IMADEV

*Treatment of chronic myeloid leukaemia in chronic phase after failure with interferon alfa:* Adult: 400 mg once daily, increased if necessary up to 800 mg daily in 2 divided doses. *Treatment of chronic myeloid leukaemia in accelerated phase, or in blast crisis:* Adult: 600 mg once daily, then increased if necessary up to 800 mg daily in 2 divided doses. Children over 3 yrs: 260 mg/m2 daily as a single dose or in two divided doses; max 400 mg daily; In advanced phase:340 mg/m2 daily as a single dose or in two divided doses; max 600 mg daily. *Treatment of newly diagnosed acute lymphoblastic leukaemia (in combination with other chemotherapy), Monotherapy for relapsed or refractory acute lymphoblastic leukaemia:* Adult: 600 mg once daily. *Treatment of c-kit (CD117)-positive unresectable or metastatic malignant gastro-intestinal stromal tumours (GIST), Adjuvant treatment following resection of c-kit (CD117)-positive GIST, in patients at significant risk of relapse, Treatment ofmyelodysplastic/myeloproliferative diseases associatedwith platelet-derived growth factor receptor genere arrangement:* Adult: 400 mg once daily. *Treatment of unresectable dermatofibrosarcoma protuberans, Recurrent or metastatic dermatofibrosarcoma protuberans, when surgery is not possible:* Adult: 800 mg daily in 2 divided doses. *Treatment of advanced hypereosinophilic syndrome and chronic eosinophilic leukaemia:* Adult: 100-400 mg once daily.

Cardiac disease, hepatitis B infection, history of renal failure, risk factors for heart failure, hepatic or severe renal impairment. Monitor for gastrointestinal haemorrhage, complete blood counts, fluid retention and liver function regularly. Contraception must be used.

Warfarin, drugs that affect or affected by CYP3A4 or CYP2D6, paracetamol, levothyroxine, phenytoin, phenobarbital, carbamazepine, rifampin.

Abdominal pain, arthralgia, ascites, conjunctivitis, cramps, GI upset, dry eyes, mouth, and skin, dyspnea, epistaxis, fatigue, flushing, gastro-oesophageal reflux, haemorrhage, headache, hypoaesthesia, increased lacrimation, influenza-like symptoms, insomnia, oedema, paraesthesia, photosensitivity, pleural effusion, pruritus, pulmonary oedema, rash, sweating, taste disturbance, visual disturbances, weight changes, acute respiratory failure, depression, drowsiness, dysphagia, gout, gynaecomastia, haematoma ,heart failure, hepatic dysfunction, hepatitis, hypertension, hypotension, impaired memory, menorrhagia, migraine, palpitation, pancreatitis, peripheral neuropathy, renal failure, sexual dysfunction, skin hyperpigmentation, syncope, tachycardia, tinnitus, tremor, urinary frequency, vertigo, alopecia, bone-marrow suppression, growth retardation in children, hepatitis B reactivation, hyperuricaemia, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting. Rare: hepatic failure (fatal cases reported), hepatic necrosis, rhabdomyolysis, Stevens-Johnson syndrome