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)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

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 latest medicines list: 01-06-2026
  • Product code: W71213001
  • Concentration: 20mg / ml
  • Pharmaceutical form: oral solution
  • Quantity: 2
  • Product type: Generic medicine
  • Price: 12488.27 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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