Leukenib 100 mg (Tablet)

Unit Price: ৳ 100.00 (3 x 10: ৳ 3,000.00)

Strip Price: ৳ 1,000.00

Medicine Details

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements
Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown
Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR a fusion kinase
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans
Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors
Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST

Small molecule protein-tyrosine kinase inhibitor
Inhibits the activity of the Bcr-Abl tyrosine kinase (TK)
Inhibits several receptor tyrosine kinases: Kit, the receptor for stem cell factor (SCF), the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R), the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta)
Can inhibit cellular events mediated by activation of these receptor kinases
Well absorbed after oral administration with Cmax achieved within 2-4 hours post-dose
Mean absolute bioavailability is 98%
Mean Imatinib AUC increases proportionally with increasing doses ranging from 25 mg to 1,000 mg
Metabolized by CYP3A4 with minor role of other cytochrome P450 enzymes
Major active metabolite in humans is the N-demethylated piperazine derivative
Elimination is predominately in feces, mostly as metabolites
Elimination half-lives of Imatinib and its major active metabolite are approximately 18 and 40 hours, respectively

Adults with Ph+ CML CP: 400 mg/day
Adults with Ph+ CML AP or BC: 600 mg/day
Pediatrics with Ph+ CML CP: 340 mg/m2/day
Adults with Ph+ ALL: 600 mg/day
Pediatrics with Ph+ ALL: 340 mg/m2/day
Adults with MDS/MPD: 400 mg/day
Adults with ASM: 100 mg/day or 400 mg/day
Adults with HES/CEL: 100 mg/day or 400 mg/day
Adults with DFSP: 800 mg/day
Adults with metastatic and/or unresectable GIST: 400 mg/day
Adjuvant treatment of adults with GIST: 400 mg/day
Patients with mild to moderate hepatic impairment: 400 mg/day
Patients with severe hepatic impairment: 300 mg/day
All doses of Imatinib should be taken with a meal and a large glass of water
Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day
Can be dissolved in water or apple juice for patients having difficulty swallowing

Concomitant administration of Leukenib and strong CYP3A4 inducers may reduce total exposure of imatinib
Concomitant administration of Leukenib and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase
Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice
Interactions with drugs metabolized by CYP3A4 and CYP2D6
Use caution when administering Leukenib with CYP3A4 and CYP2D6 substrates that have a narrow therapeutic window
Consider alternative agents when CYP3A4 metabolism is induced or inhibited

Women of childbearing potential must use effective contraception during treatment
Limited data on the use of imatinib in pregnant women
Potential risk for the fetus is unknown
Imatinib should not be used during pregnancy unless clearly necessary
Limited information on imatinib distribution in human milk
Women should not breast-feed during treatment and for at least 15 days after stopping treatment with Imatinib
Effect on fertility and gametogenesis is not well studied

Edema and severe fluid retention have occurred
Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred
Severe congestive heart failure and left ventricular dysfunction have been reported
Severe hepatotoxicity, including fatalities, may occur
Grade 3/4 hemorrhage has been reported
Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Leukenib in patients with conditions associated with high eosinophil levels
Bullous dermatologic reactions have been reported
Hypothyroidism has been reported
Fetal harm can occur when administered to a pregnant woman
Growth retardation in children and pre-adolescents receiving Leukenib has been reported
Tumor Lysis Syndrome
Reports of motor vehicle accidents have been received
Renal Toxicity

Limited experience with doses higher than the recommended therapeutic dose
Observed events include nausea, vomiting, diarrhea, rash, edema, and other symptoms
Appropriate symptomatic treatment should be given in case of overdose