Glivec 100 mg (Capsule)
Unit Price: ৳ 1,666.00 (10 x 12: ৳ 199,920.00)
Strip Price: ৳ 19,992.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Imatinib mesylate |
| Company | Novartis bangladesh ltd |
Indications
- Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
- Philadelphia chromosome positive chronic myeloid leukemia in blast crisis
- Philadelphia chromosome positive chronic myeloid leukemia in accelerated phase
- Relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
- Myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements
- Aggressive systemic mastocytosis without the D816V c-Kit mutation
- Hypereosinophilic syndrome and/or chronic eosinophilic leukemia
- Unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans
- Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors
- Adjuvant treatment following complete gross resection of Kit (CD117) positive GIST
Pharmacology
- Small molecule protein-tyrosine kinase inhibitor
- Inhibition of Bcr-Abl tyrosine kinase (TK)
- Inhibition of receptor TKs: Kit, DDR1, DDR2, CSF-1R, PDGFR-alpha and beta
- Absorption within 2-4 hours post-dose
- Metabolism by CYP3A4
- Predominant elimination in feces
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
- Patients with mild to moderate hepatic impairment: 400 mg/day
- Patients with severe hepatic impairment: 300 mg/day
- Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day
- Can be dissolved in water or apple juice
- Administer with a meal and a large glass of water
Interaction
- Concomitant administration with strong CYP3A4 inducers may reduce total exposure
- Concomitant administration with strong CYP3A4 inhibitors may result in significant exposure increase
- 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
- Women of childbearing potential advised to use effective contraception
- Limited data on use in pregnancy
- Limited distribution into human milk
- Potential effects on fertility and gametogenesis
Precautions & Warnings
- Edema and severe fluid retention
- Cytopenias
- 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
- Limited experience with higher than recommended doses
- Reported symptoms include nausea, vomiting, diarrhoea, rash, erythema, oedema, weakness, myalgia, etc.
Therapeutic Class
- Targeted Cancer Therapy
- Tyrosine Kinase Inhibitor
Storage Conditions
- Store below 30°C
- Keep away from light
- Keep out of the reach of children