Tinicev 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 Beximco pharmaceuticals ltd
Also available as
Tinicev 400 mg tablet

Indications

  • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
  • 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 (TK)
  • Inhibits receptor TKs: Kit, the receptor for stem cell factor (SCF), discoidin domain receptors (DDR1 and DDR2), colony stimulating factor receptor (CSF-1R), platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta)
  • Well absorbed after oral administration
  • Mean absolute bioavailability is 98%
  • Metabolized by CYP3A4
  • Excreted predominantly in feces
  • Elimination half-lives of approximately 18 and 40 hours

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

  • Concomitant administration with CYP3A4 inducers or inhibitors may impact imatinib exposure
  • Potential interaction with drugs metabolized by CYP3A4 or CYP2D6

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

  • Effective contraception advised for women of childbearing potential
  • Limited data on use in pregnant women
  • Distribution into human milk reported
  • Effects on fertility and gametogenesis not 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
  • Bullous dermatologic reactions
  • Fetal harm
  • Growth retardation in children and pre-adolescents
  • Tumor lysis syndrome
  • Reports of motor vehicle accidents
  • Renal toxicity

Overdose Effects

  • Variety of symptoms reported at different dose ranges
  • Experience with doses higher than recommended therapeutic dose is limited

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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