Dasanix 20 mg (Tablet)

Indications

• Treatment for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• Treatment for chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
• Treatment for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
• Treatment for pediatric patients 1 year of age and older with Ph+ CML in chronic phase
• Treatment for newly diagnosed Ph+ ALL in combination with chemotherapy

Pharmacology

• Inhibition of BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFRβ kinases
• Active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease
• Predicted binding to multiple conformations of the ABL kinase
• Active against leukemic cell lines overexpressing BCR-ABL
• Absorption between 0.5 to 6 hours following oral administration
• Inhibition of the growth of CML and ALL cell lines overexpressing BCR-ABL
• Primary metabolism by CYP3A4
• Approximately 96% binding to human plasma proteins in vitro
• Eliminated primarily via the feces
• Volume of distribution is 2505 (CV% 93%)

Dosage & Administration

• Starting dosage of 100 mg for chronic phase CML in adults
• Starting dosage of 140 mg for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults
• Oral administration once daily
• Dosage based on body weight for pediatric patients
• Tablets should not be crushed, cut, or chewed

Interaction

• Coadministration with strong CYP3A inhibitors may increase Dasanix concentrations
• Coadministration with strong CYP3A inducers may decrease Dasanix concentrations
• Coadministration with gastric acid reducing agents may decrease Dasanix 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

• Potential fetal harm when administered to a pregnant woman
• Advice for females of reproductive potential to avoid pregnancy during treatment
• Not recommended for breastfeeding

Precautions & Warnings

• Severe thrombocytopenia, neutropenia, and anemia
• Risk of serious and fatal bleeding
• Potential for fluid retention
• Risk of cardiac dysfunction
• Risk of pulmonary arterial hypertension
• Risk of QT prolongation
• Potential severe mucocutaneous dermatologic reactions
• Risk of tumor lysis syndrome

Overdose Effects

• Limited experience with overdose
• Reported severe myelosuppression and bleeding 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

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