natgillin/translations-raw huggingface dataset:
Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination. 
2. del študije CMEK162B2301 je bil zasnovan z namenom vrednotenja doprinosa binimetiniba v kombinaciji enkorafeniba in binimetiniba.
At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients. 
Pri odmerkih enkorafeniba med 600 in 800 mg enkrat dnevno je bila okvara ledvic (hiperkreatinemija 3. stopnje) opažena pri 3 od 14 bolnikov.
Gastrointestinal disorders were typically managed with standard therapy. 
Bolezni prebavil so bile večinoma obvladovane s standardnim zdravljenjem.
Visual impairment, including blurred vision and reduced visual acuity, occurred in 21.5% (59/274) of patients. 
Okvara vida, vključno z zamegljenim vidom in zmanjšano ostrino vida, je bila opažena pri 21,5 % (59/274) bolnikov.
Braftovi is an anti-cancer medicine that contains the active substance encorafenib. 
Braftovi je zdravilo proti raku, ki vsebuje zdravilno učinkovino enkorafenib.
In the 4-week and 13-week rat toxicity studies, clinical signs, reduced body weight reduced epididymides and prostate weights and microscopic findings in testes, epididymides, stomach and skin were noted. 
V 4-tedenskih in 13-tedenskih študijah toksičnosti pri podganah so bili opaženi naslednji klinični znaki: zmanjšana telesna masa, zmanjšana epididimis in masa prostate ter mikroskopske sledi v testisih, epididimisu, trebuhu in na koži.
An analysis of time to definitive 10% deterioration in EORTC QLQ-C30 score provided with similar results. 
Analiza časa do dokončnega 10-odstotnega poslabšanja pri oceni z vprašalnikom EORTC QLQ-C30 je pokazala podobne rezultate.
Model-based predictions for ketoconazole suggest an increase of approx. 5-fold for encorafenib AUC and 3 to 4-fold for encorafenib Cmax. 
Po napovedih na podlagi modela za ketokonazol se predvideva povečanje - približno 5-kratno za AUC enkorafeniba in od 3- do 4-kratno za Cmax enkorafeniba.
Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded. 
Bolniki so imeli histološko potrjen kožni ali neznani primarni melanom, vendar so bili bolniki z uvealnim ali mukoznim melanomom izključeni.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
There is no known antidote for encorafenib. 
Za enkorafenib ni znanega antidota.
Alternative agents with no or minimal CYP3A induction potential should be considered. 
Razmisliti je treba o alternativnih učinkovinah z minimalno indukcijo encima CYP3A ali brez nje.
No overall differences in safety or efficacy were observed between elderly patients (≥ 65) and younger patients. 
Med starejšimi (≥ 65 let) in mlajšimi bolniki skupno ni bilo opaženih razlik glede varnosti ali učinkovitosti.
In vitro, encorafenib inhibited the hepatic transporter OCT1, but is unlikely to be an effective inhibitor clinically. 
In vitro je enkorafenib zavrl jetrnega prenašalca OCT1, vendar je malo verjetno, da bi bil klinično učinkovit inhibitor.
Dose modification 
Sprememba odmerka
Ask your doctor, pharmacist or nurse for advice. 
Za nasvet vprašajte zdravnika, farmacevta ali medicinsko sestro.
For new primary cutaneous malignancies: No dose modifications are required for encorafenib. 
Za nove primarno dermalne malignome: odmerka enkorafeniba ni potrebno spreminjati.
Study CMEK162B2301, Part 1 
Študija CMEK162B2301, 1. del
For co-administration with CYP3A4 and UGT1A1 substrates that undergo gut extraction, a minor to moderate interaction is expected. 
Za skupno aplikacijo s substratoma CYP3A4 in UGT1A1, ki se absorbirata v črevesju, se pričakuje manjša do zmerna interakcija.
Additionally, in the 13-week rat toxicity study, reversible clinical pathology changes were noted at doses ≥ 100 mg/kg/d. 
Poleg tega so bile v 13-tedenski študiji toksičnosti pri podganah pri odmerkih ≥ 100 mg/kg/d opažene reverzibilne spremembe klinične patologije.
- Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems. 
- Težave z očmi: Zdravilo Braftovi, kadar se jemlje z binimetinibom, lahko povzroči resne težave z očmi.
A definitive 10% deterioration in FACT-M and in EORTC QLQC30 was significantly delayed in patients treated with Combo 450 relative to other treatments. 
10-odstotno dokončno poslabšanje pri oceni FACT-M in vprašalniku EORTC QLQ-C30 je bilo glede na druga zdravljenja bistveno zakasnjeno pri bolnikih, ki so se zdravili s kombinacijo 450.
In the absence of clinical data, encorafenib is not recommended in patients with moderate or severe hepatic impairment. 
Zaradi pomanjkanja kliničnih podatkov uporaba enkorafeniba ni priporočljiva za bolnike z zmerno ali hudo jetrno okvaro.
Patients should ensure adequate fluid intake during treatment. 
Med zdravljenjem morajo bolniki vnašati zadostne količine tekočin.
The recommended dose of Braftovi is 6 capsules of 75 mg once daily (corresponding to a daily dose of 450 mg). 
Priporočeni odmerek zdravila Braftovi je 6 kapsul po 75 mg enkrat dnevno (kar ustreza dnevnemu odmerku 450 mg).
Most events were Grade 1 or 2 (14.6%) and 3.3% were Grade 3-4 events. 
Večina dogodkov je bila 1. ali 2. stopnje (14,6 %), 3,3 % primerov pa je bilo 3. ali 4. stopnje.
Polyamide/aluminum/PVC/aluminum blister containing 6 capsules. 
Poliamid/aluminij/PVC/aluminij pretisni omot s 6 kapsulami.
Study CMEK162B2301, Part 2: 
Študija CMEK162B2301, 2. del:
The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC). 
Meritev rezultata primarne učinkovitosti je bila preživetje brez napredovanja (progression-free survival - PFS) pri zdravljenju s kombinacijo 450 v primerjavi z vemurafenibom po ocenah neodvisnega slepega odbora za pregled (blinded independent review committee - BIRC).
Braftovi may reduce sperm count in males. 
Zdravilo Braftovi lahko zmanjša število spermijev pri moških.
Side effects when Braftovi and binimetinib are taken together 
Neželeni učinki, ko se zdravilo Braftovi in binimetinib jemljeta skupaj
Ophthalmic lesions were partially reversible and consisted of a separation or detachment in the retina between the outer rods and cones layer and retinal pigmented epithelium at the central macula at the fovea. 
Očesne lezije so bile delno reverzibilne in so vključevale ločitev ali odstop v mrežnici med zunanjo plastjo paličic in čepkov in mrežničnega pigmentnega epitelija v centru rumene pege v fovei.
Polyamide/aluminum/PVC/aluminum blister containing 4 capsules. 
Poliamid/aluminij/PVC/aluminij pretisni omot s 4 kapsulami.
Uveitis and visual impairment were generally reversible. 
Vnetje uvee in okvare vida so bile večinoma reverzibilne.
Visual disturbances have been reported in some patients treated with encorafenib during clinical studies. 
Poročali so o motnjah vida pri nekaterih bolnikih, ki so v kliničnih študijah jemali enkorafenib.
The highest administered dose occurred as a dosing error in one patient who took encorafenib at a dose of 600 mg twice daily for 1 day (total dose 1200 mg). 
Najvišji vneseni odmerek je bil posledica napake pri določanju odmerka za enega bolnika, ki je 1 dan jemal dva 600-miligramska odmerka enkorafeniba dnevno (v skupnem odmerku 1200 mg).
The embryo-foetal development study in rabbits indicated that encorafenib induced foetal toxicity with lower foetal weights and transitory changes in skeletal development. 
Embriofetalna razvojna študija pri zajcih navaja, da je enkorafenib povzročil fetalno toksičnost z nižjo težo fetusa in prehodne spremembe v skeletnem razvoju.
Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration. 
Pri opaženih primerih okvare ledvic, vključno z akutno poškodbo ledvic in ledvično okvaro, sta se pogosto pojavila tudi bruhanje in dehidracija.
