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Larotrectinib

Larotrectinib (Vitrakvi) is a targeted cancer medicine used to treat solid tumors in adults and children that carry a specific NTRK gene fusion.

Brand names VitrakviIVitrakvi
Drug class Kinase Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Larotrectinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Larotrectinib (Vitrakvi), on the market since about 2018, is a specialist targeted cancer medicine for adults and children whose solid tumors carry an NTRK gene fusion (a genetic change found by testing the tumor); it blocks the abnormal, always-on TRK proteins driving the cancer's growth. For a cancer medicine it is usually fairly well tolerated, and the side effects people notice most are tiredness, nausea or constipation, and dizziness. Watch most for nervous system effects such as confusion, memory trouble or mood changes, and do not drive if they appear. Expect regular liver blood tests, and report new bone pain, since fractures can follow minor bumps.

Clinical pearls

  • It is taken twice a day with or without food, so pick two times that stay consistent.
  • If a dose is vomited, do not repeat it, and skip a missed dose if the next is within 6 hours.
  • Skip grapefruit and St. John's wort, and have any new prescription, especially antifungals or rifampin, checked for interactions first.
  • Both women and men need effective birth control during treatment and for one week after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asCapsule, Oral solution
Earliest FDA record2018
Companies listing it with the FDA2
FDA label last updatedMay 22, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Larotrectinib, written from its FDA label.

What Larotrectinib is used for

▾

Larotrectinib (Vitrakvi) is a targeted treatment for a specific type of cancer defined by a genetic change rather than where in the body the cancer started.

  • Vitrakvi treats adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion — a specific genetic rearrangement — and no known acquired resistance mutation to larotrectinib.
  • The tumor must be metastatic (spread beyond its original site) or be one where surgery would likely cause severe harm.
  • Patients must also have no satisfactory alternative treatments available, or their cancer must have progressed after prior treatment.
  • In certain tumor types — including secretory breast cancer, mammary analogue secretory cancer (MASC), congenital mesoblastic nephroma (CMN), and infantile fibrosarcoma — Vitrakvi may be considered without first confirming an NTRK rearrangement in a tumor specimen.
  • This approval is under the FDA's accelerated approval program, based on tumor response rates; continued approval depends on confirmatory trials verifying clinical benefit.

How Larotrectinib works

▾

Larotrectinib is a kinase inhibitor — it blocks enzymes called tropomyosin receptor kinases (TRKA, TRKB, and TRKC). In some cancers, chromosomal rearrangements create abnormal TRK fusion proteins that are permanently switched on, driving cancer cells to grow and survive. By blocking these overactive TRK proteins, larotrectinib disrupts those cancer-driving signals and can stop tumor growth.

It's worth noting that larotrectinib has little activity against tumors with certain point mutations (specific small genetic changes) in the TRK kinase domain, such as TRKA G595R or TRKC G623R — these are known acquired resistance mutations, meaning the cancer can develop them over time and stop responding to the drug.

Larotrectinib dosage

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Vitrakvi is taken by mouth twice a day — as either a capsule or an oral solution — and can be taken with or without food. Treatment continues until the cancer worsens or side effects become intolerable. If a dose is missed, skip it if the next dose is within 6 hours. If vomiting occurs after a dose, do not take an extra one; just take the next scheduled dose at the usual time.

  • Vitrakvi capsules must be swallowed whole with water — do not chew or crush.
  • Vitrakvi oral solution must be refrigerated and discarded 90 days after first opening.
  • Your prescriber may reduce or pause your dose if you experience serious side effects or certain drug interactions.

