Leaflet VITRAKVI 20mg / ml oral solution


Indicated for: cancer

Route of administration: oral

Substance: larotrectinib (antineoplastic agent)

ATC: L01EX12 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Other protein kinase inhibitors)

Larotrectinib is an anticancer medicine used in adults and children with solid tumours that have an NTRK gene fusion. It may be used when the tumour is advanced, metastatic, or cannot be removed by surgery without major harm, and when there are no satisfactory alternative treatments.

The medicine blocks TRK proteins produced by the NTRK fusion. These proteins can send signals that allow cancer cells to keep growing. For this reason, molecular testing of the tumour is required before treatment. The genetic change is more important than the original body site of the cancer.

Larotrectinib is taken by mouth, as capsules or oral solution, usually twice daily as prescribed. Treatment is continued while it is working and tolerated. Regular check-ups are needed, including liver blood tests and assessment of neurological, digestive and general symptoms.

Possible side effects include tiredness, dizziness, nausea, vomiting, constipation, diarrhoea, anaemia and increased liver enzymes. Avoid driving if you feel dizzy or sleepy. Contact your doctor if you notice yellowing of the skin, dark urine, confusion, tingling, fever or symptoms that worsen quickly.

General data about VITRAKVI 20mg / ml

  • Substance: larotrectinib
  • Date of last drug list: 01-05-2026
  • Commercial code: W71213001
  • Concentration: 20mg / ml
  • Pharmaceutical form: oral solution
  • Quantity: 2
  • Product type: generic
  • Price: 12488.27 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: BAYER AG - GERMANIA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 1097/2025/01
  • Shelf life: 2 years

Pharmaceutical forms available for larotrectinib

Concentrations available for larotrectinib

  • 100mg
  • 20mg/ml