Chronic Myeloid Leukemia
- PO (Adults): Chronic phase: 400 mg once daily, may be ↑ to 600 mg once daily; Accelerated phase or blast crisis: 600 mg once daily; may be ↑ to 800 mg/day given as 400 mg twice daily based on response and circumstances.
- PO (Children): Newly diagnosed Ph+ CML: 340 mg/m2 once daily (not to exceed 600 mg); CML recurrence after failure of bone marrow transplant or resistance to interferon-alpha: 260 mg/m2 once daily.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Gastrointestinal Stromal Tumors
- PO (Adults): Metastatic or unresectable: 400 mg once daily; may be ↑ to 400 mg twice daily if well tolerated and response insufficient; Adjuvant treatment after resection: 400 mg once daily.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Ph+ Acute Lymphoblastic Leukemia
- PO (Adults): 600 mg once daily.
- PO (Children): 340 mg/m2 once daily (not to exceed 600 mg).
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Myelodysplastic/Myeloproliferative Diseases
- PO (Adults): 400 mg once daily.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Aggressive Systemic Mastocytosis
- PO (Adults): 400 mg once daily. Patients with eosinophilia: 100 mg once daily; ↑ to 400 mg once daily if well tolerated and response insufficient.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Hypereosinophilic Syndrome and/or Chronic Eosinophilic Leukemia
- PO (Adults): 400 mg once daily. For patients with FIP1L1–PDGFRa fusion kinase: 100 mg once daily; ↑ to 400 mg once daily if well tolerated and response insufficient.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
Dermatofibrosarcoma Protuberans
- PO (Adults): 400 mg twice daily.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment: ↓ dose by 25%.
Renal Impairment
- PO (Adults): CCr 40–59 mL/min: Do not exceed dose of 600 mg/day; CCr 20–39 mL/min: ↓ initial dose by 50%; ↑ as tolerated.
