From the Guidelines
Sprycel (dasatinib) is recommended for adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) or acute lymphoblastic leukemia (ALL) at a standard dosage of 100 mg once daily for chronic phase CML and 140 mg once daily for accelerated or blast phase CML and Ph+ ALL. The dosage and administration of dasatinib are based on the patient's phase of CML or ALL, with adjustments made as necessary to manage toxicity or optimize response 1.
Key Considerations for Dosage and Administration
- For chronic phase CML, the recommended dose is 100 mg once daily, taken orally with or without food.
- For accelerated or blast phase CML and Ph+ ALL, the recommended dose is 140 mg once daily.
- Dosage adjustments may be necessary based on patient response, toxicity, or drug interactions.
- Treatment is typically continued long-term until disease progression or unacceptable toxicity occurs.
Monitoring and Managing Side Effects
- Regular monitoring of blood counts is essential, as Sprycel can cause myelosuppression.
- Dose reductions or temporary interruptions may be needed for severe neutropenia or thrombocytopenia.
- Patients should be monitored for fluid retention, as pleural effusion is a potential side effect.
- Dasatinib works by inhibiting BCR-ABL tyrosine kinase, the abnormal protein produced by the Philadelphia chromosome that drives the proliferation of leukemic cells, effectively targeting the underlying molecular cause of these leukemias 2, 3, 4.
Evidence-Based Recommendations
The recommendations for dasatinib dosage and administration are based on the most recent and highest quality studies, including those published in the Journal of the National Comprehensive Cancer Network and Leukemia 1, 2, 3, 4. These studies demonstrate the efficacy and safety of dasatinib in patients with Ph+ CML or ALL, and provide guidance on dosage adjustments and management of side effects.
From the FDA Drug Label
Dasatinib tablets are indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
The recommended starting dosage of dasatinib tablets for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of dasatinib tablets for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily
The recommended use and dosage of Sprycel (dasatinib) for patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) or acute lymphoblastic leukemia (ALL) is as follows:
- Newly diagnosed Ph+ CML in chronic phase: 100 mg orally once daily
- Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL: 140 mg orally once daily Key considerations:
- Tablets should not be crushed, cut, or chewed; they should be swallowed whole
- Dasatinib tablets can be taken with or without a meal, either in the morning or in the evening 5
From the Research
Recommended Use of Sprycel (Dasatinib)
- Sprycel (dasatinib) is indicated for the treatment of adults with newly diagnosed chronic-phase chronic myeloid leukemia (CML), CML (chronic-, accelerated- or blast-phase) with resistance or intolerance to prior therapy, including imatinib, or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy 6, 7.
- Dasatinib is effective in achieving major or complete cytogenetic responses in both newly diagnosed and imatinib-resistant or -intolerant chronic-phase CML 6, 7.
- Dasatinib is also effective in achieving major or overall hematologic responses in imatinib-resistant or -intolerant, accelerated- or blast-phase CML, or Ph+ ALL 6, 7.
Dosage of Sprycel (Dasatinib)
- The recommended dosage of dasatinib is 100 mg administered once daily for patients with chronic-phase CML 6, 7.
- For patients with accelerated-phase, myeloid blast phase, or lymphoid blast phase CML, or Ph+ ALL, a twice-daily regimen is recommended, with a starting dosage of 70 mg twice daily 8.
- Dasatinib 100 mg administered once daily was as effective as dasatinib 70 mg administered twice daily, and was better tolerated, being associated with lower incidences of pleural effusion and grade 3/4 thrombocytopenia 6, 7.
Efficacy and Tolerability
- Dasatinib has been shown to be highly effective in achieving major cytogenetic and hematologic responses in patients with CML and Ph+ ALL 6, 7, 9, 10, 8.
- The majority of adverse events with dasatinib were of mild to moderate severity, with fluid retention (including pleural effusion) being the most common adverse event 6, 7.
- Hematologic abnormalities were common, and cytopenias were the most common grade 3/4 adverse events 6, 7.