Active Ingredient: Binimetinib
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 45 milligrams binimetinib, 2 times daily.
Before taking binimetinib in combination with encorafenib, patients must have confirmation of BRAF V600E mutation assessed by a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used.
The efficacy and safety of binimetinib in combination with encorafenib have been established only in patients with melanoma tumours expressing BRAF V600E and V600K mutations. Binimetinib in combination with encorafenib should not be used in patients with wild type BRAF malignant melanoma.
The recommended dose of binimetinib is 45 mg twice daily approximately 12 hours apart, corresponding to a total daily dose of 90 mg.
Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity.
If a dose of binimetinib is missed, it should not be taken if it is less than 6 hours until the next dose is due.
In case of vomiting after administration of binimetinib, the patient should not re-take the dose and should take the next scheduled dose.
Binimetinib may be taken with or without food.
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