natgillin/translations-raw huggingface dataset:
For patients in the Phase III study (CMEK162B2301) who developed cuSCC, the median time to onset of the first event of cuSCC (all grades) was 2.3 months (range 0.3 to 12.0 months).
U bolesnika uključenih u kliničko ispitivanje faze III (CMEK162B2301) kod kojih se javio planocelularni karcinom, medijan vremena do prvog pojavljivanja planocelularnog karcinoma (za sve stupnjeve) iznosio je 2,3 mjeseca (u rasponu od 0,3 do 12,0 mjeseci).
Basal cell carcinoma* Skin papilloma*
planocelularni karcinom kožea bazocelularni karcinom* papilomi kože*
If encorafenib is permanently discontinued, then binimetinib should be discontinued.
Ako je enkorafenib trajno obustavljen, onda treba obustaviti i binimetinib.
Administration of a single 100 mg dose of encorafenib with a highfat, high-calorie meal decreased the Cmax by 36%, while the AUC was unchanged.
Primjena jedne doze od 100 mg enkorafeniba uz obrok s velikim udjelom masti snižava vrijednost Cmax za 36%, dok AUC (površina ispod krivulje plazmatske koncentracije u vremenu) ostaje nepromijenjen.
An interim OS analysis of Study CMEK162B2301 Part 1, (cut-off date 07 November 2017) demonstrated a statistically significant improvement in OS for Combo 450 compared with vemurafenib (see Table 6 and Figure 2).
Interim analiza ukupnog preživljenja (OS) ispitivanja CMEK162B2301, dio 1 (krajnji rok 7. studenoga 2017.) pokazala je statistički značajno poboljšanje OS-a u skupini kombinirane terapije 450 u usporedbi sa skupinom liječenom vemurafenibom (vidjeti Tablicu 6 i sliku 2).
Effect of encorafenib on CYP substrates
Učinak enkorafeniba na CYP supstrate
There are no data available in patients with severe renal impairment (see sections 4.2 and 5.2).
Nema dostupnih podataka o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dijelove 4.2 i 5.2).
If one of these toxicities occurs, see section 4.2 of binimetinib SmPC for dose modification instructions for binimetinib.
Ako nastupi neka od ovih toksičnosti, vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib, upute za prilagodbu doze binimetiniba.
In the safety analysis of pooled studies, the incidence of new QTc prolongation >500 ms was 0.7% (2/268) in the encorafenib 450 mg plus binimetinib group, and 2.5% (5/203) in the encorafenib single agent group.
Na temelju analize sigurnosti iz objedinjenih ispitivanja, incidencija novih produljenja intervala QTc > 500 ms bila je 0,7% (2/268) u skupini bolesnika liječenih enkorafenibom u dozi od 450 mg s binimetinibom, i 2,5% (5/203) u skupini bolesnika liječenih enkorafenibom kao monoterapijom.
Diarrhoea led to dose discontinuation in 0.4% of patients and to dose interruption or dose modification in 4.4% of patients.
Proljev je doveo do obustave liječenja u 0,4% bolesnika i privremenog prekida liječenja ili prilagodbe doze u 4,4% bolesnika.
Concurrent use of strong CYP3A inhibitors during treatment with encorafenib should be avoided.
Treba izbjegavati istodobnu primjenu snažnih inhibitora CYP3A tijekom liječenja enkorafenibom.
Effects of other medicinal products on encorafenib.
Učinak drugih lijekova na enkorafenib
- Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (raised levels of liver enzymes).
- Problemi s jetrom: Lijek Braftovi može prouzročiti odstupanja u rezultatima krvnih pretraga u svezi s funkcijom jetre (povećane razine jetrenih enzima).
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.
Preporučuje se procjena elektrokardiograma prije početka primjene enkorafeniba, jedan mjesec nakon početka primjene te približno svaka 3 mjeseca ili češće ako je klinički potrebno, tijekom trajanja liječenja.