28 hard capsules 112 hard capsules 
28 trdih kapsul 112 trdih kapsul
Encorafenib 450 mg in combination with binimetinib (n = 274) 
Enkorafenib 450 mg v kombinaciji z binimetinibom (n = 274)
Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib. 
Enkorafenib je zmerno vezan na proteine v plazmi, zato hemodializa verjetno ne bo učinkovita pri zdravljenju prevelikega odmerjanja enkorafeniba.
BRAF mutation testing 
Test mutacij gena BRAF
Each pack contains either 28 or 112 hard capsules. 
Eno pakiranje vsebuje 28 ali 112 trdih kapsul.
Encorafenib is both an inhibitor and inducer of CYP3A4. 
Enkorafenib je obenem inhibitor in induktor encima CYP3A4.
No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of encorafenib. 
Za ocenjevanje vpliva farmakokinetike enkorafeniba na okvaro ledvic ni bila izvedena nobena uradna klinična študija.
What you need to know before you take Braftovi 
Kaj morate vedeti, preden boste vzeli zdravilo Braftovi
If you continue Braftovi on its own while the other medicine (binimetinib) is temporarily stopped based on your doctor's decision, you may get some of the side effects given in the lists above, although the frequency may change (increase or decrease). 
Če zdravilo Braftovi jemljete samostojno, medtem ko je vnos drugih zdravil (binimetiniba) začasno prekinjen, ker se je tako odločil zdravnik, se lahko pri vas pojavijo nekateri stranski učinki, navedeni zgoraj, pri čemer se njihova pogostnost lahko spremeni (poveča ali zmanjša).
Do not take Braftovi if you are allergic to encorafenib or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na enkorafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Additionally, no differences in exposure have been observed clinically when binimetinib is co-administered with encorafenib. 
Poleg tega niso bile klinično opažene razlike v izpostavljenosti, ko je binimetinib apliciran skupaj z enkorafenibom.
Each pack contains either 42 or 168 hard capsules. 
Eno pakiranje vsebuje 42 ali 168 trdih kapsul.
Braftovi 50 mg hard capsules EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules Braftovi 75 mg hard capsules EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules 
Braftovi 50 mg trde kapsule EU/1/18/1314/001 28 trdih kapsul EU/1/18/1314/003 112 trdih kapsul Braftovi 75 mg trde kapsule EU/1/18/1314/002 42 trdih kapsul EU/1/18/1314/004 168 trdih kapsul
Combination with binimetinib 
Kombinacija z binimetinibom
In vitro, CYP3A4 was predicted to be the major enzyme contributing to total oxidative clearance of encorafenib in human liver microsomes (~83.3%), followed by CYP2C19 and CYP2D6 (~16.0% and 0.71%, respectively). 
predviden kot glavni encim, ki prispeva k popolnemu očistku enkorafeniba z oksidacijo v mikrosomih človeških jeter (~83,3 %), sledita CYP2C19 in CYP2D6 (~16,0 % in 0,71 %).
Encorafenib should be permanently discontinued (see monitoring in section 4.4). 
Vnašanje enkorafeniba je treba trajno prekiniti (glejte spremljanje v poglavju 4.4).
The occurrence of QTc prolongation can be managed with dose reduction, interruption or discontinuation with correction of abnormal electrolytes and control of risk factors (see section 4.2). 
Pojav podaljšanja intervala QT je mogoče nadzirati z zmanjšanjem odmerka, s prekinitvijo vnosa ali popolnim prenehanjem zdravljenja ob popravljanju abnormalnih vrednosti elektrolitov in spremljanju dejavnikov tveganja (glejte poglavje 4.2).
42 hard capsules 168 hard capsules 
42 trdih kapsul 168 trdih kapsul
Encorafenib may decrease the efficacy of hormonal contraceptives (see section 4.5). 
Enkorafenib lahko zmanjša učinkovitost hormonskih kontraceptivov (glejte poglavje 4.5).
Facial paresis was generally reversible and led to treatment discontinuation in 0.9% (2/217). 
Pareza obraza je bila večinoma reverzibilna in je privedla do prenehanja zdravljenja pri 0,9 % (2/217) bolnikov.
Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors with single doses of encorafenib in healthy volunteers resulted in a 2 and 3-fold increase in the area under the concentration-time curve (AUC), respectively and in 44.6% and 68.3% increase in maximum encorafenib concentration (Cmax) respectively. 
Sočasna uporaba zmernega (diltiazem) in močnega (posakonazol) inhibitorja encima CYP3A4 z enkratnimi odmerki enkorafeniba pri zdravih prostovoljcih je povzročila 2- in 3-kratno povečanje površine pod krivuljo koncentracija-čas (AUC) in povišanje največje koncentracije enkorafeniba (Cmax) za 44,6 % in 68,3 %.
Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, the mean (SD) blood-to-plasma concentration ratio is 0.58 (0.02) and the mean (CV%) apparent volume of distribution (Vz/F) of encorafenib is 226 L (32.7%). 
Po enojnem peroralnem odmerku 100 mg [14C] enkorafeniba pri zdravih udeležencih je srednja koncentracija (SD) kri-plazma 0,58 (0,02) in srednji (CV %) navidezni volumen porazdelitve (Vz/F) enkorafeniba 226 l (32,7 %).
If you take more Braftovi than you should 
Če ste vzeli večji odmerek zdravila Braftovi, kot bi smeli
Patients receiving Combo 450 reported no change or a slight improvement in the mean change from baseline EQ-5D-5L index score at all visits, whilst patients receiving vemurafenib or encorafenib reported decreases at all visits (with statistical significant differences). 
Bolniki v okviru zdravljenja s kombinacijo 450 niso poročali o spremembi oz. so poročali o rahlem izboljšanju glede na povprečno spremembo od izhodiščne vrednosti indeksa vprašalnika EQ-5D-5L pri vseh obiskih, medtem ko so bolniki, ki so prejemali vemurafenib ali enkorafenib, poročali o zmanjšanju pri vseh obiskih (s statistično pomembnimi razlikami).
In the event of an overdose, encorafenib treatment should be interrupted and renal function must be monitored as well as adverse reactions. 
V primeru zaužitja prevelikega odmerka je treba jemanje enkorafeniba prekiniti in spremljati delovanje ledvic ter neželene učinke.
Side effects of Braftovi such as nausea, vomiting, dehydration and blurred vision may appear or worsen. 
Pojavijo ali poslabšajo se lahko stranski učinki zdravila Braftovi, kot so slabost, bruhanje, dehidracija in zamegljen vid.
Encorafenib + binimetinib N=192 (Combo 450) 
Enkorafenib + binimetinib N = 192 (Kombinacija 450)
The pharmacokinetics of encorafenib has not been evaluated clinically in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. 
Farmakokinetika enkorafeniba ni bila klinično ocenjena pri bolnikih z zmerno (Child-Pugh razreda B) ali hudo (Child-Pugh razreda C) okvaro jeter.
Part 1 of Study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib. 
1. del študije CMEK162B2301 je pokazal statistično pomembno izboljšanje vrednosti PFS pri bolnikih, zdravljenih s kombinacijo 450, v primerjavi z bolniki, zdravljenimi z vemurafenibom.
Encorafenib is to be given in combination with binimetinib. 
Enkorafenib je treba jemati v kombinaciji z binimetinibom.
The embryo-foetal development study in rats indicated that encorafenib induced foetal toxicity with lower foetal weights and delays in skeletal development. 
Embriofetalna razvojna študija pri podganah navaja, da je enkorafenib povzročil fetalno toksičnost z nižjo težo fetusa in zakasnitvijo v skeletnem razvoju.
Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with BRAF-inhibitors including encorafenib. 
Dermalni malignomi, kot je ploščatocelični karcinom kože, vključno s keratoakantom, so bili opaženi pri bolnikih, ki so jemali inhibitorje BRAF, vključno z enkorafenibom.
Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. 
Zdravljenje z enkorafenibom v kombinaciji z binimetinibom lahko začne in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem s protirakavimi zdravili.
The recommended dose of encorafenib is 450 mg (six 75 mg capsules) once daily, when used in combination with binimetinib. 
