Applies to the following strength(s): 200 mg ; 150 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Myelogenous Leukemia
Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ CML):
-Newly Diagnosed in Chronic Phase (Ph+ CML-CP):
300 mg orally twice a day, approximately 12 hours apart
-Resistant or Intolerant in Chronic Phase and Accelerated Phase (Ph+ CML-CP and Ph+ CML-AP):
400 mg orally twice a day, approximately 12 hours apart
-This drug should be taken on an empty stomach; no food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose is taken.
-This drug may be given in combination with hematopoietic growth factors (e.g. erythropoietin or G-CSF), hydroxyurea, or anagrelide if clinically indicated.
Uses: For the treatment of newly diagnosed Ph+ CML in chronic phase, and chronic and accelerated phase Ph+ CML resistant or intolerant to prior therapy that included imatinib
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Newly diagnosed Ph+ CML-CP at 300 mg twice a day:
-Mild, moderate or severe hepatic impairment (Child-Pugh A, B, or C): Initial dose of 200 mg twice a day; may increase to 300 mg twice a day based on tolerability
Resistant or intolerant Ph+ CML-CP and Ph+ CML-AP at 400 mg twice a day:
-Mild or moderate hepatic impairment (Child-Pugh A or B): Initial dose of 300 mg twice a day; may increase to 400 mg twice a day based on tolerability
-Severe hepatic impairment (Child-Pugh C): Starting dose of 200 mg twice a day followed by a sequential dose escalation to 300 mg twice a day and then to 400 mg twice a day based on tolerability
Comments: If possible, consider alternative therapies first; if this drug is necessary, use dose adjustments and monitor QT interval closely.
QT Interval Prolongation
ECGs with QTc greater than 480 msec:
-Stop this drug; analyze serum potassium and magnesium; if below lower limit of normal, correct with supplements to within normal limits. Review concomitant medication usage.
-Resume within 2 weeks at prior dose if QTcF returns to less than 450 msec and to within 20 msec of baseline.
-If QTcF is between 450 msec and 480 msec after 2 weeks, reduce the dose to 400 mg once a day.
-If, following dose-reduction to 400 mg once a day, QTcF returns to greater than 480 msec, discontinue this drug.
-Repeat ECG approximately 7 days after any dose adjustment.
-Withhold or dose reduce for hematological toxicities (e.g., neutropenia, thrombocytopenia) that are not related to underlying leukemia.
Neutropenia and Thrombocytopenia:
Absolute Neutrophil Count (ANC) less than 1.0 x 10(9)/L and/or platelet counts less than 50 x 10(9)/L:
-Stop this drug and monitor blood counts.
-Resume within 2 weeks at prior dose if ANC is greater than 1.0 x 10(9)/L and platelets greater than 50 x 10(9)/L.
-If blood counts remain low for more than 2 weeks, reduce dose to 400 mg once a day.
Non-Hematological Laboratory Abnormalities:
Grade 3 or greater elevations of serum lipase, amylase, bilirubin, or hepatic transaminases:
-Withhold this drug and monitor levels.
-Resume treatment at 400 mg once a day when elevations return to Grade 1 or less.
-Test levels monthly or as clinically indicated.
Other Clinically Significant Moderate or Severe Non-Hematologic Abnormalities:
-Withhold this drug until toxicities resolve, then resume at 400 mg once a day.
-If clinically appropriate, consider re-escalation of the dose to 300 mg (newly diagnosed Ph+ CML-CP) or 400 mg (resistant or intolerant Ph+ CML-CP and Ph + CML-AP) twice a day.
Strong CYP450 3A4 Inhibitors (including grapefruit products):
-Avoid concomitant use; if treatment with a strong CYP450 3A4 inhibitor is required, interrupt nilotinib therapy.
-If concomitant use is required, consider reducing dose to 300 mg once a day in resistant or intolerant Ph+ CML-CP and Ph+ CML-AP or to 200 mg once a day in newly diagnosed Ph+ CML-CP; monitor closely for QT interval prolongation.
-If the strong CYP450 3A4 inhibitor is discontinued, allow a washout period before adjusting upward to indicated nilotinib dose.
Strong CYP450 3A4 Inducers (including St. John's Wort):
-Avoid concomitant use.
-Select alternative therapeutic agents with less potential for CYP450 3A4 induction since data shows increasing the dose of this drug is unlikely to compensate for the loss of exposure these inducers cause.
US BOXED WARNING: QT PROLONGATION AND SUDDEN DEATHS:
-This drug prolongs the QT interval. Prior to drug administration and periodically during treatment, monitor for hypokalemia or hypomagnesemia and correct deficiencies.
-Obtain ECGs to monitor the QTc at baseline, 7 days after initiation, periodically thereafter, and following any dose adjustments.
-Sudden deaths have been reported in patients receiving this drug. Do not administer to patients with hypokalemia, hypomagnesemia, or long QT syndrome.
-Avoid concomitant use of drugs known to prolong the QT interval and strong CYP450 3A4 inhibitors.
-Avoid food 2 hours before and 1 hour after taking the dose.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Take without food; do not consume food for at least 2 hours before the dose and for at least 1 hour after the dose is taken.
-Swallow capsules whole with water.
-If unable to swallow capsules, disperse the contents of each capsule in 1 teaspoon of applesauce and swallow the mixture immediately (within 15 minutes); do not store for future use.
-Missed dose: If a dose is missed, take the next scheduled dose at its regular time; two doses should not be taken at the same time.
-Keep in original package to protect from moisture.
-Do not store above 30 degrees Celsius.
-The effectiveness of this drug is based on major molecular response and cytogenetic response rates for newly diagnosed Ph+CML-CP, and on hematologic and cytogenetic response rates for resistant or intolerant Ph+CML-CP and Ph+CML-AP patients.
-Cardiovascular: ECG at baseline, 7 days after initiating therapy, following dose adjustments, and periodically during therapy.
-Hematologic: CBC every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated.
-Hepatic: Hepatic function tests monthly or as clinically indicated.
-Metabolic: Chemistry panels, including electrolytes, calcium, and magnesium prior to initiating and periodically during therapy; glucose prior to initiating and periodically during first year of therapy and at least yearly during chronic therapy; serum lipase levels monthly or as clinically indicated; lipid profile prior to initiation, at 3 and 6 months after beginning therapy, and at least yearly.
-Instruct patients to seek medical attention for signs and symptoms of pancreatitis, hepatotoxicity, abnormal bleeding, or unexplained weight gain or edema.
-Instruct the patient on the importance of taking this medication on an empty stomach and to not consume any food for 2 hours before the dose and 1 hour after the dose is taken.
-Inform patients that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications and herbal supplements.
-Instruct patients to talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.
-Advise patients that this drug may cause side effects such as dizziness and visual problems that may affect their ability to drive and perform potentially hazardous activities such as operating machinery.
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