Dosing details from the FDA-approved label

From the Larotrectinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult and pediatric patients with body surface area of 1 meter-squared or greater
    • 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity
    • Dose reductions for adverse reactions: first 75 mg twice daily, second 50 mg twice daily, third 100 mg once daily
  • Pediatric patients with body surface area of less than 1 meter-squared
    • 100 mg/m2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity
    • Maximum: Maximum dose should be 25 mg/m2 orally twice daily at the third dosage modification
    • Dose reductions for adverse reactions: first 75 mg/m2 twice daily, second 50 mg/m2 twice daily, third 25 mg/m2 twice daily
  • Patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment
    • Reduce the starting dose of VITRAKVI by 50%
    • Hepatic impairment starting dose adjustment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Select patients for treatment with VITRAKVI based on the presence of a NTRK gene fusion ( 2.1 , 14 ). Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of 1 Meter-Squared or greater: 100 mg orally twice daily ( 2.2 ) Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1 Meter-Squared: 100 mg/m 2 orally twice daily ( 2.2 ) 2.1 Patient Selection Select patients for treatment with VITRAKVI based on the presence of a NTRK gene fusion in tumor specimens [see Clinical Studies (14) ] . In patients with secretory breast cancer, mammary analogue secretory cancer (MASC), congenital mesoblastic nephroma (CMN), or infantile fibrosarcoma, consider treatment without confirmation of NTRK rearrangements in tumor specimens. Information on FDA-approved tests is available at http://www.fda.gov/companiondiagnostics. 2.2 Recommended Dosage Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of 1 Meter-Squared or greater 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 Meter-Squared The recommended dosage of VITRAKVI is 100 mg/m 2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity. 2.3 Dosage Modifications for Adverse Reactions For Grade 2 and higher liver function test abnormalities, refer to Section 2.4, Table 2, Dosage Modifications for Hepatotoxicity. For all other 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 reductions for VITRAKVI for adverse reactions are provided in Table 1.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Larotrectinib side effects

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The most common side effects with Vitrakvi include:

Common side effects

  • Fatigue or weakness
  • Nausea, vomiting, or diarrhea
  • Constipation or stomach pain
  • Dizziness
  • Cough
  • Muscle or joint pain
  • Rash
  • Fever
  • Elevated liver enzymes (AST, ALT) — detected on blood tests
  • Anemia (low red blood cells) and other blood count changes (low white cells, low neutrophils)
  • Low albumin or calcium levels on blood tests

When to get medical help

  • Call your doctor if you have trouble thinking clearly, confusion, memory problems, or feel unusually anxious or depressed — these may be signs of nervous system effects.
  • Call your doctor if you have bone or joint pain, pain with movement, or notice a deformity — fractures can occur.
  • Contact your doctor right away if you notice yellowing of the skin or eyes, dark urine, or severe stomach pain — these may be signs of liver problems.
  • Do not drive or use heavy machinery if you feel dizzy or have any neurological symptoms.
  • Tell your doctor immediately if you are pregnant or become pregnant while taking Vitrakvi.

Serious reactions that need prompt medical attention include significant confusion or memory problems, mood changes, bone fractures, and signs of liver injury (yellowing of skin or eyes, dark urine, severe stomach pain). Contact your doctor right away if any of these occur.

Larotrectinib warnings and precautions

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  • Nervous system effects: Dizziness, confusion, memory problems, mood changes (anxiety, depression, irritability), and sleep disturbances occurred in a significant portion of patients. Do not drive or use heavy machinery if you experience these. Your doctor may pause or adjust your dose.
  • Liver toxicity (hepatotoxicity): Liver enzyme elevations are common and can be serious. Your doctor will check liver blood tests before you start and regularly during treatment. Severe elevations may require pausing or permanently stopping Vitrakvi.
  • Skeletal fractures: Bone fractures — sometimes with minimal trauma — have been reported. Report any new bone pain, limited movement, or deformity to your doctor promptly.
  • Embryo-fetal toxicity: Vitrakvi can cause birth defects and harm an unborn baby. Women of reproductive potential must use effective contraception during treatment and for 1 week after the last dose. Males with female partners of reproductive potential should also use contraception. A pregnancy test is required before starting treatment.

