natgillin/translations-raw huggingface dataset:
In vitro-data indikerer, at regorafenib er en potent inhibitor af CYP2C8 (Ki-værdi på 0,6 mikromolær), CYP2C9 (Ki-værdi på 4,7 mikromolær), CYP2B6 (Ki-værdi på 5,2 mikromolær) ved koncentrationer, der opnås in vivo ved steady state (top-plasmakoncentration på 8,1 mikromolær).
In vitro data indicate that regorafenib is a competitive inhibitor of the cytochromes CYP2C8 (Ki value of 0.6 micromolar), CYP2C9 (Ki value of 4.7 micromolar), CYP2B6 (Ki value of 5.2 micromolar) at concentrations which are achieved in vivo at steady state (peak plasma concentration of 8.1 micromolar).
De 199 randomiserede patienter havde en gennemsnitsalder på 58 år, 64 % var mænd, 68 % var kaukasere, og alle patienterne havde baseline ECOG Performance Status (PS) på 0 eller 1.
Of the 199 randomised patients, the mean age was 58 years, 64% were male, 68% were Caucasian, and all patients had baseline ECOG Performance Status (PS of 0 or 1.
Sammenlignet med det globale fase III-KRC-studie (CORRECT), hvor der primært indgik kaukasiske patienter (~80 %), blev der observeret en højere forekomst af forhøjede leverenzymer hos patienter, der blev behandlet med Stivarga i det asiatiske fase III-KRC-studie (CONCUR), hvor der primært indgik patienter fra Østasien (> 90 %).
Compared to the global phase III CRC trial (CORRECT) with predominantly (~80%) Caucasian patients enrolled, a higher incidence of liver enzyme increases was observed in Stivarga-treated patients in the Asian phase III CRC trial (CONCUR) with predominantly (> 90%) East Asian patients enrolled.
Af de 760 randomiserede patienter var den gennemsnitlige alder 61 år, 61 % var mænd, 78 % var kaukasere, og alle patienter havde ECOG Performance Status (PS) ved baseline på 0 eller 1.
Of the 760 randomised patients, the median age was 61 years, 61% were male, 78% were Caucasian, and all patients had baseline ECOG Performance Status (PS of 0 or 1.
Der er ingen relevant brug af Stivarga hos børn og unge for indikationen kræft i leveren.
There is no relevant use of Stivarga in children and adolescents in the indication of liver cancer.
Stivarga bør ikke anvendes til patienter med svært nedsat leverfunktion (Child-Pugh C), da Stivarga ikke er undersøgt hos denne population og eksponeringen kan være forhøjet hos disse patienter.
Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as Stivarga has not been studied in this population and exposure might be increased in these patients.
Tabel 1: Anbefalede dosismodifikationer og foranstaltninger for HFSR
Table 1: Recommended dose modifications and measures for HFSR Skin toxicity grade
≤ 5 gange den øvre normalgrænse (ULN) (maks.
≤5 times upper limit of normal (ULN) (maximum Grade 2)
Tidligere behandlinger inkluderede fluorpyrimidinbaseret kemoterapi, en anti-VEGF-behandling og, hvis patienten havde en KRAS-vildtypetumor, en anti-EGFR-behandling.
Therapies included treatment with fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and, if the patient was KRAS wild type, an anti-EGFR therapy.
Regorafenib er en uridin-diphosphat-glucuronosyltransferase (UGT)-1A1-inhibitor (se pkt.
Regorafenib is a uridine diphosphate glucuronosyl transferase (UGT) 1A1 inhibitor (see section 4.5).
Hændelser med dødeligt udfald forbundet med infektion blev oftere observeret hos patienter behandlet med Stivarga (1,0 %), sammenlignet med patienter, der fik placebo (0,3 %), og var hovedsageligt hændelser i luftvejene.
Fatal outcomes associated with infection were observed more often in patients treated with Stivarga (1.0%), compared to patients receiving placebo (0.3%), and were mainly respiratory events.
- Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat, povidon (K-25) og kolloid vandfri silika, rød jernoxid (E 172), gul jernoxid (E 172), lecithin (deriveret fra soja), macrogol 3350, polyvinylalkohol (delvist hydrolyseret), talcum og titandioxid (E 171) (se også punktet ”Stivarga indeholder natrium”).
- The other ingredients are: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone (K-25) and silica colloidal anhydrous, iron oxide red (E172), iron oxide yellow (E172), lecithin (derived from soya), macrogol 3350, polyvinyl alcohol (partially hydrolysed), talc and titanium dioxide (E171) (see also section ‘Important information about some of the ingredients of Stivarga').
Der kræves ingen dosisjustering baseret på køn (se også pkt.
No dose adjustment is necessary based on gender (see also section 5.2).
I kliniske studier var der en højere forekomst af svær leverskade med dødeligt udfald hos japanske patienter (~1.5%), der blev behandlet med Stivaga, sammenlignet med ikke-japanske patienter (<0.1%).
In clinical trials, a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients (~1.5%) treated with Stivarga, compared with nonJapanese patients (<0.1%).
Stivargas sikkerhed og virkning hos børn og unge for indikationen gastrointestinale stromale tumorer (GIST) er ikke klarlagt.
The safety and efficacy of Stivarga in children and adolescents in the indication of gastrointestinal stromal tumours (GIST) have not been established.
I kliniske studier blev der ikke observeret relevante forskelle i eksponering, sikkerhed eller virkning mellem patienter med let nedsat leverfunktion (Child-Pugh A) og normal leverfunktion.
In clinical studies, no relevant differences in exposure, safety or efficacy were observed between patients with mild hepatic impairment (Child-Pugh A) and normal hepatic function.
Tabel 2: Anbefalede foranstaltninger og dosismodifikationer i tilfælde af anomalier i leverfunktionsprøven relateret til lægemidlet
Table 2: Recommended measures and dose modifications in case of drug-related liver function test abnormalities
Enhver forekomst
Any occurrence
- reduktion i antallet af hvide blodlegemer (leukopeni) - nedsat aktivitet af skjoldbruskkirtlen (hypotyreoidisme) - lave niveauer af kalium, fosfat, calcium, natrium eller magnesium i blodet (hypokaliæmi,
- reduction in the number of white blood cells (leucopenia) - decreased activity of the thyroid gland (hypothyroidism) - low levels of potassium, phosphate, calcium, sodium or magnesium in your blood
Sekundære endepunkter var progressionsfri overlevelse (PFS), tid til progression (TTP), objektiv tumorresponsrate (ORR) og sygdomskontrolrate (DCR).
Secondary endpoints were Progression-Free Survival (PFS), Time To Progression (TTP), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Denne medicin indeholder 1,68 mg lecithin (deriveret fra soja) pr. daglig dosis (4 tabletter).
This medicine contains 1.68 mg of lecithin (derived from soya) per daily dose (4 tablets).
Posteriort reversibelt leukoencefalopatisk syndrom (PRES) PRES er blevet rapporteret i forbindelse med behandling med Stivarga (se pkt.
Posterior reversible encephalopathy syndrome (PRES) PRES has been reported in association with Stivarga treatment (see section 4.8).
De alvorligste bivirkninger, for hvilke der er observeret et dødeligt udfald er: - svære leverproblemer, blødning, mave-tarm-perforation og infektion.
The most serious side effects, for which a fatal outcome has been observed, are: - Severe liver problems, bleeding, gastrointestinal perforation and infection.
BSC = Bedste understøttende behandling
* International normalized ratio BSC = Best Supportive Care
Det skal du vide, før du begynder at tage Stivarga Tag ikke Stivarga:
What you need to know before you take Stivarga Do not take Stivarga
Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejersken eller apotekspersonalet.
If you get any side effects, talk to your doctor or pharmacist.
