Chronic myeloid leukaemia (CML) Philadelphia chromosome (bcr-abl) positive (Ph+)

Active Ingredient: Imatinib

Indication for Imatinib

Population group: only adults (18 years old or older)

Imatinib is indicated for the treatment of:

  • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
  • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

For this indication, competent medicine agencies globally authorize below treatments:

400-800 mg in 1-2 divided doses daily


Dosage regimens

Oral, between 200 milligrams imatinib and 400 milligrams imatinib, 2 times daily.

Detailed description

The recommended dosage of imatinib is 400 mg/day for adult patients in chronic phase CML. Chronic phase CML is defined when all of the following criteria are met: blasts <15% in blood and bone marrow, peripheral blood basophils <20%, platelets >100 × 109/l.

The recommended dosage of imatinib is 600 mg/day for adult patients in accelerated phase. Accelerated phase is defined by the presence of any of the following: blasts ≥15% but <30% in blood or bone marrow, blasts plus promyelocytes ≥30% in blood or bone marrow (providing <30% blasts), peripheral blood basophils ≥20%, platelets <100 × 109/l unrelated to therapy.

The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis. Blast crisis is defined as blasts ≥30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.

Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression. The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.

Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.

Dosage considerations

The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.

Active ingredient


Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.

Read more about Imatinib

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