Gavreto Dosage/Direction for Use

Patient Selection: Select patients for treatment with GAVRETO based on the presence of a RET gene fusion [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Patient selection for treatment of metastatic RET fusion-positive NSCLC should be based on a validated test method.
Recommended Dosage: The recommended dosage of GAVRETO 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 GAVRETO) [see Pharmacology: Pharmacokinetics under Actions]. Continue treatment until disease progression or until unacceptable toxicity.
If a dose of GAVRETO is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for GAVRETO the next day.
Do not take an additional dose if vomiting occurs after GAVRETO but continue with the next dose as scheduled.
Dosage Modifications for Adverse Reactions: The recommended dose reductions and dosage modifications for adverse reactions are provided in Table 3 and Table 4. (See Tables 3 and 4).

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Permanently discontinue GAVRETO in patients who are unable to tolerate 100 mg taken orally once daily.
The recommended dosage modifications for adverse reactions are provided in Table 4. (See Table 4.)

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Dose Modification for Use with Combined P-glycoprotein (P-gp) and Strong CYP3A Inhibitors: Avoid coadministration of GAVRETO with known combined P-gp and strong CYP3A inhibitors. If coadministration with a combined P-gp and strong CYP3A inhibitor cannot be avoided, reduce the current dose of GAVRETO as recommended in Table 5. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume GAVRETO at the dose taken prior to initiating the combined P-gp and strong CYP3A inhibitor [see Interactions and Pharmacology: Pharmacokinetics under Actions]. (See Table 5.)

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Dose Modification for Use with Strong CYP3A Inducers: Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration with a strong CYP3A inducer cannot be avoided, increase the starting dose of GAVRETO to double the current GAVRETO dosage starting on Day 7 of coadministration of GAVRETO with the strong CYP3A inducer. After the inducer has been discontinued for at least 14 days, resume GAVRETO at the dose taken prior to initiating the strong CYP3A inducer [see Interactions and Pharmacology: Pharmacokinetics under Actions].