Larotrectinib interactions

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Larotrectinib is processed by a liver enzyme called CYP3A4, which means several common drugs and foods can raise or lower its levels in the blood:

  • Strong CYP3A4 inhibitors (e.g., itraconazole, certain HIV or antifungal medicines): Raise larotrectinib blood levels significantly — avoid if possible; a dose reduction is needed if unavoidable.
  • Grapefruit and grapefruit juice: Act as a strong CYP3A4 inhibitor — avoid while taking Vitrakvi.
  • Moderate CYP3A4 inhibitors (e.g., fluconazole): Can also raise larotrectinib levels — monitor for increased side effects.
  • Strong CYP3A4 inducers (e.g., rifampin): Greatly lower larotrectinib levels, potentially making it less effective — avoid if possible; a dose increase is needed if unavoidable.
  • St. John's Wort (herbal supplement): A strong CYP3A4 inducer — avoid, as it can reduce Vitrakvi's effectiveness.
  • Moderate CYP3A4 inducers: Can lower larotrectinib levels — a dose increase is recommended.
  • Sensitive CYP3A4 substrates (certain medicines broken down by CYP3A4): Vitrakvi can raise their blood levels, potentially worsening their side effects — avoid combining when possible.

Interactions listed in the FDA-approved label

From the Larotrectinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (including grapefruit or grapefruit juice): May increase larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions. Avoid coadministration. If it 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 used prior to the inhibitor.
  • Moderate CYP3A4 inhibitors: May increase larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions. Monitor for adverse reactions more frequently and reduce the VITRAKVI dosage based on the severity of adverse reactions.
  • Strong CYP3A4 inducers (including St. John's wort): May decrease larotrectinib plasma concentrations, which may decrease the efficacy of VITRAKVI. Avoid coadministration. If it cannot be avoided, double the VITRAKVI dose. After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the VITRAKVI dose used prior to the inducer.
  • Moderate CYP3A4 inducers: May decrease larotrectinib plasma concentrations, which may decrease the efficacy of VITRAKVI. Double the VITRAKVI dose. After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the VITRAKVI dose used prior to the inducer.
  • Sensitive CYP3A4 substrates: Coadministration with VITRAKVI may increase their plasma concentrations, which may increase the incidence or severity of adverse reactions. Avoid coadministration. If it cannot be avoided, monitor patients for increased adverse reactions of these drugs.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4 inhibitors with VITRAKVI. If coadministration cannot be avoided, reduce the VITRAKVI dose. ( 2.5 , 7.1 ) Moderate CYP3A4 Inhibitors: Monitor for adverse reactions more frequently in patients coadministered a moderate CYP3A4 inhibitor with VITRAKVI and reduce the VITRAKVI dosage based on severity of adverse reactions. ( 7.1 ) Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4 inducers with VITRAKVI. If coadministration cannot be avoided, increase the VITRAKVI dose. ( 2.6 , 7.1 ) Moderate CYP3A4 Inducers: Increase the VITRAKVI dose. ( 2.6 , 7.1 ) Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with VITRAKVI. ( 7.2 ) 7.1 Effects of Other Drugs on VITRAKVI Strong and Moderate CYP3A4 Inhibitors Coadministration of VITRAKVI with a strong or moderate CYP3A4 inhibitor may increase larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions [see Clinical Pharmacology (12.3) ]. Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors, including grapefruit or grapefruit juice. If coadministration of strong CYP3A4 inhibitors cannot be avoided, modify VITRAKVI dose as recommended [see Dosage and Administration (2.5) ] . In patients coadministered a moderate CYP3A4 inhibitor with VITRAKVI, monitor for adverse reactions more frequently and reduce the VITRAKVI dosage based on the severity of emergent adverse reactions [see Dosage and Administration (2.3) ] . Strong and Moderate CYP3A4 Inducers Coadministration of VITRAKVI with a strong or moderate CYP3A4 inducer may decrease larotrectinib plasma concentrations, which may decrease the efficacy of VITRAKVI [see Clinical Pharmacology (12.3) ]. Avoid coadministration of VITRAKVI with strong CYP3A4 inducers, including St. John's wort. If coadministration of strong CYP3A4 inducers cannot be avoided, modify VITRAKVI dose as recommended.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿143 supplements and herbs with documented Larotrectinib interactions, ranked by severity Check Larotrectinib against a supplement or herb →

