Nilotinib

Nilotinib
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. QT PROLONGATION AND SUDDEN DEATHS: Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. Sudden deaths have been reported in patients receiving nilotinib. Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and 1 hour after taking the dose.

Overview

Nilotinib is a kinase inhibitor that is FDA approved for the {{{indicationType}}} of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Newly Diagnosed Ph+ CML-CP

• The recommended dose of Tasigna is 300 mg orally twice daily.

Resistant or Intolerant Ph+ CML-CP and CML-AP

• The recommended dose of Tasigna (nilotinib) is 400 mg orally twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Nilotinib in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilotinib in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Nilotinib in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Nilotinib in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilotinib in pediatric patients.

Contraindications

• Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Warnings

WARNING See full prescribing information for complete Boxed Warning. QT PROLONGATION AND SUDDEN DEATHS: Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. Sudden deaths have been reported in patients receiving nilotinib. Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and 1 hour after taking the dose.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nilotinib in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nilotinib in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nilotinib in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nilotinib during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nilotinib with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nilotinib with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nilotinib with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nilotinib with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nilotinib with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nilotinib in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nilotinib in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nilotinib in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nilotinib in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Nilotinib in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Nilotinib in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nilotinib in the drug label.

Pharmacology

There is limited information regarding Nilotinib Pharmacology in the drug label.

Mechanism of Action

Structure

File:Nilotinib01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nilotinib in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Nilotinib in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nilotinib in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nilotinib in the drug label.

How Supplied

Storage

There is limited information regarding Nilotinib Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nilotinib in the drug label.

Precautions with Alcohol

• Alcohol-Nilotinib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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