Hronileucem

Description

Hronileucem is a medicine containing an active substance called imatinib. This medicine works by inhibiting
the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Indications

Hronileucem is indicated for the treatment of

• 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.

• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

•adult  with Ph+ CML in blast crisis.

• adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

• adult patients with relapsed or refractory Ph+ ALL as monotherapy.

• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.

The effect of Hronileucem on the outcome of bone marrow transplantation has not been determined.

Hronileucem is indicated for

• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.

• the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

In adult and paediatric patients, the effectiveness of Hronileucem is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Hronileucem in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1 of SPC). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Subject to medical prescription

Pharmaceutical form: 100 mg capsules, hard x 120 capsules

NHIF code: ICD:C18; C19; C20; C92.1

Pharmaceutical form: 400 mg capsules, hard x 30 capsules

NHIF code: ICD:C18; C19; C20; C92.1

АТС: L01XЕ01

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