Leaflet LYTGOBI 4mg film-coated tablets

Indicated for: cholangiocarcinoma

Route of administration: oral

Substance: futibatinib (tyrosine kinase inhibitor)

ATC: L01EN04 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

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.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

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.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Futibatinib is a medication used to treat certain cancers, particularly cholangiocarcinoma (bile duct cancer), in patients with an FGFR2 gene mutation. It works by blocking FGFR receptors, which are involved in the uncontrolled growth of cancer cells.

The drug is taken orally as tablets, and the dose is determined by the doctor based on the patient's condition and the stage of the disease. Treatment is ongoing and requires regular medical assessments to monitor its effectiveness and safety.

Common side effects include nausea, dry mouth, diarrhea, fatigue, and changes in blood phosphate levels. In some cases, eye or liver problems may occur, so regular check-ups, including ophthalmological evaluations, are recommended.

Futibatinib provides a valuable option for patients with rare and hard-to-treat cancers, but its use must be closely monitored by healthcare professionals to prevent and manage possible complications.

General data about LYTGOBI 4mg

  • Substance: futibatinib
  • Date of latest medicines list: 01-06-2026
  • Product code: W71199001
  • Concentration: 4mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 35
  • Product type: Generic medicine
  • Price: 14721.95 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PCI PHARMA SERVICES - IRLANDA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 1066/2025/01
  • Shelf life: 4 years