Leukenib 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 Jenphar bangladesh ltd
Also available as
Leukenib 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 who have the FIP1L1-PDGFR a fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown
  • 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

Dosage & Administration

  • 400 mg/day for adults with Ph+ CML CP
  • 600 mg/day for adults with Ph+ CML AP or BC
  • 340 mg/m2/day for pediatrics with Ph+ CML CP
  • 600 mg/day for adults with Ph+ ALL
  • 340 mg/m2/day for pediatrics with Ph+ ALL
  • 400 mg/day for adults with MDS/MPD
  • 100 mg/day or 400 mg/day for adults with ASM
  • 100 mg/day or 400 mg/day for adults with HES/CEL
  • 800 mg/day for adults with DFSP
  • 400 mg/day for adults with metastatic and/or unresectable GIST
  • 400 mg/day for adjuvant treatment of adults with GIST
  • Doses should be taken with a meal and a large glass of water

Interaction

  • Potential interactions with agents inducing or inhibiting CYP3A metabolism
  • Interactions with drugs metabolized by CYP3A4 and 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

  • Women of childbearing potential should use effective contraception during treatment and for at least 15 days after stopping treatment
  • Limited data on use in pregnant women; potential risk to the fetus
  • Limited information on distribution in human milk

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 and pre-adolescents
  • Tumor lysis syndrome
  • Reports of motor vehicle accidents
  • Renal toxicity

Overdose Effects

  • Nausea, vomiting, diarrhea
  • Fluid retention and edema
  • Rash, erythema
  • Swelling
  • Fatigue
  • Muscle spasms
  • Thrombocytopenia
  • Weakness, myalgia
  • Gastrointestinal pain

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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