Mabic 100 mg (Tablet)
Unit Price: ৳ 400.00 (3 x 10: ৳ 12,000.00)
Strip Price: ৳ 4,000.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Dasatinib |
| Company | Genvio pharma ltd |
| Also available as |
Indications
- Treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
- Treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
- Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
- Treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase
- Treatment of newly diagnosed Ph+ ALL in combination with chemotherapy
Pharmacology
- Inhibition of BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFRβ kinases
- Predicted binding to multiple conformations of the ABL kinase
- Active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease
Absorption
- Maximum plasma concentrations observed between 0.5 hours and 6 hours following oral administration
- High-fat meal increased the mean AUC of Dasatinib following a single dose of 100 mg by 14%
Distribution
- Apparent volume of distribution is 2505 (CV% 93%)
- Binding of Dasatinib to human plasma proteins in vitro was approximately 96%
Elimination
- Mean terminal half-life of Dasatinib is 3 hours to 5 hours
- Mean apparent oral clearance is 363.8 l/hr (CV% 81.3%)
- Elimination is primarily via the feces, with 4% of the administered radioactivity recovered in the urine
Metabolism
- Metabolized primarily by CYP3A4 in humans
- Exposure of the active metabolite represents approximately 5% of the AUC of Dasatinib
- Several other inactive oxidative metabolites present
Dosage & Administration
- Recommended starting dosage of 100 mg for chronic phase CML in adults
- Recommended starting dosage of 140 mg for accelerated phase CML or Ph+ ALL in adults
- Dosage for pediatric patients based on body weight
Interaction
- Coadministration with strong CYP3A inhibitors may increase Mabic concentrations
- Coadministration with strong CYP3A inducers may decrease Mabic concentrations
- Coadministration with gastric acid reducing agents may decrease Mabic concentrations
Contraindications
- Contraindicated in patients with known hypersensitivity to Dasatinib or any component of the formulation
Side Effects
- Myelosuppression
- Bleeding-related events
- Fluid retention
- Cardiovascular events
- Pulmonary arterial hypertension
- QT prolongation
- Severe dermatologic reactions
- Tumor lysis syndrome
- Effects on growth and development in pediatric patients
Pregnancy & Lactation
- Can cause fetal harm when administered to a pregnant woman
- Breastfeeding not recommended during treatment
Precautions & Warnings
- Severe thrombocytopenia, neutropenia, and anemia
- Bleeding risk
- Fluid retention risk
- Cardiac dysfunction
- Pulmonary arterial hypertension risk
- QTc prolongation risk
- Severe mucocutaneous dermatologic reactions
- Tumor lysis syndrome risk
Overdose Effects
- Severe myelosuppression and bleeding
Therapeutic Class
- Targeted Cancer Therapy
Storage Conditions
- Store below 30°C in a dry place
- Protect from light
- Keep out of the reach of children