Prescription medicine
Larotrectinib Brand names: Vitrakvi
Larotrectinib (Vitrakvi) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the larotrectinib FDA label on DailyMed (effective May 22, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 210861 record on Drugs@FDA; every larotrectinib label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVITRAKVI 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.
Forms and strengths
- 25 mg
- 100 mg
- 20 mg/ml
Capsule; solution (concentrate); solution.
On the market
- Earliest approval on file
- November 26, 2018 Vitrakvi, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 16, 2037 Vitrakvi capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 1 Class I among all firms' recalls; latest November 6, 2023
- FAERS reports
- 874 through July 30, 2026
What is larotrectinib used for?
From the label: indications and usageVITRAKVI 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. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (VITRAKVI), Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026 (SPL set 0c8ca614-58b2-4aa4-83d3-0387a8f782fd), via openFDA; the full label on DailyMed
What does the patient leaflet for larotrectinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking VITRAKVI?VITRAKVI can make you feel dizzy. Do not drive or operate machinery until you know how VITRAKVI affects you. Avoid taking St. John's wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI.
From the patient leaflet: How should I store VITRAKVI?Store VITRAKVI capsules at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Store VITRAKVI oral solution in the refrigerator between 36° F to 46° F (2° C to 8° C). Do not freeze. Throw away (dispose of) any unused VITRAKVI oral solution: Bottle of 100 mL: remaining 90 days after first opening the bottle Bottle of 50 mL: remaining 31 days after first opening the bottle Keep VITRAKVI and all medicines out of the reach of children.
Source: FDA drug label (VITRAKVI), Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026 (SPL set 0c8ca614-58b2-4aa4-83d3-0387a8f782fd), via openFDA; the full label on DailyMed
Is there a generic for larotrectinib (Vitrakvi)?
No generic larotrectinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 15 patents for Vitrakvi capsules: the compound patent runs to August 15, 2036, and the last listed entry to May 16, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has larotrectinib been recalled?
The FDA's Enforcement Report lists 1 recall naming larotrectinib since 2023: 1 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 6, 2023 | Class I | Bayer Healthcare Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for larotrectinib?
The FDA Adverse Event Reporting System holds 874 reports that list larotrectinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 161 are coded as a death and 170 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Larotrectinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other