IMATINIB-TEVA

What it is

IMATINIB-TEVA contains imatinib as the mesilate salt in film-coated tablets of 100 mg or 400 mg strength.

Approved indications

IMATINIB-TEVA is indicated for the treatment of patients with chronic myeloid leukaemia (CML). Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed. Treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). Treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). Adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Dosing overview

IMATINIB-TEVA should be initiated by a physician experienced in the treatment of haematological malignancies and malignant sarcomas, and should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal disturbances. Dosing varies by indication:

Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice daily, in the morning and in the evening.

Key safety warnings

If a severe non-haematological adverse drug reaction develops, such as severe hepatotoxicity or severe fluid retention, IMATINIB-TEVA should be withheld until the event has resolved, after which treatment can be resumed depending on initial severity. If elevations in bilirubin exceed 3 times the institutional upper limit of normal or in liver transaminases exceed 5 times this limit, IMATINIB-TEVA should be withheld until bilirubin levels return to less than 1.5 times normal and transaminase levels to less than 2.5 times normal, after which treatment may be continued at a reduced daily dose.

Regulatory history

IMATINIB-TEVA imatinib 100 mg film-coated tablets were first listed on the ARTG on 10 June 2016 (ARTG 232234), and imatinib 400 mg film-coated tablets were first listed on 10 June 2016 (ARTG 232242).