Before taking Larotrectinib

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  • Liver disease: If you have moderate to severe liver impairment, a lower starting dose of Vitrakvi is recommended. Mild impairment requires monitoring.
  • Kidney disease / dialysis: Larotrectinib levels can be higher in people with end-stage kidney disease. Tell your doctor about any kidney problems.
  • Pregnancy: Vitrakvi can harm an unborn baby. A pregnancy test is required before starting, and effective contraception must be used during treatment and for 1 week after the last dose.
  • Breastfeeding: Do not breastfeed while taking Vitrakvi or for 1 week after the last dose — potential risk to the infant.
  • Reproductive potential (men and women): Both should use effective contraception; Vitrakvi may also reduce fertility in women.
  • Children: Vitrakvi has been studied in pediatric patients and can be used in children; dosing is adjusted based on body surface area for smaller or younger patients.
  • Drug interactions: Tell your doctor and pharmacist about all medications, supplements, and herbal products you take, especially any antifungals, antibiotics, HIV medicines, or St. John's Wort.

What Larotrectinib does in the body

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At a dose nine times higher than the standard adult dose, Vitrakvi does not cause meaningful prolongation of the QTc interval — the part of the heart's electrical cycle measured on an ECG (electrocardiogram). This means Vitrakvi is not expected to cause dangerous heart rhythm problems related to QT prolongation at therapeutic doses.

How your body processes Larotrectinib

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After taking Vitrakvi by mouth, peak blood levels are reached in about 1 hour, and steady drug levels are established within 3 days of regular dosing. The body processes (metabolizes) larotrectinib primarily through a liver enzyme called CYP3A4, and the drug has a short half-life of about 3 hours — meaning it clears relatively quickly between doses. It is eliminated mostly in the stool (about 58%) and urine (about 39%). Liver impairment can significantly increase drug exposure, which is why dose adjustments are needed for people with moderate or severe liver disease.

How to store Larotrectinib

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Store capsules at room temperature 20°C to 25°C (68°F to 77°F); temperature excursions between 15°C and 30°C (59°F to 86°F) are permitted . Refrigerate oral solution at 2°C to 8°C (36°F to 46°F). Do not freeze.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

143

Supplements & herbs that interact with Larotrectinib

143 supplements and herbal products have documented interactions with Larotrectinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 100
  • Minor · 40
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ASTAXANTHIN Moderate +135 more
Every supplement checked against Larotrectinib — ranked by severity The full interaction hub: 3 major · 100 moderate · 40 minor · every one linked to its full report. Check Larotrectinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Larotrectinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Larotrectinib — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Vitrakvi and why did my doctor prescribe it for me?

▾
Vitrakvi (larotrectinib) is a targeted cancer medicine — it doesn't treat cancer by location (like 'lung cancer' or 'breast cancer') but by a specific genetic change in your tumor called an NTRK gene fusion. Your doctor likely had your tumor tested and found this gene change, which means Vitrakvi is designed to directly block what's driving your cancer's growth. It's available as a capsule or a liquid you swallow.

Can I eat before taking Vitrakvi, and is grapefruit okay?

▾
You can take Vitrakvi with or without food — your choice. However, you should avoid grapefruit and grapefruit juice entirely while on this medicine. Grapefruit interferes with the enzyme that breaks down larotrectinib, which can cause too much of the drug to build up in your body and increase the risk of side effects.

What side effects should I just watch for versus ones that need a phone call to my doctor?

▾
Common side effects like fatigue, nausea, diarrhea, constipation, dizziness, cough, and muscle pain are worth noting but don't usually need an emergency call. However, call your doctor right away if you notice confusion, memory problems, significant mood changes, bone pain or a possible fracture, or any signs of liver trouble — like yellowing of your skin or eyes, very dark urine, or severe belly pain. And don't drive if you feel dizzy or mentally foggy.