Behandling af HFSR kan inkludere brug af keratolytiske cremer (f.eks. cremer baseret på urea, salicylsyre eller alpha hydroxysyre påført sparsomt og kun på de berørte områder), fugtighedsgivende cremer (påført i rigelige mængder) for symptomatisk lindring.
Management of HFSR may include the use of keratolytic creams (e.g. urea-, salicylic acid-, or alpha hydroxyl acid-based creams applied sparingly only on affected areas) and moisturizing creams (applied liberally) for symptomatic relief.
Sekundære endepunkter var progressionsfri overlevelse (PFS), objektiv tumorresponsrate (ORR) og sygdomskontrolrate (DCR).
Secondary endpoints were Progression-Free Survival (PFS), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Få straks medicinsk hjælp, hvis du får de følgende symptomer, da de kan være tegn på et hjerteanfald eller nedsat blodomløb til hjertet: Utilpashed i brystet eller smerter, der kan spredes fra brystet til skuldrene, armene, ryggen, halsen, tænderne, kæben eller maven, og de kan komme og gå, stakåndethed, pludselig svedtendens med kold, klam hud, svimmelhed eller besvimelse.
Get medical help immediately if you get the following symptoms, as they may be signs of a heart attack or decreased blood flow to the heart: chest discomfort or pain which may spread beyond your chest to your shoulders, arms, back, neck, teeth, jaw or stomach and may come and go; shortness of breath; sudden outbreak into a sweat with cold, clammy skin, feeling dizzy or fainting.
Den anbefalede dosis regorafenib er 160 mg (4 tabletter med 40 mg), der tages én gang dagligt i 3 uger, efterfulgt af 1 uge uden behandling.
The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Hazard ratio for OS var 0,772 (95 % CI 0,423; 1,408; p = 0,199; median-OS blev ikke nået i nogen af armene); 85 % af de patienter, der til at begynde med blev randomiseret til placeboarmen, fik behandling med regorafenib efter progression (se tabel 6, figur 3).
The HR for OS was 0.772 (95% CI, 0.423, 1.408; p = 0.199; median OS not reached in either arm); 85% of patients initially randomised to the placebo arm received post-progression treatment with regorafenib (see Table 6, Figure 3).
Tabel 4: Laboratorieprøveanomalier opstået under behandlingen og rapporteret i placebokontrolleret fase III-studie hos patienter med metastaserende KRC (CORRECT), GIST (GRID) og HCC (RESORCE) mKRC (CORRECT)
Table 4: Treatment-emergent laboratory test abnormalities reported in placebo-controlled phase III trials in patients with metastatic CRC (CORRECT), GIST (GRID) and HCC (RESORCE)
Asteni/ træthed
Asthenia/ fatigue
Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
De hyppigst observerede lægemiddelbivirkninger ved denne dosis var dermatologiske hændelser, dysfoni, diaré, slimhindeinflammation, tør mund, nedsat appetit, hypertension og træthed.
The most frequently observed adverse drug reactions at this dose were dermatological events, dysphonia, diarrhoea, mucosal inflammation, dry mouth, decreased appetite, hypertension, and fatigue.
Alternativt bør det overvejes at vælge et andet samtidigt lægemiddel uden potentiale eller med minimalt potentiale for at inducere CYP3A4.
Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
I kliniske studier blev der ikke observeret relevante forskelle i eksponering, sikkerhed eller effekt mellem mænd og kvinder.
In clinical studies, no relevant differences in exposure, safety or efficacy were observed between male and female patients.
Lyserøde, ovale, filmovertrukne tabletter, der er 16 mm lange og 7 mm brede og mærket med ”BAYER” på den ene side og ”40” på den anden side.
Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER' on one side and ‘40' on the other side.
Forekomsten af hypertension af grad 3 var 8,7 % (KRC), 28,0 % (GIST) og 15,2 % (HCC).
The incidence of Grade 3 hypertension was 8.7% (CRC), 28.0% (GIST) and 15.2% (HCC).
