natgillin/translations-raw huggingface dataset:
Amongst 1,823 patients treated with lenvatinib monotherapy in clinical trials, there were 5 cases (0.3%) of PRES (0.2% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 5 primerov (0,3 %) PRES (0,2 % jih je bilo stopnje 3 ali 4), od katerih so vsi okrevali po zdravljenju in/ali prekinitvi odmerjanja ali trajni ukinitvi.
Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Ne-gastrointestinalna fistula vključuje primere fistule, ki nastane zunaj želodca in črevesa, kot so trahealna, traheo-ezofagealna, ezofagealna fistula, fistula ženskih spolovil in kožna fistula.
Lenvatinib has not been studied in patients with severe hepatic imparement (Child-Pugh C) and is not recommended for use in these patients.
Lenvatiniba niso preučevali pri bolnikih s hudo jetrno okvaro (Child-Pugh C), zato uporaba pri teh bolnikih ni priporočljiva.
Amongst 1,823 patients treated with lenvatinib monotherapy in clinical studies, there were 10 cases (0.5%) of arterial thromboembolisms (5 cases of myocardial infarction and 5 cases of cerebrovascular accident) with a fatal outcome.
Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 10 primerov (0,5 %) arterijskih trombembolij (5 primerov miokardnega infarkta in 5 primerov cerebrovaskularnega insulta) s smrtnim izidom.
Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Ker se lenvatinib pretežno izloča s presnovo v jetrih, se pri bolnikih z zmerno do hudo jetrno okvaro pričakuje večja izpostavljenost.
Patients of age ≥75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib (see section 4.8, Other special populations).
Zdi se, da starejši bolniki, stari ≥ 75 let, ki pripadajo azijski rasi in imajo sočasne druge bolezni (na primer hipertenzijo in okvaro jeter ali ledvic) ali telesno maso, ki je manjša od 60 kg, slabše prenašajo lenvatinib (glejte poglavje 4.8, Druge posebne skupine bolnikov).
• you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).
• če dojite (glejte poglavje Kontracepcija, nosečnost in dojenje v nadaljevanju).
Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
O uporabi pri bolnikih, starih 75 let ali več, je na voljo malo podatkov (glejte tudi poglavje 4.8, Druge posebne skupine bolnikov).
No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
Prilagoditev začetnega odmerka na podlagi ledvične funkcije pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
The suspension is to be swallowed.
Suspenzijo spijemo.
• underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
• premalo aktivna ščitnica (utrujenost, pridobivanje telesne mase, zaprtje, občutek mraza, suha koža),
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH
Imetnik dovoljenja za promet z zdravilom Eisai GmbH
No formal studies of the effect of lenvatinib on wound healing have been conducted.
Formalnih študij o učinku lenvatiniba na celjenje ran niso izvedli.
The median time to first onset was 11.9 weeks.
Mediani čas do nastopa je bil 11,9 tednov.
Hepatic encephalopathyl,‡,†
jetrna encefalopatijal,‡,†
Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials.
V kliničnih preskušanjih je prišlo do nehotenih napak pri dajanju zdravila, ki so imele za posledico enkratne odmerke od 40 mg do 48 mg.
Avoid driving or using machines if you feel dizzy or tired.
Če ste omotični ali utrujeni, ne vozite in ne uporabljajte strojev.
A 5-mg dose was evaluated in 6 subjects with severe hepatic impairment (Child-Pugh C).
Petmiligramski odmerek so ovrednotili pri 6 preiskovancih s hudo okvaro jeter (Child-Pugh C).
Lenvatinib displays minimimal accumulation at steady state.
Lenvatinib kaže v stanju dinamičnega ravnovesja minimalno kopičenje.
The median time to onset was 6.1 weeks.
Mediani čas do nastopa je bil 6,1 tedna.
The median time to onset of hepatotoxocity adverse reactions was 6.4 weeks.
