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)

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.

Bosutinib 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.

Bosutinib 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 latest medicines list: 01-02-2025
  • Product code: W70810001
  • Concentration: 400mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • 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: 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