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Nilotinib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 15, 2022.

Applies to the following strengths: 200 mg; 150 mg; 50 mg

Usual Adult Dose for Chronic Myelogenous Leukemia

Newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP): 300 mg orally twice a day
Resistant or intolerant Ph+ CML-CP and chronic myeloid leukemia in accelerated phase (CML-AP): 400 mg orally twice a day

Comments:

  • Doses should be administered about 12 hours apart.
  • This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor [G-CSF]), hydroxyurea, or anagrelide if clinically indicated.

Uses:
  • For the treatment of patients with newly diagnosed Ph+ CML-CP
  • For the treatment of patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant/intolerant to prior therapy that included imatinib

Usual Pediatric Dose for Chronic Myelogenous Leukemia

1 year or older: 230 mg/m2 orally twice a day

  • Rounded to the nearest 50 mg dose
  • Maximum dose: 400 mg/dose

Dosing based on BSA:
  • BSA up to 0.32 m2: 50 mg orally twice a day
  • BSA 0.33 to 0.54 m2: 100 mg orally twice a day
  • BSA 0.55 to 0.76 m2: 150 mg orally twice a day
  • BSA 0.77 to 0.97 m2: 200 mg orally twice a day
  • BSA 0.98 to 1.19 m2: 250 mg orally twice a day
  • BSA 1.2 to 1.41 m2: 300 mg orally twice a day
  • BSA 1.42 to 1.63 m2: 350 mg orally twice a day
  • BSA at least 1.64 m2: 400 mg orally twice a day

Comments:
  • Doses should be administered about 12 hours apart.
  • Therapy should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
  • This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin, G-CSF), hydroxyurea, or anagrelide if clinically indicated.

Uses:
  • For the treatment of patients with newly diagnosed Ph+ CML-CP
  • For the treatment of patients with chronic phase and accelerated phase Ph+ CML with resistance or intolerance to prior tyrosine-kinase inhibitor therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Adult Patients:
Newly diagnosed Ph+ CML in chronic phase:

  • Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): Dosage should be reduced to 200 mg orally twice a day; may increase to 300 mg twice a day based on tolerability

Resistant or intolerant Ph+ CML in chronic phase or accelerated phase:
  • Mild or moderate liver dysfunction: Dosage should be reduced to 300 mg orally twice a day; may increase to 400 mg orally twice a day based on tolerability
  • Severe liver dysfunction: Dosage should be reduced to 200 mg orally twice a day; may increase to 300 mg orally twice a day and then to 400 mg orally twice a day based on tolerability

Comments:
  • If possible, alternative therapies should be considered.
  • If this drug must be administered to patients with liver dysfunction, the above dosing regimens should be considered.

Dose Adjustments

DISCONTINUATION OF THERAPY AFTER A SUSTAINED MOLECULAR RESPONSE (MR4.5) ON THIS DRUG:
Eligibility for Discontinuation of Therapy:

  • Patients with typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2), who achieve the sustained MR4.5 criteria, are eligible for discontinuation of therapy. Patients should continue to be monitored for possible loss of molecular remission after therapy discontinuation; the same US FDA-authorized test should be used to consistently monitor molecular response levels while on and off therapy.
  • been treated with this drug for at least 3 years
  • achieved an MR4.5 for the last assessment taken immediately prior to discontinuation of therapy
  • no history of accelerated phase or blast crisis
  • Consider discontinuation in patients with Ph+ CML-CP that are resistant/intolerant to imatinib who have achieved a sustained molecular response (MR4.5) on this drug who have:
  • been treated with imatinib only prior to treatment with this drug
  • sustained an MR4.5 for at least 1 year immediately prior to discontinuation of therapy
  • no history of accelerated phase or blast crisis
  • In patients who have discontinued therapy, BCR-ABL transcript levels and CBC with differential should be monitored monthly for 1 year, then every 6 weeks for the second year, and every 12 weeks thereafter.
  • This drug should be withheld and an analysis of serum potassium and magnesium should be performed; if below lower limit of normal, correction with supplements to within normal limits is recommended. Concomitant medication usage should be reviewed.
  • An ECG should be repeated about 7 days after any dose adjustment.

MYELOSUPPRESSION:
  • Resumption within 2 weeks at prior dose is recommended if ANC greater than 1 x 10(9)/L and platelets greater than 50 x 10(9)/L.
  • Pediatric patients with newly diagnosed Ph+ CML in chronic phase at 230 mg/m2 twice a day OR resistant/intolerant Ph+ CML in chronic phase at 230 mg/m2 twice a day with ANC less than 1 x 10(9)/L and/or platelet counts less than 50 x 10(9)/L:
  • Resumption within 2 weeks at prior dose is recommended if ANC greater than 1.5 x 10(9)/L and platelets greater than 75 x 10(9)/L.
  • If the event occurs after dose reduction, discontinuation of therapy should be considered.

SELECTED NONHEMATOLOGIC LABORATORY ABNORMALITIES AND OTHER TOXICITIES:
  • Adult patients: This drug should be withheld and serum lipase or amylase should be monitored. Resumption of therapy at 400 mg once a day is recommended if serum lipase or amylase returns to Grade 1 or less.
  • Adult patients: This drug should be withheld and hepatic transaminases should be monitored. Resumption of therapy at 400 mg once a day is recommended if hepatic transaminases return to Grade 1 or less.
  • Adult patients: This drug should be withheld until toxicities resolve. Resumption of therapy at 400 mg once a day is recommended if previous dose was 300 mg twice a day in patients newly diagnosed with CML-CP or 400 mg twice a day in patients with resistant/intolerant CML-CP and CML-AP; therapy should be discontinued if the prior dose was 400 mg once a day. If clinically appropriate, re-escalation of the dose to 300 mg (newly diagnosed Ph+ CML-CP) or 400 mg (resistant/intolerant Ph+ CML-CP and CML-AP) twice a day should be considered.

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