Imatero

Imatero

imatinib

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Imatinib
Indications/Uses
Newly diagnosed Philadelphia chromosome (Bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) as well as patients w/ Ph+ CML in chronic phase after failure of interferon-α therapy, or in blast crisis, accelerated phase. Adult & ped >1 yr w/ newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemaia (Ph+ ALL) integrated chemotherapy. Adult patients w/ relapsed or refractory Ph+ ALL as monotherapy. Adult patients w/ myelodysplastic/myeloproliferative disease (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients w/ systemic mastocytosis (SM) w/o the D816V c-Kit mutation or w/ c-Kit mutational status unknown. Adult patients w/ hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukemia (CEL). Adult patients w/ unresectable, recurrent &/or metastatic dermatofibrosarcoma protuberans (DFSP).
Dosage/Direction for Use
CML Chronic phase: 400 mg/day. Accelerated phase or blast crisis: 600 mg/day. Max: 800 mg/day. Adult Ph+ ALL 600 mg/day. MDS/MPD, SM, HES/CEL 400 mg/day. DFSP 800 mg/day. Non-haematological AR Reduce dose from 400 to 300 mg, or from 600 to 400 mg or 800 mg to 600 mg. Childn Ph+ ALL Chronic & advanced phase: 340 mg/m2/day. Max: 600 mg/day. Mild, moderate or severe liver dysfunction 400 mg/day. Renal insufficiency 400 mg/day.
Administration
Should be taken with food: Take w/ meals to minimise GI irritation.
Contraindications
Special Precautions
Monitor TSH levels in thyroidectomy patients undergoing levothyroxine replacement. Severe fluid retention may occur in newly diagnosed CML patients. Patients w/ cardiac disease & risk factors, or signs & symptoms of cardiac failure. Perform ECG & serum troponin level determination in HES/CEL/MDS/MPD, or SM associated w/ high level of eosinophils; if either is abnormal, consider prophylactic use of systemic steroids for 1-2 wk concomitantly w/ imatinib at the start of therapy. Correct significant dehydration & treatment of high uric acid level prior to therapy. May affect ability to drive or use machines. Closely monitor peripheral blood counts & liver enzymes in patients w/ hepatic dysfunction. Women of childbearing potential must use highly effective contraception during treatment. Pregnancy & lactation. Closely monitor growth during therapy in childn.
Adverse Reactions
Myelosuppression, thrombocytopenia, neutropenia, anemia, pancytopenia, lymphopenia, bone marrow depression. CNS & GI hemorrhages. Edema, fluid retention. Generalized erythematous, maculopapular, pruritic skin rash. Hepatotoxicity. Low serum phosphate, hypophosphatemia. GI ulceration. Tumor lysis syndrome. Growth retardation in childn. Acute resp failure, pulmonary HTN, interstitial lung disease, pulmonary fibrosis.
Drug Interactions
Decreased plasma conc w/ CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, or Hypericum perforatum (St. John's wort). Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, erythromycin, clarithromycin. May increase plasma conc of triazolobenzodiazepines, dihydropyridine Ca channel blockers, certain HMG-CoA reductase inhibitors ie, statins. Co-administration w/ CYP3A4 substrates w/ narrow therapeutic window eg, cyclosporine or pimozide. Inhibits CYP2C9 & CYP2C19. May prolong PT w/ warfarin.
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Imatero FC tab 100 mg
Packing/Price
6 × 10's
Form
Imatero FC tab 400 mg
Packing/Price
1 × 10's
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