Mediani čas do nastopa s hepatotoksičnostjo povezanih neželenih učinkov je bil 6,4 tednov.
Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Izpostavljenost lenvatinibu na podlagi za odmerek popravljenih podatkov AUC0-t in AUC0-inf je bila 119 %, 107 % oziroma 180 % normalne vrednosti pri preiskovancih z blago, zmerno oziroma hudo okvaro jeter.
In the placebo group 0.8% of patients developed renal failure or impairment (0.8% were Grade ≥ 3).
V skupini s placebom se je odpoved ali okvara ledvic razvila pri 0,8 % bolnikov (0,8 % jih je bilo stopnje ≥ 3).
Lenvima 10 mg hard capsules EU/1/15/1002/002
Lenvima 10 mg trde kapsule EU/1/15/1002/002
EU/1/15/1002/002 (Pack size of 30 hard capsules) EU/1/15/1002/005 (Pack size of 60 hard capsules) EU/1/15/1002/006 (Pack size of 90 hard capsules)
EU/1/15/1002/002 (pakiranje 30 trdih kapsul) EU/1/15/1002/005 (pakiranje 60 trdih kapsul) EU/1/15/1002/006 (pakiranje 90 trdih kapsul)
The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily.
Priporočeni dnevni odmerek lenvatiniba je 24 mg (dve 10 mg kapsuli in ena 4 mg kapsula) enkrat na dan.
18th September 2019
DATUM ZADNJE REVIZIJE BESEDILA 18. september 2019
Efficacy Results from the REFLECT study in HCC Efficacy parameter
Table 7: Rezultati učinkovitosti v študiji REFLECT pri bolnikih s HCC
In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.110 μg/mL, mesylate).
Razmerje koncentracij lenvatiniba v krvi in plazmi in vitro je bilo v mejah od 0,589 do 0,608 (0,1-10 μg/ml, mesilat).
Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS)
Sindrom posteriorne reverzibilne encefalopatije (Posterior reversible encephalopathy syndrome ali PRES) / Sindrom reverzibilne posteriorne levkoencefalopatije (Reversible posterior leucoencephalopathy syndrome ali RPLS)
Females had a higher incidence of hypertension, fatigue, ECG QT prolongation and alopecia.
Pri ženskah so bile pogostejše hipertenzija, utrujenost, podaljšanje intervala QT na EKG in alopecija.
Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits (see section 5.3).
Lenvatinib je bil toksičen za zarodke in teratogen, ko so ga dajali podganam in kuncem (glejte poglavje 5.3).
Efficacy results in DTC patients
Preglednica 6 Rezultati učinkovitosti pri bolnikih z DTC
It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Trenutno ni znano, ali lenvatinib v kombinaciji s peroralnimi kontraceptivi zvečuje tveganje trombemboličnih dogodkov.
Although not studied directly with lenvatinib, the mechanism of action (MOA) for hypertension is postulated to be mediated by the inhibition of VEGFR2 in vascular endothelial cells.
Čeprav mehanizma hipertenzijskega delovanja niso proučevali neposredno z lenvatinibom, predpostavljajo, da gre za inhibicijoVEGFR2 v vaskularnih endotelijskih celicah.
After drinking, the same amount of water or apple juice (one tablespoon) must be added to the glass and swirled a few times.
Potem v kozarec dodamo enako količino vode ali jabolčnega soka (ena žlica) in tekočino nekaj časa vrtinčimo.
Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome.
Med 1166 bolniki, zdravljenimi z lenvatinibom, so bili 3 primeri (0,3 %) odpovedi jeter, vsi s smrtnim izidom.
In 452 patients with RAI-refractory DTC, dose reduction and discontinuation were the actions taken for an adverse reaction in 63.1% and 19.5% of patients, respectively.
Pri 452 bolnikih z DTC, odpornim proti RAI, sta bila ukrepa, ki so ju uporabili pri neželenih učinkih, zmanjšanje odmerka oziroma ukinitev zdravila pri 63,1 % oziroma 19,5 % bolnikov.