Priporočen odmerek enkorafeniba je 450 mg (šest 75 mg kapsul) enkrat dnevno v kombinaciji z binimetinibom.
Dry skin* Pruritus* Alopecia* 
Suha koža* Srbenje* Alopecija*
Palmar-plantar erythrodysaesthesia syndrome (PPES) • Grade 2 
Sindrom roka-noga (PPES) • 2. stopnja
The proportions of patients experiencing adverse events (AE) and serious adverse events (SAE) were similar in patients aged <65 years and those aged ≥65 years. 
Delež bolnikov, pri katerih je prišlo do neželenih dogodkov in resnih neželenih dogodkov, je bil podoben pri bolnikih, mlajših od 65 let, in tistih, ki so bili stari 65 let ali več.
Encorafenib should be permanently discontinued and a follow up with ophthalmologic monitoring should be performed. 
Vnašanje enkorafeniba je treba trajno prekiniti ter izvesti nadaljnji oftalmološki pregled.
In patients treated with Combo 450 (n = 274), 194 patients (70.8%) were <65 years old, 65 patients (23.7%) were 65 -74 years old and 15 patients (5.5%) were aged > 75. 
Pri bolnikih v okviru zdravljenja s kombinacijo 450 (n = 274) je bilo 194 bolnikov (70,8 %) mlajših od 65 let, 65 bolnikov (23,7 %) je bilo starih od 65 do 74 let, 15 bolnikov (5,5 %) pa je bilo starejših od 75 let.
Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine: - Heart problems: Braftovi when taken with binimetinib can make your heart work less well, alter the electrical activity of your heart called “QT interval prolongation” or make existing heart problems worse. 
Če se med jemanjem tega zdravila razvijejo naslednja stanja, nemudoma obvestite zdravnika, farmacevta ali medicinsko sestro: - Težave s srcem: Zdravilo Braftovi lahko, kadar se ga jemlje skupaj z binimetinibom, poslabša delovanje srca, povzroči spremembe v električni aktivnosti srca, ki se ji reče »podaljšanje intervala QT«, ali poslabša obstoječe težave s srcem.
The median relative dose intensity (RDI) for Combo 450 was 100% for encorafenib and 99.6% for binimetinib; the median RDI was 86.2% for Enco 300 and 94.5% for vemurafenib. 
Mediana relativne jakosti odmerka (RDI) za kombinacijo 450 je bila 100 % za enkorafenib in 99,6 % za binimetinib; mediana RDI za Enko 300 je bila 86,2 %, za vemurafenib pa
Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, radioactivity was eliminated equally in both the faeces and urine (mean of 47.2%). 
Po enojnem peroralnem odmerku 100 mg [14C] enkorafeniba pri zdravih udeležencih je bila radioaktivnost enakovredno izločena v blatu in urinu (srednja vrednost 47,2 %).
Most events were Grade 1-2, with Grade 3 reported in 0.4% (1/274) of patients and no event led to discontinuation. 
Večina dogodkov je bila 1.-2. stopnje, o dogodkih 3. stopnje so poročali pri 0,4 % (1/274) bolnikov, nobeden izmed dogodkov pa ni privedel do prenehanja zdravljenja.
The efficacy and safety of encorafenib have been established only in patients with tumours expressing BRAF V600E and V600K mutations. 
Varnost in učinkovitost enkorafeniba sta bili ugotovljeni samo pri bolnikih s tumorji, ki so posledice mutacij V600E in V600K gena BRAF.
There are no data from the use of encorafenib in pregnant women. 
Nosečnost Podatki o uporabi enkorafeniba pri nosečnicah niso na voljo.
Encorafenib N=194 (Enco 300) 
Enkorafenib N = 194 (Enko 300)
Elderly patients No dose adjustment is required for patients aged 65 years and older (see section 5.2). 
Starejši bolniki Za bolnike, stare 65 let ali več, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Your doctor will check your skin for any new skin cancers before treatment, every 2 months during treatment, and for up to 6 months after you stop taking Braftovi. 
Zdravnik vam bo kožo pregledal pred zdravljenjem in na vsaka 2 meseca med zdravljenjem, preglede pa bo izvajal do 6 mesecev po tem, ko prenehate jemati zdravilo Braftovi, da tako preveri nastanek morebitnega novega kožnega raka.