Vigtige metabolitter (M-2 og M-5) udviste lignende virkning sammenlignet med regorafenib i in vitro- og in vivo-modeller.
Major human metabolites (M-2 and M-5) exhibited similar efficacies, compared to regorafenib in in vitro and in vivo models.
Hazard ratio (95 % CI) for PFS var 0,475 (0,362-0,623) for patienter med KRAS-wildtype tumorer og 0,525 (0,425-0,649) for patienter med KRAS-muterede tumorer.
The hazard ratio (95% CI) of PFS was 0.475 (0.362 to 0.623) for patients with KRAS wild-type tumours and 0.525 (0.425 to 0.649) for patients with KRAS mutant tumours.
Behandling med Stivarga kan medføre en større risiko for infektioner, særligt i urinvejene, næsen, halsen og lungerne.
Treatment with Stivarga may lead to a higher risk of infections, especially of the urinary tract, nose, throat and lung.
Regorafenib, M-2 og M-5 undergår sandsynligvis enterohepatisk cirkulation (se pkt.
Regorafenib, M-2 and M-5 are likely to undergo enterohepatic circulation (see section 5.2).
Få omgående akuthjælp, hvis du får følgende symptomer: - høj feber - alvorlig hoste med eller uden stigning i slim(spyt)produktion - meget øm hals
Get medical help immediately if you get the following symptoms: - high fever - severe cough with or without an increase in mucus (sputum) production - severe sore throat
Alvorlige påvirkninger af leverfunktionsprøver (grad 3 og 4) og klinisk leversvigt (inklusive dødelige udfald) er blevet rapporteret hos en lille andel af patienter (se pkt.
Severe liver function test abnormalities (Grade 3 to 4) and hepatic dysfunction with clinical manifestations (including fatal outcomes) have been reported in a small proportion of patients (see section 4.8).
Da der kun foreligger begrænsede data for patienter med moderat nedsat leverfunktion (Child-Pugh B), kan der ikke gives nogen dosisanbefalinger til sådanne patienter.
Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Dosisreduktion og/eller en midlertidig afbrydelse af Stivarga, eller i svære eller vedvarende tilfælde en permanent seponering af Stivarga, bør overvejes (se pkt.
Dose reduction and/or temporary interruption of Stivarga, or in severe or persistent cases, permanent discontinuation of Stivarga should be considered (see section 4.2).
Det blev påvist, at regorafenib havde en virkning på intrauterin udvikling hos kaniner ved en lavere eksponeringer end den forventede humane eksponering (baseret på AUC-sammenligning).
An effect of regorafenib on intrauterine development was shown in rabbits at exposures below the anticipated human exposure (based on AUC comparison).
Behandling med Stivarga kan også medføre en større risiko for svampeinfektioner i slimhinderne, på huden eller kroppen.
Treatment with Stivarga may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body.
Koncentrationerne af regorafenib og dets vigtigste farmakologisk aktive metabolitter (M-2 og M-5) var højest, når det blev givet efter fedtfattig (let) morgenmad sammenlignet med enten morgenmad med højt fedtindhold eller ved fastende tilstand.
The concentrations of regorafenib and its major pharmacologically active metabolites (M-2 and M-5) were highest when given after a low-fat (light) breakfast, compared to either a high-fat breakfast or fasting condition.
Vigtig information om nogle af indholdsstofferne Dette lægemiddel indeholder 55,8 mg natrium pr. daglig dosis på 160 mg svarende til 3 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
Important information about some of the ingredients This medicinal product contains 55.8 mg sodium per daily dose of 160 mg, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya).
Dosisjustering baseret på etnicitet er ikke nødvendig (se pkt.
No dose adjustment is necessary based on ethnicity (see section 5.2).
> 5 gange ULN til ≤ 20 gange ULN (grad 3)
>5 times ULN ≤20 times ULN (Grade 3)
Stivarga 40 mg filmovertrukne tabletter.
Stivarga 40 mg film-coated tablets.
