Dasatinib

DEA Class; Rx

Common Brand Names; Sprycel

• Antineoplastics, Tyrosine Kinase Inhibitor

Chronic Myeloid Leukemia

Newly diagnosed

• Indicated for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

Advanced CML

• Indicated for treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib

Indicated for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy

—

• Fluid retention, incl CHF, pulm edema, pleural effusion (50%)
• Diarrhea (49%)
• Headache (40%)
• Hemorrhage (40%)
• Fatigue (39%)
• Pyrexia (39%)
• Skin rash (35%)
• Infection (34%)
• Nausea (34%)
• Dyspnea (32%)
• Cough (28%)
• Pain (26%)
• Abdominal pain (25%)
• Vomiting (22%)
• Anorexia (19%)
• Arthralgia (19%)
• Asthenia (19%)
• Constipation (14%)
• Dizziness (14%)
• Musculoskeletal pain (14%)
• Weight loss (14%)
• Chest pain (13%)
• Neuropathy (13%)
• Myalgia (12%)
• Abdominal distention (11%)
• Arrhythmia (11%)
• Chills (11%)
• Pneumonia (11%)
• Pruritus (11%)
• Weight gain (11%)

Use caution in hepatic impairment

Use with caution in patients who have or may develop prolongation of QT interval; may increase risk of prolongation of QTc in patients including those with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy; correct hypokalemia or hypomagnesemia prior to and during therapy

Cardiac adverse reactions were reported in 5.8% of 258 patients including cardiomyopathy (1.6%), congestive heart failure, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction; monitor patients for signs or symptoms and treat appropriately

Tumor lysis syndrome reported; maintain adequate hydration and correct uric acid levels prior to initiating therapy; monitor electrolyte levels; patients with advanced-stage disease and/or high tumor burden may be at increased risk and should be monitored more frequently

Risk of fluid retention and pleural/pericardial effusion; manage with supportive care measures and/or dose modification; evaluate patients who develop symptoms of pleural effusion or other fluid retention, such as new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough, promptly with a chest x-ray or additional diagnostic imaging as appropriate; fluid retention events were typically managed by supportive care measures that may include diuretics or short courses of steroids; severe pleural effusion may require thoracentesis and oxygen therapy; consider dose reduction or treatment interruption

Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman

No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production

140 mg/day PO for chronic-phase CML; 180 mg/day PO for advanced-phase CML and Ph+ ALL.

140 mg/day PO for chronic-phase CML; 180 mg/day PO for advanced-phase CML and Ph+ ALL.

30 kg to less than 45 kg: 70 mg/day PO for Ph+ ALL; 90 mg/day PO for chronic-phase CML.45 kg or more: 100 mg/day PO for Ph+ ALL; 120 mg/day PO for chronic-phase CML.

10 kg to less than 20 kg: 40 mg/day PO for Ph+ ALL; 50 mg/day PO for chronic-phase CML.20 kg to less than 30 kg: 60 mg/day PO for Ph+ ALL; 70 mg/day PO for chronic-phase CML.30 kg to less than 45 kg: 70 mg/day PO for Ph+ ALL; 90 mg/day PO for chronic-phase CML.45 kg or more: 100 mg/day PO for Ph+ ALL; 120 mg/day PO for chronic-phase CML.

Safety and efficacy not established.

Dasatinib 

tablet

• 20mg
• 50mg
• 70mg
• 80mg
• 100mg
• 140mg