Are there any medicines or supplements I shouldn't take with Vitrakvi?

▾
Yes — this is really important. Several common medicines can either raise or lower Vitrakvi levels in your blood. Strong antifungals (like itraconazole), some HIV medicines, and even grapefruit can raise levels dangerously. On the other side, rifampin (an antibiotic) and St. John's Wort (an herbal supplement) can lower levels so much that Vitrakvi might stop working. Always give your doctor and pharmacist a full list of everything you take, including vitamins and herbal products, before starting Vitrakvi.

Is it safe to get pregnant or try to have a baby while on this medicine?

▾
No — Vitrakvi can cause serious harm to an unborn baby, including birth defects. If you could become pregnant, you'll need to use reliable birth control during treatment and for a full week after your last dose. Men taking Vitrakvi whose partners could become pregnant should also use contraception during that same window. Your doctor will check a pregnancy test before you start. If you're breastfeeding, you'll need to stop while on Vitrakvi and for one week after finishing it.

My child has been prescribed Vitrakvi — is it safe for kids?

▾
Yes, Vitrakvi is approved for use in children and has been studied specifically in pediatric patients. Dosing for smaller or younger children is calculated based on body surface area — a measure that accounts for size — so it's adjusted to be appropriate for your child. The side effects are generally similar to those in adults, but fractures were slightly more common in children in the studies, so it's important to let your doctor know right away if your child complains of bone pain or a change in how they move.

Is Larotrectinib available over the counter?

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No. Larotrectinib is a prescription medicine: every Larotrectinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Larotrectinib first available?

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The earliest FDA record we hold for Larotrectinib is from 2018: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Larotrectinib was first used.

Who makes Larotrectinib?

▾
2 companies currently list Larotrectinib products in the FDA's NDC Directory, including Bayer HealthCare Pharmaceuticals Inc., Loxo Oncology, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Larotrectinib on HelloPharmacist

📊Larotrectinib supplement interactions143 checked — ranked by severity 🌿Drug & Supplement CheckerLarotrectinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Larotrectinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Larotrectinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Larotrectinib forms and strengths (how it comes)

Larotrectinib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Vitrakvi
How this form is used
What it may be used for
  • Vitrakvi capsules are used to treat adults and children with solid tumors that have an NTRK gene fusion, are metastatic or not safely operable, and have no satisfactory alternative treatments.
  • Vitrakvi capsules are used when the tumor has progressed following prior treatment.
Important instructions
  • Vitrakvi capsules are swallowed whole with water — do not chew or crush them.
  • Vitrakvi capsules can be taken with or without food.
  • If you vomit after taking a Vitrakvi capsule dose, do not take a replacement dose — take your next dose at the scheduled time.
  • Do not take a missed Vitrakvi capsule dose if it is within 6 hours of your next scheduled dose.
Available strengths 2 strengths
25 mg 100 mg
10 FDA-listed product records ⓘ

Oral solution

By mouth · Oropharyngeal
Brands Vitrakvi
How this form is used
What it may be used for
  • Vitrakvi oral solution is used to treat adults and children with solid tumors that have an NTRK gene fusion, are metastatic or not safely operable, and have no satisfactory alternative treatments.
  • Vitrakvi oral solution is used when the tumor has progressed following prior treatment.
Important instructions
  • Vitrakvi oral solution should be stored in the refrigerator in its glass bottle.
  • Discard any unused Vitrakvi oral solution remaining after 90 days of first opening the bottle.
  • Before preparing a dose of Vitrakvi oral solution, refer to the Instructions for Use included with the product.
  • Vitrakvi oral solution can be taken with or without food.
Available strengths 1 strength
20 mg/mL
7 FDA-listed product records ⓘ

Larotrectinib on the U.S. market: products, makers and brands

How Larotrectinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 7 Larotrectinib product records with the FDA, mostly as capsule, oral solution; the earliest marketing or approval year on record is 2018. Brand names on the directory include VitrakviI, Vitrakvi; the rest are generics.

