Patients who have progressed on a prior BRAF inhibitor therapy; patients whose melanoma tested -ve for BRAF V600 mutation; patients w/ BRAF V600 mutation +ve melanoma which has metastasized to the brain. Risk of new malignancies, cutaneous & non-cutaneous; haemorrhage; decreased left ventricular ejection fraction/left ventricular dysfunction; pyrexia; HTN; ILD or pneumonitis; disorders associated w/ visual disturbance, including retinal pigment epithelial detachment & retinal vein occlusion; rash; rhabdomyolysis; renal failure; pancreatitis; hepatic adverse events; pulmonary embolism or DVT; colitis & GI perforation. Severe renal impairment. Moderate to severe hepatic impairment. Female patients of reproductive potential should use highly effective contraception during treatment & for 4 mth after treatment. May decrease efficacy of hormonal contraceptives. May impair fertility. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Childn <18 yr.
Possible increased levels w/ strong P-gp inhibitors (eg, verapamil, cyclosporine, ritonavir, quinidine, itraconazole). May result in transient inhibition of BCRP substrates (eg, pitavastatin) in the gut.
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