Imamed

Imamed

imatinib

Manufacturer:

Shilpa Medicare

Distributor:

Unimed
Concise Prescribing Info
Contents
Imatinib mesylate
Indications/Uses
Newly diagnosed chronic myeloid leukaemia (CML) & CML in blast crisis, accelerated phase or in chronic phase after failure of interferon-α therapy. Unresectable &/or metastatic malignant GI stromal tumours (GIST). Newly diagnosed Philadelphia chromosome +ve acute lymphoblastic leukaemia (Ph+ ALL) integrated w/ chemotherapy. Relapsed or refractory Ph+ ALL as monotherapy. Myelodysplastic/-proliferative diseases (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene rearrangements. Hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukaemia (CEL) w/ FIP1L1-PDGFRα rearrangement. Unresectable, recurrent &/or metastatic dermatofibrosarcoma protuberans (DFSP). Aggressive systemic mastocytosis (ASM) w/o D816V c-Kit mutation or w/ c-Kit mutational status unknown. Adjuvant treatment of adults following GIST resection.
Dosage/Direction for Use
Adult Chronic phase CML, GIST 400 mg daily, may be increased to 600-800 mg daily. Accelerated phase or blast crisis CML 600 mg daily, may be increased to max: 800 mg daily. Ph+ ALL 600 mg daily. MDS/MPD, ASM, HES/CEL 400 mg daily. ASM w/ eosinophilia, HES/CEL w/ demonstrated FIP1L1-PDGFRα fusion kinase Initially 100 mg daily, may be increased to 400 mg daily. Adjuvant treatment following GIST resection 400 mg daily. DFSP 800 mg daily. Childn Chronic & advanced phase CML & Ph+ ALL 340 mg/m2 daily. Renal dysfunction, on dialysis & mild, moderate or severe hepatic impairment Min recommended dose: 400 mg daily.
Administration
Should be taken with food: Swallow whole w/ glass of water to minimize GI disturbances. For patients w/ difficulty swallowing, dissolve completely in glass of water/apple juice & drink immediately.
Contraindications
Special Precautions
Patients w/ cardiac disease, risk factors for cardiac failure; tumor lysis syndrome. Screen for hepatitis B infection prior to initiation. Monitor HBV carriers for signs & symptoms of active hepatitis B infection. Perform CBC & monitor liver function regularly. Evaluate renal function prior to & closely monitor during therapy. Concomitant use w/ rifampicin or other strong CYP3A4 inducers, ketoconazole or other strong CYP3A4 inhibitors, CYP3A4 substrates (eg, cyclosporin or pimozide) or CYP2C9 substrates (eg, warfarin & other coumarin derivatives) w/ narrow therapeutic window. May affect ability to drive & use machines. Hepatotoxicity; renal failure. Women of childbearing potential should use effective contraception during & for at least 15 days after last dose. Pregnancy. Not recommended during lactation. Childn w/ CML <2 yr; w/ Ph+ALL <1 yr. Growth retardation in childn & pre-adolescents.
Adverse Reactions
Neutropenia, thrombocytopenia, anaemia; headache; nausea, diarrhoea, vomiting, dyspepsia, abdominal pain; periorbital oedema, dermatitis/eczema/rash; muscle spasm & cramps, musculoskeletal pain eg, myalgia, arthralgia, bone pain; fluid retention & oedema, fatigue; increased wt. 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, gastrooesophageal reflux, constipation, dry mouth, gastritis; increased hepatic enzymes; pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction; joint swelling; weakness, pyrexia, anasarca, chills, rigors; decreased wt.
Drug Interactions
Decreased plasma conc w/ CYP3A4 inducers eg, dexamethasone, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, rifampicin, phenobarb, primidone, Hypericum perforatum (St. John's wort). Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, erythromycin, clarithromycin. Increased mean Cmax & AUC of simvastatin. Increased plasma conc of other CYP3A4-metabolized drugs eg, triazolobenzodiazepines, dihydropyridine Ca-channel blockers, certain HMG-CoA reductase inhibitors ie, statins. Prothrombin time prolongation w/ warfarin. Concomitant use w/ CYP3A4 substrates w/ narrow therapeutic window eg, cyclosporine, pimozide.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Imamed FC tab 100 mg
Packing/Price
3 × 10's;6 × 10's
Form
Imamed FC tab 400 mg
Packing/Price
3 × 10's
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