In the pooled encorafenib 300 population, new primary melanoma events occurred in 4.1% of patients (9 /217) and was reported as Grade 1 in 1.4% (3/217) of patients, Grade 2 in 2.1% (4/217) of patients, Grade 3 in 0.5% (1/217) of patients and Grade 4 in 0.5% (1/217) of patients.
U ukupnoj populaciji enkorafenib 300, novi primarni melanom se pojavio u 4,1% bolesnika (9 /217) i prijavljen je kao stupanj 1 u 1,4% (3/217) bolesnika, stupanj 2 u 2,1% (4/217) bolesnika, stupanj 3 u 0,5% (1/217) bolesnika i stupanj 4 u 0,5% (1/217) bolesnika.
When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Kada se enkorafenib primjenjuje istodobno s umjerenim inhibitorima CYP3A, bolesnike treba radi sigurnosti pomno nadzirati.
Most events were mild-moderate: Grade 1 in 2.3% (5/217); Grade 2 in 3.7% (8/217) and Grade 3 in 1.4% (3/217) of patients.
Većina je događaja bila blaga do umjerena: stupanj 1 u 2,3% (5/217), stupanj 2 u 3,7% (8/217) i stupanj 3 u 1,4% (3/217) bolesnika.
Overall, results suggest that single agent encorafenib has the potential to cause mild increases in heart rate.
Sve u svemu, rezultati ukazuju da enkorafenib kao monoterapija ima potencijal prouzročiti blago povećanje srčane frekvencije.
Dose modification
Sljedeća prilagodba
• First occurrence of Grade 4 (AST or ALT >20 ULN)
• Prvi nastup stupnja 4 (AST ili ALT > 20x GGN)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
• Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
• Povišenje transaminaza: 15,7% (43/274) ukupno - stupanj 3-4: 5,5% (15/274)
Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Želatina (E441) Titanijev dioksid (E171) Željezov oksid, crveni (E172) Željezov oksid, žuti (E172) Željezov oksid, crni (E172)
Encorafenib should be permanently discontinued and a follow up with ophthalmologic monitoring should be performed.
Treba trajno obustaviti enkorafenib te nastaviti oftalmološko praćenje.
There are no clinical data with encorafenib in patients with severe renal impairment.
Nema kliničkih podataka o primjeni enkorafeniba u bolesnika s teškim oštećenjem bubrežne funkcije.
Transporter substrates
Supstrati transportnih proteina
Administration of encorafenib should be undertaken with caution at a reduced dose in patients with mild hepatic impairment (see section 4.2).
Enkorafenib se mora oprezno davati u smanjenim dozama bolesnicima s blagim oštećenjem funkcije jetre (vidjeti dio 4.2).
Median DOR for confirmed responses per BIRC was 12.7 months [95% CI: 9.3, 15.1] for Combo 300 and 12.9 months [95% CI: 8.9, 15.5] for Enco 300.
Medijan trajanja odgovora (DoR) za potvrđene odgovore prema ocjeni BIRC-a iznosio je 12,7 mjeseci (95% CI: 9,3; 15,1) za kombiniranu terapiju 300 i 12,9 mjeseci (95% CI: 8,9; 15,5) za enkorafenib 300.
Moderate CYP3A4 inhibitors should be co-administered with caution.
Umjereni se inhibitori CYP3A4 trebaju istodobno primjenjivati s oprezom.
OS
U
Dermatologic evaluations should be performed prior to initiation of therapy with encorafenib in combination with binimetinib, every 2 months while on therapy and for up to 6 months following discontinuation of the combination.
Prije započinjanja terapije enkorafenibom u kombinaciji s binimetinibom, potrebno je napraviti dermatološki pregled, kao i svaka 2 mjeseca tijekom terapije te u razdoblju do 6 mjeseci nakon prestanka terapije.
Examples of moderate CYP3A4 inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir and imatinib.
