ARX-IMATINIB

What it is

ARX-IMATINIB contains imatinib as mesilate and is available as film-coated tablets in 100 mg and 400 mg strengths.

Approved indications ARX-IMATINIB is indicated for:

— 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

ARX-IMATINIB therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate. The prescribed dose should be administered orally, with a meal and a large glass of water to minimise the risk of gastrointestinal disturbances. 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 a day, in the morning and in the evening. Treatment should be continued as long as the patient continues to benefit.

Key safety warnings

If a severe non-haematological adverse drug reaction develops (such as severe hepatotoxicity or severe fluid retention), ARX-IMATINIB should be withheld until the event has resolved, and treatment can then be resumed as appropriate depending on the initial severity of the event. If elevations in bilirubin greater than 3 times the institutional upper limit of normal or in liver transaminases greater than 5 times the institutional upper limit of normal occur, ARX-IMATINIB should be withheld until bilirubin levels have returned to less than 1.5 times the institutional upper limit of normal and transaminase levels to less than 2.5 times the institutional upper limit of normal, and treatment may then be continued at a reduced daily dose, with adult doses reduced from 400 mg to 300 mg, from 600 mg to 400 mg, or from 800 mg to 600 mg.

Regulatory history

ARX-IMATINIB was first registered on the ARTG on 11 August 2016 with three variant entries for 50 mg, 100 mg and 400 mg capsule formulations.