Cytonib 400

Cytonib 400



Hetero Labs


Concise Prescribing Info
Imatinib mesilate
Newly diagnosed Philadelphia chromosome +ve (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the 1st line of treatment; Ph+ CML in chronic phase after failure of interferon-α therapy or in accelerated phase or blast crisis in adult & childn. Newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) integrated w/ chemotherapy; relapsed or refractory Ph+ ALL as monotherapy; myelodysplastic/myeloproliferative diseases (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene re-arrangements; advanced hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukaemia (CEL) w/ FIP1L1-PDGFRα rearrangement in adult. Adult w/ unresectable dermatofibrosarcoma protuberans (DFSP) & w/ recurrent &/or metastatic DFSP who are not eligible for surgery.
Dosage/Direction for Use
Adult Chronic phase CML 400 mg/day. Accelerated phase CML, blast crisis 600 mg/day. Ph+ ALL 600 mg/day as monotherapy or in combination w/ chemotherapy in the induction, consolidation & maintenance phases. Relapse or refractory Ph+ ALL 600 mg/day as monotherapy. MDS/MPD 400 mg/day for 24 days-60 mth. HES/CEL 100 mg/day. May increase to 400 mg. DFSP 800 mg/day. Childn Chronic phase & advanced phase CML 340 mg/m2 daily. May increase to 570 mg/m2 daily (not to exceed total dose of 800 mg).
Should be taken with food: Take w/ meals & a full glass of water to minimise GI discomfort. For patients w/ swallowing difficulties, tab may be dispersed in water/apple juice. Disperse each 100 mg tab in 50 mL of water & each 400 mg tab in 200 mL of water. Stir & administer after complete disintegration of tab.
Special Precautions
Concomitant use w/ ketoconazole or other strong CYP3A4 inhibitors, cyclosporin or pimozide, warfarin & other coumarin derivatives, strong CYP3A4 inducers. Monitor TSH levels in patients w/ hypothyroidism; hepatic function. Occurrences of severe fluid retention, tumor lysis syndrome. Correction of clinically significant dehydration & treatment of high uric acid levels are recommended prior to initiation of therapy. Perform CBC regularly. Patients w/ cardiac dysfunction, cardiac disease, risk factor for cardiac failure or history of renal failure. Childn <2 yr.
Adverse Reactions
Neutropenia, thrombocytopenia, anaemia; headache; nausea, diarrhea, vomiting, dyspepsia, abdominal pain. Pancytopenia, febrile neutropenia; anorexia; insomnia; dizziness, paraesthesia, taste disturbance, hypoaesthesia; eyelid oedema, increased lacrimation, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision; flushing, haemorrhage; dyspnoea, epistaxis, cough; flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis.
Drug Interactions
Decreased metabolism & increased conc w/ ketoconazole, itraconazole, erythromycin, clarithromycin. Reduce exposure & increase risk of therapeutic failure w/ dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, fosphenytoin, primidone or St. John's Wort. Increase mean Cmax & AUC of simvastatin, cyclosporin or pimozide. Increase plasma conc of triazolo-benzodiazepines, dihydropyridine Ca channel blockers, certain HMG-CoA reductase inhibitors. Paracetamol. Decrease plasma exposure of levothyroxine.
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Cytonib 400 FC tab 400 mg
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