Medically reviewed by Drugs.com. Last updated on Mar 25, 2021.
Generic name: LAROTRECTINIB 25mg
Dosage form: capsules, oral solution
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 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:
- 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.
- 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
Pediatric Patients with Body
Surface Area of at Least 1.0 m2
|Pediatric Patients with Body
Surface Area Less Than 1.0 m2
75 mg orally twice daily
75 mg/m2 orally twice daily
50 mg orally twice daily
50 mg/m2 orally twice daily
100 mg orally once daily
25 mg/m2 orally twice daily a
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 taken prior to initiating the CYP3A4 inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Dosage Modifications for Coadministration with Strong CYP3A4 Inducers
Avoid coadministration of strong CYP3A4 inducers with VITRAKVI. If coadministration of a strong CYP3A4 inducer cannot be avoided, double the VITRAKVI dose. After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the VITRAKVI dose taken prior to initiating the CYP3A4 inducer [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Dosage Modifications for Patients with Hepatic Impairment
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.
Swallow capsules whole with water. Do not chew or crush the capsules.
- 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.
- Prior to preparing an oral dose for administration, refer to the Instructions for Use.
Frequently asked questions
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