2
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
1
Brand names
7
FDA-listed product records ⓘ
2018
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bayer HealthCare Pharmaceuticals Inc.57%
Loxo Oncology, Inc.43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Larotrectinib is used (Medicaid data)

A general measure of how commonly Larotrectinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Larotrectinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

38
Medicaid prescriptions filled (Q1–Q4 2025)
$1.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Larotrectinib prescribed? Of the 1,601 medications we measure, Larotrectinib ranks #1,555 by Medicaid prescriptions — more than 3% of them.

Where Larotrectinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,555 of 1,601
#1,550 Luliconazole Topical 41 Rx #1,551 Plerixafor Injection 40 Rx #1,552 Sunitinib 39 Rx #1,553 Isavuconazonium Inject... 39 Rx #1,554 Mycophenolate Injectio... 39 Rx #1,555 Apomorphine Injection 38 Rx #1,556 Larotrectinib 38 Rx #1,557 Vitamin A 38 Rx #1,558 Diphenhydramine / Ibup... 36 Rx #1,559 Amoxapine 35 Rx #1,560 Mecasermin Injection 35 Rx

Utilization by Larotrectinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral capsule is the most-dispensed Larotrectinib product — about 71% of these Medicaid prescriptions.

larotrectinib 100 MG Oral Capsule Most dispensed

27 Medicaid prescriptions (Q1–Q4 2025) 71% of Larotrectinib prescriptions shown $969,074 gross reimbursement (before rebates) ≈ $35,892 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2105633

larotrectinib 20 MG/ML Oral Solution

11 Medicaid prescriptions (Q1–Q4 2025) 29% of Larotrectinib prescriptions shown $432,567 gross reimbursement (before rebates) ≈ $39,324 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2105649

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Larotrectinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 8 listed Larotrectinib NDCs with Medicaid activity.

Compare Larotrectinib products

A representative set of FDA-listed product records for Larotrectinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
25 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
100 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
25 mg Oral Loxo Oncology, Inc. NDA View NDC →
100 mg Oral Loxo Oncology, Inc. NDA View NDC →
💊Oral solution
20 mg/mL Oropharyngeal Bayer HealthCare Pharmaceuticals Inc. × 2 listings NDA View NDC →
20 mg/mL Oral Loxo Oncology, Inc. NDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Larotrectinib NDCs →

Larotrectinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Larotrectinib recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class I Nov 6, 2023 · Terminated · Bayer Healthcare Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
  • VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01 Lots: Lot# 2114228, EXP. 02/29/2024 FDA record D-0145-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Larotrectinib RxCUI 2105628 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2105632 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 2105655 100 MG RxCUI 2105633
  2. Dose form (SCDF) Oral Solution RxCUI 2105648 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 2105649

Look up RxCUI 2105628 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Larotrectinib brand names

Larotrectinib is sold under 2 brand names in the FDA directory — VitrakviI, Vitrakvi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

VitrakviI Vitrakvi

Who makes Larotrectinib: manufacturers and labelers

2 companies list Larotrectinib products with the FDA. By number of product records, the largest are Bayer HealthCare Pharmaceuticals Inc., Loxo Oncology, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bayer HealthCare Pharmaceuticals Inc. 4 Loxo Oncology, Inc. 3

Larotrectinib drug class (RxNorm)

Larotrectinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works Tropomyosin Receptor Kinases Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Larotrectinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 22, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Larotrectinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Larotrectinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
7
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Bayer HealthCare Pharmaceuticals Inc.
Linked label effective
May 22, 2026
Composite sections available
23
Linked SPL Set ID
0c8ca614-58b2-4aa4-83d3-0387a8f782fd
Linked SPL Document ID
0e3ba6e7-af8d-4840-9409-a537a09e1263
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bayer HealthCare Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →