Leaflet BOSUTINIB TEVA 100mg film-coated tablets

Product code:
W70809001
Quantity:
28
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 100mg

Substance:
bosutinib
Date of latest medicines list:
01-02-2025
Product code:
W70809001
Concentration:
100mg
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:
15734/2024/01
Shelf life:
2 years

Concentrations available for bosutinib

  • 100mg
  • 400mg
  • 500mg