Stratified by region (Europe vs. North America vs. Other), age group (≤65 years vs >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
Stratificirano po regijah (Evropa proti Severni Ameriki proti drugim regijam), starostnih skupinah (≤ 65 let proti > 65 let) in predhodnem zdravljenju, usmerjenem v VEGF/VEGFR (0 proti 1).
Hepatotoxicity events and haemorrhage events also occurred at a higher incidence in CP score 6 patients compared to CP score 5 patients.
S hepatotoksičnostjo povezani neželeni učinki in krvavitve so se z večjo incidenco pojavljali pri bolnikih z oceno CP 6 v primerjavi z bolniki z oceno CP 5.
The median time to onset was 6.7 weeks.
Mediani čas do nastopa je bil 6,7 tedna.
Subjects with end-stage renal disease were not studied.
Preiskovancev z boleznijo ledvic v končnem stadiju niso proučevali.
There is limited clinical experience regarding the timing of reinitiation of lenvatinib following a major surgical procedure.
Klinične izkušnje o času ponovne uvedbe lenvatiniba po večjem kirurškem posegu so omejene.
Lenvatinib and its metabolites are excreted in rat milk (see section 5.3).
Lenvatinib in njegovi presnovki se izločajo v mleko podgan (glejte poglavje 5.3).
It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method.
Trenutno ni znano, ali lenvatinib lahko zmanjša učinkovitost hormonskih kontracepcijskih sredstev, zato naj ženske, ki uporabljajo peroralna hormonska kontracepcijska sredstva, dodatno uporabijo še pregradno metodo kontracepcije.
Median was estimated with the Kaplan-Meier method and the 95% confidence interval was constructed with a generalised Brookmeyer and Crowley method.
Mediana je bila ocenjena s Kaplan-Meierjevo metodo; 95-odstotni IZ je bil sestavljen s posplošeno Brookmeyer-Crowleyevo metodo.
Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae.
Nekateri primeri krvavitev so se pojavili sekundarno zaradi zmanjšanja tumorske mase in nastanka fistule, npr. traheo-ezofagealnih fistul.
One fatal case of hepatic tumour haemorrhage in a patient with HCC has been reported.
Poročali so o enem primeru krvavitve jetrnega tumorja s smrtnim izidom pri bolniku s HCC.
• Uncommon (≥1/1,000 to <1/100)
(≥ 1/1.000 do < 1/100)
In 496 patients with HCC, dose modification (interruption or reduction) and discontinuation were the actions taken for an adverse reaction in 62.3% and 20.2% of patients, respectively.
Pri 496 bolnikih s HCC je bil odmerek spremenjen (prekinitev ali zmanjšanje) pri 62,3 %, zdravljenje pa ukinjeno pri 20,2 % bolnikov.
Lenvima 4mg hard capsules EU/1/15/1002/001
Lenvima 4 mg trde kapsule EU/1/15/1002/001
Gastrointestinal perforation and fistula formation
Gastrointestinalna perforacija in nastanek fistule
Lenvatinib should be used with caution in such patients, given the reduced tolerability of lenvatinib in Asian and elderly patients (see section 4.8, Other special populations).
Lenvatinib se mora pri takih bolnikih uporabljati previdno, saj bolniki, ki pripadajo azijski rasi, in starejši bolniki lenvatinib slabše prenašajo (glejte poglavje 4.8 Druge posebne skupine bolnikov).
Hepatotoxicity reactions of ≥ Grade 3 occurred in 26.1% of lenvatinib-treated patients.
S hepatotoksičnostjo povezani neželeni učinki stopnje ≥ 3 so nastopili pri 26,1 % bolnikov, zdravljenih z lenvatinibom.
Hyperbilirubinaeamia includes: hyperbilirubinaemia, increased blood bilirubin, jaundice and increased bilirubin conjugated.
