Leaflet BOSUTINIB TEVA 400mg film-coated tablets


Indicated for: chronic myeloid leukemia

Route of administration: oral

Substance: bosutinib (tyrosine kinase inhibitor)

ATC: L01EA04 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | BCR-ABL tyrosine kinase inhibitors)

Bosutinibum is a medication used for the treatment of chronic myeloid leukemia (CML) in adult patients with BCR-ABL gene mutations. It is a tyrosine kinase inhibitor that blocks the abnormal activity of the BCR-ABL protein, which drives the uncontrolled growth of leukemic cells.

The medication is taken orally, usually once daily, as directed by a doctor. The dosage may be adjusted based on the patient's response and tolerance to treatment.

Common side effects include nausea, diarrhea, vomiting, fatigue, and elevated liver enzyme levels. In rare cases, more severe adverse effects such as liver toxicity or fluid retention may occur.

Bosutinibum is not recommended for pregnant or breastfeeding women, as it may affect fetal development. Patients should inform their doctor about all medications they are taking to avoid drug interactions.

General data about BOSUTINIB TEVA 400mg

  • Substance: bosutinib
  • Date of last drug list: 01-02-2025
  • Commercial code: W70810001
  • Concentration: 400mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: PHARMADOX HEAITHCARE LTD - MALTA
  • Holder: TEVA PHARMACEUTICALS S.R.L. - ROMANIA
  • Number: 15735/2024/01
  • Shelf life: 2 years

Concentrations available for bosutinib

  • 100mg
  • 400mg
  • 500mg