Ibakin 100 mg (Tablet)
Unit Price: ৳ 100.00 (3 x 10: ৳ 3,000.00)
Strip Price: ৳ 1,000.00
Medicine Details
Category | Details |
---|---|
Generic | Imatinib mesylate |
Company | Genvio pharma ltd |
Also available as |
Indications
- Treats newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in adults and pediatric patients
- Effective for Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after interferon-alpha therapy failure
- Used for relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia in adults
- Treatment for hypereosinophilic syndrome and/or chronic eosinophilic leukemia with FIP1L1-PDGFR a fusion kinase
- Indicated for unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans
- Appropriate for patients with aggressive systemic mastocytosis without the D816V c-Kit mutation
- Adjuvant treatment post-complete gross resection of Kit positive gastrointestinal stromal tumors
- Suitable for pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia
- Treats myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene rearrangements
- Effective for patients with Kit positive unresectable and/or metastatic malignant gastrointestinal stromal tumors
Pharmacology
- A small molecule protein-tyrosine kinase inhibitor
- Potently inhibits the activity of the Bcr-Abl tyrosine kinase and several receptor tyrosine kinases
- Inhibits cellular events mediated by activation of receptor kinases
- Well absorbed after oral administration with Cmax achieved within 2-4 hours post-dose
- Mean absolute bioavailability is 98%
- Metabolized by CYP3A4 with minor role played by other cytochrome P450 enzymes
- Predominantly excreted in feces, mostly as metabolites
- Elimination half-lives of Imatinib and its major active metabolite are approximately 18 and 40 hours, respectively
Dosage & Administration
- 400 mg/day for adults with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
- 600 mg/day for adults with Philadelphia chromosome positive chronic myeloid leukemia in accelerated phase or blast crisis
- 340 mg/m2/day for pediatrics with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
- 600 mg/day for adults with Philadelphia chromosome positive acute lymphoblastic leukemia
- 340 mg/m2/day for pediatrics with Philadelphia chromosome positive acute lymphoblastic leukemia
- 400 mg/day for adults with myelodysplastic/myeloproliferative diseases
- 100 mg/day or 400 mg/day for adults with aggressive systemic mastocytosis
- 100 mg/day or 400 mg/day for adults with hypereosinophilic syndrome and/or chronic eosinophilic leukemia
- 800 mg/day for adults with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans
- 400 mg/day for patients with Kit positive unresectable and/or metastatic malignant gastrointestinal stromal tumors
- 400 mg/day for adjuvant treatment of adults following complete gross resection of Kit positive gastrointestinal stromal tumors
- Doses should be taken with food and a large glass of water
Interaction
- Concomitant administration with CYP3A4 inducers may reduce total exposure of imatinib
- Concomitant administration with CYP3A4 inhibitors may result in significant imatinib exposure increase
- Potential increase in plasma concentrations of drugs metabolized by CYP3A4
- Use caution when administering with CYP3A4 substrates that have a narrow therapeutic window
- Use caution when administering with CYP2D6 substrates that have a narrow therapeutic window
Side Effects
- Fluid retention and edema
- Hematologic toxicity
- Congestive heart failure and left ventricular dysfunction
- Hepatotoxicity
- Hemorrhage
- Gastrointestinal disorders
- Hypothyroidism
- Growth retardation in children and adolescents
- Tumor lysis syndrome
- Impairments related to driving and using machinery
- Renal toxicity
Pregnancy & Lactation
- Women of childbearing potential must use effective contraception during treatment and for at least 15 days after stopping treatment
- Limited data on the use of imatinib in pregnant women, with potential risk to the fetus
- Limited information on imatinib distribution in human milk, caution advised for breastfeeding
- Effects on fertility and gametogenesis have not been fully studied
Precautions & Warnings
- Edema and severe fluid retention
- Cytopenias, particularly anemia, neutropenia, and thrombocytopenia
- Severe congestive heart failure and left ventricular dysfunction
- Severe hepatotoxicity
- Grade 3/4 hemorrhage and gastrointestinal perforations
- Cardiogenic shock/left ventricular dysfunction
- Bullous dermatologic reactions
- Hypothyroidism
- Fetal harm, growth retardation in children and pre-adolescents
- Tumor lysis syndrome, impairments related to driving and using machinery
- Renal toxicity
Overdose Effects
- Experience with doses higher than the recommended therapeutic dose is limited
- Symptomatic treatment may be given in the event of overdose
- Reported events include nausea, vomiting, diarrhea, rash, edema, and more
- Appropriate supportive treatment should be given in case of overdose
Therapeutic Class
- Targeted Cancer Therapy
- Tyrosine Kinase Inhibitor
Storage Conditions
- Store below 30°C in a cool and dry place
- Keep away from light
- Keep out of the reach of children