natgillin/translations-raw huggingface dataset:
Der er blevet rapporteret tilfælde af cuSCC (som inkluderer tilfælde klassificeret som keratoakantom eller blandet keratoakantom-undertype) hos patienter behandlet med vemurafenib (se pkt. 
Cases of cuSCC (which include those classified as keratoacanthoma or mixed keratoacanthoma subtype) have been reported in patients treated with vemurafenib (see section 4.8).
Monitorering for hudlæsioner bør forekomme, som beskrevet i pkt. 
Monitoring for skin lesions should occur as outlined in section 4.4.
Virkningsmekanisme og farmakodynamisk virkning Vemurafenib hæmmer BRAF-serin-treonin-kinase. 
Mechanism of action and pharmacodynamic effects Vemurafenib is an inhibitor of BRAF serine-threonine kinase.
Patienter der er i samtidig behandling med sådanne lægemidler skal overvåges nøje i forhold til sikkerhed og dosisjusteringer, hvis det er klinisk relevant (se tabel 1 i afsnit 4.2). 
Patients co-treated with such agents should be carefully monitored for safety and dose modifications applied if clinically indicated (see Table 1 in section 4.2).
Hvis samtidig anvendelse ikke kan undgås skal der udvises forsigtighed eftersom vemurafenib kan øge plasma eksponeringen af CYP1A2 substrat lægemidler. 
If co-administration cannot be avoided, exercise caution, as vemurafenib may increase plasma exposure of CYP1A2 substrate drugs.
Hovedpine, dysgeusi, svimmelhed 
Headache, dysgeusia, dizziness
Data er utilstrækkelige til at bestemme effekten af nedsat metaboliserings- eller udskillelses-leverfunktion på vemurafenibs farmakokinetik (se pkt. 
Data are insufficient to determine the effect of metabolic or excretory hepatic impairment on vemurafenib pharmacokinetics (see sections 4.2 and
Der er rapporteret tilfælde af radiation recall syndrom og øget følsomhed for stråling hos patienter, som har fået strålebehandling enten før, under eller efter vemurafenib-behandling. 
Cases of radiation recall and radiation sensitization have been reported in patients treated with radiation either prior, during, or subsequent to vemurafenib treatment.
Dosisjusteringer anbefales ved lysfølsomhed af grad 2 (uacceptabel) eller højere (se pkt. 
For photosensitivity grade 2 (intolerable) or greater, dose modifications are recommended (see section
· Nyreskader i form af inflammation (akut interstitiel nefritis) eller skader på nyretubuli (akut tubulær nekrose). 
● Types of kidney injury characterized by inflammation (acute interstitial nephritis) or damage to the tubules of the kidney (acute tubular necrosis).
Samtidig anvendelse af vemurafenib øgede plasma eksponeringen (AUC) for caffein (CYP1A2 substrat) 2,6-gange. 
Co-administration of vemurafenib increased the plasma exposure (AUC) of caffeine (CYP1A2 substrate) 2.6-fold.
Tag altid Zelboraf nøjagtig efter lægens anvisning. 
Always take Zelboraf exactly as your doctor has told you.
Kutant planocellulært karcinom (d) (cuSCC) 
Cutaneous squamous cell carcinoma (d) (cuSCC)
Genoptag dosering på 480 mg to gange dagligt (eller seponer permanent, hvis dosis i forvejen er blevet reduceret til 480 mg to gange dagligt). 
Resume dosing at 480 mg twice daily (or discontinue permanently if the dose has already been lowered to 480 mg twice daily).
Et fase II, enkelt-arm, multicenter, multinationalt studie blev udført med 132 patienter, som havde BRAF-V600E-mutationspositivt melanom vist ved cobas 4800 BRAF-V600-muationstest, og som have modtaget mindst én tidligere behandling. 
A phase II single-arm, multi-centre, multinational study was conducted in 132 patients who had BRAF V600E mutation-positive metastatic melanoma according to the cobas 4800 BRAF V600 Mutation Test and had received at least one prior therapy.
Det er ikke nødvendigt at justere startdosis for patienter med nedsat leverfunktion. 
No adjustment to the starting dose is needed for patients with hepatic impairment.
Reaktioner i forbindelse med strålebehandling · Fortæl lægen, hvis du har fået eller skal have strålebehandling, da Zelboraf kan forværre bivirkningerne ved strålebehandlingen 
● Tell your doctor if you have had, or are going to have radiotherapy, as Zelboraf may worsen radiation treatment side effects.
