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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Melanoma - Metastatic
Maintenance dose: 960 mg orally every 12 hours with or without a meal
Duration of therapy: Treat patients until disease progression or unacceptable toxicity occurs.
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment.
-A missed dose can be taken up to 4 hours prior to the next dose.
-Do not take an additional dose if vomiting occurs after administration, but continue with the next scheduled dose.
Use: BRAF V600 mutation-positive unresectable or metastatic melanoma
Renal Dose Adjustments
-Mild to moderate renal dysfunction: No adjustment recommended
-Severe renal dysfunction: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.
Liver Dose Adjustments
-Mild to moderate hepatic dysfunction: No adjustment recommended
-Severe hepatic dysfunction: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.
Permanently discontinue this drug for any of the following:
-Grade 4 adverse reaction, first appearance (if clinically appropriate) or second appearance
-QTc prolongation greater than 500 ms and increased by greater than 60 ms from pre-treatment values.
Withhold for NCI Common Terminology Criteria for Adverse Events (CTC-AE) intolerable Grade 2 or greater adverse reactions. After recovery to Grade 0 to 1, restart at a reduced dose as indicated:
-720 mg twice a day for first appearance of intolerable Grade 2 or Grade 3 adverse reactions
-480 mg twice a day for second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions or for first appearance of Grade 4 adverse reaction (if clinically appropriate).
-Do not reduce dose to below 480 mg twice a day
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-This drug can be taken with or without a meal.
-Do not crush or chew tablets.
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