• Solid tumors

Vitrakvi Generic Name & Formulations

General Description

Larotrectinib 25mg, 100mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—60; Oral soln—100mL


Generic Availability


Vitrakvi Indications


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.

Vitrakvi Dosage and Administration

Adults and Children

Confirm presence of a NTRK gene fusion in tumor specimens. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: continue until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Concomitant moderate CYP3A4 inducers: double Vitrakvi dose. Moderate to severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Vitrakvi Contraindications

Not Applicable

Vitrakvi Boxed Warnings

Not Applicable

Vitrakvi Warnings/Precautions


Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Vitrakvi Pharmacokinetics




Fecal (58%), renal (39%). Half-life: 2.9 hours.

Vitrakvi Interactions


Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Potentiated by moderate CYP3A4 inhibitors; monitor more frequently and reduce dose based on severity of adverse reactions. Antagonized by strong or moderate CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Vitrakvi Adverse Reactions

Adverse Reactions

Increased AST/ALT, anemia, musculoskeletal pain, fatigue, hypoalbuminemia, neutropenia, increased alkaline phosphatase, cough, leukopenia, constipation, diarrhea, dizziness, hypocalcemia, nausea, vomiting, pyrexia, lymphopenia, abdominal pain.

Vitrakvi Clinical Trials

See Literature

Vitrakvi Note

Not Applicable

Vitrakvi Patient Counseling

See Literature