natgillin/translations-raw huggingface dataset:
Dosisjusteringer for lægemidler, der hovedsageligt metaboliseres via CYP1A2 eller CYP3A4 bør overvejes, baseret på deres terapeutiske vinduer, før samtidig behandling med vemurafenib (se pkt.
Dose adjustments for medicinal products predominantly metabolised via CYP1A2 or CYP3A4 should be considered based on their therapeutic windows before concomitantly treating with vemurafenib (see sections 4.5 and 4.6).
Artralgi, myalgi, smerter i ekstremiteter, muskuloskeletal smerte, rygsmerter
Arthralgia, myalgia, pain in extremity, musculoskeletal pain, back pain
Fokal knoglemarvsnekrose blev bemærket i én hund i et for tidligt afsluttet 39-ugers to gange dagligt studie hos hunde ved eksponeringer tilsvarende den forventede kliniske eksponering (baseret på AUC sammenligninger).
Focal bone marrow necrosis was noted in one dog in a prematurely terminated 39-week BID dog study at exposures similar to the anticipated clinical exposure (based on AUC comparisons).
Vemurafenib er indiceret i monoterapi til behandling af voksne patienter med BRAF-V600mutationspositivt ikke-operabelt eller metastatisk melanom (se pkt.
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).
Et fase I-dosiseskaleringsstudie undersøgte anvendelse af vemurafenib hos 6 unge patienter med stadie IIIC eller IV BRAF-V600-mutationspositivt melanom.
A phase I dose-escalation study evaluating the use of vemurafenib in six adolescent patients with stage IIIC or IV BRAF V600 mutation positive melanoma was conducted.
Aluminium/aluminium perforeret enkeltdosis blister Pakningsstørrelse: 56 x 1 filmovertrukket tablet (7 blister á 8 x 1 tablet).
Pack-size: 56 x 1 film-coated tablets (7 blisters of 8 x 1 tablet)
Tilfælde af cuSCC blev typisk håndteret med en enkel ekscision, og patienterne fortsatte generelt behandlingen uden dosisjustering (se pkt.
Cases of cuSCC were typically managed with simple excision, and patients generally continued on treatment without dose modification (see sections 4.2 and 4.4).
Sjælden ≥ 1/10.000 til < 1/1.000 Meget sjælden < 1/10.000
Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
2. forekomst af enhver grad 2 eller 3 bivirkning eller vedvarende bivirkning efter afbrydelse af behandling
2nd occurrence of any grade 2 or 3 AE or persistence after treatment interruption
Tag ikke Zelboraf: · hvis du er allergisk over for vemurafenib eller et af de øvrige indholdsstoffer i Zelboraf (angivet i punkt 6).
● If you are allergic to vemurafenib or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Akut nyreskade (h)
Acute kidney injury (h)
Genoptag dosering på 720 mg to gange dagligt (eller 480 mg to gange dagligt, hvis dosis i forvejen er blevet reduceret).
Resume dosing at 720 mg twice daily (or 480 mg twice daily if the dose has already been lowered).
Det sekundære mål inkluderede vurdering af vemurfenibs effekt ud fra den bedste samlede responsrate i hjernen hos tidligere behandlede patienter, responsvarighed, progressionfri overlevelse og samlet overlevelse hos melanompatienter med hjernemetastaser (se tabel 9).
Secondary objectives included an evaluation of the efficacy of vemurafenib using BORR in the brain of previously treated patients, duration of response (DOR), progression-free survival (PFS) and overall survival (OS) in patients with melanoma metastatic to the brain (see table 10).
Alvorlige hudreaktioner · Alvorlige hudreaktioner kan forekomme, mens du tager Zelboraf.
● Severe skin reactions can happen while taking Zelboraf.
Der blev observeret eksponeringsafhængig QT-forlængelse i et ukontrolleret, open-label, fase II-studie hos tidligere behandlede patienter med metastatisk melanom.
Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma.
år) oplever bivirkninger, inklusive cuSCC, nedsat appetit og hjertesygdomme.
Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Leverskade(1)(2)(g)
Liver injury(1)(2) (g)
Tabel 9: Samlet responsrate og progressionsfri overlevelse hos tidligere ubehandlede patienter med BRAF-V600-mutationspositivt melanom vemurafenib dacarbazine p-værdi(x)
Table 9: Overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma vemurafenib dacarbazine p-value (x)
Det tilsyneladende populationsfordelingsvolumen for vemurafenib hos patienter med metastatisk melanom er estimeret til at være 91 liter (med 64,8 % variabilitet mellem patienter).
