Mabic 20 mg (Tablet)
Unit Price: ৳ 80.00 (3 x 10: ৳ 2,400.00)
Strip Price: ৳ 800.00
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 (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ kinases
- Ability to bind to multiple conformations of the ABL kinase
- Activity in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease
- Inhibition of the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL
- Predicted absorption pattern with maximum plasma concentrations observed between 0.5 to 6 hours following oral administration
- Apparent volume of distribution of 2505 with 96% binding to human plasma proteins
- Metabolism primarily by CYP3A4 with active metabolite representing approximately 5% of the AUC of Dasatinib
- Excretion primarily via the feces, with 4% of administered radioactivity recovered in the urine
Dosage & Administration
- Recommended starting dosage of 100 mg for chronic phase CML in adults, and 140 mg for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults
- Dosage based on body weight for pediatric patients, with recommended doses of 40 mg to 100 mg
- Administration with or without food, either in the morning or in the evening
- Tablets should not be crushed, cut, or chewed; they should be swallowed whole
Interaction
- Coadministration with strong CYP3A inhibitors may increase Mabic concentrations
- Coadministration with strong CYP3A4 inducers may decrease Mabic concentrations
- Coadministration with gastric acid reducing agents may decrease the concentrations of Mabic
Contraindications
- Contraindicated in patients with known hypersensitivity to Dasatinib or to 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
- Potential to cause fetal harm when administered to a pregnant woman
- Females of reproductive potential advised to avoid pregnancy during treatment with Dasatinib
- Breastfeeding not recommended during treatment with Dasatinib and for 2 weeks after the final dose
Precautions & Warnings
- Severe (NCT CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia
- Bleeding-related events
- Fluid retention
- Cardiovascular events
- Pulmonary arterial hypertension
- QT prolongation
- Severe dermatologic reactions
- Tumor lysis syndrome
Overdose Effects
- Limited experience with overdose, severe myelosuppression and bleeding reported in isolated cases
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