GLIVEC

What it is

Glivec contains imatinib as the mesilate salt (beta crystals). The medicine is available as film-coated tablets in strengths of 100 mg or 400 mg of imatinib.

Approved indications

Glivec 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 rearrangements, 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

For adults with chronic phase CML, the recommended dosage is 400 mg per day, and for patients in accelerated phase or blast crisis, 600 mg per day. For adult patients with Ph+ ALL, the recommended dose is 600 mg per day. For MDS/MPD and ASM, the recommended initial dose is 400 mg per day, and for HES/CEL and unresectable and/or metastatic GIST, 400 mg per day or 600 mg per day. For DFSP, the recommended dose is 800 mg per day. For adjuvant treatment of GIST following resection, the recommended dose is 400 mg per day. The prescribed dose should be administered orally, with a meal and a large glass of water to minimise the risk of gastrointestinal disturbances.

Key safety warnings

Glivec is often associated with oedema and occasionally serious fluid retention. Severe fluid retention (pleural effusion, pericardial effusion, pulmonary oedema, ascites) was reported in 2 to 8 per cent of patients taking Glivec for CML, and severe superficial oedema was reported in 2 to 5 per cent of patients with CML. Treatment of CML patients with Glivec has been associated with neutropenia, thrombocytopenia and anaemia. The occurrence of these cytopenias is dependent on the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis compared to patients with chronic phase CML. In Phase III studies in patients with unresectable or metastatic malignant GIST, 211 patients (12.9 per cent) reported Grade 3/4 haemorrhage at any site, and in a Phase II study, eight patients (5.4 per cent) had gastrointestinal haemorrhage with seven patients (5 per cent) suffering events of grade III/IV severity. Patients should be monitored for gastrointestinal symptoms at the start of and during therapy with Glivec. When needed, Glivec discontinuation may be considered. Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving imatinib. Some cases of hepatitis B reactivation resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome. Patients should be tested for hepatitis B infection before initiating treatment with imatinib.

Contraindications

Use in patients with hypersensitivity to the active substance or to any of the excipients is contraindicated.

PBS listing

Glivec 100 mg tablets are listed on the PBS with 18 items under streamlined and authority required restrictions, at an ex-manufacturer price of A$80.03. Glivec 400 mg tablets are listed on the PBS with 18 items under streamlined and authority required restrictions, at an ex-manufacturer price of A$160.05.

Regulatory history

Glivec was first listed on the ARTG on 17 December 2003, with both the 100 mg and 400 mg tablets registered under licence category RE. In May 2025, the PBAC recommended changes to the GIST listing circumstances, including consolidation of listings for GIST into a single Authority Required (Streamlined) listing and removal of the note 'No increase in the maximum number of repeats may be authorised'.