De hyppigst observerede lægemiddelbivirkninger (≥ 30 %) hos patienter, der får Stivarga, er smerte, hånd-fod-hudreaktion, asteni/træthed, diaré, nedsat appetit og fødeindtagelse, hypertension og infektion.
The most frequently observed adverse drug reactions (≥30%) in patients receiving Stivarga are pain, hand foot skin reaction, asthenia/fatigue, diarrhoea, decreased appetite and food intake, hypertension and infection.
M-5 kan reduceres af mikrobiel flora til M-4 i mave-tarm-kanalen, og gøre reabsorption af M-4 mulig (enterohepatisk cirkulation).
M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
0,9 måneder
0.9 months
opkastning og feber (pankreatitis) - neglesygdom (ændringer i neglene, f.eks. riller og/eller flækker let) - multiple huderuptioner (erythema multiforme).
vomiting, and fever (pancreatitis) - nail disorder (changes to the nail such as ridges and/or splitting) - multiple skin eruptions (erythema multiforme).
Figur 5: Kaplan-Maier kurver for PFS (mRECIST)
Figure 5: Kaplan-Meier curve of PFS (mRECIST)
Blødning* Hypertension
Haemorrhage* Hypertension
Samtidig administration af kraftige UGT1A9-hæmmere (f.eks. mefenaminsyre, diflunisal og nifluminsyre) i løbet af behandlingen med regorafenib bør undgås, da deres indflydelse på steady state-eksponeringen over for regorafenib og metabolitter herfra ikke er blevet undersøgt.
Co-administration of a strong UGT1A9 inhibitor (e.g. mefenamic acid, diflunisal, and niflumic acid) during regorafenib treatment should be avoided, as their influence on the steady-state exposure of regorafenib and its metabolites has not been studied.
Hvis du tager for meget Stivarga, kan det gøre nogle bivirkninger mere sandsynlige eller mere alvorlige, især: - hudreaktioner (udslæt, blærer, rødme, smerte, hævelse, kløe eller afskallende hud) - stemmeændringer eller hæshed (dysfoni) - hyppig eller løs afføring (diaré)
Taking too much Stivarga may make some side effects more likely or more severe, especially: - skin reactions (rash, blisters, redness, pain, swelling, itching or peeling of your skin) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - mouth sores (mucosal inflammation)
Behandling med Stivarga kan medføre en større risiko for blødning.
Treatment with Stivarga may lead to a higher risk of bleeding.
Det anbefales at kontrollere blodtrykket og at behandle hypertension iht.
It is recommended to monitor blood pressure and to treat hypertension in accordance with standard medical practice.
57 % af patienterne havde KRAS-muteret tumor ved studiestart.
A KRAS mutation was reported in 57% of patients at study entry.
Behandling fortsættes så længe, der findes klinisk indikation herfor, eller indtil der opstår uacceptabel toksicitet (se pkt.
Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Eksponeringen for regorafenib og dets metabolitter M-2 og M-5 er sammenlignelig hos patienter med let nedsat leverfunktion (Child-Pugh A) og patienter med normal leverfunktion.
The exposure of regorafenib and its metabolites M-2 and M-5 is comparable in patients with mild hepatic impairment (Child-Pugh A) and patients with normal hepatic function.
Spørg lægen, hvis du har spørgsmål om, hvordan Stivarga virker, eller hvorfor du har fået ordineret dette lægemiddel.
If you have any questions about how Stivarga works or why this medicine has been prescribed for you, please ask your doctor.
Hver tabletbeholder indeholder 28 filmovertrukne tabletter.
Each bottle contains 28 film-coated tablets.
Det anbefales at seponere Stivarga hos patienter, der udvikler mave-tarm-perforation eller fistel.
Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula.