Hiperbilirubinemija vključuje: hiperbilirubinemijo, zvišano raven bilirubina v krvi, zlatenico in zvišano raven konjugiranega bilirubina.
In the pivotal Phase 3 SELECT trial (see section 5.1), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) je imelo 88 % vseh bolnikov izhodiščno raven TSH nižjo kot 0,5 mE/l ali enako 0,5 mE/l.
Discontinue Do not resume *Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
Zdravljenja ne začnite znova *Laboratorijske nenormalnosti stopnje 4, za katere sodimo, da niso življenjsko nevarne, lahko obravnavamo kot resne neželene učinke (npr. stopnje 3).
The incidence of QTcF interval prolongation of greater than 500ms was
Pojavnost podaljšanja intervala QT, večjega od 500 ms, je bila 2,4 %.
These patients also had a higher incidence of renal reactions and a trend towards a higher incidence of liver reactions.
Ti bolniki so imeli tudi večjo incidenco neželenih učinkov na ledvice in so bili nagnjeni k večji incidenci neželenih učinkov na jetra.
Females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Pri ženskah so bile pogostejše hipertenzija (vključno s hipertenzijo stopnje 3 ali 4), proteinurija in PPE, moški pa so imeli večje incidenco zmanjšane iztisne frakcije, gastrointestinalnih perforacij in nastanka fistul.
HCC patients other than those with moderate and severe hepatic impairment or severe renal impairment should initiate treatment at the recommended starting dose of 8 mg (two 4 mg capsules) for body weight < 60 kg and 12 mg (three 4 mg capsules) for body weight ≥ 60 kg, following which the dose should be further adjusted on the basis of individual tolerability.
Vsi bolniki s HCC razen tistih, ki imajo zmerno in hudo okvaro jeter ali hudo okvaro ledvic, naj začnejo z zdravljenjem s priporočenim odmerkom 8 mg (dve 4 mg kapsuli) za bolnike s telesno maso < 60 kg oz. 12 mg (tri 4 mg kapsule) za bolnike s telesno maso ≥ 60 kg, nato pa naj se odmerek nadalje prilagaja na podlagi prenašanja vsakega bolnika posebej.
In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients.
Pri tistih bolnikih, ki so imeli v izhodišču normalen TSH, so opazili zvišanje ravni TSH nad 0,5 mE/l po izhodišču pri 57 % bolnikov, zdravljenih z lenvatinibom, in pri 14 % bolnikov, ki so prejemali placebo.
Impairment of thyroid stimulating hormone suppression/ Thyroid dysfunction
Okvara supresije tirotropnega hormona / disfunkcija ščitnice
• have liver or kidney problems
• imate težave z jetri ali ledvicami;
Increased blood alkaline phosphatase Hepatic function abnormal Increased gammaglutamyltransferase Cholecystitis
zvišana alkalna fosfataza v krvi abnormalna funkcija jeter zvišana gamaglutamiltransferaza holecistitis hepatocelularna poškodba/hepatitism
Discontinue lenvatinib and institute appropriate medical management.
Ukinite lenvatinib in začnite z ustreznim zdravljenjem.
The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) once daily for patients with a body weight of ≥ 60 kg.
Priporočeni dnevni odmerek lenvatiniba je 8 mg (dve 4 mg kapsuli) enkrat na dan za bolnike s telesno maso < 60 kg in 12 mg (tri 4 mg kapsule) enkrat na dan za bolnike s telesno maso ≥ 60 kg.
No differences between lenvatinib- and placebo-treated patients were observed in the incidences of serious reactions (3.4% vs. 3.8%), reactions leading to premature discontinuation (1.1% vs. 1.5%), or reactions leading to dose interruption (3.4% vs. 3.8%) or reduction (0.4% vs. 0).
