Tyronib 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 Healthcare pharmaceuticals ltd
Also available as
Tyronib 100 mg tablet

Indications

  • Treatment of newly diagnosed Ph+CML in adults and pediatric patients
  • Treatment of Ph+CML in blast crisis, accelerated phase, or chronic phase after interferon-alpha therapy
  • Treatment of relapsed or refractory Ph+ ALL in adults
  • Treatment of newly diagnosed Ph+ ALL in pediatric patients
  • Treatment of myelodysplastic and myeloproliferative diseases associated with PDGFR gene rearrangements
  • Treatment of aggressive systemic mastocytosis without D816V c-Kit mutation
  • Treatment of hypereosinophilic syndrome and chronic eosinophilic leukemia with FIP1L1-PDGFR a fusion kinase
  • Treatment of dermatofibrosarcoma protuberans
  • Adjuvant treatment following complete gross resection of GIST
  • Adjunctive therapy for unresectable and/or metastatic GIST
  • Usable with water or apple juice for patients with swallowing difficulty

Pharmacology

  • Inhibition of Bcr-Abl tyrosine kinase
  • Inhibition of Kit, DDR1, DDR2, CSF-1R, PDGFR-alpha, and PDGFR-beta
  • Well-absorbed after oral administration
  • Mean absolute bioavailability of 98%
  • Metabolized by CYP3A4 and other minor cytochrome P450 enzymes
  • Predominantly eliminated in feces
  • Plasma AUC for active metabolite about 15% of AUC for Imatinib
  • Elimination half-lives of Imatinib and major active metabolite approximately 18 and 40 hours

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 metastatic and/or unresectable GIST
  • 400 mg/day for adjuvant treatment of adults with GIST
  • Doses to be taken with a meal and a large glass of water
  • 800 mg and above doses to be accomplished using 400-mg tablet to reduce iron exposure

Interaction

  • Concomitant administration with CYP3A4 inducers may reduce Imatinib exposure
  • Concomitant administration with CYP3A4 inhibitors may increase Imatinib exposure
  • Grapefruit juice may increase plasma concentrations of Imatinib
  • 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
  • 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
  • Reproductive toxicity in animal studies
  • Limited distribution into human milk
  • Effects of low-dose exposure of the infant unknown
  • Consultation advised for patients concerned about fertility on Imatinib treatment

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 (Gl) perforations
  • Cardiogenic shock/left ventricular dysfunction
  • Bullous dermatologic reactions
  • Fetal harm
  • Growth retardation in children and pre-adolescents
  • Tumor Lysis Syndrome
  • Renal Toxicity

Overdose Effects

  • Limited experience with doses higher than recommended
  • Observation and appropriate symptomatic treatment advised in case of overdose
  • Reported outcomes include nausea, vomiting, diarrhea, rash, fatigue, thrombocytopenia, and more

Therapeutic Class

  • Targeted Cancer Therapy
  • Tyrosine Kinase Inhibitor

Storage Conditions

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

Related Brands