Imaccord

Adult & paed patients w/ newly diagnosed Philadelphia chromosome +ve chronic myeloid leukaemia (Ph+ CML); Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-α therapy. Adult patients w/ relapsed or refractory Philadelphia chromosome +ve acute lymphoblastic leukemia (Ph+ ALL) as monotherapy; w/ Kit+ (CD117) unresectable &/or metastatic malignant GI stromal tumours (GIST). Paed patients w/ newly diagnosed Ph+ ALL integrated w/ chemotherapy. Adjuvant treatment of adult patients following complete gross resection of Kit+ GIST.

Adult Chronic phase CML 400 mg once daily. May be increased to 600 mg. Accelerated phase or blast crisis CML 600 mg once daily. May be increased to a max of 800 mg daily. Relapsed/refractory Ph+ ALL 600 mg daily. Unresectable &/or metastatic, malignant GIST 400 mg daily. May be increased to 600 or 800 mg in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Continue treatment until disease progression. Adjuvant treatment following resection of GIST 400 mg daily. Childn Newly diagnosed Ph+ CML, Ph+ ALL in combination w/ chemotherapy & advanced phase CML 340 mg/m² daily. Max: 600 mg daily. Chronic phase CML 260 mg/m² daily. Max: 400 mg daily. May be given as once daily dose in CML & Ph+ ALL. In CML, alternatively daily dose may be split into 2 administrations (1 in morning & 1 in evening). Hepatic impairment: Severe Initially 300 mg daily, mild or moderate Min: 400 mg daily. Patient w/ renal dysfunction or on dialysis Min: 400 mg daily as starting dose.

Should be taken with food: Take w/ large glass of water to minimize risk of GI disturbances. For patient unable to swallow, tab may be dispersed in glass of water or apple juice. Place required number of tab in appropriate vol of beverage (approx 50 mL for 100 mg tab & 200 mL for 400 mg tab) & stir until fully disintegrated. Take susp immediately.

Hypersensitivity.

Targeted Cancer Therapy

L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.

POM