemskega zdravljenja pa 28 % bolnikov.
Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Sočasna uporaba kabozantiniba z močnim zaviralcem CYP3A4, ketokonazolom, je povzročila povečanje izpostavljenosti kabozantiniba v plazmi.
In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients.
V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), so o fistulah poročali pri 1,5 % (7/467) bolnikov s HCK.
CYP3A4 inhibitors and inducers
Zaviralci in induktorji CYP3A4
Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Klinični podatki pri karcinomu ledvičnih celic po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF)
Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Kronični sočasni uporabi močnih induktorjev CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, fenobarbitala ali pripravkov zeliščnega izvora iz šentjanževke [Hypericum perforatum]) s kabozantinibom se je treba zato izogibati.
Overall Survival Median OS (95% CI), months HR (95% CI)1,2 p-value1
Celokupno preživetje (OS) Mediana OS (95-% IZ), meseci HR (95-% IZ)1,2 p-vrednost1
Median time to onset was 9.1 weeks.
Mediani čas do pojava je bil 9,1 tedna.
Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili dogodke venske trombembolije, vključno s pljučno embolijo in arterijsko trombembolijo, ki so bili včasih tudi usodni.
Cabozantinib exhibited dose-related tumour growth inhibition, tumour regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Kabozantinib kaže od odmerka odvisno zaviranje rasti tumorja, regresijo tumorja in/ali zaviranje metastaz v številnih predkliničnih tumorski modelih.
Gastrointestinal disorders diarrhoea, nausea, vomiting, stomatitis, constipation, abdominal pain, dyspepsia, upper abdominal pain gastrointestinal perforation, fistula, gastroesophageal reflux disease, haemorrhoids, oral pain, dry mouth pancreatitis, glossodynia
Bolezni prebavil driska, navzea, bruhanje, stomatitis, konstipacija, bolečine v trebuhu, dispepsija, bolečina v zgornjem predelu trebuha gastrointestinalna perforacija, fistula, gastroezofagealna refluksna bolezen, hemoroidi, bolečina v ustni votlini, suha usta pankreatitis, glosodinija
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).
Pri zdravljenju karcinoma ledvičnih celic po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF), je bil odmerek zaradi neželenega učinka zmanjšan pri 59,8 % in odmerjanje prekinjeno pri 70 % bolnikov, zdravljenih s kabozantinibom v osrednjem kliničnem preskušanju (METEOR).
HDPE bottle with a polypropylene child-resistant closure and three silica gel dessicant canisters.
Plastenka iz HDPE z za otroke varno zaporko iz polipropilena in tremi vsebniki sušilnega sredstva.
In the HCC study (CELESTIAL), thrombocytopenia and decreased platelets were reported.
V študiji HCK (CELESTIAL) so poročali o trombocitopeniji in zmanjšanju števila trombocitov.
Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Sočasna uporaba kabozantiniba z močnim induktorjem CYP3A4, rifampicinom, je povzročila zmanjšanje izpostavljenosti kabozantiniba v plazmi.
Median time to onset was 5.9 weeks.
Mediani čas do pojava je bil 5,9 tedna.
Blood and lymphatic disorders anaemia thrombocytopenia, neutropenia lymphopenia
Bolezni krvi in limfatičnega sistema anemija trombocitopenija, nevtropenija limfopenija