Patient Selection

Select patients for treatment with VITRAKVI based on the presence of a NTRK gene fusion in tumor specimens [see Clinical Studies (14)]. Information on FDA-approved tests is available at http://www.fda.gov/companiondiagnostics.

Recommended Dosage

Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared

The recommended dosage of VITRAKVI is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Recommended Dosage in Pediatric Patients with Body Surface Area Less Than 1.0 Meter-Squared

The recommended dosage of VITRAKVI is 100 mg/m2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Dosage Modifications for Adverse Reactions

For Grade 3 or 4 adverse reactions:

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Withhold VITRAKVI until adverse reaction resolves or improves to baseline or Grade 1. Resume at the next dosage modification if resolution occurs within 4 weeks.

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Permanently discontinue VITRAKVI if an adverse reaction does not resolve within 4 weeks.

The recommended dosage modifications for VITRAKVI for adverse reactions are provided in Table 1.

Table 1 Recommended Dosage Modifications for VITRAKVI for Adverse Reactions

a Pediatric patients on 25 mg/m2 orally twice daily should remain on this dosage even if body surface area becomes greater than 1.0 m2 during the treatment. Maximum dose should be 25 mg/m2 orally twice daily at the third dosage modification.

Permanently discontinue VITRAKVI in patients who are unable to tolerate VITRAKVI after three dose modifications.

Dosage Modifications for Coadministration with Strong CYP3A4 Inhibitors

Avoid coadministration of strong CYP3A4 inhibitors with VITRAKVI. If coadministration of a strong CYP3A4 inhibitor cannot be avoided, reduce the VITRAKVI dose by 50%. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the VITRAKVI dose that was used prior to initiating the CYP3A4 inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

​2.5 Dosage Modifications for Coadministration with Strong or Moderate CYP3A4 Inducers

​Avoid coadministration of strong CYP3A4 inducers with VITRAKVI. If coadministration of a strong CYP3A4 inducer cannot be avoided, double the VITRAKVI dose. Additionally, for coadministration with a moderate CYP3A4 inducer, double the VITRAKVI dose. After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the VITRAKVI dose that was used prior to initiating the CYP3A4 inducer [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Modifications for Patients with Hepatic Impairment

Reduce the starting dose of VITRAKVI by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Administration

VITRAKVI capsule or oral solution may be used interchangeably.

Do not make up a missed dose within 6 hours of the next scheduled dose.

If vomiting occurs after taking a dose of VITRAKVI, take the next dose at the scheduled time.

Capsules

Swallow capsules whole with water. Do not chew or crush the capsules.

​Oral Solution packaged in one bottle containing 100 mL

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Store the glass bottle of VITRAKVI oral solution in the refrigerator. Discard any unused VITRAKVI oral solution remaining after 90 days of first opening the bottle.

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Prior to preparing an oral dose for administration, refer to the Instructions for Use.

​Oral Solution packaged in two bottles each containing 50 mL

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​Store the glass bottles of VITRAKVI oral solution in the refrigerator. Discard any unused VITRAKVI oral solution remaining after 31 days of first opening the bottle.

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​Prior to preparing an oral dose for administration, refer to the Instructions for Use.