The population apparent volume of distribution for vemurafenib in metastatic melanoma patients is estimated to be 91 L (with 64.8% between patient variability).
2. forekomst af enhver grad 4 bivirkning eller enhver vedvarende grad 4 bivirkning efter 1. dosisreduktion
2nd occurrence of any grade 4 AE or persistence of any grade 4 AE after 1st dose reduction
Zelboraf 240 mg filmovertrukne tabletter er lyserøde-hvide til orange-hvide.
What Zelboraf looks like and contents of the pack Zelboraf 240 mg film-coated tablets are pinkish white to orange white.
Samtidig anvendelse af vemurafenib med midler, som metaboliseres af CYP1A2, med smalt terapeutisk vindue (f.eks. agomelatin, alosetron, duloxetin, melatonin, ramelteon, tacrin, tizanidin, theophyllin) kan ikke anbefales.
Concomitant use of vemurafenib with agents metabolized by CYP1A2 with narrow therapeutic windows (e.g. agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, theophylline) is not recommended.
Fremstiller Roche Pharma AG Emil-Barel-Strasse D-79639
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639
I dette afsnit er bivirkningerne baseret på resultater fra 468 patienter fra et fase III, randomiseret, openlabel studie hos voksne patienter med BRAF-V600-mutationspositivt ikke-operabelt eller stadium IV melanom, samt fra et fase II, enkelt-arm studie hos patienter med BRAF-V600-mutationspositivt stadium IV melanom.
In this section, ADRs are based on results in 468 patients from a phase III randomised open label study in adult patients with BRAF V600 mutation-positive unresectable or stage IV melanoma, as well as a phase II single-arm study in patients with BRAF V600 mutation-positive stage IV melanoma who had previously failed at least one prior systemic therapy (see section 5.1).
Der er blevet rapporteret svære hudreaktioner, herunder sjældne tilfælde af Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, i de pivotale kliniske studier hos patienter, som får vemurafenib.
Severe dermatologic reactions have been reported in patients receiving vemurafenib, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis in the pivotal clinical trial.
· Gem indlægssedlen.
● Keep this leaflet.
· Medicin som primært udskilles af metaboliseringsproteiner kaldet CYP1A2 (f.eks. caffein, olanzapin, theophyllin), CYP3A4 (f.eks. nogle orale (indtaget gennem munden) præventionsmidler) eller CYP2C8.
● Medicines that are mainly eliminated by metabolising proteins called CYP1A2 (e.g caffeine, olanzapine, theophylline), CYP3A4 (e.g. some oral contraceptives) or called CYP2C8.
Størstedelen af patienterne var mænd (61 %), kaukasiske (99 %) og med stadie
The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Dosis modifikationer for CYP3A4 substrater med smalt terapeutisk vindue kan overvejes, hvis det er klinisk relevant (se pkt.
Dose adjustments for CYP3A4 substrates with narrow therapeutic window may be considered, if clinically indicated (see sections 4.4 and 4.6).
Serumkreatinin måles før behandlingsstart og monitoreres under behandlingen som klinisk indiceret (se pkt.
Serum creatinine should be measured before initiation of treatment and monitored during treatment as clinically indicated (see sections 4.2 and 4.8).
Seponer permanent eller afbryd behandling med vemurafenib indtil grad 0-1.
Grade 4 1st occurrence of any grade 4 AE Discontinue permanently or interrupt vemurafenib treatment until grade 0 - 1.
· Medicin, som påvirker et protein kaldet P-gp eller BCRP (f.eks. verapamil, ciclosporin, ritonavir, quinidin, itraconazol, gefitinib).
● Medicines that influence a protein called P-gp or BCRP (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
3. forekomst af enhver grad 2 eller 3 bivirkning eller vedvarende bivirkning efter 2. dosisreduktion
3rd occurrence of any grade 2 or 3 AE or persistence after 2nd dose reduction
Samtidig administration af kraftige induktorer af P-gp, glukuronidering og/eller CYP3A4 (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon [Hypericum perforatum]) kan medføre en suboptimal eksponering af vemurafenib og bør undgås.
Concomitant administration of strong inducers of P-gp, glucuronidation, and/or CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [Hypericum perforatum]) may lead to suboptimal exposure to vemurafenib and should be avoided.
· Medicin, som stimulerer metaboliseringsproteiner kaldet CYP3A4 eller en metaboliseringsproces kaldet glukuronidering (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon).
