Rozlytrek Dosage/Direction for Use

Patient Selection: Select patients for the treatment of metastatic NSCLC with ROZLYTREK based on the presence of ROS1 rearrangement(s) in tumor specimens [see Pharmacology: Pharmacodynamics: Clinical Studies: ROS1-Positive Non-Small Cell Lung Cancer under Actions].
Select patients for treatment of locally advanced or metastatic solid tumors with ROZLYTREK based on the presence of a NTRK gene fusion [see Pharmacology: Pharmacodynamics: Clinical Studies: NTRK Gene Fusion-Positive Solid Tumors under Actions].
Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: The recommended dosage of ROZLYTREK is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.
Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors: Adults: The recommended dosage of ROZLYTREK in adults is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.
Pediatric Patients 12 Years and Older (Adolescents): The recommended dosage of ROZLYTREK is based on body surface area (BSA) as shown in Table 6 as follows. Take ROZLYTREK orally once daily with or without food until disease progression or unacceptable toxicity. (See Table 6.)

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Dosage Modifications for Adverse Reactions: The recommended dosage reductions for adverse reactions are provided in Table 7. (See Table 7.)

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Table 8 describes dosage modifications for specific adverse reactions. (See Table 8.)

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Dosage Modifications for Drug Interactions: Moderate and Strong CYP3A Inhibitors: Adults and Pediatric Patients 12 Years and Older with BSA Greater than 1.50 m²: Avoid coadministration of ROZLYTREK with moderate or strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the ROZLYTREK dose as follows: Moderate CYP3A Inhibitors: 200 mg orally once daily.
Strong CYP3A Inhibitors: 100 mg orally once daily.
After discontinuation of a strong or moderate CYP3A inhibitor for 3 to 5 elimination half-lives, resume the ROZLYTREK dose that was taken prior to initiating the CYP3A inhibitor [see Effect of Other Drugs on ROZLYTREK under Interactions and Pharmacology: Pharmacokinetics under Actions].
Administration: Swallow capsules whole. Do not open, crush, chew, or dissolve the contents of the capsule.
If a patient misses a dose, instruct patients to make up that dose unless the next dose is due within 12 hours.
If a patient vomits immediately after taking a dose, instruct patients to repeat that dose.