• Capsules should NOT be substituted with tablets on a milligram per milligram basis.

Newly Diagnosed Chronic Phase Ph+ Chronic Myelogenous Leukemia

• PO (Adults ): Capsules: 300 mg twice daily; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation. Tablets: 142 mg twice daily; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation. Concurrent use of strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, or voriconazole): Capsules: 200 mg once daily; Tablets: 95 mg once daily.
• PO (Children ≥1 yr): Capsules: 230 mg/m² twice daily (max single dose = 400 mg) until disease progression or unacceptable toxicity; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation. Concurrent use of strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, or voriconazole): 200 mg once daily.

Hepatic Impairment

• PO (Adults ): Mild, moderate, or severe hepatic impairment: Capsules: 200 mg twice daily; may ↑ to 300 mg twice daily if tolerated; Tablets: 95 mg twice daily; may ↑ to 142 mg twice daily if tolerated.

Hepatic Impairment

• PO (Children ≥1 yr): Mild, moderate, or severe hepatic impairment: Capsules: 200 mg twice daily; may ↑ to 300 mg twice daily if tolerated.

Resistant or Intolerant Chronic or Accelerated Phase Ph+ Chronic Myelogenous Leukemia

• PO (Adults ): Capsules: 400 mg twice daily; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation. Tablets: 190 mg twice daily; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation.Concurrent use of strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, or voriconazole): Capsules: 300 mg once daily; Tablets: 142 mg once daily.
• PO (Children ≥1 yr): Capsules: 230 mg/m² twice daily (max single dose = 400 mg) until disease progression or unacceptable toxicity; treatment discontinuation may be considered in patients who have received nilotinib for ≥3 yr and achieved a sustained molecular response; if patients lose molecular response after discontinuing therapy, restart nilotinib within 4 wk at the dose level prior to discontinuation. Concurrent use of strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, or voriconazole): 200 mg once daily.

Hepatic Impairment

• (Adults ): Mild or moderate hepatic impairment: Capsules: 300 mg twice daily; may ↑ to 400 mg twice daily if tolerated; Tablets: 142 mg twice daily; may ↑ to 190 mg twice daily if tolerated. Severe hepatic impairment: Capsules: 200 mg twice daily; may ↑ to 300 mg twice daily and eventually to 400 mg twice daily if tolerated; Tablets: 95 mg twice daily; may ↑ to 142 mg twice daily and eventually 190 mg twice daily if tolerated.

Hepatic Impairment

• (Children ≥1 yr): Mild or moderate hepatic impairment: Capsules: 300 mg twice daily; may ↑ to 400 mg twice daily if tolerated. Severe hepatic impairment: Capsules: 200 mg twice daily; may ↑ to 300 mg twice daily and eventually to 400 mg twice daily if tolerated.

Hepatic Impairment

• PO (Adults and Children ≥1 yr): Mild or moderate hepatic impairment: 300 mg twice daily; may ↑ to 400 mg twice daily if tolerated. Severe hepatic impairment: 200 mg twice daily; may ↑ to 300 mg twice daily and eventually to 400 mg twice daily if tolerated.