Imaceva 400 mg (Tablet)

Unit Price: ৳ 300.00 (3 x 10: ৳ 9,000.00)
Strip Price: ৳ 3,000.00

Medicine Details

Category Details
Generic Imatinib mesylate
Company Square pharmaceuticals plc
Also available as
Imaceva 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
  • Inhibits Bcr-Abl tyrosine kinase and several receptor tyrosine kinases
  • Potently inhibits the activity of Kit, SCF receptor, discoidin domain receptors, CSF-1R, PDGFR-alpha, and PDGFR-beta
  • Well absorbed after oral administration
  • Mean absolute bioavailability is 98%
  • Mainly metabolized by CYP3A4
  • Predominately excreted in the feces
  • Elimination half-lives of Imatinib and its major active metabolite

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

Interaction

  • Agents Inducing CYP3A Metabolism
  • Agents Inhibiting CYP3A Metabolism
  • Interactions with Drugs Metabolized by CYP3A4
  • Interactions with Drugs Metabolized by CYP2D6

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

  • Effective contraception during treatment and for at least 15 days after stopping treatment with Imatinib
  • Limited data on the use of imatinib in pregnant women
  • Reproductive toxicity in animal studies
  • Distribution of imatinib into human milk
  • Effect on fertility and gametogenesis

Precautions & Warnings

  • Edema and severe fluid retention
  • Cytopenias
  • Severe congestive heart failure and left ventricular dysfunction
  • Severe hepatotoxicity
  • Grade 3/4 hemorrhage
  • Cardiogenic shock/left ventricular dysfunction
  • Bullous dermatologic reactions
  • Hypothyroidism
  • Fetal harm
  • Growth retardation in children
  • Tumor Lysis Syndrome
  • Reported motor vehicle accidents
  • Renal Toxicity

Overdose Effects

  • Limited experience with doses higher than the recommended therapeutic dose
  • Various adverse events reported in cases of overdose
  • Appropriate symptomatic treatment given

Therapeutic Class

  • Targeted Cancer Therapy
  • Tyrosine Kinase Inhibitor

Storage Conditions

  • Store below 30°C
  • Cool and dry place
  • Keep away from light
  • Keep out of the reach of children

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