Dasacent 100 mg (Tablet)

Unit Price: ৳ 400.00 (1 x 10: ৳ 4,000.00)
Strip Price: ৳ 4,000.00

Medicine Details

Category Details
Generic Dasatinib
Company Incepta pharmaceuticals ltd
Also available as
Dasacent 140 mg tablet Dasacent 50 mg tablet

Therapeutic Class

  • Targeted Cancer Therapy

Indications

  • Treatment of adult patients with 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, PDGFRβ
  • Predicted binding to multiple conformations of the ABL kinase
  • Activity in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease
  • Metabolism primarily by CYP3A4, FMO-3 and UGT enzymes involvement
  • Primary elimination via the feces

Absorption

  • Maximum plasma concentrations observed between 0.5 hours and 6 hours following oral administration
  • High-fat meal increases mean AUC of Dasatinib by 14%
  • Apparent volume of distribution is 2505 with 96% binding to human plasma proteins

Distribution

  • Apparent volume of distribution is 2505 with 96% binding to human plasma proteins
  • P-gp substrate in vitro

Elimination

  • Mean terminal half-life is 3-5 hours
  • Apparent oral clearance is 363.8 l/hr
  • Primarily via the feces with 4% recovery in urine

Metabolism

  • Metabolized primarily by CYP3A4, FMO-3, and UGT enzymes
  • Active metabolite exposure represents approximately 5% of the AUC of Dasatinib

Dosage & Administration

  • Recommended starting dosage for chronic phase CML in adults is 100 mg once daily
  • Recommended starting dosage for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg once daily
  • Pediatric dosage based on body weight with recommended daily doses ranging from 40 mg to 100 mg

Interaction

  • Coadministration with strong CYP3A4 inhibitors may increase Dasacent concentrations
  • Coadministration with strong CYP3A4 inducers may decrease Dasacent concentrations
  • Coadministration with gastric acid reducing agents may decrease Dasacent concentrations

Contraindications

  • 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
  • Females advised to avoid pregnancy during treatment and for 30 days after final dose
  • Breastfeeding not recommended during treatment and for 2 weeks after final dose

Precautions & Warnings

  • Severe myelosuppression
  • Bleeding events
  • Fluid retention events
  • Cardiac dysfunction
  • Pulmonary arterial hypertension
  • QT prolongation
  • Severe dermatologic reactions
  • Tumor lysis syndrome

Overdose Effects

  • Limited clinical study overdose experience
  • Highest overdosage of 280 mg per day for 1 week resulting in severe myelosuppression and bleeding

Storage Conditions

  • Store below 30°C in a dry place
  • Protect from light
  • Keep out of the reach of children

Related Brands