● Medicines that stimulate the metabolising proteins called CYP3A4 or a metabolising process called glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort)
Mave-tarm-kanalen Diarré, opkastning, kvalme, konstipation
Diarrhoea, vomiting, nausea, constipation
De grad 3 bivirkninger, som blev rapporteret hyppigere hos kvinder end mænd under de kliniske studier med vemurafenib, var udslæt, artralgi og lysfølsomhed.
During clinical trials with vemurafenib, grade 3 adverse reactions reported more frequently in females than males were rash, arthralgia and photosensitivity.
Træhed, pyreksi, perifert ødem, asteni
Fatigue, pyrexia, oedema peripheral, asthenia
Tabel 4: Ændringer i kreatinin fra baseline i fase III-studiet Vemurafenib (%) Dacarbazin (%)
Table 5: Acute kidney injury cases in the phase III study Vemurafenib (%) Dacarbazine (%)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 240 mg vemurafenib (som co-præcipitat af vemurafenib og hypromelloseacetatsuccinat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Sådan skal du tage Zelboraf
How to take Zelboraf
Lammelse af 7. nerve (nervus facialis),
7th nerve paralysis, neuropathy peripheral
Samtidig administration af kraftige CYP3A4 induktorer, P-gp og glukoronidering (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon [hypericin]) kan forårsage nedsat eksponering af vemurafenib og bør undgås, når det er muligt (se pkt.
Concomitant administration of strong inducers of CYP3A4, P-gp and glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [hypericin]) might lead to decreased exposure of vemurafenib and should be avoided when possible (see section 4.5).
Kutant planocellulært karcinom (cuSCC)
Cutaneous Squamous Cell Carcinoma (cuSCC)
Nyre- eller leverproblemer · Fortæl lægen, hvis du har nyre- eller leverproblemer.
● Tell your doctor if you have kidney or liver problems.
Der bør udvises forsigtighed, hvis vemurafenib anvendes samtidig med P-gp-substrater (f.eks. aliskiren, ambrisentan, colchicin, dabigatran etexilat, digoxin, everolimus, fexofenadin, lapatinib, maraviroc, nilotinib, posaconazol, ranolazin, sirolimus, sitagliptin, talinolol, topotecan).
Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates (e.g. aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) and dose reduction of the concomitant medicinal product may be considered, if clinically indicated.
Der er kun begrænsede data tilgængelige hos patienter med svær nedsat nyrefunktion (se pkt.
There are only limited data available in patients with severe renal impairment (see section 5.2).
Pancreatitis er rapporteret hos patienter behandlet med vemurafenib.
Pancreatitis has been reported in vemurafenib-treated subjects.
Virkningen af p-piller, som metaboliseres af CYP3A4, og som anvendes samtidig med vemurafenib, kan nedsættes på grund af dette.
On this basis, the efficacy of contraceptive pills metabolized by CYP3A4 used concomitantly with vemurafenib might be decreased.
Samtidig anvendelse af vemurafenib med midler, som er metaboliseret af CYP1A2 og CYP3A4 med smalt terapeutisk vindue, kan ikke anbefales.
Concomitant use of vemurafenib with agents metabolized by CYP1A2 and CYP3A4 with narrow therapeutic windows is not recommended.
Nedsat leverfunktion
● Weight loss
Efter et tilfælde af pancreatitis bør patienten monitoreres tæt, når behandling med vemurafenib genoptages.
Patients should be closely monitored when re-starting vemurafenib after an episode of pancreatitis.
Vemurafenib bør anvendes med forsigtighed i kombination med kraftige hæmmere af CYP3A4, glukuronidering og/eller transportproteiner (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, atazanavir).
Vemurafenib should be used with caution in combination with strong inhibitors of CYP3A4, glucuronidation and/or transport proteins (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
Hazard ratio (95% konfidensinterval) Antal hændelser (%) Median progressionsfri overlevelse (måneder) (95% konfidensinterval) Cut-off 1. februar 2012 (z)
February 01, 2012 data cut-off date (z) Progression-free survival Hazard Ratio (95% CI)
Zelboraf indeholder: · Aktivt stof: Vemurafenib.
● The active substance is vemurafenib.
Forsigtighed bør udvises og yderligere INR (international nomaliseret ratio) monitorering bør overvejes, når vemurafenib anvendes samtidig med warfarin (se pkt.
Exercise caution and consider additional INR (international normalized ratio) monitoring when vemurafenib is used concomitantly with warfarin (see section 4.4).
