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