Tyrokin 400 mg (Tablet)

Unit Price: ৳ 300.00 (1 x 10: ৳ 3,000.00)
Strip Price: ৳ 3,000.00

Medicine Details

Category Details
Generic Imatinib mesylate
Company Renata limited
Also available as

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
  • 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) and several receptor TKs: Kit, DDR1, DDR2, CSF-1R, PDGFR-alpha, PDGFR-beta
  • Well-absorbed after oral administration
  • Mean absolute bioavailability is 98%
  • Metabolized by CYP3A4 enzyme
  • Elimination is predominately in the feces, mostly as metabolites
  • Plasma protein binding of N-demethylated metabolite CGP74588
  • Plasma half-lives of Imatinib and its major active metabolite

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

  • Concomitant administration of Tyrokin and strong CYP3A4 inducers may reduce total exposure of imatinib
  • Concomitant administration of Tyrokin and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase
  • Grapefruit juice may also increase plasma concentrations of imatinib
  • Use caution when administering Tyrokin with CYP3A4 substrates that have a narrow therapeutic window
  • Use caution when administering Tyrokin 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
  • Limited data on the use of imatinib in pregnant women
  • Potential risk for the fetus is unknown
  • Imatinib should not be used during pregnancy unless clearly necessary
  • Women should not breast-feed during treatment and for at least 15 days after stopping treatment
  • Studies on patients receiving Imatinib and its effect on fertility and gametogenesis have not been performed

Precautions & Warnings

  • Edema and severe fluid retention have occurred
  • Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred
  • Severe congestive heart failure and left ventricular dysfunction have been reported
  • Severe hepatotoxicity may occur
  • Grade 3/4 hemorrhage has been reported
  • Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Tyrokin
  • Bullous dermatologic reactions have been reported with the use of Tyrokin
  • Hypothyroidism has been reported in patients undergoing levothyroxine replacement
  • Fetal harm can occur when administered to a pregnant woman
  • Growth retardation occurring in children and pre-adolescents receiving Tyrokin has been reported
  • Tumor Lysis Syndrome monitoring is recommended
  • Reports of motor vehicle accidents have been received in patients receiving Tyrokin
  • Renal Toxicity evaluation is recommended

Overdose Effects

  • Experience with doses higher than the recommended therapeutic dose is limited
  • Reported outcomes in different dose ranges
  • Appropriate symptomatic treatment should be given
  • Events that have been reported at different dose ranges

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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