The median time to onset of the first event of facial paresis was 0.3 months (range 0.1 to 12.1 months). 
Mediana časa do prvega pojava pareze obraza je bila 0,3 meseca (v razponu od 0,1 do 12,1 meseca).
It is recommended that an electrocardiogram (ECG) is assessed before initiation of encorafenib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment. 
Priporočeno je, da se pred začetkom uporabe enkorafeniba oceni elektrokardiogram (EKG), nato en mesec po začetku uporabe in nato v približno 3-mesečnih intervalih ali pogosteje, kakor je klinično indicirano, v času trajanja zdravljenja.
Table 5: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review) 
Preglednica 5: Študija CMEK162B2301, 1. del: Preživetje brez napredovanja in potrjeni rezultati skupnega odziva (neodvisni centralni pregled)
27 patients (5%) had received prior checkpoint inhibitors (antiPD1/PDL1 or ipilimumab) (8 patients in Combo 450 arm (4%); 7 patients in vemurafenib arm (4%); 12 patients in Enco 300 arm (6%) including 22 patients in the metastatic setting (6 patients in Combo 450 arm; 5 patients in vemurafenib arm; 11 patients in Enco 300 arm) and 5 patients in the adjuvant setting (2 patients in Combo 450 arm; 2 patients in vemurafenib arm; 1 patient in Enco 300 arm). 
27 bolnikov (5 %) je predhodno prejelo inhibitorje imunskih stikal (checkpoint inhibitorji) (anti-PD1/PDL1 ali ipilimumab) (8 bolnikov, ki so se zdravili s kombinacijo 450 (4 %); 7 bolnikov pri zdravljenju z vemurafenibom (4 %); 12 bolnikov pri zdravljenju z Enko 300 (6 %)), vključno z 22 bolniki z metastazami (6 bolnikov, ki so se zdravili s kombinacijo 450; 5 bolnikov pri zdravljenju z vemurafenibom; 11 bolnikov pri zdravljenju z Enko 300) in 5 bolnikov z adjuvantnim zdravljenjem (2 bolnika, ki sta se zdravila s kombinacijo 450; 2 bolnika pri zdravljenju z vemurafenibom; 1 bolnik pri zdravljenju z Enko 300).
What Braftovi is and what it is used for 
Kaj je zdravilo Braftovi in za kaj ga uporabljamo
Before taking encorafenib in combination with binimetinib, patients must have BRAF V600 mutation confirmed by a validated test. 
Pred začetkom jemanja enkorafeniba v kombinaciji z binimetinibom mora biti za bolnike potrjena mutacija V600 gena BRAF s potrjenim testom.
Few patients required dose interruptions or dose reductions (0.7% or 2/274). 
Pri redkih bolnikih je bilo treba prekiniti vnos ali zmanjšati odmerek (0,7 % ali 2/274).
Dilatation of the aortic arc was observed in some foetuses. 
Pri nekaterih fetusih je bila opažena dilatacija aortnega loka.
In a population pharmacokinetic analysis, no clear trend in encorafenib CL/F was observed in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) or moderate (eGFR 30 to 59 mL/min/1.73 m2) renal impairment compared with subjects with normal renal function (eGFR ≥90 mL/min/1.73 m2). 
Glede na populacijsko farmakokinetično analizo ni bil opažen noben jasen trend enkorafeniba CL/F pri bolnikih z blago (eGFR od 60 do 90 ml/min/1,73 m2) ali zmerno (eGFR od 30 do
Facial paresis 
Pareza obraza
The most common AEs reported with a higher incidence in patients aged ≥ 65 years compared to patients aged < 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation. 
Najpogostejši dogodki, ki so se pogosteje pojavljali pri bolnikih, starih 65 let ali več, v primerjavi z bolniki, ki so bili mlajši od 65 let, so vključevali drisko, srbenje, povišane vrednosti GGT in alkalne fosfataze v krvi.
Encorafenib single agent 300 mg (n = 217) 
Samostojno zdravilo enkorafenib 300 mg (n = 217)