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Select patients with R/R FL for treatment with Tazemetostat based on the presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens.
The recommended dosage of Tazemetostat is 800 mg orally twice daily with or without food until disease progression or unacceptable toxicity.
Swallow tablets whole. Do not cut, crush, or chew tablets.
Do not take an additional dose if a dose is missed or vomiting occurs after Tazemetostat, but continue with the next scheduled dose.
Table 1 summarizes the recommended dose reductions, and Table 2 summarizes the recommended dosage modifications of Tazemetostat for adverse reactions.
Avoid coadministration of Tazemetostat with strong or moderate CYP3A inhibitors. If coadministration with a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Tazemetostat dose as shown in Table 3 below. After discontinuation of the strong or moderate CYP3A inhibitor for 3 elimination half-lives, resume the Tazemetostat dose that was taken prior to initiating the inhibitor.
from FDA，2024.08
