Leaflet VITRAKVI 100mg capsules

Product code:
W71904001
Quantity:
56
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 100mg

Substance:
larotrectinib
Date of latest medicines list:
01-06-2026
Product code:
W71904001
Concentration:
100mg
Pharmaceutical form:
capsules
Quantity:
56
Product type:
Generic medicine
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:
1229/2026/01
Shelf life:
4 years

Pharmaceutical forms available for larotrectinib

Concentrations available for larotrectinib

  • 100mg
  • 20mg/ml