Nobenih razlik med bolniki, zdravljenimi z lenvatinibom, in bolniki, ki so prejemali placebo, niso opazili glede incidenc resnih neželenih učinkov (3,4 % v primerjavi s 3,8 %), tistih, ki so povzročili prezgodnjo ukinitev zdravila (1,1 % v primerjavi z 1,5 %), ali neželenih učinkov, ki so povzročili prekinitev (3,4 % v primerjavi s 3,8 %) ali zmanjšanje odmerka (0,4 % v primerjavi z 0).
Across clinical studies in which 1327 patients received lenvatinib monotherapy in indications other than HCC, hepatic failure (including fatal events) was reported in 4 patients (0.3%), liver injury in 2 patients (0.2%), acute hepatitis in 2 patients (0.2%), and hepatocellular injury in 1 patient (0.1%).
V več študijah so med 1327 bolniki, zdravljenimi z lenvatinibom zaradi indikacij, ki niso bile HCC, poročali o jetrni odpovedi (vključno s smrtnimi izidi) pri 4 bolnikih (0,3 %), jetrni poškodbi pri 2 bolnikih (0,2 %), akutnem hepatitisu pri 2 bolnikih (0,2 %) in hepatocelularni poškodbi pri 1 bolniku
Bleeding in sites other than the brain (e.g. trachea, intra-abdominal, lung) has also been reported.
Poročali so tudi o krvavitvah drugje, ne v možganih (npr. v traheji, intraabdominalno, v pljučih).
Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions).
V kliničnih preskušanjih so se pojavile resne krvavitve, povezane s tumorjem, vključno s smrtnimi hemoragičnimi dogodki, o njih so poročali tudi v izkušnjah po prihodu zdravila na trg (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
(2 capsules of 10 mg and 1 capsule of 4 mg).
(2 kapsuli po 10 mg in 1 kapsula s 4 mg).
Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa
Preglednica 1 Spremembe odmerka od priporočenega dnevnega odmerka lenvatiniba pri bolnikih z DTCa
Hypoalbuminaemia includes hypoalbuminaemia and decreased blood albumin.
Hipoalbuminemija vključuje hipoalbuminemijo in znižano raven albumina v krvi.
Lenvatinib is mainly eliminated via the liver and exposure might be increased in these patient populations.
Ker se lenvatinib pretežno izloča s presnovo v jetrih, se pri teh bolnikih lahko poveč izpostavljenost.
The European Medicines Agency (EMA) has deferred the obligation to submit the results of a study with lenvatinib in one or more subsets of the paediatric population in the treatment of radioiodinerefractory differentiated thyroid cancer and has has waived the obligation to submit the results of studies with lenvatinib in one or more subsets of the paediatric population in the treatment of hepatocellular carcinoma (HCC).
lenvatinib sorafenib diferenciranega raka ščitnice in je odstopila od zahteve za predložitev rezultatov študij z lenvatinibom v eni ali več podskupin pediatrične populacije pri zdravljenju hepatocelularnega karcinoma (HCC).
In the Phase 3 REFLECT trial (see section 5.1), 89.6% of patients had a baseline TSH level of less than the upper limit of normal.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) je imelo 89,6 % bolnikov izhodiščno raven TSH nižjo od zgornje meje normalnega razpona.
Lenvatinib was non-inferior for OS to sorafenib with HR = 0.92 [95% CI of (0.79, 1.06)] and a median OS of 13.6 months vs 12.3 months (see Table 7 and Figure 2).
Lenvatinib je bil neinferioren sorafenibu glede OS, z razmerjem ogroženosti (HR - hazard ratio) = 0,92 [95-odstotni IZ (0,79; 1,06)] in mediano OS 13,6 mesecev v primerjav z 12,3 meseca (glejte preglednico 7 in sliko 2).
Patients in the placebo arm could opt to receive lenvatinib treatment at the time of confirmed disease progression.
Bolniki v kraku s placebom so se lahko ob času potrjenega napredovanja bolezni odločili, da bodo prejemali zdravljenje z lenvatinibom.
