Larotrectinib: Side Effects, Uses & Monitoring
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase (NTRK ) gene fusion without a known acquired resistance mutation, • are metas
- Data source
- FDA labeling via NIH DailyMed (label 9525f887…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase (NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Frequently Asked Questions
What is Larotrectinib used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Larotrectinib?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Larotrectinib require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Larotrectinib.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.