A. FREMSTILLER ANSVARLIG(E) FOR BATCHFRIGIVELSE
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
De fleste infektioner hos patienter behandlet med Stivarga var milde til moderate i sværhedsgrad (grad 1 og 2: 23,0 %) og inkluderede urinvejsinfektioner (5,7 %), nasofaryngitis (4,0 %), slimhinde- og systemiske svampeinfektioner (3,3 %) samt lungebetændelse (2,6 %).
Most infections in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 23.0%), and included urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) as well as pneumonia (2.6%).
Dødeligt udfald hos patienter i behandling med Stivarga var ikke almindelige (0,7 %) og inkluderede cerebrale hændelser og hændelser i luftvejene, mave-tarm-kanalen og urogenitalvejene.
Fatal outcome in patients treated with Stivarga was uncommon (0.7%), and included cerebral, respiratory, gastrointestinal and genitourinary events.
Alvorlige mave- og tarmproblemer (mave-tarm-perforation eller fistel) Få omgående akuthjælp, hvis du får følgende symptomer: - alvorlig mave (abdominal)-smerte eller mavesmerte, der ikke forsvinder - opkastning af blod - rød eller sort afføring.
Severe stomach and bowel problems (gastrointestinal perforation or fistula) Get medical help immediately, if you get the following symptoms: - severe stomach (abdominal) pain or stomach pain that does not go away - vomiting blood - red or black stools.
Dosisafbrydelse eller dosisreduktion eller permanent seponering af Stivarga bør overvejes i tilfælde med vedvarende eller recidiverende signifikante anomalier (se pkt.
Dose interruption or reduction, or permanent discontinuation of Stivarga should be considered in case of persistent or recurrent significant abnormalities (see section 4.2).
Undtagelse: patienter med Gilberts syndrom, der udvikler forhøjede transaminaser, skal behandles iht.
Exception: patients with Gilbert's syndrome who develop elevated transaminases should be managed as per the above outlined recommendations for the respective observed elevation of ALT and/or AST.
- Hvis du får en infektion med tegn såsom høj feber, alvorlig hoste med eller uden stigning i slim(spyt)produktion, meget øm hals, stakåndethed, brændende fornemmelse/smerte ved vandladning, usædvanligt udflåd fra skeden eller irritation, rødme, hævelse og/eller smerter vilkårlige steder på kroppen.
- if you get an infection with signs such as high fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning/pain when urinating, unusual vaginal discharge or irritation, redness, swelling and/or pain in any part of the body.
Stivarga bruges til at behandle: - kræft i tyktarmen eller endetarmen, der har spredt sig til andre dele af kroppen hos voksne patienter, som har fået andre behandlinger, eller som ikke kan behandles med andre lægemidler (fluorpyrimidin-baseret kemoterapi, et VEGF-hæmmende middel og en anti-EGFR-behandling)
Stivarga is used to treat: - colon or rectal cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with other medicines (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)
Substrater for brystcancer-resistent protein (BCRP) og P-glykoprotein Administration af regorafenib (160 mg i 14 dage) før administration af en enkeltdosis rosuvastatin (5 mg), et BCRP-substrat, gav en stigning i den gennemsnitlige eksponering (AUC) for rosuvastatin på 3,8 gange og en stigning i Cmax på 4,6 gange.
Breast cancer resistance protein (BCRP) and P-glycoprotein substrates Administration of regorafenib (160 mg for 14 days) prior to administration of a single dose of rosuvastatin (5 mg), a BCRP substrate, resulted in a 3.8-fold increase in mean exposure (AUC) of rosuvastatin and a 4.6-fold increase in Cmax.
Sygdomsspecifikke forsigtighedsregler - Hepatocellulært karcinom (HCC) I det pivotale placebokontrollerede fase III-studie fik patienterne sorafenib inden behandlingen.
Disease-specific precautions - Hepatocellular carcinoma (HCC) In the pivotal placebo-controlled phase III study, patients received prior therapy with sorafenib.
Kontrollér leverfunktionen ugentligt, indtil leverfunktionen normaliseres eller vender tilbage til baseline.
Monitor liver function weekly until resolution or return to baseline.