The pharmacokinetics of lenvatinib following a single 24-mg dose were evaluated in 6 subjects each with mild, moderate, and severe renal impairment, and compared with 8 healthy, demographically matched subjects.
Farmakokinetiko lenvatiniba po enkratnem 24-miligramskem odmerku so ovrednotili pri 6 preiskovancih z blago, 6 preiskovancih z zmerno in 6 preiskovancih s hudo okvaro jeter in rezultate primerjali z 8 zdravimi, demografsko podobnimi preiskovanci.
It has been determined that plasma protein binding in plasma from hepatically impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Ugotovilo se je, da je v plazmi preiskovancev z okvaro jeter vezava na plazemske beljakovine podobna vezavi pri ustreznih zdravih preiskovancih, odvisnost od koncentracije pa ni bila opažena.
Grade 3 or greater reactions occurred in 1.9% of lenvatinib-treated patients.
Neželeni učinek stopnje 3 ali višje se je pojavil pri 1,9 % bolnikov, zdravljenih z lenvatinibom.
• The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
• Druge sestavine zdravila so kalcijev karbonat, manitol, mikrokristalna celuloza, hidroksipropilceluloza, hipromeloza, smukec.
There is no specific antidote for overdose with lenvatinib.
Za prevelik odmerek lenvatiniba ni specifičnega antidota.
No adjustment of starting dose is required on the basis of hepatic function in patients with mild (ChildPugh A) or moderate (Child-Pugh B) hepatic impairment.
Prilagoditev začetnega odmerka na podlagi jetrne funkcije pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter ni potrebna.
Arterial thromboembolisms
Arterijske trombembolije
For previously normotensive subjects, monotherapy with one of the classes of antihypertensives should be started when elevated BP is observed.
Pri predhodno normotenzivnih osebah je treba takrat, ko opazimo zvišan KT, začeti z monoterapijo z eno od skupin antihipertenzivnih zdravil.
It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Ugotovilo se je, da je v plazmi preiskovancev z okvaro ledvic vezava na plazemske beljakovine podobna vezavi pri ustreznih zdravih preiskovancih, odvisnost od koncentracije pa ni bila opažena.
The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Najpogosteje opaženi neželeni učinki zdravila pri teh odmerkih so bili hipertenzija, navzea, driska, utrujenost, stomatitis, proteinurija, glavobol in poslabšanje PPE.
The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (44.0%), diarrhoea (38.1%), decreased appetite (34.9%), fatigue (30.6%), and decreased weight
Najpogostejši neželeni učinki (pojavljajo se pri ≥ 30 % bolnikov) so hipertenzija (44,0 %), driska (38,1 %), zmanjšan apetit (34,9 %), utrujenost (30,6 %) in hujšanje (30,4 %).
• changes in blood test results for potassium levels (low) and calcium levels (low)
• spremembe rezultatov krvnih preiskav kalija (znižan) in kalcija (znižan),
Hazard ratio (95% CI)b, e P-value b, e
razmerje tveganja (95 % IZ)b, e vrednost P b, e
Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose
Preglednica 2 Spremembe odmerka od priporočenega dnevnega odmerka lenvatiniba pri bolnikih s HCC
Hepatic encephalopathy includes: hepatic encephalopathy, coma hepatic, metabolic encephalopathy and encephalopathy.
Jetrna encefalopatija vključuje: jetrno encefalopatijo, hepatično komo, presnovno encefalopatijo in encefalopatijo.
• changes in blood test results for kidney function and kidney failure
• spremembe rezultatov krvnih preiskav delovanja ledvic in odpoved ledvic,
Talk to your doctor before taking LENVIMA if you:
Pred začetkom jemanja zdravila LENVIMA se posvetujte z zdravnikom, če:
Renal failure and impairment
Ledvična odpoved in okvara
Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis.
Primeri odpovedi ledvic vključujejo: akutno prerenalno odpoved, odpoved ledvic, akutno odpoved ledvic, akutno poškodbo ledvic in ledvično tubulno nekrozo.