Primjeri umjerenih inhibitora CYP3A4 uključuju, ali nisu ograničeni na amiodaron, eritromicin, flukonazol, diltiazem,
The most frequent haemorrhagic events were haematuria in 3.3% (9/274) of patients, rectal haemorrhage in 2.9% (8/274) and haematochezia in 2.9% (8/274) of patients.
Najčešća krvarenja obuhvaćala su hematuriju u 3,3% (9/274) bolesnika, rektalno krvarenje u 2,9% (8/274) bolesnika i hematoheziju u
Creatinine elevation has been commonly reported with encorafenib as single agent or in combination with binimetinib.
Povišene vrijednosti kreatinina često su prijavljene kod liječenja enkorafenibom kao monoterapijom ili u kombinaciji s binimetinibom.
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.
To dovodi do povećanja izloženosti nevezanom enkorafenibu za Farmakokinetika enkorafeniba nije klinički procijenjena u bolesnika s umjerenim (Child-Pugh stupanj B) ili teškim (Child-Pugh stupanj C) oštećenjem jetrene funkcije.
Call your doctor right away if you get these symptoms of eye problems: - blurred vision, loss of vision, or other vision changes (such as coloured dots in your vision) - halo (seeing blurred outline around objects) - eye pain, swellling or redness
Odmah nazovite svog liječnika ako imate ove simptome problema s očima: - zamućenje vida, gubitak vida ili druge promjene vida (npr. obojene točkice u vidnom polju) - halo (viđenje nejasnog obrisa oko objekata)
• Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
• Povišenje GGT: 14,0% (36/257) ukupno - stupanj 3-4: 4,7% (12/257)
The safety of encorafenib (450 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the pooled Combo 450 population), based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1).
Sigurnost enkorafeniba (450 mg peroralno jednom dnevno) u kombinaciji s binimetinibom (45 mg peroralno dvaput dnevno) procijenjena je na 274 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom mutacijom BRAF V600 (u daljnjem tekstu: ukupna populacija kombinirane terapije 450), na temelju dva ispitivanja faze II (CMEK162X2110 i CLGX818X2109) te jednog ispitivanja faze III (CMEK162B2301, dio 1).
The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors.
(OCT1, OATP1B1, OATP1B3 i OATPB1) ispitivana je in vitro korištenjem specifičnih inhibitora transportera.
Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Povraćanje se javilo kod 15,2% (39/257) bolesnika i to stupnja 3 prijavljenog u 0,4% (1/257) bolesnika.
Encorafenib should not be used in patients with wild type BRAF malignant melanoma.
V600K. Enkorafenib se ne smije primjenjivati u bolesnika koji imaju maligni melanom s divljim tipom BRAF gena.
Keep this medicine out of the sight and reach of children.
Kako čuvati lijek Braftovi Lijek čuvajte izvan pogleda i dohvata djece.
Before taking encorafenib in combination with binimetinib, patients must have BRAF V600 mutation confirmed by a validated test.
Prije primjene enkorafeniba u kombinaciji s binimetinibom, u bolesnika se validiranim testom mora potvrditi da je tumor pozitivan na mutaciju BRAF V600.
In Part 1, patients in the study were randomised to receive encorafenib 450 mg orally daily and binimetinib 45 mg orally twice daily (Combo 450, n = 192), encorafenib 300 mg orally daily (Enco 300, n = 194), or vemurafenib 960 mg orally twice daily (hereafter referred to as Vem, n = 191).
U dijelu 1, bolesnici su u ispitivanju randomizirani na liječenje enkorafenibom 450 mg peroralno jednom dnevno i binimetinibom 45 mg peroralno dvaput dnevno (kombinirana terapija 450, n = 192), enkorafenibom 300 mg peroralno jednom dnevno (enkorafenib 300, n = 194), ili vemurafenibom
In the pooled Combo 450 population, anaemia was reported in 19.7% (54/274) of patients; 4.7% (13/274) patients had a Grade 3 or 4.
