Leaflet NODRIGA 50mg film-coated tablets


Indicated for: chronic myeloid leukemia

Route of administration: oral

Substance: dasatinib (tyrosine kinase inhibitor)

ATC: L01EA02 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | BCR-ABL 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.

Dasatinib is a medication used for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positivity. It acts as a tyrosine kinase inhibitor, blocking signals that promote cancer cell growth.

The medication is taken orally, usually once daily, and is effective in reducing the number of leukemic cells and prolonging patient survival. It is used in both chronic and advanced phases of the disease.

Side effects may include fluid retention, nausea, diarrhea, fatigue, and muscle pain. In rare cases, severe complications such as pulmonary hypertension or bone marrow suppression may occur. Regular monitoring is essential.

Consult your doctor to discuss the benefits and risks of treatment with Dasatinib. Follow the prescribed dosage and adhere to all medical recommendations.

General data about NODRIGA 50mg

  • Substance: dasatinib
  • Date of last drug list: 01-06-2026
  • Commercial code: W69073002
  • Concentration: 50mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 60
  • Product type: generic
  • Price: 4658.67 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: ALKALOID-INT D.O.O. - SLOVENIA
  • Holder: ALKALOID-INT D.O.O. - SLOVENIA
  • Number: 14104/2021/02
  • Shelf life: 3 years

Concentrations available for dasatinib

  • 100mg
  • 111mg
  • 140mg
  • 16mg
  • 20mg
  • 40mg
  • 50mg
  • 55mg
  • 63mg
  • 70mg
  • 79mg
  • 80mg

Compensation lists for NODRIGA 50mg Alkaloid

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

4658.67 RON

4658.67 RON

0.00 RON