Da vemurafenib elimineres via leveren kan patienter med moderat til svær nedsat leverfunktion have en øget eksponering og de bør monitoreres tæt (se pkt. 
As vemurafenib is cleared by the liver, patients with moderate to severe hepatic impairment may have increased exposure and should be closely monitored (see sections 4.4 and 5.2).
Vemurafenib kan nedsætte virkningen af hormonelle præventionsmidler (se pkt. 
Vemurafenib might decrease the efficacy of hormonal contraceptives (see section 4.5).
I studier af toksicitet hos rotter og hunde efter gentagne doser blev der dog ikke bemærket histopatologiske fund i forplantningsorganer hos hanner og hunner (se pkt. 
However, in repeat-dose toxicity studies in rats and dogs, no histopathological findings were noted in reproductive organs in males and females (see section 5.3).
Alle patienter skulle have fremskredet melanom med BRAF-V600-mutationer vist ved cobas 4800 BRAF-V600mutationstest. 
All patients were required to have advanced melanoma with BRAF V600 mutations according to the cobas 4800 BRAF V600 Mutation Test.
Vemurafenib kan øge plasmaeksponeringen af lægemidler, som hovedsageligt metaboliseres af CYP1A2 og nedsætte plasmaeksponeringen af lægemidler, som hovedsageligt metaboliseres af CYP3A4. 
Effects of vemurafenib on other medicinal products Vemurafenib may increase the plasma exposure of medicinal products predominantly metabolised by CYP1A2 and decrease the plasma exposure of medicines predominantly metabolised by CYP3A4.
Efter oral dosering er absorptionshastighedskonstanten for populationen af patienter med metastatisk melanom estimeret til at være 0,19 t-1 (med 101 % variabilitet mellem patienter). 
Following oral dosing, the absorption rate constant for the population of metastatic melanoma patients is estimated to be 0.19 hr-1 (with 101% between patient variability).
I tilfælde af at patienten udvikler kutant planocellulært karcinom (cuSCC), anbefales det at fortsætte behandlingen uden at ændre dosis af vemurafenib (se pkt. 
In the event the patient develops Cutaneous Squamous Cell Carcinoma (cuSCC), it is recommended to continue the treatment without modifying the dose of vemurafenib (see sections 4.4 and 4.8).
Eksponering i de embryoføtale udviklingsstudier var dog under den kliniske eksponering baseret på sammenligning af AUC. 
However, exposures in the embryofoetal development studies were below the clinical exposure based on AUC comparison, it is therefore difficult to define to what extent these results can be extrapolated to humans.
Hvis du har glemt at tage Zelboraf · Hvis du glemmer en dosis og der er mere end 4 timer til den næste dosis, skal du tage den glemte dosis ligeså snart du kommer i tanke om det. 
● If you forget a dose and it is more than 4 hours before your next dose, just take your dose as soon as you remember it. Take the next dose at the usual time.
Non-kutant planocellulært karcinom (non-cuSCC) Der er blevet rapporteret tilfælde af non-cuSCC hos patienter, der fik vemurafenib, mens de deltog i kliniske studier. 
Non-cutaneous squamous cell carcinoma (non-cuSCC) Cases of non-cuSCC have been reported in patients receiving vemurafenib while enrolled in clinical trials.
V600M 
V600D
· Spørg lægen, hvis der er mere, du vil vide. 
● If you have any further questions, ask your doctor.
Der skal udvises forsigtighed når vemurafenib anvendes samtidig med P-gp substrater. 
Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates.
Disse tilfælde blev håndteret med ekscision og patienter fortsatte behandlingen uden dosisjustering. 
These cases were managed with excision, and patients continued treatment without dose adjustment.
Tabel 9 viser den samlede responsrate og progressionsfri overlevelse hos tidligere ubehandlede patienter med BRAF-V600-mutationspositivt melanom. 
Table 9 shows the overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma.
Tabel 1: Dosisjusteringsskema baseret på graden af enhver bivirkning 
Table 1: Dose modification schedule based on the grade of any Adverse Events (AEs)
Tilfælde blev håndteret med ekscision og patienter fortsatte behandlingen uden dosisjustering. 
Cases were managed with excision and patients continued treatment without dose adjustment.
