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Select patients for treatment with Pralsetinib based on the presence of a RET gene fusion (NSCLC or thyroid cancer).
The recommended dosage of Pralsetinib is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking Pralsetinib). Continue treatment until disease progression or until unacceptable toxicity.
If a dose of Pralsetinib is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for Pralsetinib the next day.
Do not take an additional dose if vomiting occurs after Pralsetinib but continue with the next dose as scheduled.
The recommended dose reductions and dosage modifications for adverse reactions are provided in Table 1 and Table 2.
Permanently discontinue Pralsetinib in patients who are unable to tolerate 100 mg taken orally once daily.
The recommended dosage modifications for adverse reactions are provided in Table 2.
Avoid coadministration of Pralsetinib with any of the following:
• Strong CYP3A inhibitors
• Moderate CYP3A inhibitors
• P-gp inhibitors
• Combined P-gp and strong CYP3A inhibitors
• Combined P-gp and moderate CYP3A inhibitors
If coadministration with any of the above inhibitors cannot be avoided, reduce the current dose of Pralsetinib as recommended in Table 3. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume Pralsetinib at the dose taken prior to initiating the inhibitor.
Avoid coadministration of Pralsetinib with any of the following:
• Strong CYP3A inducers
• Moderate CYP3A inducers
If coadministration with any of the above inducers cannot be avoided, increase the starting dose of Pralsetinib as recommended in Table 4 starting on Day 7 of coadministration of Pralsetinib with the inducer. After the inducer has been discontinued for at least 14 days, resume Pralsetinib at the dose taken prior to initiating the inducer.
from FDA，2024.03