U ukupnoj populaciji kombinirane terapije 450, anemija je prijavljena u 19,7% (54/274) bolesnika; 4,7% (13/274) bolesnika je imalo nuspojave stupnja 3 ili 4.
In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients.
U ukupnoj populaciji enkorafeniba 300, fotoosjetljivost je zabilježena u 4,1% (9/217) bolesnika.
erythromycin, penicillin) - medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine) - medicines typically used to treat cancer (such as methotrexate, imatinib) - medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin) - an herbal treatment for depression: St. John's wort - some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir, dolutegravir - birth control medicines containing hormones - medicines typically used to treat high blood pressure (such as diltiazem, bosentan, furosemide) - a medicine used to treat an uneven heartbeat: amiodarone.
karbamazepin) - lijekovi koji se obično koriste za liječenje raka (kao što su metotreksat, imatinib) - lijekovi kojima se obično liječi visok kolesterol (kao što su rosuvastatin, atorvastatin) - biljni lijekovi protiv depresije: gospina trava - neki lijekovi za liječenje HIV infekcije, kao što su ritonavir, amprenavir, raltegravir,
Encorafenib should be maintained.
Treba održavati dozu enkorafeniba.
Talk to your doctor immediately if you get blurred vision, loss of vision, or other vision changes (e.g. coloured dots in your vision), halo (seeing blurred outline around objects).
Odmah obavijestite svog liječnika ako primijetite zamućenje vida, gubitak vida ili druge poremećaje vida (npr. obojene točkice u vidnom polju) ili halo (viđenje nejasnog obrisa oko objekata).
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%).
Nakon jedne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, eliminacija radioaktivno označene doze lijeka bila je podjednaka putem stolice i putem mokraće (srednja vrijednost od 47,2%).
Neuropathy peripheral* Dizziness*
periferna neuropatija* omaglica* glavobolja*
Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient.
Krvarenje iz čira na želucu sa smrtnim ishodom uslijed otkazivanja brojnih organa prijavljeno je kod jednog bolesnika.
Survival at 24 months (95% CI)
Preživljenje 24 mjeseca (95 % CI)
Based on a population pharmacokinetic analysis gender was not found to be a significant model covariate on clearance or volume of distribution.
Populacijske farmakokinetičke analize pokazale su da spol ne predstavlja značajnu kovarijatu u modelu klirensa ili volumena distribucije enkorafeniba.
Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016)
Slika 1 Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje preživljenja bez progresije prema neovisnom središnjem pregledu (krajnji rok: 19. svibnja 2016.)
Most events were mild, with Grade 3 or 4 events reported in 0.7% (2/274) of patients.
Većina događaja bila je blaga, sa stupnjem 3 ili 4 prijavljenim u 0,7% (2/274) bolesnika.
• Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
• Ovojnica kapsule: želatina (E441), titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172)
The median age of patients was 56 years (range 20-89), 58% were male, 90% were Caucasian, and 72% of patients had baseline ECOG performance status of 0.
Medijan dobi bolesnika bio je 56 godina (raspon 20 - 89), 58% ispitivane populacije bili su muškarci,
If not improved despite supportive therapy within 2 weeks, encorafenib should be withheld until improved to Grade 0 or 1 and treatment should be resumed at same dose level or at a reduced dose.
Ako se ne postigne poboljšanje unutar dva tjedna usprkos potpornoj terapiji, treba prekinuti s enkorafenibom dok se ne postigne poboljšanje na stupanj 0 ili 1 te nastaviti liječenje s istom razinom doze ili smanjenom dozom.
A decision must be made whether to discontinue breast-feeding or to discontinue encorafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Uzimajući u obzir korist dojenja za dijete i dobrobit terapije za majku, nužno je donijeti odluku o tome hoće li se prekinuti dojenje ili obustaviti terapiju enkorafenibom.
BRAF V600 Mutant Unresectable or Metastatic Melanoma The safety and efficacy of encorafenib in combination with binimetinib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicentre study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay.