Cut-off datoer Behandling Antal dødsfald
Number of deaths
I studier af toksicitet efter gentagne doser blev der dog ikke bemærket histopatologiske fund i forplantningsorganerne hos hanog hunrotter og hunde ved doser på op til 450 mg/kg/døgn (ved eksponeringer under den forventede kliniske eksponering baseret på sammenligning af AUC).
However, in repeat-dose toxicity studies, no histopathological findings were noted on reproductive organs in males and females in rats and dogs at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure based on AUC comparison).
I et klinisk studie faldt plasma-eksponeringen af vemurafenib signifikant med omkring 40 % ved administration af en enkelt dosis på 960 mg vemurafenib sammen med rifampicin.
In a clinical study, co-administration of a single dose 960 mg of vemurafenib with rifampicin, significantly decreased the plasma exposure of vemurafenib by approximately 40%.
Akut interstitiel nefritis(1) (2) (h), akut tubulær nekrose(1) (2) (h)
acute tubular necrosis(1)(2) (h)
Tabletterne må ikke tygges eller knuses.
Do not chew or crush the tablets.
Progressionsfri overlevelse - total Median (måneder)e konfidensinterval)d
PFS - overall Median (months)e
Efter markedsføring er en medikamentel reaktion med eosinofili og systemiske symptomer (DRESS) rapporteret i forbindelse med vemurafenib (se pkt.
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with vemurafenib in the post-marketing setting (see section 4.8).
Cut-off 30. december 2010 data (y)
December 30, 2010 data cut-off date (y) Overall Response Rate (95% CI)
· Medicin, som hæmmer metaboliseringsprotein kaldet CYP3A4 (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, atazanavir).
● Medicines that strongly inhibit the metabolising protein called CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
Bivirkningerne skal håndteres med dosisreduktion ved midlertidig afbrydelse af behandlingen eller med permanent seponering af behandingen (se pkt.
Events should be managed with dose reduction with treatment interruption or with treatment discontinuation (see section 4.2).
Stigning i leverenzymer (c) Leverenzymanormaliteter rapporteret i det kliniske fase III-studie er udtrykt nedenfor som den andel af patienter, som oplevede en ændring fra baseline til grad 3 eller 4 leverenzymanormaliteter: · Meget almindelig: GGT · Almindelig: ALAT, alkalisk fosfatase, bilirubin · Ikke almindelig: ASAT
Liver enzyme abnormalities reported in the phase III clinical study are expressed below as the proportion of patients who experienced a shift from baseline to a grade 3 or 4 liver enzyme abnormalities:
De mest almindelige bivirkninger af alle grader (> 30 %) rapporteret ved behandling med vemurafenib inkluderer artralgi, træthed, udslæt, lysfølsomhedsreaktion, alopeci, kvalme, diarré, hovedpine, kløe, opkastning, hudpapillom og hyperkeratose.
The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache,
Virkning af samtidig brug af lægemidler på vemurafenib In vitro-studier indikerer, at CYP3A4-metabolisering og glukuronidering er ansvarlige for metabolisering af vemurafenib.
In vitro studies suggest that CYP3A4 metabolism and glucuronidation are responsible for the metabolism of vemurafenib.
Zelboraf 240 mg filmovertrukne tabletter Vemurafenib
Zelboraf 240 mg film-coated tablets vemurafenib
Samtidig anvendelse af vemurafenib med midler, som metaboliseres af CYP3A4, med smalt terapeutisk vindue kan ikke anbefales.
Concomitant use of vemurafenib with agents metabolized by CYP3A4 with narrow therapeutic windows is not recommended.
Der blev observeret eksponeringsafhængig QT-forlængelse i et ukontrolleret, open-label, fase II-studie hos tidligere behandlede patienter med metastatisk melanom (se pkt.
Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma (see section 4.8).
Grad 2 (uacceptabel) eller grad 3
Grade 1 or Grade 2 (tolerable)
· øvrige indholdsstoffer: · Tabletkerne: Kolloid vandfri silica, croscarmellosenatrium, hydroxypropylcellulose og magnesiumstearat · Filmovertræk: Rød jernoxid, macrogol 3350, polyvinylalkohol, talcum og titandioxid.
● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
Der er blevet rapporteret alvorlige overfølsomhedsreaktioner, inklusive anafylaksi, i forbindelse med vemurafenib.
Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib.
Hudreaktioner (f)
Dermatologic reactions (f)
Et multicenterstudie (n = 146) med vemurafenib med en enkelt arm blev udført hos voksne patienter med histologisk bekræftet metastatisk melanom, som havde BRAF V600 mutation (iht.
A single-arm, multicentre study (N = 146) of vemurafenib was conducted in adult patients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation (according to the cobas 4800 BRAF V600 Mutation Test) and with brain metastases.
Dosisnedsættelse og/eller supplerende monitorering af lægemiddelkoncentrationen skal overvejes for lægemidler, som er P-pg substrater, og som har et smalt terapeutisk vindue (såsom digoxin, dabigatran etexilat, aliskiren), hvis disse lægemidler gives samtidig med vemurafenib (se pkt.
Dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) may be considered if these medicinal products are used concomitantly with vemurafenib (see section 4.5).
Hver filmovertrukket tablet indeholder 240 mg vemurafenib (som copræcipitat af vemurafenib og hypromelloseacetatsuccinat).
Each film-coated tablet contains 240 milligrams (mg) of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Udskillelse via nyrerne ser ikke ud til at være vigtig for eliminationen af vemurafenib imens udskillelse af uomdannet stof via galden kan være en vigtig eliminationsvej.
Renal elimination does not appear to be of importance for vemurafenib elimiation, whereas biliary excretion of unchanged compound may be an important route of elimination.. Vemurafenib is a substrate and inhibitor of P-gp in vitro.
Kronisk myelomonocytær leukæmi(2)(4), pankreatisk adenokarcinom5
Chronic myelomonocytic leukaemia(2)(4),
Der er rapporteret tilfælde af non-cuSCC i kliniske studier, hvor patienter fik vemurafenib.
Non-Cutaneous Squamous Cell Carcinoma (non-cuSCC) Cases of non-cuSCC have been reported in clinical trials where patients received vemurafenib.
Supplerende monitorering af lægemiddelkoncentrationen skal overvejes for lægemidler, som er P-pgsubstrater, og som har et smalt terapeutisk vindue (såsom digoxin, dabigatran etexilat, aliskiren) (se pkt.
Consider additional drug level monitoring for P-gp substrate medicinal products with a narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) (see section 4.4).
Grad 1 eller grad 2 (acceptabel) Fasthold vemurafenib-dosis på 960 mg to gange dagligt.
Maintain vemurafenib at a dose of 960 mg twice daily.
Begrænsede data er tilgængelige for patienter med nedsat nyrefunktion.
Limited data are available in patients with renal impairment.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 240 mg vemurafenib (som co-præcipitat af vemurafenib og hypromelloseacetatsuccinat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Vemurafenib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion.
Vemurafenib should be used with caution in patients with severe renal impairment and patients should be closely monitored.
Nogle tilfælde, hvor indre organer var involveret, havde dødelig udgang (se pkt.
Most cases were cutaneous in nature but some cases involving visceral organs had fatal outcomes (see sections 4.5 and 4.8).
LÆGEMIDLETS NAVN Zelboraf 240 mg tabletter vemurafenib
NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg tablets vemurafenib
· Ændringer i resultater fra levertests (stigning i GGT) · Nedsat antal hvide blodlegemer (neutropeni).
● Decreased white blood cells (neutropenia).
Sjældne (kan påvirke op til 1 ud af 1.000 behandlede): · Forværring af allerede eksisterende typer kræft med RAS-mutationer (kronisk myelomonocytær leukæmi, adenokarcinom i bugspytkirtlen).
● Progression of a type of pre-existing cancers with RAS mutations (Chronic Myelomonocytic
- Kohort 1 med ikke-tidligere behandlede patienter (n = 90): Patienter, som ikke tidligere havde fået behandling for hjernemetastaser.
- Cohort 1 with previously untreated patients (N = 90): Patients who had not received previous treatment for brain metastases; prior systemic therapy for metastatic melanoma was allowed, excluding BRAF inhibitors and MEK inhibitors.
Dosisjusteringer
Posology adjustments
Der er rapporteret tilfælde af leverskade, inklusive tilfælde af svære leverskader, ved behandling med vemurafenib (se pkt.
Liver injury, including cases of severe liver injury, has been reported with vemurafenib (see section 4.8).
Hud og subkutane væv Lysfølsomhedsreaktion, aktinisk keratose, udslæt, makulo-papuløst udslæt, kløe, hyperkeratose, erytem, palmoplantar erytrodysæstesisyndrom, alopeci, tør hud, solskoldning
Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, pruritus, hyperkeratosis, erythema, palmarplantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn
Det anbefales at fortsætte behandling uden dosisjustering hos patienter, som udvikler cuSCC.
In patients who develop cuSCC, it is recommended to continue the treatment without dose adjustment.