GILMAT

What it is

GILMAT contains imatinib as mesilate and is available as 100 mg or 400 mg film-coated tablets.

Approved indications —

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

Dosing varies by indication. For chronic phase CML, the recommended dose is 400 mg daily. For accelerated phase or blast crisis CML, 600 mg daily is recommended. For Ph+ ALL, 600 mg daily is recommended. For MDS/MPD, the initial dose is 400 mg daily. For HES/CEL, the initial dose is 400 mg daily. For unresectable and/or metastatic GIST, 400 mg daily or 600 mg daily is recommended. For DFSP, 800 mg daily is recommended. GILMAT should be administered orally with a meal and a large glass of water to minimise gastrointestinal disturbances.

Key safety warnings

Severe non-haematological adverse reactions such as severe hepatotoxicity or severe fluid retention require withholding GILMAT until resolution. If bilirubin levels exceed 3 times the institutional upper limit of normal or liver transaminases exceed 5 times the upper limit, GILMAT should be withheld until bilirubin returns to below 1.5 times normal and transaminases to below 2.5 times normal. Treatment may then be resumed at a reduced daily dose, with adults reducing from 400 mg to 300 mg, from 600 mg to 400 mg, or from 800 mg to 600 mg.

Contraindications

No contraindication information is provided in the source documents.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

GILMAT was first registered on the ARTG on 14 November 2017. Four variants are registered: 100 mg film-coated tablets in blister pack and bottle, and 400 mg film-coated tablets in blister pack and bottle.