Neoperabilni ili metastatski melanom s mutacijom BRAF V600 Sigurnost i djelotvornost enkorafeniba u kombinaciji s binimetinibom procijenjena je u dvodijelnom randomiziranom (1:1:1), aktivno kontroliranom, otvorenom, multicentričnom ispitivanju faze III u bolesnika s neoperabilnim ili metastatskim melanomom s mutacijom BRAF V600 E ili K
It is used in adults in combination with another medicine containing binimetinib to treat a type of skin cancer called melanoma when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body, or cannot be removed by surgery
- koji ima određenu promjenu (mutaciju) gena pod nazivom BRAF, odgovornog za stvaranje proteina, i - koji se proširio na druge dijelove tijela ili se ne može ukloniti kirurškim zahvatom
LVD defined as symptomatic or asymptomatic decreases in ejection fraction has been reported when encorafenib is used in combination with binimetinib.
Disfunkcija lijeve klijetke (engl. left ventricular dysfunction, LVD) LVD karakteriziran simptomatskim ili asimptomatskim smanjenjem ejekcijske frakcije zabilježen je pri primjeni enkorafeniba u kombinaciji s binimetinibom.
In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients.
U ukupnoj populaciji enkorafeniba 300, osip je prijavljen u 43,3% (94/217) bolesnika.
Serious side effects Braftovi may cause serious side effects.
Ozbiljne nuspojave Lijek Braftovi može izazvati ozbiljne nuspojave.
Braftovi is not recommended while breast-feeding.
Lijek Braftovi se ne preporučuje tijekom dojenja.
Abdominal pain was reported in 27.4% (75/274) of patients and was Grade 3 in 2.6% (7/274) patients.
Bol u abdomenu prijavljena je u 27,4% (75/274) bolesnika i bila je stupnja 3 u 2,6% (7/274) bolesnika.
• Recurrent Grade 4 (AST or ALT > 20 ULN)
• Ponovni nastup stupnja 4 (AST ili ALT > 20x GGN)
Or, encorafenib should be permanently discontinued.
Ili, treba trajno obustaviti enkorafenib.
Amylase increased *composite terms which included more than one preferred term a includes keratoacanthoma, squamous cell carcinoma, lip squamous cell carcinoma and squamous cell carcinoma of skin b includes angioedema, drug hypersensitivity, hypersensitivity, hypersensitivity vasculitis and urticaria c includes facial nerve disorder, facial paralysis, facial paresis d includes extrasystoles, sinus tachycardia, supraventricular extrasystoles, tachyarrhythmia, tachycardia e includes erythema, generalised erythema, plantar erythema f includes dermatitis exfoliative, skin exfoliation, exfoliative rash g includes myalgia, muscle fatigue, muscle injury, muscle spasm, muscle weakness h includes left ventricular dysfunction, ejection fraction decreased, cardiac failure and ejection fraction abnormal i includes haemorrhage at various sites including cerebral haemorrhage j includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, thrombophlebitis superficial and thrombosis k includes colitis, colitis ulcerative, enterocolitis and proctitis l includes myalgia, muscular weakness, muscle spasm, muscle injury, myopathy, myositis m includes fluid retention, peripheral oedema, localised oedema
tahikardiju e uključujući eritem, generalizirani eritem, plantarni eritem f uključujući eksfolijativni dermatitis, eksfolijaciju kože, eksfolijativni osip g uključujući mijalgiju, umor mišića, oštećenje mišića, grčenje mišića, slabost mišića h uključujući disfunkciju lijeve klijetke, smanjenje ejekcijske frakcije, zatajenje srca i poremećaj ejekcijske frakcije i uključujući krvarenje u bilo kojem dijelu tijela, uključujući i krvarenje u mozgu j uključujući plućnu emboliju, trombozu dubokih vena, emboliju, tromboflebitis, površinski tromboflebitis i trombozu k uključujući kolitis, ulcerozni kolitis, enterokolitis i proktitis l uključujući mijalgiju, slabost mišića, oštećenje mišića, grčenje mišića, miopatiju, miozitis m uključujući zadržavanje tekućine, periferni edem, lokalizirani edem
The most common adverse drug reactions (ADRs) (>25%) reported with encorafenib 300 were hyperkeratosis, alopecia, PPES, fatigue, rash, arthralgia, dry skin, nausea, myalgia, headache, vomiting and pruritus.
Najčešće nuspojave (≥ 25%) prijavljene kod liječenja enkorafenibom od 300 mg su hiperkeratoza, alopecija, sindrom palmarno plantarne eritrodizestezije, umor, osip, artralgija, suha koža, mučnina, mijalgija, glavobolja, povraćanje i pruritus.
Encorafenib N=194 (Enco300)
Enkorafenib n = 194 (enkorafenib 300)
If rash worsens or does not improve within 2 weeks with treatment, encorafenib should be withheld until Grade 0 or 1 and then resumed at the same dose.
Ako se osip pogorša ili se ne poboljša unutar 2 tjedna uz liječenje, treba prekinuti s enkorafenibom dok se ne poboljša do stupnja 0 ili 1, a potom nastaviti s istom dozom.
Due to the potential risk for QT prolongation, it is recommended that serum electrolytes abnormalities, including magnesium and potassium, are corrected and risk factors for QT prolongation controlled (e.g. congestive heart failure, bradyarrhythmias) before treatment initiation and during treatment.
Uslijed potencijalnog rizika od produljenja QT intervala, preporučuje se korigiranje poremećaja serumskih elektrolita, uključujući magnezij i kalij, te kontroliranje čimbenika rizika za produljenje QT
For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC.
Za dodatne informacije o upozorenjima i mjerama opreza tijekom liječenja binimetinibom, vidjeti dio 4.4 sažetka opisa svojstava lijeka za binimetinib.
If binimetinib is permanently discontinued, encorafenib should be discontinued.
Ako je binimetinib trajno obustavljen, treba obustaviti i enkorafenib.
Basal cell carcinoma
Manje često bazocelularni karcinom
Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje interim ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
Encorafenib in combination with binimetinib in patients who have progressed on a BRAF inhibitor There are limited data for the use of the combination of encorafenib with binimetinib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Ograničeni su podaci o uporabi enkorafeniba u kombinaciji s binimetinibom u bolesnika koji su imali progresiju pri primjeni prethodnog BRAF inhibitora korištenog za liječenje neoperabilnog ili metastatskog melanoma s BRAF V600 mutacijom.
Effect of encorafenib on transporters
Učinak enkorafeniba na transportne proteine
If uveitis is Grade 2 or 3 and it improves to Grade 0 or 1, then treatment should be resumed at a reduced dose.
Ako nastupi uveitis stupnja 2 ili 3 i poboljša se do stupnja 0 ili 1, treba nastaviti sa smanjenom dozom.
Pancreatitis was reported in 0.7% (2/274) of patients.
Upala gušterače prijavljena je u 0,7% (2/274) bolesnika.
In the pooled Combo 450 population, rash occurred in 19.7% (54/274) of patients.
U ukupnoj populaciji kombinirane terapije 450, osip se pojavio u 19,7% (54/274) bolesnika.
In case of vomiting after administration of encorafenib, the patient should not take an additional dose and should take the next scheduled dose.
Ako bolesnik povrati nakon primjene enkorafeniba, ne smije uzeti dodatnu dozu lijeka, već liječenje mora nastaviti prema uobičajenom rasporedu.
Encorafenib should be permanently discontinued.
Treba trajno obustaviti enkorafenib.
New melanomas may also occur while taking Braftovi.
Novi melanomi mogu se također pojaviti tijekom uzimanja lijeka
Survival at 12 months (95% CI)
Preživljenje 12 mjeseci (95 % CI)