Imitab 400 mg (Tablet)

Unit Price: ৳ 350.00 (3 x 10: ৳ 10,500.00)
Strip Price: ৳ 3,500.00

Medicine Details

Category Details
Generic Imatinib mesylate
Company Eskayef pharmaceuticals ltd
Also available as
Imitab 100 mg tablet

Indications

  • 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
  • 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

Pharmacology

  • Small molecule protein-tyrosine kinase inhibitor
  • Potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK)
  • Inhibits several receptor tyrosine kinases: Kit, DDR1, DDR2, CSF-1R, PDGFR-alpha, and PDGFR-beta
  • Absorbed well after oral administration with Cmax achieved within 2-4 hours post-dose
  • Mean absolute bioavailability is 98%
  • Metabolized by CYP3A4
  • Elimination is predominately in the feces, mostly as metabolites

Dosage & Administration

  • 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 should be taken with a meal and a large glass of water
  • Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet

Interaction

  • Concomitant administration of Imitab and strong CYP3A4 inducers may reduce total exposure of imatinib
  • Concomitant administration of Imitab and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase
  • Imatinib will increase plasma concentration of CYP3A4 metabolized drugs
  • Use caution when administering Imitab 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
  • Hypereosinophilic Cardiac Toxicity
  • Dermatologic Toxicities
  • 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
  • Imatinib should not be used during pregnancy unless clearly necessary
  • There is limited information on imatinib distribution in human milk
  • In non-clinical studies, the fertility of male and female rats was not affected

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
  • Bullous dermatologic reactions
  • Hypothyroidism
  • Fetal harm
  • Growth retardation in children and pre-adolescents
  • Tumor Lysis Syndrome
  • Reports of motor vehicle accidents
  • Renal Toxicity

Overdose Effects

  • Nausea, vomiting, rash, oedema, fatigue, thrombocytopenia, pancytopenia
  • Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain
  • Vomiting, gastrointestinal pain
  • Decreased white blood cell count and diarrhoea

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

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