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Dasatinib

DASATINIB

Manufacturer: Apotex Corp.

Score: 142.0

Quick Summary

PHYRAGO (dasatinib) is a kinase inhibitor used for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as those with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib. It is also used for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. The recommended starting dosage is 100 mg orally once daily for chronic phase CML and 140 mg orally once daily for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL. Dose adjustments may be necessary based on strong CYP3A4 inhibitors or inducers, and patients should be monitored for myelosuppression, bleeding-related events, fluid retention, and other adverse reactions.

Key Clinical Findings and Indications

  • Treatment of adult patients with newly diagnosed Ph+ CML in chronic phase
  • Treatment of adult patients with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy
  • Treatment of adult patients with Ph+ ALL with resistance or intolerance to prior therapy

Important Safety Information

Warning

Dasatinib can cause fetal harm when administered to a pregnant woman, and breastfeeding is not recommended during treatment

Contraindications

Adverse Reactions

  • Myelosuppression
  • Bleeding-related events
  • Fluid retention
  • Cardiovascular toxicity
  • Pulmonary arterial hypertension
  • QT prolongation
  • Severe dermatologic reactions
  • Tumor lysis syndrome

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on strong CYP3A4 inhibitors or inducers

Chronic phase CML

Adult Dose

100 mg orally once daily

Pediatric Dose

Not applicable

Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL

Adult Dose

140 mg orally once daily

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

  • Dasatinib can cause fetal harm when administered to a pregnant woman

Nursing Mothers

  • Breastfeeding is not recommended during treatment with PHYRAGO

Pediatric Use

  • Monitor bone growth and development in pediatric patients

Geriatric Use

  • Patients aged 65 years and older are more likely to experience certain adverse reactions