What is VITRAKVI used for?

VITRAKVI is used to treat adults and children with solid tumors that have an NTRK gene fusion.

Can VITRAKVI cause dizziness or mood changes?

Yes, VITRAKVI may cause central nervous system effects like dizziness, mood disorders, or sleep disturbances.

Is VITRAKVI safe to take while pregnant?

No, VITRAKVI can cause harm to a developing fetus and should be used with caution and effective birth control.

Does VITRAKVI affect the liver?

Yes, VITRAKVI can cause liver issues, so regular blood tests to monitor liver function are required.

Can VITRAKVI increase the risk of broken bones?

Yes, skeletal fractures are a known risk, and you should report any bone pain to your doctor.

How should I take VITRAKVI?

It is usually taken as a pill twice a day, either with or without food.

Can I drive while taking VITRAKVI?

You should not drive or operate machinery if you experience dizziness or other neurological side effects from VITRAKVI.

Are there interactions with other medicines?

Yes, medicines that affect the CYP3A4 enzyme can change how VITRAKVI works in your body.

larotrectinib | CAS 1223403-58-4 | NYNZQNWKBKUAII

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Kinase inhibitor

VITRAKVI (larotrectinib) is a medicine used to treat adult and pediatric patients with solid tumors that have a specific genetic change called an NTRK gene fusion. It is intended for patients whose cancer is metastatic (has spread) or cannot be easily removed by surgery, and for whom there are no other good treatment options.

How it worksVITRAKVI works by blocking a specific protein called a neurotrophic receptor tyrosine kinase (NTRK) that helps cancer cells grow.

Brand names:VITRAKVI

Used for

Solid tumors with an NTRK gene fusionMetastatic solid tumors with NTRK gene fusionSolid tumors where surgery is not a good option and an NTRK gene fusion is present

Conditions

Solid tumors with NTRK gene fusion

Class

Kinase inhibitorNervous systemSkeletal systemHepatic

How to take

FormsOral

RoutesOral, Oropharyngeal

For adults and children with a body surface area of 1 m² or more, the dose is 100 mg taken by mouth twice daily. For children with a body surface area less than 1 m², the dose is 100 mg/m² taken by mouth twice daily. It can be taken with or without food.

Treatment continues until the cancer progresses or the patient experiences unacceptable side effects.

Key warnings

·Brain and nerve effects: VITRAKVI may cause dizziness, difficulty thinking, mood changes, or sleep issues. Do not drive or use heavy machinery if you feel these effects.
·Bone fractures: There is a risk of broken bones; report any bone pain or changes in how you move to your doctor.
·Liver health: You will need regular blood tests to check your liver function.
·Pregnancy risk: This drug can cause harm to a fetus. Use effective birth control while taking it.

Do not use if

·None listed

Side effects

Common

Increased liver enzymes (AST, ALT, ALP)AnemiaLow protein levels (hypoalbuminemia)Muscle or bone painLow white blood cell counts (leukopenia, lymphopenia, neutropenia)Low calcium levels (hypocalcemia)FatigueVomitingCoughConstipationFever (pyrexia)DiarrheaNauseaStomach painDizzinessRash

Serious

·Central Nervous System (CNS) issues like dizziness, mood changes, or sleep problems
·Bone fractures
·Liver problems (hepatotoxicity)
·Harm to an unborn baby (embryo-fetal toxicity)

Seek help if

·Dizziness or confusion
·Severe bone pain
·Yellowing of eyes/skin (jaundice)
·Signs of infection

Interactions

·Avoid taking VITRAKVI with strong CYP3A4 inhibitors unless the dose is reduced.
·Avoid taking VITRAKVI with strong CYP3A4 inducers unless the dose is increased.
·Monitor closely if taking moderate CYP3A4 inhibitors or inducers.

FoodVITRAKVI can be taken with or without food.

Special populations

PregnancyVITRAKVI can cause harm to an unborn baby. Pregnant women should be aware of this risk, and people of reproductive age should use effective contraception.

PediatricVITRAKVI is approved for use in both adult and pediatric patients with certain NTRK gene fusion tumors. Its safety and effectiveness have been studied in children.

GeriatricNo major differences in how safe or effective VITRAKVI is were found in patients aged 65 and older compared to younger adults.

Talk to your doctor

Monitor

·Liver function (ALT, AST, ALP, bilirubin)
·Signs of bone pain or fractures
·Neurological changes (dizziness, mood, sleep)
·Blood counts (anemia, white blood cell levels)

Questions to ask

·Should I have my liver function tested regularly while on VITRAKVI?
·How will VITRAKVIs affect my ability to drive or work?
·What birth control should I use while taking VITRAKVIs?
·Are there any specific foods or medicines I must avoid with VITRAKVIs?

Pharmacokinetics

MetabolismSubject to CYP3A4 metabolism

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-26.