Der blev ikke observeret teratogenicitet i embryoføtale udviklingsstudier hos rotter og kaniner ved doser på henholdsvis 250 mg/kg/døgn og 450 mg/kg/døgn førende til eksponeringer under den forventede kliniske eksponering (baseret på sammenligning af AUC). 
No teratogenicity was observed in embryofoetal development studies in rats and rabbits at doses up to respectively 250 mg/kg/day and 450 mg/kg/day leading to exposures below the anticipated clinical exposure (based on AUC comparison).
Tabel 7: Samlet overlevelse hos tidligere ubehandlede patienter med BRAF-V600-mutationspositivt melanom ved studie cut-off dato (n=338 dacarbazin, n=337 vemurafenib) 
Table 7: Overall survival in previously untreated patients with BRAF V600 mutation-positive melanoma by study cut-off date (N=338 dacarbazine, N=337 vemurafenib) Cut-off dates
Tabuleret sammenfatning af bivirkninger 
Tabulated summary of adverse reactions
Vemurafenib udviste fototoksicitet in vitro på dyrkede murine fibroblaster efter UVA-bestråling, men ikke in vivo i et rottestudie ved doser på op til 450 mg/kg/døgn (ved eksponeringer under den forventede kliniske eksponering baseret på sammenligning af AUC). 
Vemurafenib was shown to be phototoxic, in vitro, on cultured murine fibroblasts after UVA irradiation, but not in vivo in a rat study at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure (based on AUC comparison).
På grund af den høje akkumulering af vemurafenib ved steady-state forventes det, at lejlighedsvis indtagelse af vemurafenib på tom mave har begrænset indflydelse på steady-state eksponeringen. 
Occasional intake of vemurafenib on an empty stomach is expected to have limited influence on steady state exposure due to the high accumulation of vemurafenib at steady state.
Der er kun meget begrænsede data tilgængelige for patienter med moderat til svær nedsat leverfunktion. 
There are only very limited data available in patients with moderate to severe hepatic impairment.
Asymptomatiske grad 3-stigninger i aminotransferaser (ALAT/ASAT > 5x ULN) og bilirubin (totalbilirubin > 3x ULN) er rapporteret i et fase I-studie, hvor ipilimumab (3 mg/kg) og vemurafenib (960 mg to gange dagligt eller 720 mg to gange dagligt) blev administreret samtidigt. 
In a Phase I trial, asymptomatic grade 3 increases in transaminases (ALT/AST >5 x ULN) and bilirubin (total bilirubin >3x ULN) were reported with concurrent administration of ipilimumab (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID).
Det er rapporteret tilfælde af radiation recall syndrom, stråleskader på huden, stråle pneumonitis, stråle øsofagitis, stråle proktitis, stråle hepatitis, stråle cystitis og stråle nekrose 
Cases reported include recall phenomenon, radiation skin injury, radiation pneumonitis, radiation esophagitis, radiation proctitis, radiation hepatitis, cystitis radiation, and radiation necrosis.
· Medicin, som kan påvirkes af et protein kaldet P-gp (f.eks. aliskiren, colchicin, digoxin, everolimus, fexofenadin) eller et protein kaldet BCRP (f.eks. methotrexat, mitoxantron, rosuvastatin). 
● Medicines that could be influenced by a protein called P-gp (e.g. aliskiren, colchicine, digoxin, everolimus, fexofenadine) or a protein called BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Der er blevet rapporteret let til svær lysfølsomhed hos patienter, som fik vemurafenib i kliniske studier (se pkt. 
Mild to severe photosensitivity was reported in patients who received vemurafenib in clinical studies (see section 4.8).
Før anvendelse af vemurafenib skal patienterne have en BRAF-V600-mutationspositiv tumorstatus bekræftet ved en valideret test (se pkt. 
Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Den tilsyneladende populationsclearance for vemurafenib hos patienter med metastatisk melanom er estimeret til at være 29,3 l/døgn (med 31,9 % variabilitet mellem patienter). 
The population apparent clearance of vemurafenib in patients with metastatic melanoma is estimated to be 29.3 L/day (with 31.9% between patient variability).
Monitorering af hudlæsioner bør foretages, som beskrevet ovenfor for kutant planocellulært karcinom. 
Monitoring for skin lesions should occur as outlined above for cutaneous squamous cell carcinoma.
Anormale fund bør håndteres som klinisk indiceret. 
Abnormal findings should be managed according to clinical practices.
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.